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1.  A Graphical Framework for Specification of Clinical Guidelines at Multiple Representation Levels 
Formalization of a clinical guideline for purposes of automated application and quality assessment mainly involves conversion of its free-text representation into a machine comprehensible representation, i.e., a formal language, thus enabling automated support. The main issues involved in this process are related to the collaboration between the expert physician and the knowledge engineer. We introduce GESHER - a graphical framework for specification of clinical guidelines at multiple representation levels. The GESHER architecture facilitates incremental specification through a set of views adapted to each representation level, enabling this process to proceed smoothly and in a transparent fashion, fostering extensive collaboration among the various types of users. The GESHER framework supports specification of guidelines at multiple representation levels, in more than one specification language, and uses the DeGeL digital guideline library architecture as its knowledge base. The GESHER architecture also uses a temporal abstraction knowledge base to store its declarative knowledge, and a standard medical-vocabularies server for generic specification of key terms, thus enabling reuse of the specification at multiple sites.
PMCID: PMC1560835  PMID: 16779126
2.  Applying Hybrid-Asbru Clinical Guidelines Using the Spock System 
Clinical Guidelines are a major tool for improving the quality of medical care. Currently, a major research direction is automating the application of guidelines at the point of care. To support that automation, several requirements must be fulfilled, such as specification in a machine-interpretable format, and connection to an electronic patent record. We propose an innovative approach to guideline application, which capitalizes on our Digital electronic Guidelines Library (DeGeL). The DeGeL framework includes a new hybrid model for incremental specification of free-text guidelines, using several intermediate representations. The new approach was implemented, in the case of the Asbru guideline ontology, as the Spock system. Spock’s hybrid application engine supports application of guideline represented at an intermediate format. Spock was evaluated in a preliminary fashion by applying several guidelines to sample patient data.
PMCID: PMC1560650  PMID: 16779161
3.  A Distributed, Collaborative, Structuring Model for a Clinical-Guideline Digital-Library 
The Digital Electronic Guideline Library (DeGeL) is a Web-based framework and a set of distributed tools that facilitate gradual conversion of clinical guidelines from free text, through semi-structured text, to a fully structured, executable representation. Thus, guidelines exist in a hybrid, multiple-format representation The three formats support increasingly sophisticated computational tasks. The tools perform semantic markup, classification, search, and browsing, and support computational modules that we are developing, for run-time application and retrospective quality assessment. We describe the DeGeL architecture and its collaborative-authoring authorization model, which is based on (1) multiple medical-specialty authoring groups, each including a group manager who controls group authorizations, and (2) a hierarchical authorization model based on the different functions involved in the hybrid guideline-specification process. We have implemented the core modules of the DeGeL architecture and demonstrated distributed markup and retrieval using the knowledge roles of two guidelines ontologies (Asbru and GEM). We are currently evaluating several of the DeGeL tools.
PMCID: PMC1480281  PMID: 14728241
4.  Versioning computer-interpretable guidelines: Semi-automatic modeling of ‘Living Guidelines’ using an information extraction method☆ 
Clinical practice guidelines (CPGs) are means to provide evidence-based medical knowledge. In order to make up-to-date “best” scientific evidence available these documents need to be updated on an ongoing basis. An effective method to accomplish this aim is offered by the so-called “living guidelines”: Living guidelines are documents presenting up-to-date and state-of-the-art knowledge to practitioners. To have guidelines implemented by computer-support they have to be formalized in a computer-interpretable form in a first step. Due to the complexity of such formats the formalization process is burdensome and time-consuming. Automating parts of the modeling process and, consequently, modeling updates of these guideline documents are demanded.
Methods and material
The LASSIE methodology supports this task by formalizing guidelines in several steps from the textual form to the guideline representation language Asbru using a document-centric approach. LASSIE uses information extraction techniques to semi-automatically accomplish these steps. We apply LASSIE to support the implementation of living guidelines.
Based on a living guideline published by the Scottish Intercollegiate Guidelines Network (SIGN) we show that adaptations of previously formalized guidelines can be accomplished easily and fast. Thereby, the different versions of guideline documents are compared and updates are identified. Due to the traceable formalization method of linking text parts and their corresponding formal models, we are able to inherit unchanged models from previously formalized versions. Thus, we only need to formalize updated text parts using the semi-automatic formalization method LASSIE.
We propose a simple, time-saving, but effective method called LASSIE to formalize new guideline versions of previously formalized CPGs. Furthermore, models that have been added or modified by knowledge engineers in previous versions can also be transferred easily. This will result in a faster implementation of new guideline versions also known as living guidelines to provide up-to-date knowledge necessary for accomplishing the daily work of health care professionals.
PMCID: PMC2859225  PMID: 18950994
Information extraction; Clinical practice guidelines; Living guidelines; Computer-interpretable guidelines; Guideline representation; Treatment processes; Asthma
5.  Inclusion of Ethical Issues in Dementia Guidelines: A Thematic Text Analysis 
PLoS Medicine  2013;10(8):e1001498.
Clinical practice guidelines (CPGs) aim to improve professionalism in health care. However, current CPG development manuals fail to address how to include ethical issues in a systematic and transparent manner. The objective of this study was to assess the representation of ethical issues in general CPGs on dementia care.
