Medical Technology Assessment Directory: A Pilot Reference to Organizations, Assessments, and Information Resources (1988)

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MEDICAL TECHNOLOGY ASSESSMENT DIRECTORY A Pilot Reference to Organizations, Assessments, en c! Information Resources Clifforct Goodman, Eclitor COUNCIL ON HEALTH CARE TECHNOLOGY INSTITUTE OF MEDICINE NAnoNAL ACADEMY PRESS Washington, D.C. ~ 98~3

NATIONAL ACADEMY PRESS 2101 Constitution Ave., NW Washington, DC 20418 NOTICE: This Directory, a project of the Council on Health Care Technology of the Institute of Medicine, fulfills in part the provision in Section 309 of Public Law 98-551 that the council serve as a clearinghouse for information on health care technologies and assessments. Activities of the council are supported by private sector contributions and grants (see Appendix B for a list of contributors) and federal matching grants provided by grant number HS 05526 from the National Center for Health Services Research and Health Care Technology Assessment. Program representatives who consider their program, or others, to be appropriate for future revisions of the Directory should contact the Council on Health Care Technology, Institute of Medicine, 2101 Constitution Ave., NW, Washington, DC 20418. Subscription to the council's quarterly newsletter, CHCTASSESSMENT, may be obtained for $20 per year from the same address. The Institute of Medicine was chartered in 1970 by the National Academy of Sciences to enlist distinguished members of the appropriate professions in the examination of policy matters pertaining to the health of the public. In this, the Institute acts under both the Academy's 1863 congressional charter responsibility to be an advisor to the federal government and its own initiative in identifying issues of medical care, research, and education. Library of Congress Cataloging-in-Publication Data Medical technology assessment directory: a pilot reference to organizations, assessments, and information resources / Clifford Goodman, editor; Council on Health Care Technology, Institute of Medicine. p. cm. Prepared by the Council on Health Care Technology's Information Panel. Includes bibliographies and indexes. ISBN 0-309-03829-4 1. Medical technology-United States-Directories. 2. Medical technology-Directories. I. Goodman, Clifford. II. Council on Health Care Technology (Institute of Medicine). Information Panel. [DNLM: 1. Technology Assessment, Biomedical-United States- directories. W 22 AA1 M4916] R855.3.M43 1988 610'.28~c19 DNLM/DLC for Library of Congress Copyright ~ 1988 by the National Academy of Sciences 88-5358 CIP No part of this book may be reproduced by any mechanical, photographic, or electronic process or in the form of a phonographic recording, nor may it be stored in a retrieval system, transmitted, or otherwise copied for public or private use, without written permission from the publisher, except for the purposes of official use by the United States Government. Printed in the United States of America

INFORMATION PANEL OF THE COUNCIL ON HEALTH CARE TECHNOLOGY LAWRENCE C. MORRIS Senior Vice President, Health Benefits Management, Blue Cross and Blue Shield Association, Chicago, Illinois (Chairman" GAIL L. WARDEN President and Chief Executive Officer, Group Health Cooperative of Puget Sound, Seattle, Washington (Co-Chairman) MORRIS F. COLLEN Consultant, Division of Research, Kaiser Permanente Medical Care Program, Oakland, California RICHARD C. FARMER Chairman, Division of Medicine, The Cleveland Clinic Foundation, Cleveland, Ohio MELVIN A. GLASSER Director, Health Security Action Council, Washington, D.C. G. MAX K. HUGHES Vice President, Systems and Communication, Pfizer Pharmaceuticals, New York, New York RICHARD J. JOHNS Massey Professor and Director, Department of Biomedical Engineering, Johns Hopkins University and Hospital, Baltimore, Maryland DONALD A.B. LINDBERG Director, National Library of Medicine, National Institutes of Health, Bethesda, Maryland WALTER B. MAHER Director, Employee Benefits and Health Services, Chrysler Corporation, Detroit, Michigan ROSIN H. MOXLEY, III President, MetaMedical Inc., Beverly Hills, California C. THOMAS SMITH President, Yale-New Haven Hospital, New Haven, Connecticut GEORGE E.T. STEBBING Director, Professional Activities, Office of the Secretary of Defense, Health Affairs, Washington, D.C. Project Staff CLIFFORD S. GOODMAN, Staff Officer LESLIE M. HARDY, Research Associate PAMELA J. SIMERLY, Research Associate  ·.- 111

COUNCIL ON HEALTH CARE TECHNOLOGY WILLIAM N. HUBBARD, JR. former President, The Upjohn Company, Hickory Corners, Michigan (Chairman) JEREMIAH A. BARONDESS . Irene F. and I. Roy Psaty Distinguished Professor of Clinical Medicine, Cornell University Medical College, New York, New York (Co-Chairman) HERBERT L. ABRAMS Professor of Radiology, Stanford University School of Medicine, Stanford, California RICHARD E. BEHRMAN Dean, School of Medicine, Case Western Reserve University, Cleveland, Ohio PAUL A. EBERT Director, American College of Surgeons, Chicago, Illinois PAUL S. ENTMACHER Senior Vice President and Chief Medical Director, Metropolitan Life Insurance Company, New York, New York MELVIN A. GLASSER Director, Health Security Action Council, Washington, D.C. GERALD D. LAUBACH President, Pfizer Inc., New York, New York WALTER B. MAHER Director, Employee Benefits and Health Services, Chrysler Corporation, Detroit, Michigan ROBERT FI. McCAFFREY Chairman and Chief Executive Officer, C.R. Bard Inc., Murray Hill, New Jersey iv LAWRENCE C. MORRIS Senior Vice President, Health Benefits Management, Blue Cross and Blue Shield Association, Chicago, Illinois FREDERICK MOSTELLER Roger I. Lee Professor, Harvard School of Public Health, Boston, Massachusetts MARY O. MUNDINGER Dean, School of Nursing, Columbia University, New York, New York  ANNE A. SCITOVSKY Chief, Health Economics Department, Palo Alto Medical Foundation, Palo Alto, California C. THOMAS SMITH President, Yale-New Haven Hospital, New Haven, Connecticut GAIL L. WARDEN President and Chief Executive Officer, Group Health Cooperative of Puget Sound, Seattle, Washington Stay ENRIQUETA C. BOND, Director, Division of Health Promotion and Disease Prevention RICHARD A. RETTIG, Director KATHLEEN N. LOHR, Senior Staff Officer ROBIN WEISS, Senior Staff Officer CLIFFORD S. GOODMAN, Staff Officer LESLIE M. HARDY, Research Associate PAMELA I. SIMERLY, Research Associate BOBBIE I. ALEXANDER, Assistant to the Director ANNETINE C. GELIJNS, International Fellow CHARLENE E. GREENE, Senior Secretary PATRICIA M. O'NEAL, Senior Secretary BRENDA E. PATTERSON, Senior Secretary

ACKNOWLEDGMENTS A novel effort to assemble information from diverse sources, this Directory called for a blend of experience, original thinking, and resolve. We wish to acknowledge those who contributed these qualities to the project. O We are grateful to the members of the Information Panel for lending their experience in health plan and facility management, medicine, bioengineering, health care product development, third party payment, medical informatics, and national health policy to building a technology assessment information capacity. Of import to meeting this, the first charge of the congressional mandate for the council, is the members' ability to coalesce their sectorial interests into a group effort of needs assessment, systems design, product development, strategic planning, and marketing. Pamela Simerly deserves special recognition for her skill and perseverance in helping to plan the project, and in assembling, reviewing, and processing information used for the assessment program profiles. Leslie Hardy collected and organized descriptive infor- mation for many of the entries in the information and data reso',rrec nary of the ~ . ~ . . ~ ~rectory. Wallace Watertall and James Gormley provided advice on editorial matters and layout. Peter Goldschmidt's knowledge of information systems, medicine, and management made him a worthy consultant to the project. He brought systematic thinking and thoroughness to matters ranging from reviewing for relevance thousands of assess- ment report citations to setting the project within a long range plan. Grace McCarn provided insightful consultation regarding the needs and capabilities of the medical information community relevant to this project, including technical aspects of such matters as indexing, production, and market placement. Since the early stages of the project, we have sought counsel from leading institutions in management of health care information systems. The staff of the National Library of Medicine has been consistently forthcoming with constructive advice. NLM's Betsy Humphreys coordinated planning sessions with key library staff to share technological expertise and to formulate strategies for development of a broadly integrated technol- ogy assessment information base. The review undertaken by NLM staff of the Directory provides encouraging evidence of the utility of this body of information. Guidance concerning the design and implementation of information bases for the health commu- nity was provided by Eloise Foster and staff of the American Ho.snit~1 A.csori~tion Resource Center and by LeRoy Walters and stati of the K,~nneriv Inctir,,r`~ of Fthirc Georgetown University. HATE 1 __ 1 ·.1 .1 . ~ . ~ ~ ~CAM ~ ·~V<~- · HAVE AA ~BAND ^~_~] ISAAC._ ~F1 ~1~111~ YY ~ "l C V~1 y I Witi} til~ work or Ine 1 K1 1 ~1N corporation, which was responsible for assembling the information base of assessment program profiles and report cita- tions, indexing of citation records, and preparing camera-ready copy of the Directory. Meriting special recognition are Patricia President, who coordinated all aspects of the contractor's effort, and Linda Malcom, who had a key role in indexing a disparate and technical body of literature. This resourceful and adaptive group also included Patricia Chang and Karen Inscoe, who were resnon.sible for nrn~r~mmin~ car] Bits ~~7 corporate officer Edsel Billingy. --Rae rA~-~- ~ Finally, we thank the people associated with the organizations described in the Directory who completed surveys and forwarded other material incorporated here. Many of these individuals are shown as contact persons for the profiled assessment programs and the resource organizations in the Directory. Lawrence C. Morris, Chairman, Information Panel Clifford S. Goodman, Staff Officer v

FOREWORD The Medical Technology Assessment Directory is the first major published work of the Council on Health Care Technology. The Directory is an introductory vehicle that organizes recent and current assessment information from a broad though not com- prehensive selection of assessment programs and related activities. With this edition, the council makes an overture to those with interests in medical technology assessment to become partners in building a wider and more integrated information network. How users respond to the Directory will help to determine which among a variety of ways this information capacity will evolve. The council was mandated by the U.S. Congress in the Health Promotion and Disease Prevention Amendments of 1984 (P.L. 98-551) and by technical amendments made in 1985 (P.L. 99-117~. The purpose of the council is to promote the development and application of technology assessment in health care and to review health care technol- ogies for their appropriate use. Provision for the council in P.L. 98-551 was the culmination of two streams of activity conducted under the auspices of the Institute of Medicine, National Academy of Sciences. The first was the initiative to create an entity, supported jointly by the private and public sectors, to enhance the assessment of medical technology. The second was a comprehensive study of the state of medical technology assessment. In December 1982, the Institute of Medicine established the Committee to Plan a Private/Public Sector Entity to Assess Technology in Medical Care under the chairman- ship of Jeremiah Barondess. The committee was charged with developing a plan for a technology assessment organization that would be based in the private sector but supported by both government and non-governmental parties~. This initiative grew out of an exploratory meeting convened by the Institute on June 16, 1982, in response to growing concerns in both the public and private sectors about the proliferation of technologies in medical care. These concerns were characterized by pressures to elimi- nate technologies that may be obsolete, harmful, or ineffective; desires to affirm the benefits of other technologies; and stringencies of the need to slow the growth of costs while maintaining and improving the quality of American medical care. The committee completed its work on June 30, 1983. The final report, published in November 1983, recommended the creation of a medical technology assessment con- sortium within the Institute of Medicine. The consortium was conceived of as seeking support divided approximately evenly between governmental and non-governmental resources. It was not intended as a competitor or as a replacement for any existing entity involved in assessing medical technologies. Rather, it was to be complementary and facilitative of the efforts of others involved in responsible assessments. As a first step, the consortium was to establish and maintain an information clearinghouse for medical technology assessment. This clearinghouse function would help to build a communication network among the principal parties to technology assessment, includ- ing other technology assessment entities, third party payers, major health care provid- ers, and others; serve to reduce unneeded or unrecognized redundancies in evalua- tion; establish a source of information on completed and ongoing assessments; provide a forum for all the parties at interest in the development and validation of technologies; and facilitate the dissemination of information on medical technology assessments. Subsequent to legislation enacting the ideas in the committee's report, the Council on Health Care Technology was formed in March 1986. At its first meeting in April 1986, the council created the Information Panel to plan and establish the clearinghouse. This Directory is the Information Panel's first substantive product. ·. V11

