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Designing effective theory-driven digital behaviour change interventions (DBCI) is a challenging task. To ease the design process, and assist with knowledge sharing and evaluation of the DBCI, we propose the SATO (IDEAS expAnded wiTh BCIO) design workflow based on the IDEAS (Integrate, Design, Assess, and Share) framework and aligned with the Behaviour Change Intervention Ontology (BCIO). BCIO is a structural representation of the knowledge in behaviour change domain supporting evaluation of behaviour change interventions (BCIs) but it is not straightforward to utilise it during DBCI design. IDEAS (Integrate, Design, Assess, and Share) framework guides multi-disciplinary teams through the mobile health (mHealth) application development life-cycle but it is not aligned with BCIO entities. SATO couples BCIO entities with workflow steps and extends IDEAS Integrate stage with consideration of customisation and personalisation. We provide a checklist of the activities that should be performed during intervention planning with concrete examples and a tutorial accompanied with case studies from the Cancer Better Life Experience (CAPABLE) European project. In the process of creating this workflow, we found the necessity to extend the BCIO to support the scenarios of multiple clinical goals in the same application. To ensure the SATO steps are easy to follow for the incomers to the field, we performed a preliminary evaluation of the workflow with two knowledge engineers, working on novel mHealth app design tasks.

Patients with chronic multimorbidity are becoming more common as life expectancy increases, making it necessary for physicians to develop complex management plans. We are looking at the patient management process as a goal-attainment problem. Hence, our aim is to develop a goal-oriented methodology for providing decision support for managing patients with multimorbidity continuously, as the patient's health state is progressing and new goals arise (e.g., treat ulcer, prevent osteoporosis). Our methodology allows us to detect and mitigate inconsistencies among guideline recommendations stemming from multiple clinical guidelines, while consulting medical ontologies and terminologies and relying on patient information standards. This methodology and its implementation as a decision-support system, called GoCom, starts with computer-interpretable clinical guidelines (CIGs) for single problems that are formalized using the PROforma CIG language. We previously published the architecture of the system as well as a CIG elicitation guide for enriching PROforma tasks with properties referring to vocabulary codes of goals and physiological effects of management plans. In this paper, we provide a formalization of the conceptual model of GoCom that generates, for each morbidity of the patient, a patient-specific goal tree that results from the PROforma engine's enactment of the CIG with the patient's data. We also present the "Controller" algorithm that drives the GoCom system. Given a new problem that a patient develops, the Controller detects inconsistencies among goals pertaining to different comorbid problems and consults the CIGs to generate alternative non-conflicted and goal-oriented management plans that address the multiple goals simultaneously. In this stage of our research, the inconsistencies that can be detected are of two types - starting vs. stopping medications that belong to the same medication class hierarchy, and detecting opposing physiological effect goals that are specified in concurrent CIGs (e.g., decreased blood pressure vs. increased blood pressure). However, the design of GoCom is modular and generic and allows the future introduction of additional interaction detection and mitigation strategies. Moreover, GoCom generates explanations of the alternative non-conflicted management plans, based on recommendations stemming from the clinical guidelines and reasoning patterns. GoCom's functionality was evaluated using three cases of multimorbidity interactions that were checked by our three clinicians. Usefulness was evaluated with two studies. The first evaluation was a pilot study with ten 6th year medical students and the second evaluation was done with 27 6th medical students and interns. The participants solved complex realistic cases of multimorbidity patients: with and without decision-support, two cases in the first evaluation and 6 cases in the second evaluation. Use of GoCom increased completeness of the patient management plans produced by the medical students from 0.44 to 0.71 (P-value of 0.0005) in the first evaluation, and from 0.31 to 0.78 (P-value < 0.0001) in the second evaluation. Correctness in the first evaluation was very high with (0.98) or without the system (0.91), with non-significant difference (P-value ≥ 0.17). In the second evaluation, use of GoCom increased correctness from 0.68 to 0.83 (P-value of 0.001). In addition, GoCom's explanation and visualization were perceived as useful by the vast majority of participants. While GoCom's detection of goal interactions is currently limited to detection of starting vs. stopping the same medication or medication subclasses and detecting conflicting physiological effects of concurrent medications, the evaluation demonstrated potential of the system for improving clinical decision-making for multimorbidity patients.

