Introduction

Participants in this proposed medical informatics research fellowship would be expected to attain two types of knowledge: general knowledge relevant to any area of emphasis within medical informatics research, and knowledge specific to a particular area of enhancement.

They would have two vehicles for learning: didactic instruction and personal experience. The didactic sessions will include two general curricula: the medical informatics curriculum and the research core curriculum.

Personal experience will come from a variety of sources: 1) working directly with existing RMRS computer systems during their practice experience; 2) being a member of at least one hospital computer committee-(usually a committee charged to select a clinical computer system); 3) through their research projects; 4) via a practicum experience with individual medical informatics researchers and on hospital clinical computer committees; 5) developing/honing skills in a major computer language; and 6) the writing of papers, drafting of NIH proposals, and the organization and completion of their research projects.

Number, types of trainees and focus of training

The goal of our program is to train physicians and Ph.D.s who have special interest, training and/or experience with computers to be researchers in Medical Informatics. Our intention is to prepare our fellows to contribute to the field of medical informatics and to shape the field of medical informatics and the related medical industry.

We are aiming for a small number of very competent fellows and will provide them with intensive faculty attention. Our initial goal will be to admit 4 general medical informatics fellows per year for a minimum 2-year fellowship. We will extend the fellowship to three years in special cases. We would expect in the steady state to have 8 to 10 fellows.

To maintain their clinical competence and to provide them with the hands-on experience with the clinical computer tools (now being used by physicians in our environment) physician trainees will be encouraged to spend some time in clinical care. We limit clinical care time to approximately 10% (one half day per week in clinic or a comparable amount of ward duty).

Curriculum Overview

The curriculum includes many aspects:

1. Mastery of core medical informatics curriculum
2. Medical informatics practicum experience
3. Competency in one widely available computer language-we suggest JAVA, but other languages might be more appropriate for fellows with special interests
4. Use of clinical computer and research systems in their work on clinical
5. Weekly 1-hour session with Medical Informatics Director
6. Core curriculum in research methodology
7. Weekly Regenstrief Work in Progress presentation
8. Special invited lectures: We have special lectures throughout the year. In the last year, for example, we had a variety of special half and full-day lectures
9. Professional Development Seminars
10. Journal Club
11. Development of paper and grant writing skills
12. Projects-this is the meat of the fellowship program. Fellows will have to complete at least 2 research projects.

In addition, individuals with special interests may choose to take additional formal course work in statistics, computer science, bioinformatics or imaging as listed in the following sections.

Core Medical Informatics Curriculum

These are 90-minute lectures given once or twice a week. In the first half of the 1st year the focus is on pragmatic content and what the fellows will need to know to develop project ideas and to accomplish them. The lecturers are given once per week. In the following full year the focus is on principles and theory including lectures of bioinformatics and bio imaging content and the lectures are given once or twice per week.

Practical Aspects of Informatics and Tools Needed for Research Projects (15 lectures)

This lecture series starts with descriptions of function and data content of local systems, including use of the Regenstrief Medical Record System, Fast Retrieval query system, Gopher order entry system and care rules for reminders - both as examples of real clinical application and to suggest ideas and provide tools for accomplishing early projects. We will also review all of the large currently funded informatics projects, e.g., the NGI telemedicine project, the NCI shared pathology network, present starter lectures in JAVA, and data modeling so that fellows can understand and help develop Open Source 3rd generation RMRS.

After these lectures the fellows will have the skills and knowledge to:

• Understand the structure, and content of the existing and planned, clinical and administrative data bases available for epidemiology study
• Pose an epidemiologic research question that can be answered with the kinds of data now available in the RMRS and allied files
• Know how to use the query and decision support tools, well enough to plan a research project
• Develop some competence with data bases, XML and a computer language
• Understand the goals and find research opportunities in the externally funded medical informatics projects.

The materials used for this part of the course will include local users guides, the HL7 vs 2.x standards manual, WC3 standards manuals, internal notes, and handouts from the published literature.

