BIOMEDICAL INFORMATICS PROGRAM College of Osteopathic Medicine Health Professions Division Course Title: Clinical Decision Support Systems Course Number: MI – 5204 Course Credits: 3 Course Director: Jacob Krive, Ph.D., MBA, MS, CPHIMS, LSS Green Belt Adjunct Assistant Professor Phone: 954.262.1038 Email: jkrive@nova.edu 3200 South University Drive, Fort Lauderdale, FL 33328 Dates: 01/06/2014 – 04/20/2014 Days and Time: Thursdays: 01/09, 01/23, 02/06, 02/20, 03/06, 03/20, 04/03, 04/17 from 7:00PM – 8:00PM, ET Location: Online within Blackboard Course Description: This course introduces students to theoretical, statistical, and practical concepts underlying modern medical decision making. Students will be provided a review of the multiple methods of knowledge generation for clinical decision support systems (CDSS) and create their own prototype of CDSS. Current implementations of stand-alone and integrated CDSS will be evaluated. Techniques for planning, management, and evaluation of CDSS implementations will be reviewed. Human factors, including workflow integration, and the ethical, legal and regulatory aspects of CDSS use will be explored, as applicable to commercial implementations in patient care settings. Future models of healthcare, supported by CDSS and evidence-based medicine, will be discussed and reviewed. 1/10 Course Textbooks (Required): Berner, Eta S. (Ed.) Clinical Decision Support Systems (2nd Ed.). Springer, 2009. ISBN-10: 1441922237, ISBN-13: 978-1441922236 Osheroff, Jerome A., Teich, Jonathan M., Levick, Donald, Saldana, Luis, Velasco, Ferdinand T., Sittig, Dean F., Rogers, Kendall M., & Jenders, Robert A. (2012). Improving outcomes with clinical decision support: An Implementer’s Guide (2nd Ed.). Chicago, HIMSS. ISBN: 978-0-9844577-3-1 Topol, Eric J. (2012). The creative destruction of medicine: How the digital revolution will create better health care (1st Ed.). New York, Basic Books. ISBN-10: 0465025501, ISBN-13: 978-0465025503 Course Textbooks (Recommended): Shortliffe, Edward H. and Cimino, James J. Biomedical Informatics: Computer Applications in Health Care and Biomedicine, May 25, 2006). Springer; 3rd edition 2006. ISBN-10: 0387289860 ISBN-13: 978-0387289861 Greenes, Robert A. (Ed.) Clinical Decision Support: The Road Ahead (1st Ed.) Elsevier, 2007. ISBN10: 0123693772, ISBN-13: 978-0123693778 Course Software (no cost to student): Exsys Corvid: http://www.exsys.com/ Course Structure and Requirements: Students are required to be familiar with the course contents. The course material will be reinforced through participation in bulletin-board discussions, written assignments, quizzes, programming projects, and a team course capstone project presented via discussion groups in Power Point format and the last live online session at the end of the course. Course Goals: After completion of the course, the student should be able to analyze clinical problems using one of several knowledge-generation methods for CDSS; design a prototype of a successful CDSS; review the history of CDSS development and implementation; assess the human-factors and regulatory issues of CDSS systems; describe current CDSS software marketplace and industry implementations; understand basic concepts of evidence-based medicine and the main building blocks linking evidence-based and CDSS; and apply their knowledge to constructing basic CDSS components and logic. Students should also be able to summarize and apply fundamental statistical concepts involved in medical decision making. Course Learning Objectives: Upon completion of this course, the student will comprehend the following issues and objectives: 1. Describe the scope and kinds of clinical decision support systems; analyze CDSS effectiveness in terms of implementing for diagnostic and therapeutic purposes. 2. Evaluate the linkage of CDSS to the basic concepts of evidence-based medicine. 2/10 3. Apply practice guidelines for clinical decision support, including commonly-used formalisms and authoring tools for computer-interpretable guidelines. 4. Describe the social and political forces driving implementations of CDSS in the clinical field. 5. Compare and contrast the types of CDSS available in commercial and research implementations. 6. Apply statistical methods and logic concepts, such as probability, regression, Boolean logic, set theory, and inference, to underlying medical decision making. 7. Evaluate at least three methods of knowledge generation for CDSS, including decision trees, neural networks, and Bayesian analysis. 8. Compare the advantages and disadvantages of supervised vs. unsupervised learning methods in data-mining applications. 9. Evaluate how CDSS fold into the overall hospital and/or medical office health information technology environment. 10. Analyze technology and business characteristics of successful CDSS implementations using recent industry cases as guidelines and input to build student’s own attributes of an effective CDSS implementation. 11. Recognize business and clinical implementation and maintenance challenges in commercial CDSS projects, as well as possible resolutions to these challenges. 12. Assess risks involved with poor CDSS implementations from the following standpoints: health outcomes, quality of care, medical error rates, and patient and provider satisfaction standpoints. 