Methods and Findings
To identify national CPGs on dementia care, five databases of guidelines were searched and national psychiatric associations were contacted in August 2011 and in June 2013. A framework for the assessment of the identified CPGs' ethical content was developed on the basis of a prior systematic review of ethical issues in dementia care. Thematic text analysis and a 4-point rating score were employed to assess how ethical issues were addressed in the identified CPGs. Twelve national CPGs were included. Thirty-one ethical issues in dementia care were identified by the prior systematic review. The proportion of these 31 ethical issues that were explicitly addressed by each CPG ranged from 22% to 77%, with a median of 49.5%. National guidelines differed substantially with respect to (a) which ethical issues were represented, (b) whether ethical recommendations were included, (c) whether justifications or citations were provided to support recommendations, and (d) to what extent the ethical issues were explained.
Ethical issues were inconsistently addressed in national dementia guidelines, with some guidelines including most and some including few ethical issues. Guidelines should address ethical issues and how to deal with them to help the medical profession understand how to approach care of patients with dementia, and for patients, their relatives, and the general public, all of whom might seek information and advice in national guidelines. There is a need for further research to specify how detailed ethical issues and their respective recommendations can and should be addressed in dementia guidelines.
Please see later in the article for the Editors' Summary
Editors’ Summary
In the past, doctors tended to rely on their own experience to choose the best treatment for their patients. Faced with a patient with dementia (a brain disorder that affects short-term memory and the ability tocarry out normal daily activities), for example, a doctor would use his/her own experience to help decide whether the patient should remain at home or would be better cared for in a nursing home. Similarly, the doctor might have to decide whether antipsychotic drugs might be necessary to reduce behavioral or psychological symptoms such as restlessness or shouting. However, over the past two decades, numerous evidence-based clinical practice guidelines (CPGs) have been produced by governmental bodies and medical associations that aim to improve standards of clinical competence and professionalism in health care. During the development of each guideline, experts search the medical literature for the current evidence about the diagnosis and treatment of a disease, evaluate the quality of that evidence, and then make recommendations based on the best evidence available.
Why Was This Study Done?
Currently, CPG development manuals do not address how to include ethical issues in CPGs. A health-care professional is ethical if he/she behaves in accordance with the accepted principles of right and wrong that govern the medical profession. More specifically, medical professionalism is based on a set of binding ethical principles—respect for patient autonomy, beneficence, non-malfeasance (the “do no harm” principle), and justice. In particular, CPG development manuals do not address disease-specific ethical issues (DSEIs), clinical ethical situations that are relevant to the management of a specific disease. So, for example, a DSEI that arises in dementia care is the conflict between the ethical principles of non-malfeasance and patient autonomy (freedom-to-move-at-will). Thus, healthcare professionals may have to decide to physically restrain a patient with dementia to prevent the patient doing harm to him- or herself or to someone else. Given the lack of guidance on how to address ethical issues in CPG development manuals, in this thematic text analysis, the researchers assess the representation of ethical issues in CPGs on general dementia care. Thematic text analysis uses a framework for the assessment of qualitative data (information that is word-based rather than number-based) that involves pinpointing, examining, and recording patterns (themes) among the available data.
What Did the Researchers Do and Find?
The researchers identified 12 national CPGs on dementia care by searching guideline databases and by contacting national psychiatric associations. They developed a framework for the assessment of the ethical content in these CPGs based on a previous systematic review of ethical issues in dementia care. Of the 31 DSEIs included by the researchers in their analysis, the proportion that were explicitly addressed by each CPG ranged from 22% (Switzerland) to 77% (USA); on average the CPGs explicitly addressed half of the DSEIs. Four DSEIs—adequate consideration of advanced directives in decision making, usage of GPS and other monitoring techniques, covert medication, and dealing with suicidal thinking—were not addressed in at least 11 of the CPGs. The inclusion of recommendations on how to deal with DSEIs ranged from 10% of DSEIs covered in the Swiss CPG to 71% covered in the US CPG. Overall, national guidelines differed substantially with respect to which ethical issues were included, whether ethical recommendations were included, whether justifications or citations were provided to support recommendations, and to what extent the ethical issues were clearly explained.
What Do These Findings Mean?
These findings show that national CPGs on dementia care already address clinical ethical issues but that the extent to which the spectrum of DSEIs is considered varies widely within and between CPGs. They also indicate that recommendations on how to deal with DSEIs often lack the evidence that health-care professionals use to justify their clinical decisions. The researchers suggest that this situation can and should be improved, although more research is needed to determine how ethical issues and recommendations should be addressed in dementia guidelines. A more systematic and transparent inclusion of DSEIs in CPGs for dementia (and for other conditions) would further support the concept of medical professionalism as a core element of CPGs, note the researchers, but is also important for patients and their relatives who might turn to national CPGs for information and guidance at a stressful time of life.
Additional Information
Please access these Web sites via the online version of this summary at
Wikipedia contains a page on clinical practice guidelines (note: Wikipedia is a free online encyclopedia that anyone can edit; available in several languages)
The US National Guideline Clearinghouse provides information on national guidelines, including CPGs for dementia
The Guidelines International Network promotes the systematic development and application of clinical practice guidelines
The American Medical Association provides information about medical ethics; the British Medical Association provides information on all aspects of ethics and includes an essential tool kit that introduces common ethical problems and practical ways to deal with them
The UK National Health Service Choices website provides information about dementia, including a personal story about dealing with dementia
MedlinePlus provides links to additional resources about dementia and about Alzheimers disease, a specific type of dementia (in English and Spanish)
The UK Nuffield Council on Bioethics provides the report Dementia: ethical issues and additional information on the public consultation on ethical issues in dementia care
PMCID: PMC3742442  PMID: 23966839
6.  How can information extraction ease formalizing treatment processes in clinical practice guidelines? A method and its evaluation☆ 
Formalizing clinical practice guidelines (CPGs) for a subsequent computer-supported processing is a challenging, but burdensome and time-consuming task. Existing methods and tools to support this task demand detailed medical knowledge, knowledge about the formal representations, and a manual modeling. Furthermore, formalized guideline documents mostly fall far short in terms of readability and understandability for the human domain modeler.
