PillHarmonics: An Orchestrated Pharmacogenetics Medication Clinical Decision Support Service.

OBJECTIVES: Pharmacogenetics (PGx) is increasingly important in individualizing therapeutic management plans, but is often implemented apart from other types of medication clinical decision support (CDS). The lack of integration of PGx into existing CDS may result in incomplete interaction information, which may pose patient safety concerns. We sought to develop a cloud-based orchestrated medication CDS service that integrates PGx with a broad set of drug screening alerts and evaluate it through a clinician utility study. METHODS: We developed the PillHarmonics service for implementation per the CDS Hooks protocol, algorithmically integrating a wide range of drug interaction knowledge using cloud-based screening services from First Databank (drug-drug/allergy/condition), PharmGKB (drug-gene), and locally curated content (drug-renal/hepatic/race). We performed a user study, presenting 13 clinicians and pharmacists with a prototype of the system's usage in synthetic patient scenarios. We collected feedback via a standard questionnaire and structured interview. RESULTS: Clinician assessment of PillHarmonics via the Technology Acceptance Model questionnaire shows significant evidence of perceived utility. Thematic analysis of structured interviews revealed that aggregated knowledge, concise actionable summaries, and information accessibility were highly valued, and that clinicians would use the service in their practice. CONCLUSION: Medication safety and optimizing efficacy of therapy regimens remain significant issues. A comprehensive medication CDS system that leverages patient clinical and genomic data to perform a wide range of interaction checking and presents a concise and holistic view of medication knowledge back to the clinician is feasible and perceived as highly valuable for more informed decision-making. Such a system can potentially address many of the challenges identified with current medication-related CDS.

Introducing HL7 FHIR Genomics Operations: a developer-friendly approach to genomics-EHR integration.

OBJECTIVE: Enabling clinicians to formulate individualized clinical management strategies from the sea of molecular data remains a fundamentally important but daunting task. Here, we describe efforts towards a new paradigm in genomics-electronic health record (HER) integration, using a standardized suite of FHIR Genomics Operations that encapsulates the complexity of molecular data so that precision medicine solution developers can focus on building applications. MATERIALS AND METHODS: FHIR Genomics Operations essentially "wrap" a genomics data repository, presenting a uniform interface to applications. More importantly, operations encapsulate the complexity of data within a repository and normalize redundant data representations-particularly relevant in genomics, where a tremendous amount of raw data exists in often-complex non-FHIR formats. RESULTS: Fifteen FHIR Genomics Operations have been developed, designed to support a wide range of clinical scenarios, such as variant discovery; clinical trial matching; hereditary condition and pharmacogenomic screening; and variant reanalysis. Operations are being matured through the HL7 balloting process, connectathons, pilots, and the HL7 FHIR Accelerator program. DISCUSSION: Next-generation sequencing can identify thousands to millions of variants, whose clinical significance can change over time as our knowledge evolves. To manage such a large volume of dynamic and complex data, new models of genomics-EHR integration are needed. Qualitative observations to date suggest that freeing application developers from the need to understand the nuances of genomic data, and instead base applications on standardized APIs can not only accelerate integration but also dramatically expand the applications of Omic data in driving precision care at scale for all.

Structured representation for core elements of common clinical decision support interventions to facilitate knowledge sharing.

At present, there are no widely accepted, standard approaches for representing computer-based clinical decision support (CDS) intervention types and their structural components. This study aimed to identify key requirements for the representation of five widely utilized CDS intervention types: alerts and reminders, order sets, infobuttons, documentation templates/forms, and relevant data presentation. An XML schema was proposed for representing these interventions and their core structural elements (e.g., general metadata, applicable clinical scenarios, CDS inputs, CDS outputs, and CDS logic) in a shareable manner. The schema was validated by building CDS artifacts for 22 different interventions, targeted toward guidelines and clinical conditions called for in the 2011 Meaningful Use criteria. Custom style sheets were developed to render the XML files in human-readable form. The CDS knowledge artifacts were shared via a public web portal. Our experience also identifies gaps in existing standards and informs future development of standards for CDS knowledge representation and sharing.

A continuum of sociotechnical requirements for patient-centered problem lists.