13. Discuss ethical and regulatory issues involved in design and implementation of CDSS systems. 14. Identify opportunities for use of CDSS in personal health records and shared decision making. 15. Identify a basic clinical problem or an operational situation with the purpose of simulating an expert system to assist clinicians with problem resolution process. 16. Present a full implementation of CDSS with commercially applicable attributes, aimed at solving specific clinical problem or improving clinical workflow. 17. Integrate theoretical and practical knowledge of current and future CDSS learned in class, to apply in healthcare settings. Evaluation Format: The following evaluation formats will be employed in this course: quizzes, written assignments, programming projects, online discussions, and integrative CDSS capstone project. Grading Policy: This course adheres to the examination policy as stated in the COM student handbook. Student grades will be based upon the level of performance in meeting course requirements. These requirements include assignments, class participation in online sessions and discussion boards, and course project. Task Quiz #1 Quiz #2 Online Session Attendance (1st and Last) CDSS Research Paper Evidence-Based Medicine Paper Medical Data Vocabulary Paper: Part I % of Final Grade 5% 5% 5% 10% 10% 5% 3/10 Medical Data Vocabulary Paper: Part II (online discussion) Expert System Programming Project CDSS Programming Project Comparative Case Analysis Paper CDSS Capstone Project Total 5% 10% 10% 10% 25% 100% Course Grading Scale: 0 – 100 Scale 94 - 100 90 - 93 87 - 89 84 - 86 80 - 83 77 - 79 73 - 76 70 - 72 Below 70 Letter Grade Scale A AB+ B BC+ C CF Quality Points Scale 4.0 3.7 3.3 3.0 2.7 2.3 2.0 1.7 0.0 Course Online Sessions: There will be 8 synchronous discussion sessions throughout the course occurring from 7:00 to 8:00 pm (ET) on Thursday evenings on the weeks listed in the syllabus. A computer with audio in (microphone) and out (speakers or headphones) and an internet connection, preferably broadband speed, will be required to participate in the synchronous discussion sessions. Course Attendance Policy: Attendance of online sessions and scheduled bulletin board discussions is required by HPD policy. Nonattendance without prior approval from the instructor will be considered unexcused, and will be penalized with a grade of 0% for the relevant sessions. Attendance of the first and last class meetings is required; penalty above applies for failure to show up. All other sessions are not mandatory but crucial to your success in this course, so attendance is highly encouraged and recommended. There is a penalty for delayed submissions of assignments, assessed at 10% per day after the due date. Assignments not submitted or presented within 5 days of the deadline in Blackboard, without prior arrangement with the course director, will receive a grade of zero (0) for the assignment. 4/10 Course Assignments: There will be 4 papers, 2 quizzes, 1 online board discussion, and 2 programming projects to be submitted online by due date. Assignments will be graded within one week after due date. Descriptions and grading criteria will be available in the Blackboard course area. Course Final Project: Each student will be required to create a decision support system prototype to assist with a specific problem in medical decision making. Details of the project can be found in the assignments tab on the course page. Course Schedule: This course starts on 01/06/2014 and ends on 04/20/2013, total of 14 weeks. Week Date Topic(s) Assignment(s) Readings 01/06/2014 Overview and Mathematical Foundations of CDSS Online Session #1 Thursday, 01/09 7-8PM Berner, Chapters 1 and 2 01/13/2014 Evidence-Based Medicine as Foundation for CDSS Evidence-Based Medicine Paper 01/20/2014 Data Mining for CDSS; Types of CDSS; Design and Implementation of CDSS 1 2 3 4 01/27/2014 Diagnostic Decision Support Systems Topol, Chapter 2 Online Session #2 Thursday, 01/23 7-8PM Readings in Blackboard Berner, Chapters 3 and 4 Quiz 1 Research of a Clinical Decision Support System Paper Berner, Chapter 5 5 02/03/2014 Clinical Trials of Information Intervention Online Session #3 Thursday, 02/06 7-8PM Berner, Chapter 7 Review Exsys Corvid Tutorials 5/10 6 02/10/2014 The Future of CDSS and Related Technologies: Genomics, Genomic Algorithms, and Genome Sequencing 7 02/17/2014 8 02/24/2014 Ethical and Legal Issues in Decision Support Conceptual Foundations for Commercial CDSS Implementations Download Exsys Corvid Software Expert System Programming Exercise Online Session #4 Thursday, 02/20 7-8PM Topol, Chapters 5 and 6 Berner, Chapter 6 Start CDSS Programming Exercise Complete CDSS Programming Exercise Osheroff, Part I Intro and Chapter 1 (pp. 1 41) 9 03/03/2014 Organizing a Successful CDSS Program Online Session #5 Thursday, 03/06 7-8PM Osheroff, Chapter 2 Vocabulary Coding System Exercise: Part I 10 Osheroff, Chapter 3 03/10/2014 Key CDSS Building Blocks 03/17/2014 Foundations for Effective CDSS Interventions Vocabulary Coding System Exercise: Part II Topol, Chapters 7 and 8 11 Online Session #6 Thursday, 03/20 7-8PM Osheroff, Part II Intro, Chapters 5 and 6 (pp.129 – 212) Quiz 2 03/24/2014 Spring Break 12 03/31/2014 CDSS Industry Implementation: Case Analysis No assignments – enjoy your time off No reading assignments – enjoy your time off Online Session #7 Thursday, 04/03 7-8PM Berner, Chapters 8, 9, and 10 (pick two cases for reading and analysis from Berner or Osheroff texts, or find your own cases) Comparative Case Analysis Paper 6/10 13 04/07/2014 Practical Implementation of Clinical Interventions with CDSS 14 Start CDSS Capstone Project Osheroff, Chapters 7 and 8 Online Session #8 Thursday, 04/17 7-8:30PM 04/14/2014 The Future of CDSS: Rebooting the Life Sciences Industry Complete and Submit CDSS Capstone Project Topol, Chapters 10 and 11 Present Projects During Online Session #8 Course Topics: 1. Overview and Mathematical Foundations of CDSS a. Describe the history of CDSS development. b. Describe the type of CDSS available in commercial and research implementations. c. Define and compare knowledge based and non knowledge based CDSS. d. Define the four components/benefits of most CDSS. e. Describe the dependencies and interactions between CDSS, EMR, and CPOE applications. f. Understand limitations of CDSS, general implementation challenges, and political landscape surrounding CDSS projects in healthcare organizations. g. Define basic statistical concepts, including sensitivity, specificity, PPV, NPV, incidence, and prevalence. h. Apply Boolean logic to solving clinical workflow problems i. Derive Bayes Rule from conditional and joint probabilities j. Understand odds ratios k. Learn how to choose and interpret diagnostic tests l. List the steps involved in constructing a differential diagnosis m. Define inference engine as one of the core knowledge-based methodologies n. Conceptually understand neural networks and genetic algorithms as core examples of the non knowledge based systems. o. Understand basic purpose of genetic algorithms. 2. Evidence-Based Medicine as Foundation for CDSS a. Understand basic concepts of evidence based medicine (EBM) and its impact on healthcare. b. Understand operational, political, and philosophical issues surrounding application of evidence based practice methods in the clinical settings c. Review examples of evidence based knowledge, systems, and applications d. Understand links and dependencies between CDSS and evidence based. e. Become familiar with a 5-step EBM model. f. Understand several types of clinical trials and analyze their impact on building, managing, and using CDSS. g. Conceptualize health outcomes research and analyze CDSS impact in this new field h. Ask main questions assumed when constructing successful EBM. 7/10 Produce an EBM analysis paper, covering main concepts of EBM and students’ opinions on it based on material learned in class. Data Mining for CDSS, Types of CDSS, Design and Implementation of CDSS a. Define knowledge discovery in databases. b. Compare and understand data mining and machine learning. c. Define supervised vs. unsupervised learning and appropriate situations for application of these strategies d. Become familiar with knowledge presentation formats. e. Learn how to capture, store, transfer, and exchange knowledge through using several types of clinical vocabularies, or ontologies. f. Become aware of and navigate vocabulary utilization issues. Diagnostic Decision Support Systems a. Understand the medical decision making process. b. Understand cognitive decision making. c. Describe the uncertainties associated with clinical decision making. d. List common psychological biases that negatively impact decision making. e. Understand challenges associated with CDSS relative to myriads of decisions faced by medical professionals on the daily basis. f. Research one academic or commercial implementation of CDSS in detail. Clinical Trials of Information Intervention a. Understand the purpose of clinical trials. b. Become familiar with basic types of clinical trials. c. Understand why clinical trials are important and what challenges they face. d. Understand the relationship between clinical trials and CDSS; know why trials are reviewed as part of the CDSS course. e. Learn how to use software to build expert systems that represent foundation for knowledge acquisition and more sophisticated CDSS. The Future of CDSS and Related Technologies: Genomics, Genomic Algorithms, and Genome Sequencing a. Understand the basic concepts of genetics, genome-wide association studies, and genome sequencing. b. Analyze strengths and weaknesses of pharmacogenomics in this field’s current state, along with far-reaching consequences of breakthroughs within this domain of discovery c. Discover the promises of genome sequencing; analyze past failures, current challenges, and future potential. d. Review highlights of progress the cutting-edge imaging technologies, including brain mapping and low-radiation scans. e. Build a basic expert knowledge system advising users how to perform simple operational tasks. Ethical and Legal Issues in Decision Support a. Discuss ethical concerns associated with CDSS. b. Outline legal issues with design and implementation of CDSS, i.e. liability and negligence c. Discuss exposure of CDSS application vendors to malpractice lawsuits. d. Review FDA regulation of CDSS and as a service or product e. Discuss copyright and patent in relation to CDSS f. Outline the ‘medical device’ status of CDSS in healthcare markets g. Understand the software market landscape since popularization of various easily accessible and inexpensive “apps” that often pretend to serve as authoritative software solutions for complex clinical problems h. Recognize opportunities for data convergence and risks associated with explosion of “big data” in healthcare. i. 3. 