Methods and material:
We propose a new multi-step approach using information extraction methods to support the human modeler by both automating parts of the modeling process and making the modeling process traceable and comprehensible. This paper addresses the first steps to obtain a representation containing processes which is independent of the final guideline representation language.
We have developed and evaluated several heuristics without the need to apply natural language understanding and implemented them in a framework to apply them to several guidelines from the medical subject of otolaryngology. Findings in the evaluation indicate that using semi-automatic, step-wise information extraction methods are a valuable instrument to formalize CPGs.
Our evaluation shows that a heuristic-based approach can achieve good results, especially for guidelines with a major portion of semi-structured text. It can be applied to guidelines irrespective to the final guideline representation format.
PMCID: PMC2858817  PMID: 16962747
Information extraction and integration; Clinical practice guidelines; Computer-interpretable guidelines; Guideline representation; Treatment processes; Time-oriented information; Otolaryngology
7.  Understanding the relationship between the perceived characteristics of clinical practice guidelines and their uptake: protocol for a realist review 
Clinical practice guidelines have the potential to facilitate the implementation of evidence into practice, support clinical decision making, specify beneficial therapeutic approaches, and influence public policy. However, these potential benefits have not been consistently achieved. The limited impact of guidelines can be attributed to organisational constraints, the complexity of the guidelines, and the lack of usability testing or end-user involvement in their development. Implementability has been referred to as the perceived characteristics of guidelines that predict the relative ease of their implementation at the clinical level, but this concept is as yet poorly defined. The objective of our study is to identify guideline attributes that affect uptake in practice by considering evidence from four disciplines (medicine, psychology, management, human factors engineering) to determine the relationship between the perceived characteristics of recommendations and their uptake and to develop a framework of implementability.
A realist-review approach to knowledge synthesis will be used to understand attributes of guidelines (e.g., its text and content) and how changing these elements might impact clinical practice and clinical decision making. It also allows for the exploration of 'what works for whom, in what circumstances, and in what respects'. The realist review will be structured according to Pawson's five practical steps in realist reviews: (1) clarifying the scope of the review, (2) determining the search strategy, (3) ensuring proper article selection and study quality assessment, (4) extracting and organising data, and (5) synthesising the evidence and drawing conclusions. Data will be synthesised according to a two-stage analysis: (1) we will extract and define all relevant guideline attributes from the different disciplines, then create a shortlist of unique attributes and investigate their relationships with uptake, and (2) we will compare and contrast the attributes and guideline uptake within each and between the four disciplines to create a robust framework of implementability.
Creating guidelines that are designed to maximise uptake may be a potentially effective and inexpensive way of increasing their impact. However, this is best achieved by a comprehensive framework to inform the design of guidelines drawing on a range of disciplines that study behaviour change. This study will use a customised realist-review approach to synthesising the literature to better understand and operationalise a complex and under-theorised concept.
PMCID: PMC3224565  PMID: 21733160
8.  The ALARM Monitor and the Bone-Marrow Transplant Therapy Advisor: A Demonstration of Two Probabilistic Expert Systems in KNET 
ALARM (A Logical Alarm Reduction Mechanism) is a diagnostic application used to explore probabilistic reasoning techniques in belief networks. ALARM implements an alarm message system for patient monitoring; it calculates probabilities for a differential diagnosis based on available evidence [1]. The medical knowledge is encoded in a graphical structure connecting 8 diagnoses, 16 findings and 13 intermediate variables.
The goal of the ALARM monitoring system is to provide specific text messages advising the user of possible problems. This is a diagnostic task, and we have chosen to represent the relevant knowledge in the language of a belief network. This graphical representation [6] facilitates the integration of qualitative and quantitative knowledge, the assessment of multiple faults, as required by our domain, and nonmonotonic and bidirectional reasoning.
We have also created a belief network, the Bone-Marrow Transplant Therapy Advisor, that represents prognostic factors and their effects on possible outcomes of a bone-marrow transplant. For pediatric patients in the advanced stages of acute lymphoblastic leukemia (ALL), bone-marrow transplantation is generally considered the most promising therapy. For the patient and parents, the decision to proceed with transplantation is often difficult. Morbidity after transplantation is usually severe, and a significant percentage of those who receive a bone marrow transplantation die within a year of transplantation [7]. Many factors, however, offer significant insight into the expected outcome of marrow transplantation. A few examples of such prognostic factors include the white blood count at diagnosis, the age at diagnosis, the number of recurrence episodes before transplantation, and the quality of the match with the marrow donor. Some of those factors indicate the progress of the disease, whereas others define sensitivity to the chemotherapeutic conditioning regimee or the likelihood of Graft-versus-Host Disease (GvHD).
Within the discipline of medical informatics, many researchers have studied methodologies for encoding the knowledge of expert clinicians as computational artifacts. KNET, the support software for ALARM and the bone-marrow transplant advisor, is a general-purpose environment for constructing probabilistic, knowledge-intensive systems based on belief networks and decision networks [2]. KNET differs from other tools for expert-system construction in that it combines a direct-manipulation visual interface with a normative, probabilistic scheme for the management of uncertain information and inference. The KNET architecture defines a complete separation between the hypermedia user interface on the one hand, and the representation and management of expert opinion on the other.
In our laboratory, we and others have used KNET to build not only the ALARM and bone-marrow transplant systems, but also consultation programs for lymph-node pathology and clinical epidemiology [2,4]. KNET imposes few restrictions on the interface design. Indeed, we have rapidly prototyped several direct-manipulation interfaces that use graphics, buttons, menus, text, and icons to organize the display of static and inferred knowledge. The underlying normative representation of knowledge remains constant.