MEDICAL TECHNOLOGY ASSESSMENT DIRECTORY Another Institute committee, the Committee for Evaluating Medical Technologies in Clinical Use, under the chairmanship of Frederick Mosteller, was charged with examin- ing the state of medical technology assessment. This study was begun following a 1980 Institute conference on linking the clinical use of biomedical technologies and the collection of evaluative data. Major areas addressed in the committee's 1985 study report, Assessing Medical Technologies2, included the scope of medical technology assess- ment in the U.S., methods of assessment, effects of clinical evaluation on the diffusion of medical technology, the relationship of assessment and reimbursement policy, as sessment activities In other countries, and papers on such topics as clinical trials, cost-effectiveness, and values and preferences in health care delivery. Also included were detailed profiles of 20 technology assessment programs in the U.S. and topics of their respective assessment reports. The work on the scope of medical technology assessment and the program profiles constituted important groundwork for this Direc- tory, just as the entire study report has been a touchstone for the deliberations of our council. On behalf of the Council on Health Care Technology, I trust you will find the Directory a useful working document. The council plans to expand and update the Directory periodically, and intends to make its information base available in a machine readable format. If you think that your organization, or another organization, has an assessment program that ought to be incorporated in an updated Directory, please let us know. We welcome your comments. William N. Hubbard, Jr., Chairman References 1. Institute of Medicine Committee to Plan a Private/Public Sector Entity to Assess Technology in Medical Care. Planning study report: a consortium for assessing medical technology. Washington, D.C.: National Academy Press, 1983. 2. Institute of Medicine Committee for Evaluating Medical Technologies in Clinical Use. Assessing medical technologies. Washington, D.C.: National Academy Press, 1985. · ~ ~ vail

PREFACE During the last decade, various sectors of the health care enterprise have taken a con- verging interest in determining the safety, effectiveness, cost-effectiveness, and social, ethical, and legal impacts of health care technologies. Each of these sectors physicians and other health professionals, patients and other consumers, biomedical researchers, health product makers, third party payers, health plan managers, institutional adminis- trators, academicians, public policy makers, and others tends to rely on some famil- iar, though different. set of literature and information sources in an attempt to meet assessment needs. Although more of the health care community has taken explicit interest in medical technology assessment, there remain inadequacies in the supply of good assessment information and the manner in which existing information is organized and made available to those who need it. I have learned as a committee member for the Institute of Medicine study Assessing Medical Technologies and from the perspective of a health care payer that the demand for assessment information is outstripping the aggregation of well conducted clinical trials, authoritative group judgments, surveillance studies, and other inquiries concerning medical technologies. Therefore, as we encourage an increase in competent assessment activity, we seek to assemble what good assessment findings there are, both from our traditional sources and from sources that are new to us. As the emerging field of medical technology assessment becomes the shared prov- ince of multiple health industry sectors, each one stands to benefit by gaining familiar- ity with and access to new information resources. Further, we seek to identify a coher- ent body of assessment literature from which all of us may benefit. In authorizing the Council on Health Care Technology, Congress specified establish- ment of a clearinghouse on medical technology assessment information. The Medical Technology Assessment Directory is the first major step toward fulfilling this purpose. It encompasses programs that produce medical technology assessments, information and data resources, and other organizations to which inquiries about medical technology can be directed. An important contribution of the Directory is to make a first attempt at organizing certain valuable "gray" or "fugitive" literature, i.e. technology assessments not published in widely circulated peer reviewed medicaljournals or accessible through the better known citation bases such as the National Library of Medicine's (NLM) MED- LARS (Medical Literature Analysis and Retrieval System). Thus, this Directory describes relevant mainstream information sources, and complements them with its collection of . . pertinent gray literature. Assessments cited in this first edition of the Directory are limited to those produced by organizations with an ongoing medical technology assessment program. Future ver- sions, whether in hard-copy or machine readable format, will expand coverage to in- clude more and different sources of literature. For purposes of indexing the assess- ment report citations, we have used NLM's MeSH (Medical Subject Headings) terms wherever possible. In the technology thesaurus particularly, we have begun to craft a controlled vocabulary that builds upon MeSH terms to make the indexing as relevant as practical to the technology assessment community. The Directory is intended to be a resource to the wider technology assessment communi- ty. We hope that this edition, with alphabetical listings of organizations, contact infor- mation, descriptions of activities, list of defined acronyms, indexes, and a thesaurus of technology terms designed to lead different types of users to assessments of interest, will be a worthy guide to this multidisciplinary field. Because it assembles and organizes .

MEDICAL TECHNOLOGY ASSESSMENT DIRECTORY a strong sample of assessment activity rather than being an exhaustive compendium, we view it as a prototype for a more comprehensive, adaptive information base for medical technology assessment. The Directory is the first substantive product of the council's Information Panel. In future months and years, the Information Panel plans to work with the NLM to aug- ment the Library's MeSH vocabulary and certain files of organizational based informa- tion, produce access guides to standard literature sources, enhance and update the Directory, institute clearinghouse services, and establish online access to the Directory information base. We hope that the Directory will enhance communication in the assess- ment community, and will prompt greater participation in development of our clear . . . . ng. souse activities. Lawrence C. Morris, Chairman, Information Panel

CONTENTS Introduction Guide to the Directory's Contents xxix Ways to Use the Directory Glossary of Acronyms . . . . . ... XV11 .............. xxxvii Part 1: Assessment Program Profiles and Report Citations American Academy of Neurology, Practice Committee 3 American Academy of Ophthalmology, Ophthalmic Procedures Assessment Program American Academy of Pediatrics American College of Cardiology/American Heart Association, Task Force on Assessment of Cardiovascular Procedures American College of Obstetricians and Gynecologists, Committee Opinions American College of Obstetricians and Gynecologists, Committee on Technical Bulletins American College of Physicians, Clinical Efficacy Assessment Project American College of Radiology, Task Force on Breast Cancer American Dental Association, Council on Dental Materials, Instruments, and Equipment American Dental Association, Council on Dental Therapeutics American Diabetes Association American Gastroenterological Association, Patient Care Committee American Hospital Association, Hospital Technology Series Program American Medical Association, Council on Scientific Affairs American Medical Association, Diagnostic and Therapeutic Technology Assessment Program American Medical Association, Drug Evaluations American Society for Gastrointestinal Endoscopy, Committee on Technology Assessment ............... Battelle Memorial Institute Blue Cross and Blue Shield Association, Medical Necessity Program Blue Cross and Blue Shield Association, Technology Evaluation and Coverage Program Brandeis University Health Policy Center, Organ Procurement Project California Medical Association, Medical Practice Opinion Program CBO National Organization for Quality Assurance in Hospitals, Consensus Development Program (Netherlands) College of American Pathologists, Surveys Program Congress of the United States, Office of Technology Assessment Health Program Duke University, Center for Health Policy Research and Education ECRI Health Devices Program ECRI Technology Assessment Program Food and Drug Administration (Overview) 93 Food and Drug Adminstration, Center for Devices and Radiological Health 94 Food and Drug Administration, Center for Drugs and Biologics 108 6 9 14 16 18 22 27 31 34 44 47 51 52 56  58 61 63 65 70 72 75 81 84 88 X1

MEDICAL TECHNOLOGY ASSESSMENT DIRECTORY Food and Drug Administration, Center for Food Safety and Applied Nutrition .................................................. Georgetown University Medical Center, Institute for Health Policy Analysis . . . Harvard School of Public Health, Institute for Health Research Hastings Center ....................................................... Health Care Financing Administration, Bureau of Eligibility, Reimbursement, and Coverage ..... Health Care Financing Administration, Office of Research and Demonstrations Health Council of The Netherlands ..... Health and Welfare Canada, Health Services and Promotion Branch .... Johns Hopkins Program for Medical Technology and Practice Assessment .... Kings Fund Centre for Service Development, Kings Fund Forum Consensus and Controversies in Medicine ........................................ Lewin and Associates, Inc., Medical Technology Group ..................... Linkoping University, Center for Medical Technology Assessment ........... McGill University, Department of Epidemiology and Biostatistics ............ McMaster University, Department of Clinical Epidemiology and Biostatistics . . Medical Research Council, National Health and Welfare Canada ............ Medical Technology and Practice Patterns Institute ........................ National Center for Health Services Research and Health Care Technology Assessment (Overview) ................................ National Center for Health Services Research and Health Care Technology Assessment, Division of Extramural Research ............ National Center for Health Services Research and Health Care Technology Assessment, Office of Health Technology Assessment ...... National Health Research and Development Program (Canada) National Heart, Lung, and Blood Institute ................... National Institute of Child Health and Human Development . . . National Institutes of Health, Consensus Development Program National Library of Medicine ........................................... Netherlands Organization for Applied Scientific Research, Medical Technology Unit (TNO) .... Policy Analysis, Inc.............. Project HOPE Center for Health Affairs ..... Prospective Payment Assessment Commission . . . Steering Committee on Future Health Scenarios, Commission on Future Health Care Technology ....................................... Swedish Planning and Rationalization Institute of Health Services ......... United Kingdom Department of Health and Social Security, Supplies Technology Division ............................................. U.S. Administrators, Inc............................................ University of California, San Francisco, Institute for Health Policy Studies University of Lausanne, Institute of Social and Preventive Medicine ...... University of Pennsylvania, Leonard Davis Institute of Health Economics . Veterans Administration, Cooperative Studies Program ........... Veterans Administration, Health Services Research and Development Service ....................... Assessment Report Code Prefixes Index to Report Citations .................. ·e X11 . 118 120 . 123 126 . . . . . 129 134 141  144 147 150 151 153 156 159 162 165 168 169 176 182 191 202 205 210 213 215 216 219 223 225 227 232 236 239 241 244 248 254

CONTENTS Part 2: Assessment Report Citations Listed by Technology Technology Thesaurus 313 Assessment Report Citations by Technology 361 Part 3: Information and Data Resources Categories of Ir~formation and Data Resources . Abstracts of Health Care Machine-Readable Data Files ................. Alcohol, Drug Abuse, and Mental Health Administration Publications and Data ................................. AMA/NET ............................. Baseline Reports ..................................................... BIOETHICSLINE ............................... Birth Defects and Developmental Disabilities Reports BMEDSS ...................................... Boston Collaborative Drug Surveillance Program . . . BPS/SEARCH ........................................... CANCERLIT ............................ CASSIS (Classification and Search Support Information System) ........... CCC Bibliography on Regional Variations in Health Care .................. Center for Health Promotion and Education .............. CLINPROT .................................................... COLLEAGUE ............................................... COMPASS and DURbase .... Compendium of HHS Evaluations and Relevant Other Studies . . . CPHA Files ................................................ CRISP (Computer Retrieval of Information on Scientific Projects) Current Assessments, New Technology Abstracts .... Device Experience Network (DEN) ..................................... DIALOG ............................................................ Directory of Health Services Research Organizations ................... DIRLINE (Directory of Information Resources Online) ................ Drug Product Problem Reporting Program (DPPR) ................... Duke Comprehensive Cancer Center Database ....................... Environmental Hazards and Health Effects Reports .................. Environmental Health Laboratory Sciences Reports .................... FDA Bulletin Board ................................................... F-D-C Reports ........................................................ Futures Program ...................................................... HEALTH (Health Planning and Administration) ............... Health Devices Alerts ..... Health Devices Sourcebook . . Health Information Resources in the Federal Government .................. HEALTHLAWYER ..................................... HECLINET (Health Care Literature Information Network) . . HIAA Medical Appropriateness Compilation High Blood Pressure Information Center ................................. IMPAC (Information for Management Planning Analysis and Coordination) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 501 504 504 505 506 506 507 508 508 509 510  510 511 511 512 513 513 514 515 515 516 517 518 518 519 519 520 521 521 522 523 523 524 525 525 525 526 526 527 528 528 · ·- X111