Display Omitted Method for predicting disease genes based on a processes affected in comorbidities.The approach uses a stochastic Petri Net model and is applied to ASD and IBD.Two genes are predicted for ASD and one gene is predicted for IBD. We propose a model-driven methodology aimed to shed light on complex disorders. Our approach enables exploring shared etiologies of comorbid diseases at the molecular pathway level. The method, Comparative Comorbidities Simulation (CCS), uses stochastic Petri net simulation for examining the phenotypic effects of perturbation of a network known to be involved in comorbidities to predict new roles for mutations in comorbid conditions. To demonstrate the utility of our novel methodology, we investigated the molecular convergence of autism spectrum disorder (ASD) and inflammatory bowel disease (IBD) on the autophagy pathway. In addition to validation by domain experts, we used formal analyses to demonstrate the models self-consistency. We then used CCS to compare the effects of loss of function (LoF) mutations previously implicated in either ASD or IBD on the autophagy pathway. CCS identified similar dynamic consequences of these mutations in the autophagy pathway. Our method suggests that two LoF mutations previously implicated in IBD may contribute to ASD, and one ASD-implicated LoF mutation may play a role in IBD. Future targeted genomic or functional studies could be designed to directly test these predictions.

A study's lifecycle is design, execution, reporting, interpretation, application.The Ontology of Clinical Research (OCRe) models the study design of human studies.OCRe is a generic model applicable to multiple applications and clinical domains.ERGO Annotation represents the essential meaning of eligibility criteria.OCRe supports the entire study lifecycle and the science of clinical research. To date, the scientific process for generating, interpreting, and applying knowledge has received less informatics attention than operational processes for conducting clinical studies. The activities of these scientific processes - the science of clinical research - are centered on the study protocol, which is the abstract representation of the scientific design of a clinical study. The Ontology of Clinical Research (OCRe) is an OWL 2 model of the entities and relationships of study design protocols for the purpose of computationally supporting the design and analysis of human studies. OCRe's modeling is independent of any specific study design or clinical domain. It includes a study design typology and a specialized module called ERGO Annotation for capturing the meaning of eligibility criteria. In this paper, we describe the key informatics use cases of each phase of a study's scientific lifecycle, present OCRe and the principles behind its modeling, and describe applications of OCRe and associated technologies to a range of clinical research use cases. OCRe captures the central semantics that underlies the scientific processes of clinical research and can serve as an informatics foundation for supporting the entire range of knowledge activities that constitute the science of clinical research.

Formalizing eligibility criteria in a computer-interpretable language would facilitate eligibility determination for study subjects and the identification of studies on similar patient populations. Because such formalization is extremely labor intensive, we transform the problem from one of fully capturing the semantics of criteria directly in a formal expression language to one of annotating free-text criteria in a format called ERGO annotation. The annotation can be done manually, or it can be partially automated using natural-language processing techniques. We evaluated our approach in three ways. First, we assessed the extent to which ERGO annotations capture the semantics of 1000 eligibility criteria randomly drawn from ClinicalTrials.gov. Second, we demonstrated the practicality of the annotation process in a feasibility study. Finally, we demonstrate the computability of ERGO annotation by using it to (1) structure a library of eligibility criteria, (2) search for studies enrolling specified study populations, and (3) screen patients for potential eligibility for a study. We therefore demonstrate a new and practical method for incrementally capturing the semantics of free-text eligibility criteria into computable form.