We present ALARM and the transplant therapy advisor as part of a suite of probabilistic, knowledge-intensive medical expert systems. Such systems
• Manage large quantities of extensively cross-referenced information
• Emphasize clarity in acquiring, storing, and displaying expert knowledge
• Incorporate tools for building hypertext user interfaces
• Impose a limited number of constraints on the knowledge engineer's design choices
• Share an axiomatic grounding for diagnosis and decision-making in probability theory and utility theory
• Make normatively correct decisions and diagnoses in the face of uncertain, incomplete, and contradictory information
• Draw inferences from knowledge bases large enough to model significant, real-world medical domains, and do so in polynomial time on low-cost hardware
In this demonstration, we show how ALARM and the therapy advisor synthesize physiologic measurements and prognostic indicators into a diagnostic conclusion according to a belief-network model of the domains. We demonstrate KNET's hypertext interface and the transparent integration of probabilistic reasoning into a diagnostic application. KNET runs on any Macintosh II personal computer with at least 4 megabytes of random-access memory. The authors will provide all the necessary software on a SCSI hard disk. KNET fully supports color and monochrome monitors of any size, and requires no special hardware. We prefer, but do not require, a large color monitor, which demonstrates the capabilities of KNET to greatest advantage.
PMCID: PMC2245721
9.  Architecture for a multipurpose guideline execution engine. 
Integration of guideline knowledge into the clinical workflow is essential, for improving adherence to guidelines. Guidelines in structured formats can be utilized by computer programs to provide decision support in clinical information systems, as well as to facilitate workflow. We have designed an architecture for a flexible guideline execution engine that can be utilized in clinical decision support applications. The engine may be utilized for other applications such as referral management, medical education, and conducting clinical trials. The engine executes guidelines that are defined in an extension of the Guideline Interchange Format (GLIF). GLIF was extended to support representation of constructs that are essential to the execution of the guideline. A prototype of the engine was implemented based on this architecture. The engine is being utilized in two clinical applications that draw on guidelines for decision support. The engine was also used for developing an educational application aimed at testing knowledge of guideline recommendations.
PMCID: PMC2232598  PMID: 10566450
10.  Representing Clinical Guidelines in GLIF 
Abstract Objective: An evaluation of the cognitive processes used in the translation of a clinical guideline from text into an encoded form so that it can be shared among medical institutions.
Design: A comparative study at three sites regarding the generation of individual and collaborative representations of a guideline for the management of encephalopathy using the GuideLine Interchange Format (GLIF) developed by members of the InterMed Collaboratory.
Measurements: Using theories and methods of cognitive science, the study involves a detailed analysis of the cognitive processes used in generating representations in GLIF. The resulting process-outcome measures are used to compare subjects with various types of computer science or clinical expertise and from different institutions.
Results: Consistent with prior studies of text comprehension and expertise, the variability in strategies was found to be dependent on the degree of prior experience and knowledge of the domain. Differing both in content and structure, the representations developed by physicians were found to have additional information and organization not explicitly stated in the guidelines, reflecting the physicians' understanding of the underlying pathophysiology. The computer scientists developed more literal representations of the guideline; additions were mostly limited to specifications mandated by the logic of GLIF itself. Collaboration between physicians and computer scientists resulted in consistent representations that were more than the sum of the separate parts, in that both domain-specific knowledge of medicine and generic knowledge of guideline structure were seamlessly integrated.
Conclusion: Because of the variable construction of guideline representations, understanding the processes and limitations involved in their generation is important in developing strategies to construct shared representations that are both accurate and efficient. The encoded guidelines developed by teams that include both clinicians and experts in computer-based representations are preferable to those developed by individuals of either type working alone.
PMCID: PMC61328  PMID: 9760394
11.  Ontological approach for safe and effective polypharmacy prescription 
The intake of multiple medications in patients with various medical conditions challenges the delivery of medical care. Initial empirical studies and pilot implementations seem to indicate that generic safe and effective multi-drug prescription principles could be defined and reused to reduce adverse drug events and to support compliance with medical guidelines and drug formularies. Given that ontologies are known to provide well-principled, sharable, setting-independent and machine-interpretable declarative specification frameworks for modeling and reasoning on biomedical problems, we explore here their use in the context of multi-drug prescription. We propose an ontology for modeling drug-related knowledge and a repository of safe and effective generic prescription principles. To test the usability and the level of granularity of the developed ontology-based specification models and heuristic we implemented a tool that computes the complexity of multi-drug treatments, and a decision aid to check the safeness and effectiveness of prescribed multi-drug treatments.
PMCID: PMC3540569  PMID: 23304299
12.  A study of diverse clinical decision support rule authoring environments and requirements for integration 
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.
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.
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.
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.
PMCID: PMC3554596  PMID: 23145874
Clinical decision support; Knowledge management; Knowledge engineering; Knowledge authoring tool; Rule-based decision support; Knowledge lifecycle
13.  Coupling computer-interpretable guidelines with a drug-database through a web-based system – The PRESGUID project 
Clinical Practice Guidelines (CPGs) available today are not extensively used due to lack of proper integration into clinical settings, knowledge-related information resources, and lack of decision support at the point of care in a particular clinical context.
The PRESGUID project (PREScription and GUIDelines) aims to improve the assistance provided by guidelines. The project proposes an online service enabling physicians to consult computerized CPGs linked to drug databases for easier integration into the healthcare process.