MEDICAL I~CHNOLOGY ASSESS ~ NT DIRECTORY IMS Audits International Market Research Studies INTERNIST-1/QUICK MEDICAL :REFERENCE (QMR) Market Research Reports : Market/Technology Reports Medical Device and Laboratory Product Problem Reporting Program Medical Device Register Medical Device Reporting (MDR) MEDIS MEDLINE MEDLINK (Massachusetts Medical Information Link) Multi-Client Reports NAHDO (National Association of Health Data Organizations) Resource Manual 537 National Center for Health Statistics Publications and Data 538 National Cholesterol Education Program/NHLBI Smoking Education Program Information Center National Reference File National Technical Information Service Publications and Data NEXIS NHLBI Publications Oxford Database of Perinatal Trials . PDQ (Physician Data Query) Pharmaprojects POPLINE (Population Information Online) Product Development Directory, Product SOS . . Randomized Controlled Clinical Trials Report Collection Report on Cost-Effective Products and Technologies Scrip . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 529 . 530 . 531 . 531 . 532 533 533 . 534 . 535 . 535 536 537 SEER (Surveillance, Epidemiology, and End Results Program) .......... SPRILINE ........................................................... Technical Data Center ......... U.S. Industrial Outlook ......... WHO/LINFO Database on Health Technology Assessment .......... World Health Organization Publications ........................... Subject Index to Information and Data Resources ................. Part 4: Organizational Resources Alliance for Engineering in Medicine and Biology ..... American Academy of Dermatology ................. American Academy of Orthopaedic Surgeons ........ American Academy of Otolaryngology Head and Neck Surgery ........... American Academy of Physical Medicine and Rehabilitation ................ American Association of Blood Banks . . American Association for Medical Systems and Informatics ....... American Association of Tissue Banks ....  American College of Emergency Physicians American College of Gastroenterology . . . American College of Nuclear Physicians .................................. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . XIV . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. 539 539 540 .. 541 .. 541 .. 542 .. 542 ........................... 543 .. 544 .. 544 .. 545 . 545 .. 546 .. 546 547 .. 548 .. 548 .. 549 .. 550 .... 551 . 557 . 558 . 558 559 559 . 560 . 561 . 561 . 562 562 563

CONTENTS American College of Preventive Medicine ........... American Council on Transplantation ............... American American American American American American American American American American American American American American American American American American American - Association for the Advancement of Medical Instrumentation Association of Biotechnology Companies Association for Health Services Research Canadian Association of Manufacturers of Medical Devices . . . Center for the Study of Drug Development ................. Council of Medical Specialty Societies ...................... Employee Benefit Research Institute ....................... Federation of American Health Systems .................... Finnish Society of Technology Assessment in Health Care .... Generic Pharmaceutical Industry Association . . George Washington University Medical Center Group Health Association of America ........ Health Industry Manufacturers Association . . . Health Insurance Association of America ..... Institute for Alternative Futures ............. Institute of Electrical and Electronics Engineers Institute for the Future .............................................. International Federation for Medical and Biological Engineering ........ International Federation of Voluntary Health Service Funds ............. International Society of Technology Assessment in Health Care ......... Maryland Hospital Association ........................................ National Advisory Council on Health Care Technology Assessment ........ National Association of Health Data Organizations ........ National Association of Manufacturers ...... National Electrical Manufacturers Association National Health Council .................. Oley Foundation for Home Parenteral and Enteral Nutrition Pan American Health Organization ................. Pharmaceutical Manufacturers Association ........... Physician Payment Review Commission ............ Geriatrics Society ....................... Healthcare Institute ...................... Institute of Ultrasound in Medicine . . Medical Care and Review Association Medical Peer Review Association .... Medical Review Research Center .... National Standards Institute ....... Psychiatric Association ............. Public Health Association .......... Rheumatism Association ...........  Society of Anesthesiologists ......... Society of Clinical Pathologists ..... Society of Internal Medicine ........ Society of Mechanical Engineers .... Society for Parenteral and Enteral Nutrition .... Society for Testing and Materials Society of Transplant Physicians . . Society of Transplant Surgeons . . Urological Association .......... - . . - . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. 563 ................... 564 .. 564 .. 565 .. 565 .. 566 .. 567 .. 567 .. 568 .. 569 .. 569 .. 570 .. 571 .. 571 . 572 .. 572 .. 573 .. 574 .. 574 .. 575 .. 575 .. 576 .. 577 .. 577 .. 578 .. 578 .. 579 .. 580 .. 580 .. 581 .. 581 .. 582 583 .. 583 .. 584 .. 585 585 . 586 587 . 587 588 .. 589 .. 590 590 .. 591 592  .. 592 593 .. 593 .. 594 .. 595 xv

MEDICAL I~CHNOLOGY ASSESSMENT DIRECTORY Renal Physicians Association RESNA Association for the Advancement of Rehabilitation Technology Society for Medical Decision Making ....... Society of Non-Invasive Vascular Technolo~v . .~ri~tv Of N1 1rl~~r Mm~i~imm Swedish National Center for Technology Assessment in Health Care Technology Assessment and Forecast Program United States Pharmacopeial Convention ....... United Network for Organ Sharing ...................... University Hospital Consortium .................. . . . . Subject Index to Organizational Resources Part 5: Index to Organizations Organization Addresses and Telephone Numbers Index to Organizations .................................. Appendices Appendix A About the Council on Health Care Technology and Rosters of Council and Panels .................................................. Appendix B Funding Sources for the Council on Health Care Technology Appendix C Survey of Organizations with an Ongoing Medical Technology Assessment Program XVI 595 596 597 597 598 598 599 600  601 601 603 609 622 631 641 645

INTRODUCTION This introduction to the Medical Technical Assessment Directory: A Pilot Reference to Organi- zations, Assessments, and Information Resources describes the purpose of the Directory, its major parts, its scope and limitations, how it was compiled, and activities planned to follow up this work, including ties with the National Library of Medicine and the World Health Organization. PURPOSE OF THE DIRECTORY The Medical Technology Assessment Directory is the first substantial published guide to the field of medical technology assessment. It is intended to better define the substance of medical technology assessment, and to crystallize the emerging network of organiza- tions, institutions, and individuals that generate and use technology assessments. The Directory is a reference to medical technology organizations, assessments, and informa- tion and data resources. It covers activities in the U.S. and certain other countries, including those of government agencies, private companies and associations, and research and educational institutions. It represents the first indexed bibliographic compilation devoted to medical technology assessments produced, in progress, or planned by a broad set of assessment programs spanning the public and private sectors. The Directory was developed to increase access to valuable health care technology assessment information, much of which is found outside standard published sources. This is a product of the Information Panel of the Council on Health Care Technology. One of four panels of the council, the role of the Information Panel is to oversee the development and operation of an information clearinghouse for health care technol- ogies and health care technology assessments, as called for in the congressional man- date for the council. Although the various constituencies of the council have different sets of needs regarding technology assessment, nearly all have expressed a desire for the council to collect, organize, and disseminate technology assessment report informa- t~on. As implied by the term "Pilot" in its subtitle, the Directory takes a leading step toward a more comprehensive capacity for information services in medical technology assess- ment. Though it has immediate utility in its own right, the Directory is an experimental compilation of information in an emerging field. The assessment report citations and other categories of information included here represent a cross-section of the field, and cover assessment activity of the recent several years of a selection of programs in the U.S. and abroad. One of the major functions of the Directory is to act as a hard-copy precursor of a computerized technology assessment information base. The develop- ment and testing of the Directory will help guide the Information Panel's clearinghouse plans. With its extensive descriptions and contact information, the Directory provides ready access to assessment people, programs, and resources. It is intended for users who wish to identify available assessments and contact people currently conducting assessments of a particular technology before making a decision on medical practice. coverage reimbursement, acquisition, or standard-setting. 1 ~-- ~O-, Private and government third party payers, HMOs, and self-insured employers cur- rently reviewing technologies for coverage or inclusion in their health plans may use the Directory to locate assessments of these technologies by regulatory bodies and physi- cians' groups. Physicians seeking medical consensus regarding appropriate use of tech · ~ XV11

MEDICAL TECHNOLOGY ASSESSMENT DIRECTORY nologies may find guidance from assessments indexed here. Pharmaceutical and health device and equipment makers may use the Directory as a reference to the processes and scope of activity of programs that are likely to assess their products. Procurement deci- sions for health care facilities may be more informed by reviewing assessments of de- vices and equipment, and by consulting organizations currently assessing new technol- ogies. Assessors seeking information concerning such areas as postmarketing surveil- lance, drug utilization, or new product development may use the Directory to locate appropriate resources. The Directory may help to advance the field in many other ways. Organizations that conduct or are considering initiating assessment activities may discern ways of strength- ening their programs by examining the attributes of profiled programs. By identifying, describing, and providing contact information for assessment organizations, the Direc- tory should raise the level of, and render more efficient, communication in the assess- ment community. Knowing the types of technologies generally assessed by programs, as well as methods used and other program characteristics, those seeking assessment information may prompt appropriate programs to undertake assessments to address specific needs. Those in the academic, research, and public policy sectors who study the field of technology assessment may contrast and compare assessment processes and consider how better to set assessment priorities and otherwise strengthen the assess- ment enterprise. Thus, the Council on Health Care Technology and others may use the Directory information base to review the capacity and products of technolo~v ns.~.~.cment and to discern trends, gaps, and redundant efforts in the field. a, Given that this edition could not be a comprehensive rendering of medical technology assessment and that this is an emerging field, wide dissemination of the Directory is crucial for building and updating its information base. The council hopes that, by re- viewing the Directory, assessment programs and other resource organizations not al- ready included will recognize that they conduct activities similar to certain of those described here, and will contact the council about being included in forthcoming edi- tions. Gray Literature for Assessment Certainly an important step in carrying out most assessments of medical technologies is searching an information base covering the relevant peer reviewed literature in health and biomedicine. Perhaps the foremost example of such an information base is the online bibliographic citation base MEDLINE, a major component of the National Li- brary of Medicine's MEDLARS system. MEDLINE is one of more than 70 information and data resources described in Part 3 of the Directory. It contains all of the citations published in Index Medicos. MEDLINE covers more than 5 million articles from some 3,200 biomedical journals, out of the more than 25,000 cataloged by the library. Yet, given the rapid evolution of health care's technological portfolio and the breadth of assessment perspectives on medical technologies, valuable technology assessment information may be found outside the mainstream of published periodical literature available from traditional sources. This "gray" or "fugitive" literature is found in indus- try and government monographs, regulatory documents, professional association re- ports and guidelines, market research reports, policy and research institute studies, spot publications of special panels and commissions, conference proceedings, online services, and other sources. Although users of the gray literature must consider that much of it has not been subject · -- xv

INTRODUCTION to the quality screen of peer review, it often has great utility for assessment given its scope beyond traditionally selected sets of journal literature and a currency not subject to the lag time of peer review. The border between gray and standard literature is not distinct; what is gray and what is standard may differ according to one's familiarity with and access to various sources. To be sure, some gray literature eventually passes into the standard literature. Many of the assessment reports generated by organizations pro- filed in this Directory, such as the American College of Physicians Clinical Efficacy Assessment Project, American Medical Association Diagnostic and Therapeutic Tech- nology Assessment Program, and the National Institutes of Health Consensus Develop- ment Program, do appear in the peer reviewed literature, though months or perhaps one or two years after initial release in some gray form. Conducting a good assessment may depend not only upon awareness of key gray litera- ture sources, but one's ability to access them. Desired reports may be available through press releases, journal articles, or books; provided free of charge or at a fee; made available in open libraries or held as proprietary. For instance, the comparative medical device and equipment assessments published by the independent evaluator ECRI are not made available to open libraries such as the National Library of Medicine (NLM), but only to subscribing hospitals, HMOs, and other institutions because ECRI's reve- nues could be eroded by free or low-cost (e.g., by photocopying) access to its publica- tions. Many of the Food and Drug Administration's (FDA) technical reports on drugs and devices are available only upon request from the FDA or from the National Tech- nical Information Service. Certain reports on emerging and new medical technologies generated by market research firms are publicly available, though at costs ranging from a few hundred to tens of thousands of dollars. Rather than devoting considerable effort to already organized and indexed assessment reports appearing in the peer reviewed journal literature, much of the Directory is ad- dressed to gray sources, including many of the profiled assessment programs and the information and data resource descriptions. Thus, this Directory is the first attempt to organize gray literature sources in the field of medical technology assessment. MAJOR PARTS OF THE DIRECTORY Part 1 of the Directory includes profiles of 68 assessment programs and a total of approx- imately 3,200 citations of their respective assessment reports. These assessment pro- grams are located in a variety of public and private sector organizations, including professional, scientific, and industry associations, biomedical research institutions, edu- cational institutions, government advisory bodies, regulatory agencies, third party pay- ers, policy institutes, and for-profit corporations. The profiled programs are primarily from the United States; among other countries represented are Canada, the Nether- lands, Sweden, and the United Kingdom. These are ongoing programs that generate medical technology assessments. For the purposes of this Directory, a medical technol- ogy assessment is a study or inquiry, the object of which is to provide information regarding the effects of a technology that is intended to maintain or improve health, or be used as part of an intervention for such purpose, whether or not the study evaluates these effects directly. Using a common multidimensional framework, these categorical profiles represent a systematic characterization of a diverse community of assessors. This framework was adapted from the one used to profile 20 assessment programs in the 1985 Institute of Medicine study assessing Medical Technologies. The profiles address the purpose, types of technology assessed, topic selection, assessment methods, properties assessed, report Ax