Principles and Theory of Medical Informatics (38 90-Minute Lectures)

This part of the curriculum will provide the theory and principles of medical informatics including computer technology, system development, and decision science. The curriculum will also cover basic languages, database systems, and object-oriented technology and gives special emphasis to applicable standards ranging from general system standards (eg. IP, XML, PDF, JPEG, MPEG, SQL) to medically specific standards (eg. HL7, the HL7 RIM, DICOM, LOINC, ICD9, CPT4). A portion of the curriculum is dedicated to bioinformatics and imaging informatics.

After this series of lectures the fellows will have the skills and knowledge to:

• Understand the core informatics issues related to clinical and bio medical imaging, and of bioinformatics, and have an idea of the research opportunities in both of these fields
• Be conversant with the broad range of issues in computer systems and computer systems development
• Understand the broad set of medical informatics issues ranging from representation to input and display mechanics
• Be able to use a variety of decision science techniques for decision support
• Appreciate the complex social/privacy issues and security/encryption based-techniques.

Principles and Theory of Medical Informatics

The textbooks used for this course will include:

• Sox, Blatt, Higgins, Marton, "Medical Decision Making". 1988, Butterworths
• Plous, "The Psychology of Judgement and Decision Making". 1993, McGraw-Hill
• Van Bummel, JH, "Handbook of Medical Informatics". 1997 Musen MA, eds., New York: Springer-Verlag
• Shortliff, EH, "Medical Informatics: Computer Applications in Health Care". 1990 Perreault LE, eds., Reading, MA: Addision-Wesley Publishing.
• Plus many class handouts.

Bio- and Imaging Informatics Supplements

For imaging informatics, the core curriculum includes five 90-minute lectures on clinical imaging that cover the computer structure of standard clinical images, as well as compression techniques and the problems of clinical imaging applications. It will also cover 3-dimensional biomedical imaging in small animals and cells, including such things as confocal microscopy and 2 photon imaging, and the computer algorithms needed to visualize such three dimensional shapes. We will recruit special outside lecturers for some of these lecturers.

For fellows with interests in imaging informatics, we have mentors from a variety of fields (radiology, microscopy, and computer science) and IUPUI offers a four credit course in the computer algorithms use for visualizing multiplane data of many kinds as a volume in space. Available IUPUI courses in graphics follows:

• 550 Computer Graphics (3 cr.)
• 552 Adv Graphics & Visualization (3 cr.)

Bioinformatics is covered in the core curriculum as four 90-minute lectures that cover the various genomic (including protein and protein interaction) databases, heuristic, and mathematical, methods for finding sequence similarities and predicting function, ab-initio methods for predicting the shape of macromolecules, direct measure of protein configuration through x-ray defraction and spectrophotometry techniques, and the analysis of micro array data. We also have a whole day course in Hidden Markov Models and lectures in neuro networks given by invited lecturers.

For fellows who have a special interest in bioinformatics a number of formal courses on the biology and computational side are available as listed below. IUPUII offers a masters degree in bioinformatics and the courses are listed as follows.

• Genetic Linkage (G580) - covers basic human genetics
• BIOL L519 Bioinformatics: Theory and Application (3 cr.)
• BIOL L529 Bioinformatics in Molecular Biology and Genetics: Practical Applications (4 cr.)
• C571 Chemical Information Technology (3 cr.)
• C572 Computational Chemistry and Molecular Modeling (3 cr.)
• Molecular Biology (G890) - a 3-week introductory course in the summer

Institutional Data Management and Practicum Experience

Both of the hospital systems, Wishard and Clarian, where the RMRS provides service to day-to-day care, have committed to accept our medical informatics fellows as regular members on hospital computer committees. We will place each fellow on a hospital committee or task force organized to select or implement a commercial clinical computer system. These task forces reveal the range of products and functions available in a particular clinical nitch (eg. pharmacy system, cardiac cath system), reveal the strengths and weakness of the institutional decision processes, and provide opportunities for a medical informatics trained individual to contribute. All of our current fellows have been members of such committees. Indeed, one is developing the solution to the committee's problem. The hospitals will also accept a fellow in a 3-6 month internship role related to informatics management problems- in the case that a fellow wants to follow the institutional information management track.