Specific requirements for patient-centered health information technology remain ill-defined. To create operational definitions of patient-centered problem lists, we propose a continuum of sociotechnical requirements with five stages: 1) Intradisciplinary Care Planning: Viewing and searching for problems by discipline; 2) Multi-disciplinary Care Planning: Categorizing problem states to meet discipline-specific needs; 3) Interdisciplinary Care Planning: Sharing and linking problems between disciplines; 4) Integrated and Coordinated Care Planning: Associating problems with assessments, tasks, interventions and outcomes across disciplines for coordination, knowledge development, and reporting; and 5) Patient-Centered Care Planning: Engaging patients in identification of problems and maintenance of their problem list.

A pilot study of distributed knowledge management and clinical decision support in the cloud.

OBJECTIVE: Implement and perform pilot testing of web-based clinical decision support services using a novel framework for creating and managing clinical knowledge in a distributed fashion using the cloud. The pilot sought to (1) develop and test connectivity to an external clinical decision support (CDS) service, (2) assess the exchange of data to and knowledge from the external CDS service, and (3) capture lessons to guide expansion to more practice sites and users. MATERIALS AND METHODS: The Clinical Decision Support Consortium created a repository of shared CDS knowledge for managing hypertension, diabetes, and coronary artery disease in a community cloud hosted by Partners HealthCare. A limited data set for primary care patients at a separate health system was securely transmitted to a CDS rules engine hosted in the cloud. Preventive care reminders triggered by the limited data set were returned for display to clinician end users for review and display. During a pilot study, we (1) monitored connectivity and system performance, (2) studied the exchange of data and decision support reminders between the two health systems, and (3) captured lessons. RESULTS: During the six month pilot study, there were 1339 patient encounters in which information was successfully exchanged. Preventive care reminders were displayed during 57% of patient visits, most often reminding physicians to monitor blood pressure for hypertensive patients (29%) and order eye exams for patients with diabetes (28%). Lessons learned were grouped into five themes: performance, governance, semantic interoperability, ongoing adjustments, and usability. DISCUSSION: Remote, asynchronous cloud-based decision support performed reasonably well, although issues concerning governance, semantic interoperability, and usability remain key challenges for successful adoption and use of cloud-based CDS that will require collaboration between biomedical informatics and computer science disciplines. CONCLUSION: Decision support in the cloud is feasible and may be a reasonable path toward achieving better support of clinical decision-making across the widest range of health care providers.

Key principles for a national clinical decision support knowledge sharing framework: synthesis of insights from leading subject matter experts.

OBJECTIVE: To identify key principles for establishing a national clinical decision support (CDS) knowledge sharing framework. MATERIALS AND METHODS: As part of an initiative by the US Office of the National Coordinator for Health IT (ONC) to establish a framework for national CDS knowledge sharing, key stakeholders were identified. Stakeholders' viewpoints were obtained through surveys and in-depth interviews, and findings and relevant insights were summarized. Based on these insights, key principles were formulated for establishing a national CDS knowledge sharing framework. RESULTS: Nineteen key stakeholders were recruited, including six executives from electronic health record system vendors, seven executives from knowledge content producers, three executives from healthcare provider organizations, and three additional experts in clinical informatics. Based on these stakeholders' insights, five key principles were identified for effectively sharing CDS knowledge nationally. These principles are (1) prioritize and support the creation and maintenance of a national CDS knowledge sharing framework; (2) facilitate the development of high-value content and tooling, preferably in an open-source manner; (3) accelerate the development or licensing of required, pragmatic standards; (4) acknowledge and address medicolegal liability concerns; and (5) establish a self-sustaining business model. DISCUSSION: Based on the principles identified, a roadmap for national CDS knowledge sharing was developed through the ONC's Advancing CDS initiative. CONCLUSION: The study findings may serve as a useful guide for ongoing activities by the ONC and others to establish a national framework for sharing CDS knowledge and improving clinical care.

A study of diverse clinical decision support rule authoring environments and requirements for integration.