Computable CPGs are structured as decision trees and coded in XML format. Recommendations related to drug classes are tagged with ATC codes. We use a mapping module to enhance computerized guidelines coupling with a drug database, which contains detailed information about each usable specific medication. In this way, therapeutic recommendations are backed up with current and up-to-date information from the database.
Two authoritative CPGs, originally diffused as static textual documents, have been implemented to validate the computerization process and to illustrate the usefulness of the resulting automated CPGs and their coupling with a drug database. We discuss the advantages of this approach for practitioners and the implications for both guideline developers and drug database providers. Other CPGs will be implemented and evaluated in real conditions by clinicians working in different health institutions.
PMCID: PMC375539  PMID: 15053828
14.  Patient Safety in Guideline-Based Decision Support for Hypertension Management: ATHENA DSS 
The Institute of Medicine recently issued a landmark report on medical error.1 In the penumbra of this report, every aspect of health care is subject to new scrutiny regarding patient safety. Informatics technology can support patient safety by correcting problems inherent in older technology; however, new information technology can also contribute to new sources of error. We report here a categorization of possible errors that may arise in deploying a system designed to give guideline-based advice on prescribing drugs, an approach to anticipating these errors in an automated guideline system, and design features to minimize errors and thereby maximize patient safety. Our guideline implementation system, based on the EON architecture, provides a framework for a knowledge base that is sufficiently comprehensive to incorporate safety information, and that is easily reviewed and updated by clinician-experts.
PMCID: PMC419409
15.  Patient safety in guideline-based decision support for hypertension management: ATHENA DSS. 
The Institute of Medicine recently issued a landmark report on medical error.1 In the penumbra of this report, every aspect of health care is subject to new scrutiny regarding patient safety. Informatics technology can support patient safety by correcting problems inherent in older technology; however, new information technology can also contribute to new sources of error. We report here a categorization of possible errors that may arise in deploying a system designed to give guideline-based advice on prescribing drugs, an approach to anticipating these errors in an automated guideline system, and design features to minimize errors and thereby maximize patient safety. Our guideline implementation system, based on the EON architecture, provides a framework for a knowledge base that is sufficiently comprehensive to incorporate safety information, and that is easily reviewed and updated by clinician-experts.
PMCID: PMC2243380  PMID: 11825183
16.  The SAGE Guideline Model: Achievements and Overview 
The SAGE (Standards-Based Active Guideline Environment) project was formed to create a methodology and infrastructure required to demonstrate integration of decision-support technology for guideline-based care in commercial clinical information systems. This paper describes the development and innovative features of the SAGE Guideline Model and reports our experience encoding four guidelines. Innovations include methods for integrating guideline-based decision support with clinical workflow and employment of enterprise order sets. Using SAGE, a clinician informatician can encode computable guideline content as recommendation sets using only standard terminologies and standards-based patient information models. The SAGE Model supports encoding large portions of guideline knowledge as re-usable declarative evidence statements and supports querying external knowledge sources.
PMCID: PMC1975799  PMID: 17600098
17.  A multi-layered framework for disseminating knowledge for computer-based decision support 
There are several challenges in encoding guideline knowledge in a form that is portable to different clinical sites, including the heterogeneity of clinical decision support (CDS) tools, of patient data representations, and of workflows.
We have developed a multi-layered knowledge representation framework for structuring guideline recommendations for implementation in a variety of CDS contexts. In this framework, guideline recommendations are increasingly structured through four layers, successively transforming a narrative text recommendation into input for a CDS system. We have used this framework to implement rules for a CDS service based on three guidelines. We also conducted a preliminary evaluation, where we asked CDS experts at four institutions to rate the implementability of six recommendations from the three guidelines.
The experience in using the framework and the preliminary evaluation indicate that this approach has promise in creating structured knowledge, to implement in CDS systems, that is usable across organizations.
PMCID: PMC3241169  PMID: 22052898
Knowledge bases; Translational research - application of biological knowledge to clinical care; developing/using clinical decision support (other than diagnostic) and guideline systems; knowledge acquisition and knowledge management; clinical informatics; clinical decision support; semantic web; Manning Maddux; bioinformatics; datamining; predictive modeling; developing/using computerized provider order entry; knowledge representations; classical experimental and quasi-experimental study methods (lab and field); designing usable (responsive) resources and systems; statistical analysis of large datasets; visualization of data and knowledge; knowledge representations; knowledge acquisition and knowledge management; distributed systems; agents; software engineering: architecture; developing and refining ehr data standards (including image standards); data models; data exchange; controlled terminologies and vocabularies; communication and integration across care settings (inter- and intra-enterprise); knowledge bases; knowledge representations; uncertain reasoning and decision theory; designing usable (responsive) resources and systems; personal health records and self-care systems; knowledge acquisition and knowledge management; demonstrating return on it investment; other specific ehr applications (results review; medication administration; disease progression
18.  EMB1/370: Facilitating Evidence-Based Healthcare: Clinical Practice Guidelines on the Internet 
Evidence-based clinical practice guidelines (CPGs) can help physicians and patients make appropriate health-care decisions. However, CPGs must be readily accessible at the point of care and pertinent to the health-care environment. To facilitate access of Canadian physicians to CPGs reflecting the Canadian health care environment, the Canadian Medical Association (CMA) created the CPG Infobase (, a comprehensive, Internet-based resource.
