Computers and Medicine Helmuth F. Orthner, Series Editor Springer Science+Business Media, LLC Computers and Medicine Use and Impact of Computers in Clinical Medicine James G. Anderson and Stephen J. Jay (Editors) Information Systems for Patient Care Bruce I. Blum (Editor) A Clinical Information System for Oncology John P. Enterline, Raymond E. Lenhard, Jr., and Bruce I. Blum (Editors) Evaluation Methods in Medical Informatics Charles P. Friedman and Jeremy C. Wyatt (Editors) HELP: A Dynamic Hospital Information System Gilad J. Kuperman, Reed M. Gardner, and T. Allan Pryor Expert Critiquing Systems Perry L. Miller Selected Topics in Medical Artificial Intelligence Perry L. Miller (Editor) Implementing Health Care Information Systems Helmuth F. Orthner and Bruce I. Blum (Editors) Computer-Assisted Medical Decision Making, Volume 1 James A. Reggia and Stanley Tuhrim (Editors) Computer-Assisted Medical Decision Making, Volume 2 James A. Reggia and Stanley Tuhrim (Editors) Nursing and Computers: An Anthology Virginia K. Saba, Karen A. Rieder, and Dorothy B. Pocklington (Editors) Knowledge Engineering in Health Informatics Homer R. Warner, Dean K. Sorenson, and Omar Bouhaddou Charles P. Friedman Jeremy C. Wyatt Evaluation Methods in Medical Informatics Foreword by Edward H. Shortliffe With 40 Illustrations Springer Charles P. Friedman, Ph.D. Jeremy C. Wyatt, M.B., B.S., D.M., M.R.C.P. Formerly Assistant Dean for Medical Consultant, Medical Informatics Education and Informatics, University of Imperial Cancer Research Fund North Carolina P.O. Box 123 Professor and Director Lincoln's Inn Fields Center for Biomedical Informatics London WC2A 3PX, UK University of Pittsburgh 8074 Forbes Tower Pittsburgh, PA 15213, USA Contributors: Bonnie Kaplan, Ph.D. Allen C. Smith, m, Ph.D. Associate Professor, Computer Science! Assistant Professor and Associate Director Information Systems Office of Educational Development Director, Medical Information Systems Program CB 7530-322 MacNider Building School of Business University of North Carolina School of Quinnipiac College Medicine Hamden, cr 06518, USA Chapel Hill, NC 27599, USA Series Editor: Helmuth F. Orthner, Ph.D. Professor of Medical Informatics University of Utah Health Sciences Center Salt Lake City, UT 84132, USA Library of Congress Cataloging-in-Publication Data Evaluation methods in medical informatics/Charles P. Friedman, Jeremy C. Wyatt, with contributions by Bonnie Kaplan, Allen C. Smith m p. cm.-(Computers and medicine) Includes bibliographical references and index. 1. Medical informatics--Research--Methodology. 2. Medicine-Data processing-Evaluation. I. Friedman, Charles P. II. Wyatt, J. (Jeremy) m. Series: Computers and medicine (New York, N.Y.) [DNLM: 1. Medical informatics. 2. Technology, Medical. 3. Decision Support Techniques. W 26.55.A 7 E92 1996] R858.E985 1996 610.285--dc20 96-18411 Printed on acid-free paper. © 1997 Springer Science+Business Media New York Originally Published by Springer-Verlag New York, Inc. in 1997 Softcover reprint of the hardcover 1st edition 1997 All rights reserved. This work may not be translated or copied in whole or in part without the written permission of the publisher (Springer-Verlag New York, Inc., 175 Fifth Avenue, New York, NY 10010, USA), except for brief excerpts in connection with reviews or scholarly analysis. Use in con nection with any form of information storage and retrieval, electronic adaptation, computer software, or by similar or dissimilar methodology now known or hereafter developed is forbidden. The use of general descriptive names, trade names, trademarks, etc., in this publication, even if the for mer are not especially identified, is not to be taken as a sign that such names, as understood by the Trade Marks and Merchandise Marks Act, may accordingly be used freely by anyone. While the advice and information in this book are believed to be true and accurate at the date of going to press, neither the authors, nor the editors, nor the publisher can accept any legal responsibility for any errors or omissions that may be made. The publisher makes no warranty, express or implied, with respect to the material contained herein. Production coordinated by Carlson Co. and managed by Natalie Johnson; manufacturing supervised by Jeffrey Taub. Typeset by Carlson Co., Yellow Springs, OH, from the authors' electronic files. 9 8 765 432 1 ISBN 978-1-4757-2687-9 ISBN 978-1-4757-2685-5 (eBook) DOI 10.1007/978-1-4757-2685-5 To Pat and Sylvia Foreword As director of a training program in medical informatics, I have found that one of the most frequent inquiries from graduate students is, "Although I am happy with my research focus and the work I have done, how can I design and carry out a practical evaluation that proves the value of my contribution?" Informatics is a multifaceted, interdisciplinary field with research that ranges from theoretical developments to projects that are highly applied and intended for near-term use in clinical settings. The implications of "proving" a research claim accordingly vary greatly depending on the details of an individual student's goals and thesis state ment. Furthermore, the dissertation work leading up to an evaluation plan is often so time-consuming and arduous that attempting the "perfect" evaluation is fre quently seen as impractical or as diverting students from central programming or implementation issues that are their primary areas of interest. They often ask what compromises are possible so they can provide persuasive data in support of their claims without adding another two to three years to their graduate student life. Our students clearly needed help in dealing more effectively with such dilem mas, and it was therefore fortuitous when, in the autumn of 1991, we welcomed two superb visiting professors to our laboratories. We had known both Chuck Friedman and Jeremy Wyatt from earlier visits