Main Clinical Manifestation (MCM)-oriented diagnosis starts with a chief problem and reasons about possible diagnoses that can be manifested in that way. The reasoning process often starts by considering abstract diagnosis groups (e.g., infectious vs. non-infectious diarrhea) and refines them. Most existing diagnostic decision-support systems (DSSs) are not specially tailored toward assisting non-expert physicians in the proper and efficient investigation workup of MCM-oriented diagnosis. We developed a prototype diagnostic decision-support model called TiMeDDx that is MCM-oriented and follows the hypothetico-deductive clinical reasoning process of differential diagnosis. The model guides users in a phase-by-phase manner regarding abstract diagnosis groups and diagnoses that should be considered and appropriate data that should be collected during the clinical investigation process. TiMeDDx’s knowledge base contains, when possible, knowledge derived from MCM-oriented evidence-based sources. We explain the knowledge model and diagnostic algorithms (Bayesian and heuristic) of TiMeDDx, using the clinical problem of diarrhea as a case study, and contrast TiMeDDx with models of existing diagnostic DSSs.

Decision-support systems, and specifically rule-based clinical reminders, are becoming common in medical practice. Despite their potential to improve clinical outcomes, physicians do not always use information from these systems. Concepts from the cognitive engineering literature on users’ responses to warning systems may help to define physicians’ responses to reminders. Based on this literature, we suggest an exhaustive set of possible responses to clinical reminders, consisting of four responses named “Compliance”, “Reliance”, “Spillover” and “Reactance”. We suggest statistical measures to estimate these responses and empirically demonstrate them on data from a large-scale clinical reminder system for secondary prevention of cardiovascular diseases. There was evidence for Compliance, probably since the physicians found the reminders informative, but not for Reliance, in line with the notion that Compliance and Reliance are two distinct types of trust in information from decision-support systems. Our research supports the notion that CDSS can promote closing the treatment gap and improve physicians’ adherence to guidelines.

Children with developmental disorders usually exhibit multiple developmental problems (comorbidities). Hence, such diagnosis needs to revolve on developmental disorder groups. Our objective is to systematically identify developmental disorder groups and represent them in an ontology. We developed a methodology that combines two methods (1) a literature-based ontology that we created, which represents developmental disorders and potential developmental disorder groups, and (2) clustering for detecting comorbid developmental disorders in patient data. The ontology is used to interpret and improve clustering results and the clustering results are used to validate the ontology and suggest directions for its development. We evaluated our methodology by applying it to data of 1175 patients from a child development clinic. We demonstrated that the ontology improves clustering results, bringing them closer to an expert generated gold-standard. We have shown that our methodology successfully combines an ontology with a clustering method to support systematic identification and representation of developmental disorder groups.

Access control is a central problem in privacy management. A common practice in controlling access to sensitive data, such as electronic health records (EHRs), is Role-Based Access Control (RBAC). RBAC is limited as it does not account for the circumstances under which access to sensitive data is requested. Following a qualitative study that elicited access scenarios, we used Object-Process Methodology to structure the scenarios and conceive a Situation-Based Access Control (SitBAC) model. SitBAC is a conceptual model, which defines scenarios where patient’s data access is permitted or denied. The main concept underlying this model is the Situation Schema, which is a pattern consisting of the entities Data-Requestor, Patient, EHR, Access Task, Legal-Authorization, and Response, along with their properties and relations. The various data access scenarios are expressed via Situation Instances. While we focus on the medical domain, the model is generic and can be adapted to other domains.

Clinical guidelines recommend quality standards for patient care. Encoding guidelines in a computer-interpretable format and integrating them with an Electronic Medical Record (EMR) can enable delivery of patient-specific recommendations when and where needed. GLIF3 is a language for representing computer-interpretable guidelines (CIGs) and sharing them among healthcare institutions. Sharing a CIG necessitates mapping its data items to the institutional EMRs. We developed a framework called Knowledge-Data Ontological Mapper (KDOM) that enables bridging the gap from abstractions used in CIGs to specific EMRs. Briding the gap involves: (1) using an ontology of mappings, and an optional reference information model, to map an abstraction gradually into EMR codes, and (2) automatically creating SQL queries to retrieve the EMR data. We evaluated the KDOM framework by mapping a GLIF3-encoded guideline into two different EMR schemas and by using the mapping ontology to define mappings from 15 GLIF3 CIGs and one SAGE CIG into our reference information model.