The CMA maintains a database of information on all current Canadian CPGs. Details on new CPGs and revisions, including their development, implementation and evaluation, and on related documents such as quick-reference guides for physicians and patient-oriented material, are added daily. In March 1995 the CMA began publishing online or licensing hyperlinks to evidence-based Canadian CPGs through its Web site, CMA Online, in a section named the CPG Infobase. As the CPG Infobase grew, browsing became increasingly inefficient. In addition, demand grew for information that would help the end-user determine which of several guidelines on a topic would be appropriate in a particular clinical situation. That information was available only through personal contact with the database staff. In 1998-99 the CMA developed a search engine and Web interface for the database to integrate it with the CPG Infobase. Needs assessment and iterative usability testing were conducted with physicians, the primary end-users.
The CPG Infobase now provides fast, one-stop access to information on more than 2000 evidence-based Canadian CPGs. By involving physicians in the design of the search engine and interface, the CMA maximized ease of use while ensuring the functionality needed by the primary end-users. Searching is flexible: novices can use a basic technique, whereas more experienced searchers can easily customize a strategy to target CPGs directly applicable to a clinical situation. The information retrieved permits the user to quickly assess which guideline is appropriate. Then, through hypertext links, the full text or structured abstract of nearly 1000 of the CPGs can be viewed, as can many of the related documents. Ordering information is available for documents not yet online.
In an era of information overload, rapid access to a thorough resource containing pertinent, reliable, evidence-based guidelines to best clinical practices is crucial for continual improvement in the quality of patient care. The Internet is an ideal access mechanism. However, acceptance and use of such a resource by physicians, who tend to be computer-search novices pressed for time, necessitate an intuitive interface and a powerful search engine. Quickly determining which of several conflicting guidelines is valid and appropriate in a specific clinical situation remains problematic. The CMA is now addressing this challenge and others related to guideline implementation.
PMCID: PMC1761789
Evidence-Based Medicine; Information Systems; Internet; Practice Guidelines; User-Computer Interface
19.  Semi-automated Entry of Clinical Temporal-abstraction Knowledge 
Objectives: The authors discuss the usability of an automated tool that supports entry, by clinical experts, of the knowledge necessary for forming high-level concepts and patterns from raw time-oriented clinical data.
Design: Based on their previous work on the RESUMÉ system for forming high-level concepts from raw time-oriented clinical data, the authors designed a graphical knowledge acquisition (KA) tool that acquires the knowledge required by RÉSUMÉ. This tool was designed using Protégé, a general framework and set of tools for the construction of knowledge-based systems. The usability of the KA tool was evaluated by three expert physicians and three knowledge engineers in three domains—the monitoring of children's growth, the care of patients with diabetes, and protocol-based care in oncology and in experimental therapy for AIDS. The study evaluated the usability of the KA tool for the entry of previously elicited knowledge.
Measurements: The authors recorded the time required to understand the methodology and the KA tool and to enter the knowledge; they examined the subjects' qualitative comments; and they compared the output abstractions with benchmark abstractions computed from the same data and a version of the same knowledge entered manually by RÉSUMÉ experts.
Results: Understanding RÉSUMÉ required 6 to 20 hours (median, 15 to 20 hours); learning to use the KA tool required 2 to 6 hours (median, 3 to 4 hours). Entry times for physicians varied by domain—2 to 20 hours for growth monitoring (median, 3 hours), 6 and 12 hours for diabetes care, and 5 to 60 hours for protocol-based care (median, 10 hours). An increase in speed of up to 25 times (median, 3 times) was demonstrated for all participants when the KA process was repeated. On their first attempt at using the tool to enter the knowledge, the knowledge engineers recorded entry times similar to those of the expert physicians' second attempt at entering the same knowledge. In all cases RÉSUMÉ, using knowledge entered by means of the KA tool, generated abstractions that were almost identical to those generated using the same knowledge entered manually.
Conclusion: The authors demonstrate that the KA tool is usable and effective for expert physicians and knowledge engineers to enter clinical temporal-abstraction knowledge and that the resulting knowledge bases are as valid as those produced by manual entry.
PMCID: PMC61392  PMID: 10579607
20.  Implementation of workflow engine technology to deliver basic clinical decision support functionality 
Workflow engine technology represents a new class of software with the ability to graphically model step-based knowledge. We present application of this novel technology to the domain of clinical decision support. Successful implementation of decision support within an electronic health record (EHR) remains an unsolved research challenge. Previous research efforts were mostly based on healthcare-specific representation standards and execution engines and did not reach wide adoption. We focus on two challenges in decision support systems: the ability to test decision logic on retrospective data prior prospective deployment and the challenge of user-friendly representation of clinical logic.
We present our implementation of a workflow engine technology that addresses the two above-described challenges in delivering clinical decision support. Our system is based on a cross-industry standard of XML (extensible markup language) process definition language (XPDL). The core components of the system are a workflow editor for modeling clinical scenarios and a workflow engine for execution of those scenarios. We demonstrate, with an open-source and publicly available workflow suite, that clinical decision support logic can be executed on retrospective data. The same flowchart-based representation can also function in a prospective mode where the system can be integrated with an EHR system and respond to real-time clinical events. We limit the scope of our implementation to decision support content generation (which can be EHR system vendor independent). We do not focus on supporting complex decision support content delivery mechanisms due to lack of standardization of EHR systems in this area. We present results of our evaluation of the flowchart-based graphical notation as well as architectural evaluation of our implementation using an established evaluation framework for clinical decision support architecture.
We describe an implementation of a free workflow technology software suite (available at and its application in the domain of clinical decision support. Our implementation seamlessly supports clinical logic testing on retrospective data and offers a user-friendly knowledge representation paradigm. With the presented software implementation, we demonstrate that workflow engine technology can provide a decision support platform which evaluates well against an established clinical decision support architecture evaluation framework. Due to cross-industry usage of workflow engine technology, we can expect significant future functionality enhancements that will further improve the technology's capacity to serve as a clinical decision support platform.