Computer Language Competency

We require fellows to have, or to develop, competency in a modern computer language so that they have some real understanding about system development and the ability to implement projects that require some degree of programming effort. We favor JAVA, but will accept other alternatives depending upon the fellows' primary interest. We will provide a few session starter course on JAVA in the summer, with the expectation that some fellows will have skills to acquire competence in JAVA with self study and help from faculty. A 3-hour Computer Science course in JAVA is available as an eight week session in the summer and as a full semester course in the fall. We will recommend it to many fellows.

IUPUI offers beginners and advanced computer science courses in JAVA, Visual Basic and PERL as follows:

• N307 Intro to Programming Using JAVA (3 cr.)
• N345 Advanced Programming, JAVA (3 cr.)
• N331 Visual Basic Programming & PERL (3 cr.)

Weekly Session with Medical Informatics Fellowship Director

These sessions are used to track, and provide advice, regarding fellows' projects, discuss special topics requested by the fellows. These hours will also be used to cover special topics as requested by the fellows, planned topics based on special reading, including writing skills (Revising Prose by Lanham, RA, Needham Heights: Allyn & Bacon, 1992), modern development strategies (Wicked Problems, righteous solutions: a catalogue of modern software engineering paradigms by DeGrace P, Stahl LH. Englewood Cliffs, NJ: Prentice-Hall, Inc., 1990 and Extreme Programming Explained: Embrace Change (XP Series) by Kent Beck, Addison-Wesley Pub.Co., 1999). The open source movement (The Cathedral and The Bazaar by Eric S. Raymond, O'Reilly & Associates, Inc., 1999, 2001),as well as special topics in medical informatics text books (Handbook of Medical Informatics by Van Bemmel JH, Musen MA, eds., New York: Springer-Verlag, 1997 and Medical Informatics: Computer Applications in Health Care by Shortliffe EH, Perreault LE, eds., Reading, MA: Addision-Wesley Publishing Co., 1990).

Training in Research Methods

The IU Medical Center's fellowship training in primary care and health services research have been very strong, well-funded, and consistently productive (of both research reports and academic faculty) during the past 15 years. This is important to this proposal, because:

• Medical informatics curriculum for research design, clinical trial, epidemiology, grant application skill, comes en block from the research methods curriculum. Medical informatics fellows are required to take the core series of lectures in research methods
• The research method fellowship has developed a masters degree program in research methods "Clinical Investigator Training Enhancement (CITE) Program". Medical informatics fellows can also obtain masters degree with a special emphasis in Medical Informatics through this program.

Lectures have been organized, honed, and in many cases, taught by Dr. Kroenke for the past 5 years. The competencies and topics in these lectures come from these experiences, as well as a review of the literature on clinical research training.

General Research Methods

This is a required curriculum for all medical informatics fellows. It is taught in the first half of the year at two 90-minutes sessions per week. Upon completion, trainees will have the skills to:

• Initiate a research project
• Critically appraise the literature using principles of evidence-based medicine
• Define, differentiate, and critique major types of study designs
• Understand instruments and methods for measuring health status, quality of care, and other nonphysiological data.

The required textbooks for this course are "Clinical Epidemiology:A Basic Science for Clinical Medicine" 2nd Ed., Sackett DL, et al (Little, Brown and Co, 1991), and "Epidemiology in Medicine", Hennekens C, Buring J (Little, Brown and Co, 1987). Many of the individual sessions will have selected readings that will be compiled as a course syllabus.