BACKGROUND: Efficient rule authoring tools are critical to allow clinical Knowledge Engineers (KEs), Software Engineers (SEs), and Subject Matter Experts (SMEs) to convert medical knowledge into machine executable clinical decision support rules. The goal of this analysis was to identify the critical success factors and challenges of a fully functioning Rule Authoring Environment (RAE) in order to define requirements for a scalable, comprehensive tool to manage enterprise level rules. METHODS: The authors evaluated RAEs in active use across Partners Healthcare, including enterprise wide, ambulatory only, and system specific tools, with a focus on rule editors for reminder and medication rules. We conducted meetings with users of these RAEs to discuss their general experience and perceived advantages and limitations of these tools. RESULTS: While the overall rule authoring process is similar across the 10 separate RAEs, the system capabilities and architecture vary widely. Most current RAEs limit the ability of the clinical decision support (CDS) interventions to be standardized, sharable, interoperable, and extensible. No existing system meets all requirements defined by knowledge management users. CONCLUSIONS: A successful, scalable, integrated rule authoring environment will need to support a number of key requirements and functions in the areas of knowledge representation, metadata, terminology, authoring collaboration, user interface, integration with electronic health record (EHR) systems, testing, and reporting.

A Prototype Knowledge-Sharing Service for Clinical Decision Support Artifacts.

This article, by researchers from Partners HealthCare and the RAND Corporation, primarily describes the work associated with Task 4.8 of the Advancing Clinical Decision Support (ACDS) effort, a project intended to accelerate the effective use of computer-based clinical decision support (CDS) interventions to facilitate evidence-based clinical practice and the meaningful use of health information technology. The key objectives of Task 4.8 were to develop CDS artifacts for at least 20 interventions of different types, targeted toward guidelines and clinical conditions called for in the 2011 meaningful use criteria, and to disseminate the tools, content, and materials through a knowledge-sharing service (KSS) that could potentially be deployed on a national scale. The ACDS interventions or artifacts were built utilizing the extensible markup language (XML) schema developed by the Clinical Decision Support Consortium (CDSC) project and were published on the CDSC portal (http://cdsportal.partners.org/), which functions as the ACDS KSS. While the original CDSC Level 3 XML schema adequately supported the development of the ACDS artifacts, the authors worked with the CDSC team to expand the schema to support additional intervention types (order sets, documentation templates, infobuttons, relevant data display, and value sets). Twenty-two CDS artifacts and 16 value sets were developed that cover the five CDS intervention types. Three custom style sheets were developed to render the XML files in human-readable form. The authors recommend investment in the foundational building blocks for shareable CDS, such as dictionaries and value sets, as these will be essential. The CDS content on the portal will need to be expanded and maintained in order for it to remain a viable resource for CDS implementers.

A legal framework to enable sharing of Clinical Decision Support knowledge and services across institutional boundaries.

The goal of the CDS Consortium (CDSC) is to assess, define, demonstrate, and evaluate best practices for knowledge management and clinical decision support in healthcare information technology at scale - across multiple ambulatory care settings and Electronic Health Record technology platforms. In the course of the CDSC research effort, it became evident that a sound legal foundation was required for knowledge sharing and clinical decision support services in order to address data sharing, intellectual property, accountability, and liability concerns. This paper outlines the framework utilized for developing agreements in support of sharing, accessing, and publishing content via the CDSC Knowledge Management Portal as well as an agreement in support of deployment and consumption of CDSC developed web services in the context of a research project under IRB oversight.

The morningside initiative: collaborative development of a knowledge repository to accelerate adoption of clinical decision support.