PMCID: PMC3079703  PMID: 21477364
21.  Technical aspects of quality assurance in radiation oncology 
The technical aspects of quality assurance (QA) in radiation oncology as practice in the United States will be reviewed and updated in the spirit of offering the experience to the radiation oncology communities in the Asia-Pacific region. The word “technical” is used to express the organisational components or processes and not the materials within the QA program. A comprehensive QA program in radiation oncology will have an official statement declaring the quality plan for effective patient care services it provides in a document. The QA program will include all aspects of patient care: physical, clinical, and medical aspects of the services. The document will describe the organisational structure, responsibilities, checks and procedures, and resources allocated to ensure the successful implementation of the quality of patient management. Regulatory guidelines and guidelines from accreditation agencies should be incorporated in the QA program to ensure compliance. The organisational structure will have a multidisciplinary QA committee that has the authority to evaluate continuously the effectiveness of the QA program to provide prompt corrective recommendations and to request feedback as needed to monitor the response. The continuous monitoring aspects require meetings to be held at regular intervals with the minutes of the meetings officially recorded and documented. To ensure that a QA program is effective, the program itself should be audited for quality at regular intervals at least annually. It has been recognised that the current QA program has not kept abreast with the rapid implementation of new and advanced radiation therapy technologies with the most recent in image-based radiation therapy technology. The societal bodies (ASTRO and AAPM) and federal agency (NCI) acknowledge this inadequacy and have held workshops to address this issue. The challenges for the societal bodies and federal agency are numerous that include (a) the prescriptive methodology used may not be appropriate for currently implemented new technologies, (b) resources are becoming scarce, (c) advanced radiation therapy technologies have been introduced too rapidly, (d) advances in radiation therapy technologies have become too sophisticated and specialised with each therapy modality having its own separate set of equipment, for example its own dose planning software, computer system and dose delivery systems requiring individualised QA procedures. At the present time, industrial engineers are being recruited to assist in devising a methodology that is broad-based and more process-oriented risk-based formulation of QA in radiation oncology.
PMCID: PMC3097727  PMID: 21611011
quality assurance; radiation therapy; treatment planning
22.  Falls Prevention within the Australian General Practice Data Model: Methodology, Information Model, and Terminology Issues 
The iterative development of the Falls Risk Assessment and Management System (FRAMS) drew upon research evidence and early consumer and clinician input through focus groups, interviews, direct observations, and an online questionnaire. Clinical vignettes were used to validate the clinical model and program logic, input, and output. The information model was developed within the Australian General Practice Data Model (GPDM) framework. The online FRAMS implementation used available Internet (TCP/IP), messaging (HL7, XML), knowledge representation (Arden Syntax), and classification (ICD10-AM, ICPC2) standards. Although it could accommodate most of the falls prevention information elements, the GPDM required extension for prevention and prescribing risk management. Existing classifications could not classify all falls prevention concepts. The lack of explicit rules for terminology and data definitions allowed multiple concept representations across the terminology–architecture interface. Patients were more enthusiastic than clinicians. A usable standards-based online-distributed decision support system for falls prevention can be implemented within the GPDM, but a comprehensive terminology is required. The conceptual interface between terminology and architecture requires standardization, preferably within a reference information model. Developments in electronic decision support must be guided by evidence-based clinical and information models and knowledge ontologies. The safety and quality of knowledge-based decision support systems must be monitored. Further examination of falls and other clinical domains within the GPDM is needed.
PMCID: PMC212779  PMID: 12807809
23.  A virtual medical record for guideline-based decision support. 
A major obstacle in deploying computer-based clinical guidelines at the point of care is the variability of electronic medical records and the consequent need to adapt guideline modeling languages, guideline knowledge bases, and execution engines to idiosyncratic data models in the deployment environment. This paper reports an approach, developed jointly by researchers at Newcastle and Stanford, where guideline models are encoded assuming a uniform virtual electronic medical record and guideline-specific concept ontologies. For implementing a guideline-based decision-support system in multiple deployment environments, we created mapping knowledge bases to link terms in the concept ontology with the terminology used in the deployment systems. Mediation components use these mapping knowledge bases to map data in locally deployed medical record architectures to the virtual medical record. We discuss the possibility of using the HL7 Reference Information Model (RIM) as the basis for a standardized virtual medical record, showing how this approach also complies with the European pre-standard ENV13606 for electronic healthcare record communication.
PMCID: PMC2243604  PMID: 11825198
24.  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.
PMCID: PMC1839410  PMID: 17238374
25.  Cost-Effectiveness of Early Versus Standard Antiretroviral Therapy in HIV-Infected Adults in Haiti 
PLoS Medicine  2011;8(9):e1001095.
This cost-effectiveness study comparing early versus standard antiretroviral treatment (ART) for HIV, based on randomized clinical trial data from Haiti, reveals that the new WHO guidelines for early ART initiation can be cost-effective in resource-poor settings.
In a randomized clinical trial of early versus standard antiretroviral therapy (ART) in HIV-infected adults with a CD4 cell count between 200 and 350 cells/mm3 in Haiti, early ART decreased mortality by 75%. We assessed the cost-effectiveness of early versus standard ART in this trial.