MEDICAL TECHNOLOGY ASSESSMENT DIRECTORY dissemination, budget, contact information, and other characteristics of each program. Each profile is followed by a listing of bibliographic citations of the program's recent assessment reports (over approximately the last five years). Following the profiles is a subject index to the citations. Each of the assessment report citations is indexed using from one to five terms. For instance, a report titled "Dialysis treatment for end stage renal disease (outpatient)" is indexed under the terms Dialysis; Kidney failure, Chronic; and Outpatients. Part 2 has two major sections: a technology thesaurus and a cross-listing of the assess- ment report citations by technology. The technology thesaurus was developed for this Directory to help users search for assessment reports by technology topic. It was generat- ed based upon the technologies appearing in the titles of the assessment report cita- tions. Where appropriate, it uses the NLM's MeSH (Medical Subject Headings) vocabu- lary terms. To enhance searching by all types of users, the 1,200-term thesaurus in- cludes many synonyms, acronyms, and cross-references, and indicates broader and narrower terms to help clarify relationships among technology terms. The cross-listing arranges the assessment report citations by technology, e.g., Apnea monitoring, Coronary artery bypass grafting, and Infusion pumps, so that all citations for each type of technology may be viewed together. Under any particular technology heading, the citations are listed in reverse chronological order to provide the newest information first. This listing is analogous to printouts of computer searches for citations involving particular technologies. In addition to bibliographic information, most citations note the general type of assessment method used, e.g., clinical trial, group judgment, and information synthesis. Because not all of the 3,200 assessment report citations have a technology term in their titles, Part 2 contains about 2,500 citations arranged by technology. Of course, the subject index to report citations at the end of Part 1 uses technology and other terms to index all 3,200 citations with respect to their source assessment programs. It is important for users to take advantage of the technology thesaurus for searching the cross-listing of assessment report citations by technology. Unless a report citation has more than one technology in its title, it is shown only once in the cross-listing, usually appearing under its most specific technology term. For citations listed in this section, distinctions generally are made between procedures and the equipment used for them. For example, headings include Computed tomography as well as Computed tomography scanners, and Fetal monitoring as well as Fetal monitors. Part 3 describes 73 public and private sector information and data resources that may be of value for assessing medical technologies. Arranged alphabetically by name of resource, these are of many types, including online citation bases and services; data files; compendiums, inventories, and directories; market research reports; and others. Each is described in terms of source, subject, content, compilation, and access informa- tion. The resource descriptions are preceded by a categorical chart indicating for each resource its file type (directory, bibliographic information, data set, etc.), format (hard copy, online, etc.), and degree of access (public or limited). At the end of this part is a subject index to the information and data resources. Part 4 provides 300-word descriptions and contact information for 72 organizations that are active in affairs related to medical technology and are stakeholders in medical technology assessment. These include medical societies. scientific organizations. indus ~, . <A · , . · . . . ~ . · · try assomat~ons, and others. Although most ot these organizations do not generate technology assessment reports on a regular basis, they have memberships concerned with medical technologies, conduct relevant meetings and symposiums, publish confer xx

INTRODUCTION ence proceedings and other documents of note, establish standards for technologies, or are active in government, regulatory, or other policy affairs relevant to the field. At the end of this part is a subject index to these organizations. Part 5 includes an alphabetical listing with addresses and telephone numbers for all organizations described in the Directory, as well as a page index to the organizations. Among the appendices to the Director are a description of the council, rosters of council and panel members, a listing of organizations that have contributed financial support to the council, and the survey form used to collect information for the 68 profiles in Part 1. SCOPE AND LIMITATIONS This Directory covers many of the major national level assessment activities in the U.S. and certain significant ones from around the rest of the world. Its immediate utility as a hard-copy reference notwithstanding, the Directory is not a complete guide to the field or an all-encompassing information base. The set of 68 profiled programs and their 3,200 assessment report citations in Part 1, the listing of 2,500 of the assessment report citations by technology in Part 2, the 73 information and data resources in Part 3, and the 72 organizational resources in Part 4 are illustrative, not exhaustive, of the scope of technology assessment activities in the U.S. and on the international scene. The Directory does represent an important step toward a more comprehensive resource, as a founda- tion and a template for building an online medical technology assessment information base and related services. Types of assessment programs and other assessment resources are variously repre- sented in the Directory. That an assessment program or other resource is not described in the Directory implies nothing about its value. Rather, the breadth of the sample of those included in this first edition helps to suggest how the Directory information base might be expanded. For instance, of the various bureaus, institutes, divisions, and other components of the National Institutes of EIealth that conduct clinical trials or other assessment activities, just three are profiled here. Seventeen of the 24 member organi- zations of the Council of Medical Specialty Societies (CMSS) provided information for the assessment program profiles or resource organization descriptions in the Directory; other CMSS members may also be appropriate for addition to the information base. Eleven university based programs are profiled; there are others worthy of note. A recent publication of the American College of Radiology noted more than 50 U.S. and international societies in the field of radiology alone; certainly, some of these organiza- tions generate technology assessment documents or engage in other activities relevant to technology assessment. A survey of existing inventories of health care data sets conducted for the Methods Panel of the council by intern Norma Gavin identified more than 260 data sets that meet minimum provisional criteria for inclusion in a proposed inventory of data sources for health care technology assessment. Although the data sets were identified too late in 1987 to be categorically described in this volume, that survey suggests how the set of information and data resources in Part 3 of the Directory could be expanded and its contents more thoroughly elucidated. Inclusion in the Directory of descriptions of any assessment programs, information or data resources, or other organizations does not imply any judgment on behalf of the council, Information Panel, or staff as to the quality of those assessment resources. Similarly, inclusion of any assessment report citations in the Directory implies no judg xxi

MEDICAL TECHNOLOGY ASSESSMENT DIRECTORY ment as to the validity, utility, or other aspect of the quality of the assessment reports. The bulk of the content of the Directory was self reported by assessment programs and other resource organizations, and this information was not independently or systemati- cally verified. Compilation of the Directory was largely limited by staff awareness of assessment activities, availability of information about these, and limitations of time, personnel, and other resources available for this edition. The technology thesaurus in Part 2 was generated based upon the technologies appear- ing in the titles of the assessment report citations of the 68 profiled programs. There- fore, the 1,200-term thesaurus does not encompass all medical technologies, although it may be readily augmented with additional technology terminology. The technology heading under which an assessment report citation is listed in Part 2 does not imply that the technology has been found to be safe, effective, or otherwise appropriate for the use implied by that heading. That a report citation is listed under a particular heading implies only that the technology that is the subject of that citation may have been assessed for the application represented by that heading. For instance, a particular drug may be listed under Antineoplastics and under Antiarthr~tics. Assessed as an antineo- plastic, the drug may have been determined by a regulatory or other organization to be safe, effective, cost-effective, etc. Assessed as an antiarthritic, the drug may or may not have been found to possess one or more of these qualities. Nevertheless, it would be listed under both headings because the report citations indicate that it was assessed for both applications, regardless of the assessment findings, not because the drug was determined to be appropriate for those uses. COMPILATION OF THE DIRECTORY Information for the Directory was compiled largely from three surveys. The assessment program profiles and report citation listings of Parts 1 and 2 are based primarily upon responses to a survey of organizations with ongoing medical technology assessment programs. Many of the descriptions in Part 3 were written from responses to a survey of organizations that compile or make available data or information relevant to medical technology assessment. The organizational resources descriptions in Part 4 were drawn largely from a request for brief descriptions of professional. industry, and other organizations having Interests In technology assessment. Council staff reviewed and edited all returned survey forms. No attempt was made to verify with third parties the information provided by the organizations. Staff did not assess the quality of assessment programs, information and data resources, organiza- tional resources, or assessments listed in the Directory. Organizations known or thought to have an ongoing medical technology assessment program were identified initially from council staff files in October 1986. Additional organizations were identified by those organizations surveyed initially and by further council staff work. More than 80 organizations were sent the survey instrument, which is shown in the appendices. This survey was not applicable to organizations that may have conducted medical technology assessments but did not have an ongoing program; that cataloged, indexed, or evaluated assessments but did not produce them; or that conducted assessments but generally did not make results available outside of the organization. Due to resource constraints and because this was not an effort to assemble a library, the survey requested bibliographic citations of assessment reports and sample reports, rather than complete sets of reports from all programs. · ~ XX11

INTRODUCTION Most of the surveys were returned to council staff fully or partially completed. In several cases, council staff and program contacts determined that a program did not constitute an ongoing assessment program, but was appropriate for inclusion in Part 4 or another part of the Directory. Surveys were returned to several organizations with requests for additional information or more thorough responses to portions of the survey; often such requests were for more complete citations for assessment reports. Council staff also used telephone or face-to-face interviews with assessment program staff, as well as reports and other literature submitted by the programs, to complete the surveys. Following editing by council staff and further preparation by the contractor, these descriptions were forwarded to the contact persons at each assessment program with a request to verify their factual content or make other suggestions and to return these to council staff by a deadline date, or to expect no modifications if no response was received by that date. Staff and consultants reviewed the lists of assessment report citations provided by the programs and deleted those that did not meet the criteria of a medical technology assessment report. For purposes of deciding whether or not a report should be listed in the Directory, the title had to contain or suggest orate or more medical technologies, or imply the consideration of medical technologies, e.g., the management of cervical cancer. Further, it had to either state or imply technology assessment, or one or more properties or attributes of a technology that could be determined by an assessment, e.g., safety, efficacy, ethical implications, or state or imply an evaluation; or be or appear to be guidelines issued by a professional body or its equivalent known by staff to conduct assessments. Staff deleted, for example, assessments of the health effects of Agent Orange because it was neither intended to be nor has it been used as a medical technology. On the other hand, staff retained in the listing assessments of the detrimen- tal consequences of medical technologies, such as the risk of birth defects among nurse anesthetists. Staff tended to be inclusive in determining what constituted assessment reports for listing with program profiles in Part 1. The primary reasons for this leniency were that decisions were necessarily based on limited information, i.e. report titles rather than full reports; that as a first effort, this Directory ought not severely circumscribe this body of literature; and that users might gain a better understanding of programs' scope by viewing fuller portfolios of their reports. Somewhat stricter criteria were applied for including reports in the list of assessment report citations by technology in Part 2. In instances where titles were ambiguous in this regard and where full reports were on file with council staff, these reports were reviewed to determine whether they constituted assessment reports. However, staff did not make special requests to acquire reports for this purpose. Edited survey forms were sent to TRITON Corporation, a contractor retained by the council. Using the surveys, TRITON prepared uniform descriptions, or "profiles," of ongoing medical technology assessment programs and created a record for each of their assessment report citations. Each profile has approximately 20 descriptors such as program name, address, telephone, contact person, purpose, methods, reports, etc. Descriptions were edited for consistency and to ensure, as far as possible, uniformity in detail. In creating database records for assessment citations, TRITON followed Index Medicus style. The base of citation records was used for two purposes: for generating the coded list of citations following each profile in Part 1, and for generating the listing of assessment report citations by technology in Part 2. TRITON indexed each assessment report citation using from one to five subject · ~ - xx