Randomized Clinical Trials

This is an existing course required for all medical informatics fellows. It is taught in the second half of the academic year at two 60-minute sessions per week. Upon completion, trainees will have the skills to:

• Understand thoroughly the major stages involved in conducting a randomized clinical trial
• Be familiar with the regulatory issues related to clinical trials.

The required textbooks for this course are "Fundamentals of Clinical Trials", Friedman LM, Furberg CD, DeMets DL. (Mosby, 1996).

The General Medicine and Specialty research fellows in Dr. Kroenke's Research Methods program are required to take one course in statistics, Biostatistics G651, that teaches basic statistical principles, categorical data analysis, analysis of variance, correlations, problems of multiple comparisons, and non parametric statistics, as well as how to use the SAS statistical analysis program to perform such analyses. The required textbook is "Introduction to Probability and Statistics", 10th Ed., by Mendenhall, Beaver, and Beaver. This course is an elective for medical informatics fellows whose curriculum is full of other required subjects, but about 2/5ths of the medical informatics fellows have taken it.

A second semester in statistics is available as one of the research method electives:

• Biostatistics (G652) - a follow-up course to the Biostatistics course in the curriculum. Covers multiple linear regressions, logistic regression, ANCOVA, survival analysis, etc.

Professional Development Seminars

A series of six 90-minute interactive seminars covering important skills in professional development, taught by Stephen Bogdewic, PhD, Vice-Chairman of Family Practice.

General Writing and Grant Writing Skills

Medical informatics fellows will be taught to improve their writing skills through four mechanisms; first, through a short series of lectures given as part of the medical informatics fellowship. These sessions use "How to Write and Publish Papers in the Medical Sciences" by HJ Huth, Philadelphia: ISI Press, 1982. Second, as part of the dedicated time in the weekly fellowship director sessions, the fellows will be required to read "Revising Prose" by RA Lanham, Needham Heights: Allyn & Bacon 1992. During the sessions the fellows will examine samples of their own, writing in light of Lanham's rules in order to improve their writing and re-writing skills. All fellows will also be required to participate in the biennial course taught in the Regenstrief Institute by Duke Professor George Gopen, well known for his course in scientific writing from the reader's point of view (50). This is taught as a full 2-day course. This course has been provided and paid for biennially by the Regenstrief Institute.

In addition, the fellows are expected to submit a paper and write their project in the form of an NIH grant. The fellowship director will assist each of the fellows in improving the prose in their submitted papers by helping them to re-write them. Fourth, during the last three months of his/her first fellowship year, each fellow will be required to write a grant application that will describe his/her plans for an informatics developmental project to be initiated and completed in Year 2. They will use PHS form 398, and will include all of the standard sections e.g., Specific Aims, Background and Significance, Research Plan, Human Subjects, and a listing of the Literature Cited. The fellows' primary mentor will help the fellow to polish the writing in this document.

The didactic portion of the fellowship consists of a series of lectures delivered by the faculty and invited speakers.

Plan for Instruction in the Responsible Conduct of Research

There will be several components to this curriculum. First, fellows will each complete the five-part series produced by the American Association for the Advancement of Science (AAAS) and funded by the NIH, entitled "Integrity in Scientific Research". This is a video vignette series with a resource and discussion guide that covers the following topics: Role and responsibilities of mentors and lab chiefs; Determination of authorship; Allocation of credit; Impact of legal rules on conduct of science; Data retention, selection, sharing, and reporting; Sloppiness in research; Pressures in the research environment; Scientific misconduct and institutional responses; Whistle blowing; Peer review; Use of animals in research; Intellectual property; Privileged information; Responsibilities of collaborators. Second, all fellows will take the Indiana University web-based 2-part course, entitled "Guidelines and Policies on Research of Human Subjects" and "Conflict of Interest". They will be required to pass the examination for this course. Third, each fellow's research protocol, including Human Use issues, will be reviewed by a senior faculty scientist. Their projects will also require IRB approval.