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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.  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
6.  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
7.  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
8.  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
9.  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
10.  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
11.  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
12.  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
13.  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
14.  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
15.  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
16.  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
17.  Incorporating personalized gene sequence variants, molecular genetics knowledge, and health knowledge into an EHR prototype based on the Continuity of Care Record standard 
The current volume and complexity of genetic tests, and the molecular genetics knowledge and health knowledge related to interpretation of the results of those tests, are rapidly outstripping the ability of individual clinicians to recall, understand and convey to their patients information relevant to their care. The tailoring of molecular genetics knowledge and health knowledge in clinical settings is important both for the provision of personalized medicine and to reduce clinician information overload. In this paper we describe the incorporation, customization and demonstration of molecular genetic data (mainly sequence variants), molecular genetics knowledge and health knowledge into a standards-based electronic health record (EHR) prototype developed specifically for this study.
We extended the CCR (Continuity of Care Record), an existing EHR standard for representing clinical data, to include molecular genetic data. An EHR prototype was built based on the extended CCR and designed to display relevant molecular genetics knowledge and health knowledge from an existing knowledge base for cystic fibrosis (OntoKBCF). We reconstructed test records from published case reports and represented them in the CCR schema. We then used the EHR to dynamically filter molecular genetics knowledge and health knowledge from OntoKBCF using molecular genetic data and clinical data from the test cases.
The molecular genetic data were successfully incorporated in the CCR by creating a category of laboratory results called “Molecular Genetics ” and specifying a particular class of test (“Gene Mutation Test”) in this category. Unlike other laboratory tests reported in the CCR, results of tests in this class required additional attributes (“Molecular Structure” and “Molecular Position”) to support interpretation by clinicians. These results, along with clinical data (age, sex, ethnicity, diagnostic procedures, and therapies) were used by the EHR to filter and present molecular genetics knowledge and health knowledge from OntoKBCF.
This research shows a feasible model for delivering patient sequence variants and presenting tailored molecular genetics knowledge and health knowledge via a standards-based EHR system prototype. EHR standards can be extended to include the necessary patient data (as we have demonstrated in the case of the CCR), while knowledge can be obtained from external knowledge bases that are created and maintained independently from the EHR. This approach can form the basis for a personalized medicine framework, a more comprehensive standards-based EHR system and a potential platform for advancing translational research by both disseminating results and providing opportunities for new insights into phenotype-genotype relationships.
PMCID: PMC3272091  PMID: 21946299
Molecular Genetic Information; Sequence variants; Electronic Health Record; Personalized information; Standards; Information filters
18.  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
19.  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
20.  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
21.  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
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.  Implementing the American Academy of Pediatrics Attention-Deficit/Hyperactivity Disorder Diagnostic Guidelines in Primary Care Settings 
Pediatrics  2004;114(1):129-140.
To evaluate the feasibility of the San Diego Attention-Deficit/Hyperactivity Disorder Project (SANDAP) protocol, a pediatric community-initiated quality improvement effort to foster implementation of the American Academy of Pediatrics (AAP) attention-deficit/hyperactivity disorder (ADHD) diagnostic guidelines, and to identify any additional barriers to providing evidence-based ADHD evaluative care.
Seven research-naïve primary care offices in the San Diego area were recruited to participate. Offices were trained in the SANDAP protocol, which included 1) physician education, 2) a standardized assessment packet for parents and teachers, 3) an ADHD coordinator to assist in collection and collation of the assessment packet components, 4) educational materials for clinicians, parents, and teachers, in the form of handouts and a website, and 5) flowcharts delineating local paths for referral to medical subspecialists, mental health practitioners, and school-based professionals. The assessment packet included the parent and teacher versions of the Vanderbilt ADHD Diagnostic Rating Scales. In this study, we chose a conservative interpretation of the AAP ADHD guidelines for diagnosing ADHD, requiring that a child met criteria for ADHD on both the parent and teacher rating scales. A mixed-method analytic strategy was used to address feasibility and barriers, including quantitative surveys with parents and teachers and qualitative debriefing sessions conducted an average of 3 times per year with pediatricians and office staff members.