and professional encounters, but it was coincidence that offered them sabbatical breaks in our laboratory during the same academic year. Knowing that each had strong interests and skills in the areas of evaluation and clinical trial design, I hoped they would enjoy getting to know one another and would find that their scholarly pursuits were both complementary and synergistic. To help stir the pot, we even assigned them to a shared office that we try to set aside for visitors, and within a few weeks they were putting their heads together as they learned about the evaluation issues that were rampant in our laboratory. The contributions by Drs. Friedman and Wyatt during that year were mar velous, and they continue to have ripple effects today. They served as local con sultants as we devised evaluation plans for existing projects, new proposals, and student research. By the spring they had identified the topics and themes that needed to be understood better by those in our laboratory, and they offered a well received seminar on evaluation methods for medical information systems. It was out of the class notes formulated for that course that the present volume evolved. vii viii Foreword Its availability will allow us to rejuvenate and refine the laboratory's knowledge and skills in the area of evaluating medical information systems, so we have eagerly anticipated its publication. This book fills an important niche that is not effectively covered by other med ical informatics textbooks or by the standard volumes on evaluation and clinical trial design. I know of no other writers who have the requisite knowledge of sta tistics coupled with intensive study of medical informatics and an involvement with creation of applied systems as well. Drs. Friedman and Wyatt are scholars and educators, but they are also practical in their understanding of the world of clinical medicine and the realities of system implementation and validation in set tings that defy formal controlled trials. Thus the book is not only of value to stu dents of medical informatics but will be a key reference for all individuals involved in the implementation and evaluation of basic and applied systems in medical informatics. EDWARD H. SHORTLIFFE, M.D., PH.D Section of Medical Informatics Stanford University School of Medicine Series Preface This monograph series intends to provide medical information scientists, health care administrators, physicians, nurses, other health care providers, and computer science professionals with successful examples and experiences of computer appli cations in health care settings. Through these computer applications, we attempt to show what is effective and efficient, and hope to provide guidance on the acquisi tion or design of medical information systems so that costly mistakes can be avoided. The health care provider organizations such as hospitals and clinics are experi encing large demands for clinical information because of a transition from a "fee for-service" to a "capitation-based" health care economy. This transition changes the way health care services are being paid for. Previously, nearly all heath care services were paid for by insurance companies after the services were performed. Today, many procedures need to be pre-approved, and many charges for clinical services must be justified to the insurance plans. Ultimately, in a totally capitated system, the more patient care services are provided per patient, the less profitable the health care provider organization will be. Clearly, the financial risks have shifted from the insurance carriers to the health care provider organizations. In order for hospitals and clinics to assess these financial risks, management needs to know what services are to be provided and how to reduce them without impacting the quality of care. The balancing act of reducing costs but maintaining health care quality and patient satisfaction requires accurate information of the clinical ser vices. The only way this information can be collected cost-effectively is through the automation of the health care process itself. Unfortunately, current health infor mation systems are not comprehensive enough, and their level of integration is low and primitive at best. There are too many "islands" even within single health care provider organizations. With the rapid advance of digital communications technologies and the accep tance of standard interfaces, these "islands" can be bridged to satisfy most infor mation needs of health care professionals and management. In addition, the migration of health information systems to client/server computer architectures allows us to re-engineer the user interface to become more functional, pleasant, and also responsive. Eventually, we hope, the clinical workstation will become the tool that health care providers use interactively without intermediary data entry support. ix x Series Preface Computer-based information systems provide more timely and legible informa tion than traditional paper-based systems. In addition, medical information systems can monitor the process of health care and improve quality of patient care by pro viding decision support for diagnosis or therapy, clinical reminders for follow-up care, warnings about adverse drug interactions, alerts to questionable treatment or deviations from clinical protocols, and more. The complexity of the health care workplace requires a rich set of requirements for health information systems. Fur ther, the systems must respond quickly to user interactions and queries in order to facilitate and not impede the work of health care professionals. Because of this and the requirement for a high level of security, these systems can be classified as very complex and, from a developer's perspective, also as "risky" systems. Information technology is advancing at an accelerated pace. Instead of waiting for three years for a new