MEDICAL TECHNOLOGY ASSESSMENT DIRECTORY headings, including but not limited to technology terms. Of necessity, TRITON had to rely exclusively on titles to index assessment reports. The subject headings used for indexing are taken primarily though not entirely from the National Library of Medi- cine's controlled biomedical vocabulary MeSH. The departure from MeSH terms occurred most often for terms related to technologies. The index to the citations appears at the end of Part 1, and is coded to citations appearing after their respective assessment programs. The technology thesaurus that appears at the beginning of Part 2 was developed in order to arrange the listing of assessment report citations by technology that follows it. The technology thesaurus terms used as headings for Part 2 constitute, largely, a subset of the indexing terms used in Part 1, i.e., those that identify technologies. As noted above, technology terms accounted for most of the instances where indexing departed from MeSH. If MeSH did not contain a subject heading appropriate for a technology used in an assessment report citation title, one was designated based on usage in the medical technology assessment literature as determined by staff, consultants, and TRITON. In some instances, MeSH did not include a term for a particular technology. In others, the closest MeSH term may have been too broad or too narrow to adequately identify a technology, or one not commonly used or perhaps not readily recognized by users who do not have a particular medical or scientific expertise. Linkages to MeSH are retained wherever possible with the use of synonyms, acronyms, cross-references, and broader and narrower terms that are used in MeSH. Information and data resources described in Part 3 were identified by council staff and by respondents who completed surveys for this part. About half of the descriptions of information and data resources in Part 3 were based entirely or in part on survey responses. The remainder of the descriptions was derived by staff from literature and samples received from the source organizations and telephone interviews. The cony for Part 3 that was submitted to TItITON was generated by staff. 1 ~ The organizational resource descriptions in Part 4 were derived primarily from re- quests for narratives of 300 words or less made to organizations identified by council staff and suggested to staff by certain of these organizations. Following editing by council staff, drafts of these descriptions were forwarded to the contact persons at each organization with a request to verify their factual content or make other suggestions and to return these to council staff by a deadline date, or to expect no modifications if no response was received by that date. The copy for Part 4 that was forwarded to TRITON was generated by staff. TRITON submitted final, camera-ready copy of the Directory to council staff, who turned it over to the National Academy Press for printing. PLANS OF THE INFORMATION PANEL The Information Panel plans to develop technology assessment information products beyond this first edition of the Directory. Among the major proposed areas of activity are wide dissemination of the Directory, working with the NLM to augment the Library's MeSH vocabulary and DIRLINE (Directory of Information Resources Online) file with new information from the Directory, producing access guides to standard literature sources, enhancing and updating the Directory, instituting clearinghouse services, and establishing online access to a technology assessment information base. Users of the Directory will be surveyed regarding its utility and format, and will be asked for suggestions for improvement. Additional responses will come in the form of XXIV

INTRODUCTION number and distribution of sales, book reviews, and other user feedback. The Informa- tion Panel will take account of user responses in formulating its plans for further development of the Directory information base and related efforts. The Information Panel plans a joint vocabulary project with the NLM to better index and thereby improve access to technology assessment information. The vocabulary effort began with the indexing of assessment report titles for the Directory and prepara- tion of the technology thesaurus. From this project, the Information Panel may better determine the topical scope of the technology assessment literature, as well as the capacity of the NLM's MeSH vocabulary for indexing technology assessment topics. Instances in which current MeSH terms are found inappropriate for indexing technol- ogy assessment report titles in the Directory provide opportunities for augmenting MeSH with the intention of improving its utility for searching MEDLINE for assess- ment related information. Because the Directory indexes many report citations drawn from gray literature sources, it may provide a means for identifying newer terms that have not yet entered the lexicon of more traditional sources. The vocabulary project would establish a framework for, and could begin mapping, certain existing terminology sets such as MeSH, ECRI device codes, ICD-9-CM (Inter- national Classif cation of Diseases, 9th Revision, Clinical Modification) and CPT-4 (Current Procedural Terminology, 4th Edition' procedure codes, and DRG (diagnosis-related group) terms to the technology topics used in the Directory. The mapping of vocabulary terms is consistent with the mission of the Library's Unified Medical Language System project. Information gathered in compiling the Director will be used to add, update, and modify organizational descriptions in the NLM's DIRLINE file. A component of MEDLARS, DIRLINE is accessible for all users of MEDLARS and certain commercial databases. It contains descriptive information on many organizations and resource centers in the health field. Users interested in particular subjects may enter appropriate keywords to locate information about organizations active in those areas. Adding to DIRLINE descriptive information from the Directory about organizations involved in technology assessment will provide broad online access to it through MEDLARS, and any services that download DIRLINE from MEDLARS. Whereas the Directory deals primarily with technology assessments generated by specific assessment organizations and found to a large extent in the gray literature, the Infor- mation Panel is planning access guides that would address retrieval of technology assessment information from existing citation bases and other sources. Some of these sources, such as BIOETHICSLINE, MEDLINE, and the National Technical Informa- tion Service, are noted in the information and data resources part of this Directory. The purpose of these guides would be to help users extract valuable medical technology assessment information from sources that are not specifically devoted to the field or are structured in ways that are not amenable to searching for this information. The guides would describe these sources in greater detail, explain what subfiles or other aspects of each may be useful for assessment purposes, indicate how to access them, and provide examples of assessment searches. The Directory information base may be developed in several major ways. Profiles of programs entered in the first edition may be updated and their new assessments indexed. Additional assessment programs may be profiled and their assessments in- dexed, and the technology thesaurus updated accordingly. Based upon the informa- tion and data resources in Part 3, an expanded, more detailed inventory of data sets for technology assessment could be developed using more quantitative and qualitative xxv

MEDICAL TECHNOLOGY ASSESSMENT DIRECTORY descriptors. This inventory would be guided in part by the survey work on data sets described above. Of particular interest to both the Evaluation Panel and Information Panel of the council is strengthening the information base to enable tracking of new and emerging medical technologies. Such information has value to different sectors of the health care enterprise. It can be used to anticipate assessment needs and prepare timely and well informed assessments, e.g., at the time of market entry of a new drug or device, or when a reimbursement claim is made for a new procedure. Further, it may be useful for remaining apprised of the state-of-the-art in medical practice, planning clinical services, making resource allocation decisions to foster development and diffusion of promising technologies, charting trends in health care product and practice innova- tion, and identifying investment opportunities. Sources that might be monitored for information concerning emerging and new technologies might include status reports of biomedical research projects, patent information, medical and bioengineering con- ference proceedings, medical and scientific bibliographic information bases, future-or- iented surveys and monographs, market research reports, financial investment sources, product development databases, annual and quarterly reports of health care product companies, news services, FDA approval documents for new drugs and de- vices, and health insurance claims data. Although this edition of the Directory has descriptions of certain information sources that fall into these categories, development of the information base could emphasize addition of information sources, indexing, and retrieval means to help meet needs for intelligence about new and emerging technologies. The Information Panel is considering implementing selected clearinghouse services with expanded staff or under contract. Initial clearinghouse services may be established based upon the Directory and continued updating of its information base, and access to MEDLINE and other online information sources. With these resources, the council could begin to respond to certain types of assessment related inquiries received via written correspondence, telephone, or electronic mail. Staff assigned to this activity could also conduct special searches or generate assessment report bibliographies on topics of current interest for broad distribution. These services would be initiated on an experimental basis, and the demand for them monitored carefully. Commitments to phone answering and conducting searches would have to be adjusted according to demand and availability of resources. The Information Panel will continue to study the feasibility of providing computer access to technology assessment information. Computer access may entail use of central information bases and distribution of the Directory, its updates, and related products via optical or magnetic disks. The panel has determined that appending a technology assessment information base to an existing online system would be preferable to initiating a new stand-alone system. The panel will take account of what is learned from the response to the Directory and other current efforts, consult with the NLM and other information base authorities, and plan accordingly. Providing computer access to the technology assessment information base will be furthered by implementing other of the Information Panel's plans. Together, the Directory and access guides will account for much of the gray literature and other online and traditional sources that could be integrated in an online system. Augmenting DIRLINE and MeSH will help to make NLM's MEDLARS more useful to users concerned with technology assessment. Response to the Directory, which represents a hard-copy analog of certain aspects of an online system, and access guides will inform XXVI

INTRODUCTION the Information Panel about the desirable content and format of assessment informa- tion compilations. Clearinghouse services would enhance the council's ability to meet, and learn more about, user needs. NLM's review of the Directory, described below, and other council efforts will provide insight into the extent to which an online technology assessment information base may be linked with the MEDLARS system. One venue for such a link would be to append the Directory information base to the HEALTH (HEALTH Planning and Administra- tion) file of MEDLARS, which covers citations on nonclinical aspects of health care delivery such as facilities planning and administration, manpower, insurance, financial management, regulation, and quality assurance. HEALTH is compiled primarily by the American Hospital Association using selections from MEDLINE and augmented by a variety of sources not indexed by NLM. Thus, HEALTH stands as a model of an online base formed from published literature sources as well as certain gray literature sources. Ties with the National Library of Medicine In devising the clearinghouse plan and developing this Directory, the Information Panel and staff have worked closely with the NLM to develop an information base that complements NLM resources. As indicated above, of particular interest are the extent to which the Directory information base identifies new indexing terminology, adds to what is known concerning descriptions of organizations that are significant in biomedi- cal affairs, and identifies valuable sources of literature not indexed by NLM. Pursuant to these interests, NLM staff members have reviewed pertinent portions of an early draft of the Directory to gain preliminary measures of these characteristics of the Directory information base. 1 . · 1 · , · . ,% . The NLM review indicates that the technology thesaurus terms derived from the assessment reports cited in the draft Directory provide some 40 potential new MeSH headings and nearly 400 potential entry terms, i.e. new synonyms for cross-references in MeSH. NLM also reviewed more than 2,500 of the assessment reports citations to determine what proportion were owned and/or indexed by the library. (Approximately 1,000 of the 3,500 report citations in the draft Directory were not reviewed because they were assessments in progress, were more than five years old, or were then incomplete citations.) Of the citations reviewed from the draft Directory, NLM found that 23 percent were owned and indexed by NLM. Of the remaining 77 percent, about half were owned but not indexed by NLM, and half were neither owned nor indexed by NLM. Since NLM was given the preliminary draft of the Directory, some assessment report titles were added, and a few hundred were deleted as irrelevant to medical technology assessment. Also, a few program profiles were added to the Directory, and the technology thesaurus was revised. These morlifi~ntions wo~'lr1 not ~n~reri~hiv affect the findings of the NLM review. rr ~ NLM compared approximately 190 organizational descriptions from the profile, infor- mation and data resources, and organizational resources parts of the draft Directory with DIRLINE records to determine the extent to which those in the Directory might be used to augment DIRLINE. NLM found that about 28 percent of the organizational descriptions in the Directory had directly comparable records in DIRLINE. Another 28 percent of the descriptions were entirely new to DIRLINE. Of the remaining 44 percent of the draft Directory descriptions, half were represented only at a more general level in DIRLINE. The rest of the Directory organization descriptions were mentioned in DIRLINE records but had no DIRLINE record of their own, were described only in ·- XXV11

MEDICAL TECHNOLOGY ASSESSMENT DIRECTORY part in DIRLINE records, or were part of larger organizations for which the DIRLINE records did not describe the part included in the Directory. Thus, most of the organiza- tion descriptions in the draft Directory are suitable for augmenting DIRLINE. Some 20 organizational descriptions have been added to various parts of the Directory since the preliminary draft was given to NLM. NLM's review provides some insight into the extent to which the Director information base may be used to complement existing NLM and other major resources for technol- ogy assessment, and will help to plan a appropriate strategy for providing this informa . . . ton online. International Ties The Information Panel seeks to incorporate valuable sources of international informa- tion on technology assessment into the Directory information base. This first edition of the Directory includes profiles and assessments of 14 programs outside of the U.S., as well as descriptions of other European and international organizations and informa- tion resources of interest to the assessment community. This represents only a sample of international sources of potential value to users in the U.S. and abroad. Although the information concerning assessment activities in other countries was provided directly to council staff for this Directory, other organizations in particular countries or certain international agencies could collect such information to be shared with the Directory information base. In particular, the Information Panel has been planning certain of its efforts with the European Office of the World Health Organiza- tion (WHO), which has among its charges to act as a health technology assessment information clearinghouse for its member countries. In 1987, WHO established a collaborative effort with the University of Linkoping in Sweden, known as WlIO/LINFO, to further this charge. The first project of WHO- /LINFO is to assemble a technology assessment information base, modeled in part after this Directory. The Information Panel and WHO/LINFO have agreed to coordinate their efforts by using similar information collection, indexing, and display formats to facilitate exchange of assessment information and to avoid duplicative work. As compi- lation of the council's Directory was launched prior to that of WHO/LINFO, WHO- /LINFO was able to use a modified version of the council's Directory profile survey to collect information about European organizations involved in assessment. Further, the council is sharing the technology thesaurus used to index the assessment report cita- tions in the Directory so that WHO/LINFO may consider using similar terminology to index assessments of its participating programs. Plans concerning responsibility for ongoing collection of assessment information from European and other international sources and related collaboration will be made subject to response to the Directory and WHO/LINFO products. · ·- XXV111