Methods and Findings
Trial data included use of ART and other medications, laboratory tests, outpatient visits, radiographic studies, procedures, and hospital services. Medication, laboratory, radiograph, labor, and overhead costs were from the study clinic, and hospital and procedure costs were from local providers. We evaluated cost per year of life saved (YLS), including patient and caregiver costs, with a median of 21 months and maximum of 36 months of follow-up, and with costs and life expectancy discounted at 3% per annum. Between 2005 and 2008, 816 participants were enrolled and followed for a median of 21 months. Mean total costs per patient during the trial were US$1,381 for early ART and US$1,033 for standard ART. After excluding research-related laboratory tests without clinical benefit, costs were US$1,158 (early ART) and US$979 (standard ART). Early ART patients had higher mean costs for ART (US$398 versus US$81) but lower costs for non-ART medications, CD4 cell counts, clinically indicated tests, and radiographs (US$275 versus US$384). The cost-effectiveness ratio after a maximum of 3 years for early versus standard ART was US$3,975/YLS (95% CI US$2,129/YLS–US$9,979/YLS) including research-related tests, and US$2,050/YLS excluding research-related tests (95% CI US$722/YLS–US$5,537/YLS).
Initiating ART in HIV-infected adults with a CD4 cell count between 200 and 350 cells/mm3 in Haiti, consistent with World Health Organization advice, was cost-effective (US$/YLS <3 times gross domestic product per capita) after a maximum of 3 years, after excluding research-related laboratory tests.
Trial registration NCT00120510
Please see later in the article for the Editors' Summary
Editors' Summary
AIDS has killed more than 25 million people since 1981, and about 33 million people (most of them living in low- and middle-income countries) are now infected with HIV, the virus that causes AIDS. HIV destroys immune system cells (including CD4 cells, a type of lymphocyte), leaving infected individuals susceptible to other infections. Early in the AIDS epidemic, most HIV-infected people died within 10 years of infection. Then, in 1996, highly active antiretroviral therapy (ART) became available and, for people living in affluent countries HIV/AIDS became a chronic condition. However, ART was extremely expensive and so a diagnosis of HIV infection remained a death sentence for people living in developing countries. In 2003, this situation was declared a global health emergency, and governments, international agencies, and funding bodies began to implement plans to increase ART coverage in developing countries. In 2009, more than a third of people in low- and middle-income countries who needed ART were receiving it, on the basis of guidelines that were in place at that time.
Why Was This Study Done?
Until recently, the World Health Organization (WHO) recommended that all HIV-positive patients with CD4 cell count below 200/mm3 blood or an AIDS-defining illness such as Kaposi's sarcoma should be given ART. Then, in 2009, the CIPRA HT-001 randomized clinical trial, which was undertaken in Haiti, reported that patients who started ART when their CD4 cell count was between 200 and 350 cells/mm3 (“early ART”) had a higher survival rate than patients who started ART according to the WHO guidelines (“standard ART”). As a result, WHO now recommends that ART is started in HIV-infected people when their CD4 cell count falls below 350 cells/mm3. But is this new recommendation cost-effective? Do its benefits outweigh its costs? Policy-makers need to know the cost-effectiveness of interventions so that they can allocate their limited resources wisely. A medical intervention is generally considered cost-effective if it costs less than three times a country's per capita gross domestic product (GDP) per year of life saved (YLS). In this study, the researchers assess the cost-effectiveness of early versus standard ART in the CIPRA HT-001 trial.
What Did the Researchers Do and Find?
The researchers used trial data on the use and costs of ART, other medications, laboratory tests, outpatient visits, radiography, procedures, and hospital services to evaluate the costs associated with early ART and standard ART among the 816 CIPRA HT-001 trial participants. The average total costs per patient after a maximum of 3 years treatment were US$1,381 for early ART and US$1,033 for standard ART. These figures dropped to US$1,158 and US$979, respectively, when the costs of research-related tests without clinical benefit were excluded. Patients who received early ART had higher average costs for ART but lower costs for other aspects of their treatment than patients who received standard ART. The incremental cost-effectiveness ratio after 3 years for early ART compared to standard ART was US$3,975/YLS if the costs of research-related tests were included in the calculation. That is, the cost of saving one year of life by starting ART early instead of when the CD4 cell count dropped below 200/mm3 was nearly US$4,000. Importantly, exclusion of the costs of research-related tests reduced the incremental cost-effectiveness ratio of early ART compared to standard ART to US$2,050/YLS.
What Do These Findings Mean?
Because the Haitian GDP per capita is US$785, these findings suggest that, in Haiti, early ART is a cost-effective intervention over a 3-year period. That is, the incremental cost per year of life saved of early ART compared to standard ART after exclusion of research-related tests is less than three times Haiti's per capita GDP. The researchers note that their incremental cost-effectiveness ratios are likely to be conservative because they did not consider the clinical benefits of early ART that continue beyond 3 years—early ART is associated with lower longer-term mortality than standard ART—or the effect of early ART on disability and quality of life. Cost-effectiveness studies now need to be undertaken at different sites to determine whether these findings are generalizable but, for now, this cost-effectiveness study suggests that the new WHO guidelines for ART initiation can be cost-effective in resource-poor settings, information that should help policy-makers in developing countries allocate their limited resources.
Additional Information
Please access these Web sites via the online version of this summary at
Information is available from the US National Institute of Allergy and infectious diseases on HIV infection and AIDS
HIV InSite has comprehensive information on all aspects of HIV/AIDS
Information is available from Avert, an international AIDS charity on many aspects of HIV/AIDS, including information on the HIV/AIDS in the Caribbean, and on HIV/AIDS treatment and care (in English and Spanish)
WHO provides information about universal access to AIDS treatment (in English, French and Spanish); its 2010 ART guidelines can be downloaded
More information about the CIPRA HT-001 clinical trial is available
Patient stories about living with HIV/AIDS are available through Avert and through the charity website Healthtalkonline
More information about GHESKIO is available from Weill Cornell Global Health
PMCID: PMC3176754  PMID: 21949643

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