generation of computer hardware, we are now confronted with new computing hardware every 18 months. The forthcoming changes in the telecommunications industry will be revolutionary. Within the next five years, and certainly before the end of this century, new digital communications tech nologies, such as the Integrated Services Digital Network (ISDN), Asynchronous Data Subscriber Loop (ADSL) technologies, and very high speed local area net works using efficient cell switching protocols (e.g., ATM), will not only change the architecture of our information systems, but also the way we work and manage health care institutions. The software industry constantly tries to provide tools and productive develop ment environments for the design, implementation, and maintenance of informa tion systems. Still, the development of information systems in medicine is an art, and the tools we use are often self-made and crude. One area that needs desperate attention is the interaction of health care providers with the computer. While the user interface needs improvement and the emerging graphical user-interfaces form the basis for such improvements, the most important criterion is to provide relevant and accurate information without drowning the physician in too much (irrelevant) data. To develop an effective clinical system requires an understanding of what is to be done and how to do it, as well as an understanding on how to integrate informa tion systems into an operational health care environment. Such knowledge is rarely found in anyone individual; all systems described in this monograph series are the work ofteams. The size of these teams is usually small, and the composition is het erogeneous, i.e., health professionals, computer and communications scientists and engineers, statisticians, epidemiologists, and so on. The team members are usually dedicated to working together over long periods of time, sometimes spanning decades. Clinical information systems are dynamic systems, their functionality con stantly changing because of external pressures and administrative changes in health care institutions. Good clinical information systems will and should change the operational mode of patient care which, in tum, should affect the functional requirements of the information systems. This interplay requires that medical information systems be based on architectures that allow them to be adapted Series Preface xi rapidly and with minimal expense. It also requires a willingness by management of the health care institution to adjust its operational procedures, and, most of all, to provide end-user education in the use of information technology. While med ical information systems should be functionally integrated, these systems should also be modular so that incremental upgrades, additions, and deletions of modules can be done in order to match the pattern of capital resources and investments available to an institution. We are building medical information systems just as automobiles were built early in this century, i.e., in an ad-hoc manner that disregarded even existent stan dards. Although technical standards addressing computer and communications technologies are necessary, they are insufficient. We still need to develop conven tions and agreements, and perhaps a few regulations that address the principal use of medical information in computer and communications systems. Standardization allows the mass production of low cost parts which can be used to build more com plex structures. What exactly are these parts in medical information systems? We need to identify them, classify them, describe them, publish their specifications, and, most importantly, use them in real health care settings. We must be sure that these parts are useful and cost effective even before we standardize them. Clinical research, health service research, and medical education will benefit greatly when controlled vocabularies are used more widely in the practice of med icine. For practical reasons, the medical profession has developed numerous classi fications, nomenclatures, dictionary codes, and thesauri (e.g., lCD, CPT, DSM-III, SNOMED, COSTAR dictionary codes, BAlK thesaurus terms, and MESH terms). The collection of these terms represents a considerable amount of clinical activi ties, a large portion of the health care business, and access to our recorded knowl edge. These terms and codes form the glue that links the practice of medicine with the business of medicine. They also link the practice of medicine with the literature of medicine, with further links to medical research and education. Since informa tion systems are more efficient in retrieving information when controlled vocabu laries are used in large databases, the attempt to unify and build bridges between these coding systems is a great example of unifying the field of medicine and health care by providing and using medical informatics tools. The Unified Medical Language System (UMLS) project of the National Library of Medicine, NIH, in Bethesda, Maryland, is an example of such an effort. The purpose of this series is to capture the experience of medical informatics teams that have successfully implemented and operated medical information sys tems. We hope the individual books in this series will contribute to the evolution of medical informatics as a recognized professional discipline. We are at the threshold where there is not just the need but already the momentum and interest in the health care and computer science communities to identify and recognize the new disci pline called Medical Informatics. I would like to thank the editors of Springer-Verlag New York for the opportu nity to edit this series. Also, many thanks to the present and past departmental chairmen who allowed me to spend time on this activity: William S. Yamamoto, M.D., and Thomas E. Piemme, M.D., of the Department of Computer Medicine at