The Morningside Initiative is a public-private activity that has evolved from an August, 2007, meeting at the Morningside Inn, in Frederick, MD, sponsored by the Telemedicine and Advanced Technology Research Center (TATRC) of the US Army Medical Research Materiel Command. Participants were subject matter experts in clinical decision support (CDS) and included representatives from the Department of Defense, Veterans Health Administration, Kaiser Permanente, Partners Healthcare System, Henry Ford Health System, Arizona State University, and the American Medical Informatics Association (AMIA). The Morningside Initiative was convened in response to the AMIA Roadmap for National Action on Clinical Decision Support and on the basis of other considerations and experiences of the participants. Its formation was the unanimous recommendation of participants at the 2007 meeting which called for creating a shared repository of executable knowledge for diverse health care organizations and practices, as well as health care system vendors. The rationale is based on the recognition that sharing of clinical knowledge needed for CDS across organizations is currently virtually non-existent, and that, given the considerable investment needed for creating, maintaining and updating authoritative knowledge, which only larger organizations have been able to undertake, this is an impediment to widespread adoption and use of CDS. The Morningside Initiative intends to develop and refine (1) an organizational framework, (2) a technical approach, and (3) CDS content acquisition and management processes for sharing CDS knowledge content, tools, and experience that will scale with growing numbers of participants and can be expanded in scope of content and capabilities. Intermountain Healthcare joined the initial set of participants shortly after its formation. The efforts of the Morningside Initiative are intended to serve as the basis for a series of next steps in a national agenda for CDS. It is based on the belief that sharing of knowledge can be highly effective as is the case in other competitive domains such as genomics. Participants in the Morningside Initiative believe that a coordinated effort between the private and public sectors is needed to accomplish this goal and that a small number of highly visible and respected health care organizations in the public and private sector can lead by example. Ultimately, a future collaborative knowledge sharing organization must have a sustainable long-term business model for financial support.

Creating shareable decision support services: an interdisciplinary challenge.

Creating shareable decision support services is a complex task requiring effort from multiple interdisciplinary role players with a wide variety of experience and expertise. The CDS Consortium research project has developed such a service, defining a multi-layer representation of knowledge and building upon an architectural service design created at Partners Health Care, and is demonstrating its use in both a local and an external institutional setting. The process was iterative, and we encountered unexpected requirements based on decisions made at various points. We report in this paper on challenges we faced while pursuing this research: knowledge representation and modeling, data interchange and standards adoption, the process of getting agreement on content, logistics of integrating into a system that already has multiple CDS interventions, legal issues around privacy and access, inter-team communication and organization.

Creating and sharing clinical decision support content with Web 2.0: Issues and examples.

Clinical decision support is a powerful tool for improving healthcare quality and patient safety. However, developing a comprehensive package of decision support interventions is costly and difficult. If used well, Web 2.0 methods may make it easier and less costly to develop decision support. Web 2.0 is characterized by online communities, open sharing, interactivity and collaboration. Although most previous attempts at sharing clinical decision support content have worked outside of the Web 2.0 framework, several initiatives are beginning to use Web 2.0 to share and collaborate on decision support content. We present case studies of three efforts: the Clinfowiki, a world-accessible wiki for developing decision support content; Partners Healthcare eRooms, web-based tools for developing decision support within a single organization; and Epic Systems Corporation's Community Library, a repository for sharing decision support content for customers of a single clinical system vendor. We evaluate the potential of Web 2.0 technologies to enable collaborative development and sharing of clinical decision support systems through the lens of three case studies; analyzing technical, legal and organizational issues for developers, consumers and organizers of clinical decision support content in Web 2.0. We believe the case for Web 2.0 as a tool for collaborating on clinical decision support content appears strong, particularly for collaborative content development within an organization.

A study on design and development of enterprise-wide concepts for clinical documentation templates.

Structured clinical documents are associated with many potential benefits. Underlying terminologies and structure of information are keys to their successful implementation and use. This paper presents a methodology for design and development of enterprise-wide concepts for clinical documentation templates for an ambulatory Electronic Medical Record (EMR) system.

Knowledge management and content integration: a collaborative approach.

Knowledge Management (KM) is the development and maintenance of decision support knowledge within clinical healthcare systems. At Partners Healthcare System (PHS), Knowledge Management is facilitated by a dedicated team consisting of Subject Matter Experts (SME), Knowledge Engineers (KE), and software developers. This group relies upon sound knowledge management principles to support the knowledge lifecycle.

Advancing translational research with the Semantic Web.