4. 5. 6. 7. 8/10 i. Work on a comprehensive CDSS programming exercise that involves defining a clinical workflow and programming it in the Exsys Corvid application. 8. Conceptual Foundations for Commercial CDSS Implementations a. Define quality goals of CDSS in the healthcare industry setting, including health outcomes and quality metrics. b. Define business definitions of care success and understand hospital/practice expectations from commercial CDSS implementations. c. List common pitfall and political challenges in CDSS implementations d. Learn how to determine software requirements and identify vendors that can satisfy hospital’s information technology needs. e. Complete the exercise of building a simple CDSS solving one clinical workflow problem. 9. Organizing a Successful CDSS Program a. Learn how to establish foundations for successful commercial CDSS implementation, including building a team, getting the right individuals from various levels in the organization involved, set strategic and detailed targets for CDSS, analyze clinical expectations in terms of the outcomes, and perform full stakeholder analysis b. Learn how to start a successful change management program and why it is important. c. Define shared governance and understand why it is critical to CDSS project success. d. Become familiar with several project communication strategies. e. Build a worksheet for establishing a successful CDSS program. f. Become familiar with one of the medical ontologies and complete a short paper outlining details, purposes, and strengths. 10. Key CDSS Building Blocks a. Define CDSS building blocks. b. Understand the role of CDSS in clinical interventions. c. Expand the knowledge of clinical data vocabularies most frequently utilized in commercial settings. d. Deepen understanding of HL7, its purpose, and the latest CDA/CCD format that enables comprehensive clinical data exchange and systems interoperability. e. Learn basic systems integration principles. f. Understand why measurements are important, from defining initial baseline to quantitative evaluation of project success. g. Review and critically assess potential of modern CDSS based on a different approach to practicing medicine: breakaway from traditional diagnosis methods, digital patient data storage and exchange, reliance on data convergence to provide physicians with mountains of summarized knowledge and diagnostic data, and the role of knowledge/content management in supporting progress of the modern life science fields. h. Discuss medical ontologies with classmates, discover more ontologies as part of the online peer-to-peer interaction process, and compare/contrast vocabularies presented in class. 11. Foundations for Effective CDSS Interventions a. Learn how to identify opportunities for CDSS assistance with solving clinical problems. b. Learn how to help clinicians prevent medical errors using CDSS. c. Investigate clinical and patient care quality targets; learn how to incorporate into CDSS. d. Continue to expand practical skills necessary to be able to set project goals and establish a baseline. e. Understand the definition and purpose of order sets, their importance to CPOE and CDSS success. f. Define and utilize alerts as an effective intervention method. g. Learn how to select the right interventions and prioritize project goals among myriads of critical hospital and quality management needs. 12. CDSS Industry Implementation: Case Analysis 9/10 a. Review, analyze, contrast, and compare two commercial CDSS implementation cases. 13. Practical Implementation of Clinical Interventions with CDSS a. Learn key steps to succeeding with selecting and implementing CDSS interventions. b. Discover usability elements that need to be analyzed prior to implementation. c. Learn how to configure interventions. d. Understand who needs to be involved with implementation projects. e. Learn how to plan, implement, measure, and evaluate interventions. f. Describe common pitfalls in implementing interventions. g. Begin working on a comprehensive capstone project building a CDSS. 14. The Future of CDSS: Rebooting the Life Sciences Industry a. Review promises of the new life science technologies. b. Understand the clash between immediate profit driving big business and future direction of life sciences and healthcare. c. Analyze challenges associated with commercial implementations of new technologies d. Discuss ethical concerns in the process of aggressive rollout of discoveries that rapidly make their way from laboratory to market. e. Put all technologies and processes covered in the course in perspective and critically assess how these taken as a whole will affect the future of disease diagnosis and treatment f. Understand how knowledge management via CDSS and data convergence will support fundamental shifts in medicine. g. Present team discoveries in the field of CDSS, along with theoretical CDSS models developed as part of the capstone project. 10/10