GUIDE TO DIRECTORY'S CONTENTS The Directory includes the following five major parts, described below: · Part 1: Assessment Program Profiles and Report Citations · Part 2: Assessment Report Citations Listed by Technology · Part 3: Information and Data Resources · Part 4: Organizational Resources · Part 5: Index to Organizations. PART 1: ASSESSMENT PROGRAM PROFILES AND REPORT CITATIONS This part has two major sections. First are the profiles of 68 medical technology assessment programs, with citations of their approximately 3,200 completed, ongoing, and planned assessments. Second is a subject index to the citations, to be used for locating citations on particular subjects among the profiles. Profiles and Citations The profiles are of ongoing programs that generate medical technology assessments. For the purposes of this Directory, a medical technology assessment is a study or inquiry, the object of which is to provide information regarding the effects of a technology that is intended to maintain or improve health, or be used as part of an intervention for such purpose, whether or not the study evaluates these effects directly. Most of the information for the assessment program profiles was drawn from the survey of organizations with an ongoing medical technology assessment program, reproduced in Appendix C. Entries for the information categories in each profile include responses to checklists and other questions on the survey. The survey shows these checklists and questions, as well as definitions of terms where necessary. The level of detail in the information categories across the profiles varies. Although staff worked with some assessment program representatives to complete responses to the survey, certain information was unavailable from programs. The assessment program profiles are listed alphabetically by name of parent organiza- tion, and are arranged according to the following common format. Parent orgaliizadon and assessment program name, address, and telephone number. Contact personas): name, title, address, telephone number if different from the above, telex, telefax, and other numbers. Overview provides a brief description of the parent organization's purpose, and the assessment program's purpose and origins. Primary intended users describes the intended audience of the program's assess- ments. Taken from the checklist of more than 20 categories of primary intended users on page 4 of the survey in Appendix C, examples of these are: general public, patients, physicians, acute facility administrators, long-term care facility administrators, health product manufacturers, health/medical professional asso- ciations, third party payers, government regulators, biomedical researchers, and specified others. Ax

MEDICAL TECHNOLOGY ASSESSMENT DIRECTORY Technologies lists the general categories of technology usually assessed by the program. The first listed, in italics, is the one assessed most often. The categories, shown and defined on page 4 of the survey, are: drug, device, medical or surgical procedure, support system, organizational or administrative system, and speci- f~ed others. Intervention lists the types of technological intervention normally assessed by the program. The first listed, in italics, is the one assessed most often. The types, shown and defined on page 5 of the survey, are: prevention, diagnosis, treatment, rehabilitation, and specified others. Stage lists the stages in the life-cycle of technologies at which the program normal- ly conducts its assessments. The first listed, in italics, is the stage assessed most often. The stages, shown and defined on page 5 of the survey, are: emerging, new, established or widespread practice, obsolete, and specified others. Properties lists the properties or attributes of a technology that the program normally assesses. The first listed, in italics, is the property or attribute usually emphasized. The properties or attributes of technologies assessed, shown and defined on page 5 of the survey, are: safety, efficacy, effectiveness, cost, cost-bene- fit, cost-effectiveness, service requirements, acceptance/adoption level, system impact, economic implications, and ethical, legal, social implications. Selection process describes how the program generally selects technologies for assessment. As posed on pages 9 and 10 of the survey, this may encompass who can request that an assessment be conducted, how requests for assessment are made, how and by whom assessment priorities are set, and what provisions are made for reassessing technologies. Methods lists the broad categories of assessment methods that the program normally employs to conduct an assessment. The first listed, in italics, is the method the program relies on primarily, or exclusively if no other method is listed. The categories of assessment methods, shown and defined on page 6 of the survey, are: information syntheses, expert opinion, group judgment, modeling, cost analyses, epidemiological and other observational methods, clinical trials, and bench testing. This section also includes supplemental descriptive information encompassing: how the assessment process is conducted and by whom, the ap- proximate (average or range of) turnaround time from selection of assessment topic to report of findings, and approximate cost per assessment. Assessors describes the types of expertise of a program's assessors. Assessment reports include lists the types of items generally included or ad- dressed in a program's assessment reports. Taken from the checklist of more than 20 items listed on page 6 of the survey, examples of these are: abstract, purpose of assessment, who sponsored assessment, who conducted assessment, description of technology, how the technology works, properties assessed, sources of data/in- formation, methods for analyzing/synthesizing data/information, limitations of findings, regulatory agency approval status, coverage/reimbursement status, and specified others. Dissemination lists the means by which a program disseminates its assessment findings. The first listed, in italics, is the one relied on primarily. The general types of dissemination means, shown on page 6 of the survey, are: printed reports (excluding journal articles); journal articles; advisories to members/constituents; xxx

GUIDE TO THE DIRECTORY'S CONTENTS press conferences/news releases; TV/radio broadcasts, video products; clearing- house, data/citation bases, online services; other (specify). This section also in- cludes supplemental information encompassing: types of assessment products, details of how assessment results are disseminated, and how to acquire copies of assessment reports. Budget gives the program's annual budget in U.S. dollars for calendar 1986 unless specified otherwise, and the percentage from type of source. These sources, shown on page 7 of the survey, are: parent organization; government grants/contracts; foundations and other private grants; sponsors/members dues contributions; sales of assessments, consultant services, etc.; and specified others. Use describes how assessments are used by the parent organization, who else uses them and for what purpose (and how the program knows this); documented use of assessment reports and their impact, including citation of published docu- ments; and citations in the published literature to the program or its assessments. Program evaluation describes the evaluations that have been conducted of the program, who did them, evaluation results, and how evaluation results have been used to improve the program. Related acquires describes additional information about the technology assess- ment activities of the program not covered elsewhere in a profile. Completed Reports are listed in reverse chronological order and then in alpha- betical order by author and title. For most of the profiles, the citations cover assessments generated since 1980. The completeness of bibliographic citations varies. To the extent possible, the citations are in Index Medicos style. If an organization sponsoring the technology assessment is not the author of the report, the organization name is enclosed within brackets. Reports issued by programs of the U.S. Government often are available from the U.S. Government Printing Office or the National Technical Information Service. Where provided by assessment programs, order numbers are included in the bibliographic cita- tion. The report code preceding each citation (consisting of a two letter prefix and a number) is used to link the report to the index to report citations at the end of Part 1. Information in brackets following the citation indicates the type of meth- od~s) used by the program to conduct its assessments. Ongoing Assessments are listed in chronological order (based on expected com- pletion date), earliest first and then in alphabetical order by author and title. The citation provides the expected date of the report, if the program provided one. Assessments for which the program did not provide a completion date are listed alphabetically by author and title after those for which it provided a completion date. Some of the ongoing assessments have been completed and made available by the time of publication of this Directory. Not all programs provided information about ongoing assessments. Planned Assessments lists assessments the program expects to conduct by author and title. Some of the planned assessments may have been completed and made available by the time of publication of the Directory. Not all programs provided information about ongoing assessments. Not all reports generated by the 68 programs are cited in the Directory. In most instances, reports dated prior to 1980 are excluded, although for certain smaller programs earlier reports are retained. The scope of activity of certain of the 68 xxx'

MEDICAL TECHNOLOGY ASSESSMENT DIRECTORY programs does not neatly or consistently coincide with medical technology assessment. In other cases, an understanding of a program's activity does indicate that it conducts assessments of medical technologies, but pertinent report titles are not written in a manner reflecting this. Many report titles produced by certain programs mention no medical technology and/or do not indicate that an assessment was involved. In general, to appear in the Directory, report citations must, in at least a broad sense, mention or imply an assessment of one or more technologies. For example, a report title reading "Evaluation of. . . " qualifies, as do titles mentioning one or more attri- butes or properties of an assessment such as safety, effectiveness, cost-effectiveness, or economic, ethical, legal, or social implications, or such related extensions as market analysis or analysis of variation in clinical practice. Reports that are "Guidelines for . . . " or "Standards for... " are also listed, although some are, strictly speaking, model practices or criteria developed based upon assessment findings. Assessments of the effects of environmental hazards, substances, and interactions neither intended nor used as medical technologies are excluded from the Directory. However, interventions to prevent, diagnose, or treat the effects of these are consid- ered medical technologies. Assessments of certain natural processes, e.g., breast feed- ing, are included because other interventions (e.g., infant formula, in this case) create the possibility of alternative modalities. Excluded specifically are documents describing regulatory requirements. Examples of reports generated by assessment programs but excluded from the Directory because they are not about medical technologies or assess- ments of technologies are: "Carcinogen regulation," "Effects of toxic chemicals on the reproductive cycle," "Health effects of smokeless tobacco," "Health effects of Agent Orange and dioxin contaminants," and "Smoking related deaths and financial costs." Because the conduct and utility of technology assessments depends on the availability of suitable methods for this purpose, assessments of methods are considered within the scope of the Directory. Examples of reports about assessments of methods are "Assess- ment of double-blindness at the conclusion of the Beta-Blocker Heart Attack Trial," "Postmarketing surveillance of prescription drugs," and "The impact of randomized clinical trials on health policy and medical practice." In certain instances where council staff was aware by discussion with assessment pro- gram representatives and familiarity with program reports, citations were included that had short titles not indicating that report content did address assessments of technol- ogies. This is the case, for example, for certain citations of the American College of Obstetricians and Gynecologists Committee on Technical Bulletins. Reports with such titles as "Carcinoma of the endometrium," "Hemorrhagic shock," and "Osteoporosis" deal with the management of these conditions or alternative technologies for diagnosis or treatment of them, and therefore were retained in the listing of citations following the program profile in Part 1 of the Directory. Similarly, reports of the NIH Consensus Development Program titled "Travelers' diarrhea," "Osteoporosis," and "Health impli- cations of obesity" are included in Part 1. Instances such as these are exceptions, however, and staff did not seek on a systematic basis to determine report content beyond what could be discerned from titles. Further, because titles such as these do not name a specific technology, they are not included in the listing of assessment report citations by technology in Part 2. Index to Report Citations At the end of Part 1 is an index to report citations. The index has approximately 1,900 subject terms, e.g., Aspirin, Decubitus ulcer, Monoclonal antibodies, and Urinary calculi. · ~ XXX11

GUIDE TO THE DIRECTORY'S CONTENTS These terms were compiled by indexing the titles of the assessment reports generated by the programs profiled in Part 1. Each assessment report citation is indexed using from one to five terms. The indexing terms are listed alphabetically, each followed by one or more relevant assessment report codes. Each code has a two letter prefix Indicating an assessment program in Part 1, and a number indicating the report's placement in the program's list of citations. For instance, the term Decubitus ulcer is followed by the codes AG49, CB 10, CB 13, NC74, NC 104, NC 122, and ND 19. A list of prefixes and their respective programs is shown immediately preceding this subject index. Because each assessment report citation is indexed with from one to five terms, a particular report citation may be shown under more than one term in the index to report citations at the end of Part 1. For instance, the report code NC2, corresponding to the NCHSR Office of Health Technology Assessment report "Apheresis in the treatment of systemic lupus erythematosus (SLE)," is listed under Apheresis and under Lupus erythematosus, Systemic. This index includes technology terms (e.g., Dental sealants, Magnetic resonance imaging, and Tonometry) as well as non-technology terms (e.g., Esophagus, Fetus, and Thrombophle- bitis). For non-technology terms, the subject index to report citations relies primarily upon the National Library of Medicine's (NLM) MeSH (Medical Subject Headings) terminology. For technology terms, this index relies primarily upon the terms devel- oped for the technology thesaurus in Part 2, which includes some MeSH terms. PART 2: ASSESSMENT REPORT CITATIONS LISTED BY TECHNOLOGY This part has two major sections: a technology thesaurus and a cross-listing of the assessment report citations by technology. These two sections are directly related in that the listing of assessment report citations by technology is arranged according to the terminology set forth in the technology thesaurus. Technology Thesaurus The technology thesaurus was developed for the Directory to help users search for assessment reports by technology topic. It was generated based upon the technologies- appearing in the titles of the assessment report citations shown in Part 1. Where appropriate, it uses the NLM's MeSH vocabulary terms. To enhance searching, the 1,200-term thesaurus includes many synonyms, acronyms, and cross-references, and indicates broader and narrower terms to lead users to desired citations and to help clarify relationships among technology terms. Technologies are listed at the most specific level suggested by terms used in report titles, usually the name or class of a drug, procedure, device, etc. In general, drugs are listed by generic name, and procedures, devices, etc. are listed by class, e.g., Radiograph- ic equipment, in preference to individual brands or models. Thus, assessments of all brands of hydrophilic contact lenses are listed together. The technology thesaurus lists a technology's synonyms, including abbreviations as well as alternative terms. For each synonym, the thesaurus indicates the listing term under which pertinent citations are shown, using SEE (listing terms. For each listing term, the thesaurus indicates terms from which the user may have been referred using x (e.g., from a SEE (listing terms); indicates which terms are broader than the listing term, using BT; and which terms are narrower than the listing term, using NT; and indicates · -- xxx