BACKGROUND: A fundamental goal of the U.S. National Institute of Health (NIH) "Roadmap" is to strengthen Translational Research, defined as the movement of discoveries in basic research to application at the clinical level. A significant barrier to translational research is the lack of uniformly structured data across related biomedical domains. The Semantic Web is an extension of the current Web that enables navigation and meaningful use of digital resources by automatic processes. It is based on common formats that support aggregation and integration of data drawn from diverse sources. A variety of technologies have been built on this foundation that, together, support identifying, representing, and reasoning across a wide range of biomedical data. The Semantic Web Health Care and Life Sciences Interest Group (HCLSIG), set up within the framework of the World Wide Web Consortium, was launched to explore the application of these technologies in a variety of areas. Subgroups focus on making biomedical data available in RDF, working with biomedical ontologies, prototyping clinical decision support systems, working on drug safety and efficacy communication, and supporting disease researchers navigating and annotating the large amount of potentially relevant literature. RESULTS: We present a scenario that shows the value of the information environment the Semantic Web can support for aiding neuroscience researchers. We then report on several projects by members of the HCLSIG, in the process illustrating the range of Semantic Web technologies that have applications in areas of biomedicine. CONCLUSION: Semantic Web technologies present both promise and challenges. Current tools and standards are already adequate to implement components of the bench-to-bedside vision. On the other hand, these technologies are young. Gaps in standards and implementations still exist and adoption is limited by typical problems with early technology, such as the need for a critical mass of practitioners and installed base, and growing pains as the technology is scaled up. Still, the potential of interoperable knowledge sources for biomedicine, at the scale of the World Wide Web, merits continued work.

A description and functional taxonomy of rule-based decision support content at a large integrated delivery network.

OBJECTIVE: This study sought to develop a functional taxonomy of rule-based clinical decision support. DESIGN: The rule-based clinical decision support content of a large integrated delivery network with a long history of computer-based point-of-care decision support was reviewed and analyzed along four functional dimensions: trigger, input data elements, interventions, and offered choices. RESULTS: A total of 181 rule types were reviewed, comprising 7,120 different instances of rule usage. A total of 42 taxa were identified across the four categories. Many rules fell into multiple taxa in a given category. Entered order and stored laboratory result were the most common triggers; laboratory result, drug list, and hospital unit were the most frequent data elements used. Notify and log were the most common interventions, and write order, defer warning, and override rule were the most common offered choices. CONCLUSION: A relatively small number of taxa successfully described a large body of clinical knowledge. These taxa can be directly mapped to functions of clinical systems and decision support systems, providing feature guidance for developers, implementers, and certifiers of clinical information systems.

Design and implementation of a clinical rule editor for chronic disease reminders in an electronic medical record.

Clinical reminders have well-documented benefits in improving quality of care. Once clinicians approve evidence-based rules, they should be quickly implemented. However, most of the reminders in our home-grown EMR historically were hard-coded, making it difficult to maintain old rules and implement new ones. We designed a web-based editor to make rule logic readable and editable by non-programmers. We hope to decrease the turnaround time of reminder authoring and maintenance, thereby improving quality of care.

Creation of structured documentation templates using Natural Language Processing techniques.

Structured Clinical Documentation is a fundamental component of the healthcare enterprise, linking both clinical (e.g., electronic health record, clinical decision support) and administrative functions (e.g., evaluation and management coding, billing). One of the challenges in creating good quality documentation templates has been the inability to address specialized clinical disciplines and adapt to local clinical practices. A one-size-fits-all approach leads to poor adoption and inefficiencies in the documentation process. On the other hand, the cost associated with manual generation of documentation templates is significant. Consequently there is a need for at least partial automation of the template generation process. We propose an approach and methodology for the creation of structured documentation templates for diabetes using Natural Language Processing (NLP).

On implementing clinical decision support: achieving scalability and maintainability by combining business rules and ontologies.

We present an approach and architecture for implementing scalable and maintainable clinical decision support at the Partners HealthCare System. The architecture integrates a business rules engine that executes declarative if-then rules stored in a rule-base referencing objects and methods in a business object model. The rules engine executes object methods by invoking services implemented on the clinical data repository. Specialized inferences that support classification of data and instances into classes are identified and an approach to implement these inferences using an OWL based ontology engine is presented. Alternative representations of these specialized inferences as if-then rules or OWL axioms are explored and their impact on the scalability and maintenance of the system is presented. Architectural alternatives for integration of clinical decision support functionality with the invoking application and the underlying clinical data repository; and their associated trade-offs are discussed and presented.