We have developed the GLIF3 Guideline Execution Engine (GLEE) as a tool for executing guidelines encoded in the GLIF3 format. In addition to serving as an interface to the GLIF3 guideline representation model to support the specified functions, GLEE provides defined interfaces to electronic medical records (EMRs) and other clinical applications to facilitate its integration with the clinical information system at a local institution. The execution model of GLEE takes the “system suggests, user controls” approach. A tracing system is used to record an individual patient's state when a guideline is applied to that patient. GLEE can also support an event-driven execution model once it is linked to the clinical event monitor in a local environment. Evaluation has shown that GLEE can be used effectively for proper execution of guidelines encoded in the GLIF3 format. When using it to execute each guideline in the evaluation, GLEE's performance duplicated that of the reference systems implementing the same guideline but taking different approaches. The execution flexibility and generality provided by GLEE, and its integration with a local environment, need to be further evaluated in clinical settings. Integration of GLEE with a specific event-monitoring and order-entry environment is the next step of our work to demonstrate its use for clinical decision support. Potential uses of GLEE also include quality assurance, guideline development, and medical education.

Clinical guidelines are being developed for the purpose of reducing medical errors and unjustified variations in medical practice, and for basing medical practice on evidence. Encoding guidelines in a computer-interpretable format and integrating them with the electronic medical record can enable delivery of patient-specific recommendations when and where needed. Since great effort must be expended in developing high-quality guidelines, and in making them computer-interpretable, it is highly desirable to be able to share computer-interpretable guidelines (CIGs) among institutions. Adoption of a common format for representing CIGs is one approach to sharing. Factors that need to be considered in creating a format for sharable CIGs include (i) the scope of guidelines and their intended applications, (ii) the method of delivery of the recommendations, and (iii) the environment, consisting of the practice setting and the information system in which the guidelines will be applied. Several investigators have proposed solutions that improve the sharability of CIGs and, more generally, of medical knowledge. These approaches can be useful in the development of a format for sharable CIGs. Challenges in sharing CIGs also include the need to extend the traditional framework for disseminating guidelines to enable them to be integrated into practice. These extensions include processes for (i) local adaptation of recommendations encoded in shared generic guidelines and (ii) integration of guidelines into the institutional information systems.

Exceptions in safety–critical systems must be addressed during conceptual design and risk analysis. We developed a conceptual model of exceptions, a methodology for eliciting and modeling exceptions, and templates for modeling them in an extension of the Object-Process Methodology (OPM)—a system analysis and design methodology and language that uses a single graphical model for describing systems, including their timing exceptions, which has been shown to be an effective modeling methodology. Using an antibiotics treatment guideline as a case study, we demonstrate the value of our approach in eliciting and modeling exceptions that occur in clinical care systems.

Errors in clinical practice guidelines may translate into errors in real-world clinical practice. The best way to eliminate these errors is to understand how they are generated, thus enabling the future development of methods to catch errors made in creating the guideline before publication. We examined the process by which a medical expert from the American College of Physicians (ACP) created clinical algorithms from narrative guidelines, as a case study. We studied this process by looking at intermediate versions produced during the algorithm creation. We identified and analyzed errors that were generated at each stage, categorized them using Knuth’s classification scheme, and studied patterns of errors that were made over the set of algorithm versions that were created. We then assessed possible explanations for the sources of these errors and provided recommendations for reducing the number of errors, based on cognitive theory and on experience drawn from software engineering methodologies.