MEDICAL TECHNOLOGY ASSESSMENT DIRECTORY related terms, using SEE ALSO (related terms. With respect to BTs and NTs, each indicates only one level broader or narrower. However, by referring to the next BT or NT, a user can find other terms yet broader or narrower. Because a technology may have more than one type of application, or may be classified along a number of dimensions, two or more BTs may be shown for a given technology. For example, Ibuprofen has as broader terms Antipyretics and Nonsteroidal anti-inflamma- tory analgesics, so that a user looking under either of these broader terms would be referred to assessment report citations concerning ibuprofen. Laser ang~oplas) has as broader terms Ang~oplasty and Laser surgery, so that a user seeking citations about means for performing angioplasty, or about applications of laser surgery, would be referred to assessment citations concerning laser angioplasty. Where assessment report citations exist of both a device and its use in practice, each is referred to the other. For example, Fetal monitors suggests SEE ALSO Fetal monitoring, and vice-versa. Designation of broader or narrower terms is not intended to-be complete according to some established framework, although a hierarchically arranged framework of tech- nology terms is conceivable. The extent to which portions of such a framework appear here reflects only the need to accommodate the terms drawn from the assessment report citations included in the Directory. MeSH terms are used in preference to other terms, unless a MeSH term appears to vary substantially from common usage. Thus, pertinent assessment citations are listed under Coronary artery bypass grafting in the Directory instead of the corresponding MeSH term Aortocoronary bypass; Beta blockers is used instead of the MeSH term Adrenerg~c beta receptor blockaders; and Computed tomography is used instead of the MeSH term Tomogra- phy, X-ray computed. Nevertheless, such MeSH terms are shown as synonyms so that users using these as "entry terms" will be referred to the term under which pertinent assessments are listed, so that linkages with MeSH are retained. Word form variations are consistent with the basic term, e.g., Computed tomography scanners. Technologies are listed by full name, in preference to an abbreviation, except where an abbreviation is used more commonly or the full name is unwieldy, e.g., APACHE instead of Acute Physiology and Chronic Health Evaluation, and BCG vaccine instead of Bacillus Calmette- Guertn strain of Mycobacterzum bovine. Assessment Report Citations by Technology The cross-listing of assessment report citations listed by technology arranges the cita- tions under technology terms from the thesaurus, e.g., Cataract extraction, Heart valve prosthesis, and Propranolol, so that all citations for each type of technology may be viewed together. Citations listed are those in which the title includes one or more identifiable medical technologies. For example, a report titled "Evaluation of nadolol in treatment of hypertension" is listed under Nadolol. Under any particular technology heading, the citations are listed in reverse chronological order, and then in alphabetical order by author and title. In addition to bibliographic information, most citations note, in brackets at the end of the citation, the general type of assessment method used, e.g., clinical trial, group judgment, and information synthesis. Because not all of the 3,200 assessment report citations shown with the assessment program profiles in Part 1 have a technology term in their titles, Part 2 contains a subset of these, i.e. about 2,500 citations. XXX1V

GUIDE TO THE DIRECTORY'S CONTENTS . Given its synonyms, acronyms, cross-references, and broader and narrower terms, referring to the technology thesaurus first is the best way to search the listing of assessment report citations by technology in Part 2. Unless a report citation has more than one technology in its title, it is shown only once in the technology listing, usually appearing under its most specific technology term. Where a title indicates that two or more specific medical technologies are assessed ei- ther individually or one in comparison to the other, the citation is listed under both terms. If two or more technologies appear to be used in combination, e.g., "Protein- calorie therapy in combination with anabolic steroids in alcoholic hepatitis," the citation is listed only once under the combined term, in this instance, Protein-calorze therapy with anabolic steroids. If a title is ambiguous in this respect, the report is listed under each of the medical technologies mentioned. For citations listed in this section, distinctions generally are made between procedures and the equipment used for them. For example, headings include Computed tomography as well as Computed tomography scanners, and Fetal monitoring as well as Fetal monitors. Where a report involves a technology to address consequences of a previously applied technology, the active technology is indexed. For instance, the title "Prevalence and pathogenesis of cholesterol gallstones in Halifax: prevention of recurrence by diet changes after medical dissolution therapy" is listed under Diet therapy, rather than under a technology for medical dissolution of cholesterol gallstones. PART 3: INFORMATION AND DATA RESOURCES This part describes 73 public and private sector information and data resources that may be useful in conducting medical technology assessments. Included are a cate~ori rql ash-~t ~11 ~ lo_ -o 1 ~1 ~11~1 L ~1 "ll Q1 L11= 1 c~QU1~5, tI1~ / ~ resource aescrlptlons, and a subject index to the resources. At the beginning of Part 3, a categorical chart indicates which of three types of descriptors characterizes each resources. These are: File type directories/compendiums bibliographic information/abstracts reports/texts/references data sets news bulletins Format hard copy/print/microfiche online computer machine-readable/disk/magnetic tape Access public limited. xxxv

MEDICAL TECHNOLOGY ASSESSMENT DIRECTORY An information or data resource may be characterized by more than one descriptor for each of the three main types. For instance, a resource may have bibliographic as well as full text files, may appear in hard copy as well as online format, or may have both public and limited access files. The descriptions of each of the 73 information and data resources are arranged alphabetically by name of resource. Each is described according to the following common format. Name of information or data resource. Source gives the name, address, and telephone number of the organization that produces or makes available the information or data. Subject indicates the general subject matter covered by the information or data resource. Content describes the information or data contained in the resource, such as scope of coverage, file format, and descriptions of subfiles. Compilation describes how the information or data resource is assembled, such as primary sources, when compilation began, and how often the resource is updat- ed. Access describes how to acquire the information or data, including subscription and use charges, limitations to public access, need for computer hook-up, etc. At the end of Part 3 is a subject index for identifying information and data resources relevant to particular topics, e.g., market research. PART 4: ORGANIZATIONAL RESOURCES This part provides brief descriptions and contact information for 72 organizations that are active in affairs related to medical technology and are stakeholders in medical technology assessment. Although most of these organizations do not generate technol- ogy assessment reports on a regular basis, they have memberships concerned with medical technologies, conduct relevant meetings and symposiums, publish conference proceedings and other documents of note, establish standards for technologies, or are active in government, regulatory, or other policy affairs relevant to the field. The organizational descriptions are arranged alphabetically by organization name. Each includes name, address, and telephone number of the organization; contact personas), and a narrative description of the organization in 300 words or less, includ- ing discussion of medical technology related activities. At the end of Part 4 is a subject index for identifying organizations involved in particular areas, e.g., biomedical engi- neering. PART 5: INDEX TO ORGANIZATIONS This part includes an alphabetical listing with addresses and telephone numbers for all organizations described in the Directory, as well as a page index to the organizations. XXXV1

WAYS TO USE THE DIRECTORY DO YOU WANT TO SEE IF AN ORGANIZATION IS LISTED, OR WHAT IT DOES? Check the index to organizations in Part 5 to find the Dames on which or~ani7.~tion.c Are described in the Directory. r ; ~A ~ A _ ~ ~ ~ t~ ~ A ~ ~- ~ ~ ~4 Hi_ ~ ~ ~ ~ At_ DO YOU WANT TO FIND ASSESSMENT REPORTS ON A SPECIFIC TECHNOLOGY? Check the technology thesaurus at the beginning of Part 2 on page 313. The thesaurus will inform you whether reports are listed under the technology term that you have in mind, or under a synonym or related term. Once you have located the appropriate term, you can find the pertinent report citations under that heading in Part 2. YOU MAY BE INTERESTED IN REPORTS THAT HAVE TITLES REFERRING TO TECHNOLOGY TERMS THAT ARE BROADER OR NARROWER THAN THE ONE YOU HAVE IN MIND. For example, if you are interested in reports about beta-blockers, you will find reports under the heading Beta-blockers. But, as the thesaurus indicates, additional reports are to be found under more specific names for beta-blockers, such as Propranolol. Except for cases in which more than one technology is shown in the title of a report citation, a citation is listed only once in Part 2, i.e. under the most specific technology heading. So, it is important to refer to the thesaurus first to get the most out of the listing of assessment report citations by technology in Part 2. DO YOU WANT TO FIND REPORTS INDEXED BY NON-TECHNOLOGY TERMS SUCH AS COST BENEFIT ANALYSIS, PARTICULAR DISEASES, OR OTHER SUBJECTS? Check under the desired term in the index to report citations at the end of Part 1, and use the report codes found there to look up the assessments in the indicated program profiles. Each code under that term has a two letter prefix indicating the assessment program in Part 1, and a number indicating the report's placement in the program's list of citations. A list of prefixes and their respective programs is shown immediately preceding this subject index. Under Cost benefit analysis, you would find the reference numbers BA2, CP3, CU62, etc., which correspond to the numbered assessment report citations following the profiles on Battelle Memorial Institute, College of American Pathologists, Congress of the United States Office of Technology Assessment, etc. Similarly, under Asthma, you would find AC110, MG14, and ND86; under Breast neoplasms are AE15, AH4, AH6, etc.; under Hypertension are AGO, BAT, HN28, etc., and under Postmarketing surveil- lance are CU56, HN79, MG9, and MG10. Because each assessment report citation is indexed with from one to five terms, a particular report citation may be shown under more than one term in the index to report citations at the end of Part 1. For instance, the 1987 report by the Medical Technology and Practice Patterns Institute, "Dialysis treatment for end stage renal disease (outpatient)," is indexed under the terms Dialysis; Kidney failure, Chronic; and · - XXXV11

MEDICAL TECHNOLOGY ASSESSMENT DIRECTORY Outpatients. This means that the code for that report, MT6, is shown under each of these three terms. For non-technology terms such as asthma, cost benefit analysis, or hypertension, the subject index to report citations relies primarily upon MeSFI terminology. The actual titles of the the aforementioned three reports indexed under Cost benefit analyses, i.e. BA2, CP3, and CU62, include the phrases "cost-effectiveness analysis, "cost-effective," and "Allocating costs and benefits," respectively. Cost benefit analysis is the MeSH index- ing term assigned for these. For technologies such as beta-blockers, coronary artery bypass grafting, or chorionic villi sampling, this index relies primarily upon the terms developed for the technology thesaurus in Part 2, which includes some MeSt[ terms. Searching for reports by technologies is best done using the technology thesaurus at the beginning of Part 2 because it shows cross-references, synonyms, and related terms. DO YOU WANT TO FIND REPORTS THAT ADDRESS MORE THAN ONE SUBJECT? This involves locating the set of reports common to the multiple subjects of interest. For instance, to find reports that address both cost benefit analysis and cervical cancer screening, note the reports listed under Cost benefit analysts in the subject index at the end of Part 1. Next, determine if any of these reports is also listed under Cancer screening Cervical in the index at the end of Part 1 or the listing of assessment report citations by technology in Part 2. Remember that the thesaurus at the beginning of Part 2 is the best guide in the Directory for locating reports by their technology subjects. Among the reports found under both Cost benefit analyses and Cancer screening Cervical is a report from the Congress of the U.S. Office of Technology Assessment, "Allocating costs and benefits in disease prevention: an application to cervical cancer screening." This manual approach of looking under two or more subject headings is necessary given that the Directory information base is available only in hard-copy format at the time of printing this first edition. In a computer format, the "and/or" operations of Boolean algebra could be used more readily for searching reports involving such constraints as multiple subjects. DO YOU WANT TO OBTAIN A TECHNOLOGY ASSESSMENT REPORT? Check the subject index to assessment report citations at the end of Part 1 or the listing of assessment report citations by technology in Part 2 to find out which assessment program produced it. Find the program's profile in the alphabetical listing of assess- ment programs in Part 1, and see the section on Dissemination for ordering information. The program's address, telephone number, and other contact information are shown at the beginning of the profile. DO YOU WANT TO GET IN TOUCH WITH AN ORGANIZATION THAT DEALS WITH A CERTAIN TOPIC? Use the subject indexes to the different parts of the Directory to identify organizations active in certain areas. The index to report citations at the end in Part 1 and the listing of assessment report citations by technology in Part 2 may be used to identify profiled assessment programs, arranged alphabetically in Part 1, by the topics of their assess- ment reports. The information and data resources in Part 3 and the organizational resources in Part 4 are indexed by subject at the ends of those parts. For instance, under · - - XXXV111