Between December 2000 and April 2003, 159 children were consecutively enrolled for evaluation of school and/or behavioral problems. Clinically, only 44% of the children met criteria for ADHD on both the parent and teacher scales, and 73.5% of those children were categorized as having the combined subtype. More than 40% of the subjects demonstrated discrepant results on the Vanderbilt scales, with only the parent or teacher endorsing sufficient symptoms to meet the criteria of the Diagnostic and Statistical Manual of Mental Disorders, 4th ed. Other mental health and learning problems were common in the sample; 58.5% of subjects met screening criteria for oppositional defiant disorder/conduct disorder, 32.7% met screening criteria for anxiety/depression, and approximately one-third had an active individualized education program in place or had received an individualized education program in the past. On evaluation, the SANDAP protocol was acceptable and feasible for all stakeholders. However, additional barriers to implementing the AAP ADHD guidelines were identified, including 1) limited information in the guidelines regarding the use of specific ADHD rating scales, the evaluation and treatment of children with discrepant and/or negative results, and the indications for psychologic evaluation of learning problems, 2) families’ need for education regarding ADHD and support, 3) characteristics of physical health and mental health plans that limited care for children with ADHD, and 4) limited knowledge and use of potential community resources.
Our results indicate that children presenting for evaluation of possible ADHD in primary care offices have complex clinical characteristics. Providers need mechanisms for implementing the ADHD diagnostic guidelines that address the physician education and delivery system design aspects of care that were developed in the SANDAP protocol. Additional barriers were also identified. Careful attention to these factors will be necessary to ensure the sustained provision of quality care for children with ADHD in primary care settings.
PMCID: PMC1519417  PMID: 15231919
pediatrics; primary care; attention-deficit/hyperactivity disorder; guidelines; DSM-IV, Diagnostic and Statistical Manual of Mental Disorders, 4th ed.; AAP, American Academy of Pediatrics; ADHD, attention-deficit/hyperactivity disorder; NICHQ, National Initiative for Children’s Healthcare Quality; PCP, primary care provider; SANDAP, San Diego ADHD Project; AC, ADHD coordinator; ODD, oppositional defiant disorder; CD, conduct disorder
24.  Toward successful migration to computerized physician order entry for chemotherapy 
Current Oncology  2014;21(2):e221-e228.
Computerized physician order entry (cpoe) systems allow for medical order management in a clinical setting. Use of a cpoe has been shown to significantly improve chemotherapy safety by reducing the number of prescribing errors. Usability of these systems has been identified as a critical factor in their successful adoption. However, there is a paucity of literature investigating the usability of cpoe for chemotherapy and describing the experiences of cancer care providers in implementing and using a cpoe system.
A mixed-methods study, including a national survey and a workshop, was conducted to determine the current status of cpoe adoption in Canadian oncology institutions, to identify and prioritize knowledge gaps in cpoe usability and adoption, and to establish a research agenda to bridge those gaps. Survey respondents were representatives of cancer care providers from each Canadian province. The workshop participants were oncology clinicians, human factors engineers, patient safety researchers, policymakers, and hospital administrators from across Canada, with participation from the United States.
A variety of issues related to implementing and using a cpoe for chemotherapy were identified. The major issues concerned the need for better understanding of current practices of chemotherapy ordering, preparation, and administration; a lack of system selection and procurement guidance; a lack of implementation and maintenance guidance; poor cpoe usability and workflow support; and other cpoe system design issues. An additional three research themes for addressing the existing challenges and advancing successful adoption of cpoe for chemotherapy were identified: The need to investigate variances in workflows and practices in chemotherapy ordering and administrationThe need to develop best-practice cpoe procurement and implementation guidance specifically for chemotherapyThe need to measure the effects of cpoe implementation in medical oncology
Addressing the existing challenges in cpoe usability and adoption for chemotherapy, and accelerating successful migration to cpoe by cancer care providers requires future research focusing on workflow variations, chemotherapy-specific cpoe procurement needs, and implementation guidance needs.
PMCID: PMC3997455  PMID: 24764707
Chemotherapy; cpoe; computerized physician order entry; usability
25.  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

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