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BACKGROUND: Opioid prescribing for chronic pain is common and controversial, but recommended clinical practices are followed inconsistently in many clinical settings. Strategies for increasing adherence to clinical practice guideline recommendations are needed to increase effectiveness and reduce negative consequences of opioid prescribing in chronic pain patients. METHODS: Here we describe the process and outcomes of a project to operationalize the 2003 VA/DOD Clinical Practice Guideline for Opioid Therapy for Chronic Non-Cancer Pain into a computerized decision support system (DSS) to encourage good opioid prescribing practices during primary care visits. We based the DSS on the existing ATHENA-DSS. We used an iterative process of design, testing, and revision of the DSS by a diverse team including guideline authors, medical informatics experts, clinical content experts, and end-users to convert the written clinical practice guideline into a computable algorithm to generate patient-specific recommendations for care based upon existing information in the electronic medical record (EMR), and a set of clinical tools. RESULTS: The iterative revision process identified numerous and varied problems with the initially designed system despite diverse expert participation in the design process. The process of operationalizing the guideline identified areas in which the guideline was vague, left decisions to clinical judgment, or required clarification of detail to insure safe clinical implementation. The revisions led to workable solutions to problems, defined the limits of the DSS and its utility in clinical practice, improved integration into clinical workflow, and improved the clarity and accuracy of system recommendations and tools. CONCLUSIONS: Use of this iterative process led to development of a multifunctional DSS that met the approval of the clinical practice guideline authors, content experts, and clinicians involved in testing. The process and experiences described provide a model for development of other DSSs that translate written guidelines into actionable, real-time clinical recommendations.
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OBJECTIVE: Evaluate KNAVE-II, a knowledge-based framework for visualization, interpretation, and exploration of longitudinal clinical data, clinical concepts and patterns. KNAVE-II mediates queries to a distributed temporal-abstraction architecture (IDAN), which uses a knowledge-based problem-solving method specializing in on-the-fly computation of clinical queries. METHODS: A two-phase, balanced cross-over study to compare efficiency and satisfaction of a group of clinicians when answering queries of variable complexity about time-oriented clinical data, typical for oncology protocols, using KNAVE-II, versus standard methods: both paper charts and a popular electronic spreadsheet (ESS) in Phase I; an ESS in Phase II. The measurements included the time required to answer and the correctness of answer for each query and each complexity category, and for all queries, assessed versus a predetermined gold standard set by a domain expert. User satisfaction was assessed by the Standard Usability Score (SUS) tool-specific questionnaire and by a "Usability of Tool Comparison" comparative questionnaire developed for this study. RESULTS: In both evaluations, subjects answered higher-complexity queries significantly faster using KNAVE-II than when using paper charts or an ESS up to a mean of 255 s difference per query versus the ESS for hard queries (p=0.0003) in the second evaluation. Average correctness scores when using KNAVE-II versus paper charts, in the first phase, and the ESS, in the second phase, were significantly higher over all queries. In the second evaluation, 91.6% (110/120) of all of the questions asked within queries of all levels produced correct answers using KNAVE-II, opposed to only 57.5% (69/120) using the ESS (p<0.0001). User satisfaction with KNAVE-II was significantly superior compared to using either a paper chart or the ESS (p=0.006). Clinicians ranked KNAVE-II superior to both paper and the ESS. CONCLUSIONS: An evaluation of the functionality and usability of KNAVE-II and its supporting knowledge-based temporal-mediation architecture has produced highly encouraging results regarding saving of physician time, enhancement of accuracy of clinical assessment, and user satisfaction.