WAYS TO USE THE DIRECTORY the heading Market research in the index to information and data resources in Part 3 are listed IMS Audits, Scrip, Market/Technology Reports (Biomedical Business Interna- tional), and other resources. Under the heading Biomedical engineering in the index to organizational resources in Part 4 are listed the Alliance for Engineering in Medicine and Biology, American Society of Mechanical Engineers, RESNA-Association for the Advancement of Rehabilitation Technology, Institute of Electrical and Electronics Engineers, and the International Federation for Medical and Biological Engineering. Contact information and descriptions of these are arranged alphabetically. xxx~x

GLOSSARY OF ACRONYMS AABB AAD AAFP AAN AAO AATB ACC ACEP ACG ACNP ACOG ACP ACPM ACR ACS American Association of Blood ACT Banks American Academy of Derm- ADA atology American Academy of Family Physicians AAMC Association of American Medical Colleges AAMI Association for the Advancement of Medical Instrumentation AAMSI American Association for Medical Systems and Informatics American Academy of Neurology American Academy of Ophthal mology AAOHNS American Academy of Otolaryn gology-Head and Neck Surgery AAOS American Academy of Orthopaedic Surgeons AAP American Academy of Pediatrics AAPMR American Academy of Physical  Medicine and Rehabilitation American Association of Tissue Banks American College of Cardiology American College of Emergency Physicians American College of Gastro enterology American College of Nuclear Physicians American College of Obstetricians and Gynecologists American College of Physicians American College of Preventive Medicine American College of Radiology American Cancer Society or American College of Surgeons American Council on Transplan- tation American Dental Association or American Diabetes Association ADAMHA Alcohol, Drug Abuse, and Mental Health Administration ADM AEMB AGS AHA AHCI AHSR AIUM alcohol, drug abuse, and mental health Alliance for Engineering in Medicine and Biology American Geriatrics Society American Hospital Association or American Heart Association American Health Care Institute Association for Health Services Research American Institute of Ultrasound in Medicine AMA American Medical Association AMCRA American Medical Care and Review Association AMPRA American Medical Peer Review Association AAMRC American Medical Review Research Center American National Standards Institute Associated Press American Psychiatric Association American Public Health Association American Rheumatism Association American Society of Anesthe  SiOlO~StS ASCP American Society of Clinical Pathologists ASCPT American Society for Clinical Pharmacology and Therapeutics ANSI AP APA APHA ARA ASA xli

ASGE ASIM ASTM ASTP ASTS AUA AZT BCBS BCDSP BDDD 1BERC American Society for Gastrointestinal Endoscopy American Society of Internal Medicine ASPEN American Society of Parenteral and Enteral Nutrition American Society of Testing and Materials American Society of Transplant Physicians American Society of Transplant Surgeons American Urological Association azidothymidine Blue Cross and Blue Shield Boston Collaborative Drug Surveillance Program Division of Birth Defects and Developmental Disabilities (CDC) Bureau Eligibility, Reimbursement and Coverage (HCFA) BMEDSS Biomedical Engineering Decision Support Services BRS Bibliographic Retrieval Service CABG coronary artery bypass grafting CAMMD Canadian Association of Manu facturers of Medical Devices CAP College of American Pathologists CASSIS Classification and Search Support Information System (Patent and Trademark Office) CAT CBO CCC CDB CDC ,  X111 CPHA CPT-4 computerized axial tomography Centraal Begeleidingsorgaan voor de Intercollegiate Toetsing (The Netherlands) Copenhagen Collaborating Center (WHO) Center for Drugs and Biologics (FDA) Centers for Disease Control CRISP CSDD CSS CT CVS MEDICAL TECHNOLOGY ASSESSMENT DIRECTORY CDRH Center for Devices and Radiological Health (FDA) CEAP Clinical Efficacy Assessment Project (ACP) CFSAN Center for Food Safety and Applied Nutrition (FDA) CHA Center for Health Affairs (Project HOPE) CHAMPUS Civilian Health and Medical Program of the Uniformed Services CHID Combined Health Information Database CHPE Center for Health Promotion and Education (CDC) CHPRE Center for Health Policy Research and Education (Duke University) CMA California Medical Association CMSS Council of Medical Specialty Societies CMT Center for Medical Technology Assessment (Linkoping University) COMPASS Computerized On-Line Medicaid Pharmaceutical Analysis and Surveillance System (Health Information Designs, Inc.) Commission on Professional-and Hospital Activities Current Procedural Terminology, 4th Edition Computer Retrieval of Information on Scientific Projects (NIH) Center for the Study of Drug Development (Tufts University) Council of Subspecialty Societies computed tomography chorionic villi sampling DATTA Diagnostic and Therapeutic Technology Assessment Program (AMA)

DCCC Duke Comprehensive Cancer GFIC Center Database DEN Device Experience Network (FDA) GPIA DHHS U.S. Department of Health and Human Services GPO Department of Health and Social GWUMC Security (United Kingdom) DIMDI Deutsches Institut fur Medizinische HANES Dokumentation und Information (Germany) HBP DIRLINE Directory of Information Resources HCFA U.S. Department of Defense Drug Product Problem Reporting System (FDA, USP) HHS diagnosis-related group or Division of Research Grants (NIH) DURbase Drug Utilization Review base (Health Information Designs, HIMA Inc.) Employee Benefit Research Institute formerly Emergency Care Research Institute ECRI/HDP ECRI Health Devices Program HSR&D ECRI/TAP ECRI Technology Assessment IAF Program Division of Environmental Health Laboratory Sciences (CDC) EMBASE Excerpta Medica Database (Elsevier) EPA Environmental Protection Agency IEEE ERIC Educational Resources Information Center DHSS DOD DPPR DRG EBRI ECRI EHLS Group Health Cooperative of Puget Sound Generic Pharmaceutical Industry Association U.S. Government Printing Off~ce George Washington University Medical Center National Health and Nutrition Examination Survey (NCHS) high blood pressure Health Care Financing Administration (DHHS) HECLINET Health Care Literature Infor mation Network (DIMDI) U.S. Department of Health and Human Services  HIAA HMO HRSA ESRD end stage renal disease FAHS Federation of American Health Systems FDA Food and Drug Administration IFVHSF GHAA Group Health Association of America Health Insurance Association of America Health Industry Manufacturers Association health maintenance organization Health Resources and Services Administration Health Services Research and Development Service (VA) Institute for Alternative Futures ICD-9-CM International Classification of Diseases, 9th Revision, Clinical Modification IDE investigational device exemption (FDA) Institute of Electrical and Electronics Engineers IFMBE International Federation for Medical and Biological Engineering Institute for the Future IFTF International Federation of Voluntary Health Service Funds , x'~

MEDICAL TECHNOLOGY ASSESSMENT DIRECTORY IHPS IND IOM IRCS MDR NAM Institute for Health Policy Studies (UCSF) IMPAC Information for Management Planning Analysis and Coordination (NIH) investigational new drug (FDA) Institute of Medicine (NAS) International Research Communications System (Elsevier) ISTAHC International Society of Technology Assessment in Health Care Medical Device Reporting regulation (FDA) MEDITEC Medizinische Technik MEDLARS Medical Literature Analysis and Retrieval System (NLM) MEDLINE MEDLARS online (NLM) MeSH Medical Subject Headings (NLM) MHA Maryland Hospital Association MHRST Medical and Health Related Sciences Thesaurus (NIH) MRC Medical Research Council (Canada) MTPPI Medical Technology and Practice Patterns Institute NAHDO National Association of Health Data  Organizations National Association of Manu facturers NAS National Academy of Sciences NASA National Aeronautics and Space Administration NCEP National Cholesterol Education Program NCHS National Center for Health Statistics NCHSR/ National Center for Health HCTA Services Research and Health Care Technology Assessment xliv NCI National Cancer Institute NCQHC National Committee for Quality Health Care NDA new drug application (FDA) Nd:YAG Neodymium:yttrium aluminum garnet NEMA National Electrical Manufacturers Association NEMT Nordic Evaluation of Medical Technology NHC National Heart Council NHLBI National Heart, Lung, and Blood Institute NHRDP National Health Research and Development Program (Canada) NHS National Health Service (United Kingdom) NHSPPS National Health Services and Practice Patterns Survey NIA National Institute on Aging NIAAA National Institute on Alcohol Abuse and Alcoholism NICHD National Institute of Child Health and Human Development NIDA National Institute on Drug Abuse NIH National Institutes of Health (PHS, DHHS) NIMH National Institute of Mental Health NINCDS National Institute of Neurological and Communicative Disorders and Stroke NIOSH National Institute for Occupational Safety and Health NLM NMR NSEP National Library of Medicine nuclear magnetic resonance NHLBI Smoking and Education Program NTIS National Technical Information Service

GLOSSARY OF ACRONYMS OASH Office of the Assistant Secretary for Health (DHHS) ODPHP Office of Disease Prevention and Health Promotion (DHHS) OHTA Office of Health Technology Assessment (NCHSR) OMAR Office of Medical Applications of Research (NIH) ONHIC ODPHP National Health Information Center Office of Planning and Evaluation (NIH) Organ Procurement and Trans plantation Network (UNOS) Office of Research and Demonstrations (HCFA) Occupational Safety and Health Administration Office of Technology Assessment (U.S. Congress) Pan American Health Organization Physician Data Query (NCI) U.S. Public Health Service (DHHS) Pharmaceutical Manufacturers Association PPRC or Physician Payment Review PhysPRC Commission PPS Medicare Prospective Payment System PRO professional review organization ProPAC Prospective Payment Assessment Commission Medical Device and Laboratory Product Problem Reporting Program (FDA, USP) PTO U.S. Patent and Trademark Office R&D research and development RESNA Association for the Advancement of Rehabilitation Technology, formerly Rehabilitation Engineering Society of North America OPE OPTN ORD OSHA OTA PAHO PDQ PHS PMA PRP RCT randomized (controlled) clinical trial RFA RFP  SBA SEER SMD request for application request for proposal RPA Renal Physicians Association RTECS Registry of Toxic Effects of Chemical Substances (NIOSH? NLM) Summary Basis of Approval (FDA) Surveillance, Epidemiology, and End Results Program (NCI) Standard Industrial Classification Society for Medical Decision Making SNM Society of Nuclear Medicine SNIVT Society of Non-Invasive Vascular Technology Special Projects Office (VA) Swedish Planning and Ration alization Institute of the Health Services SPRILINE Swedish Planning and Ration alization Institute of the Health Services line SPO SPRI SREPCIM Society for Research and Education in Primary Care Internal Medicine SSED TAF TDC TNO UCSF UHC UNOS USDA Summaries of Safety and Effectiveness Data (FDA) Technology Assessment and Forecast Program (PTO) Technical Data Center (OSHA) Medical Technology Unit, Netherlands Organization for Applied Scientific Research University of California at San ~ . ranasco University Hospital Consortium United Network for Organ Sharing U.S. Department of Agriculture xlv

MEDICAL TECHNOLOGY ASSESSMENT DIRECTORY USDHHS U.S. Department of Health and Human Services VA Veterans Administration xlvi WHO World Health Organization  YAG yttrium aluminum garnet