R A 335 Agency for Health Care Policy and Research fi R46 1991 PUBL ’ Report to Congress: Progress of Research on Outcomes of Health Care Services and Procedures :5 u.s. DEPARTMENT OF HEALTH AND HUMAN SERVICES C Public Health Service Agency for Health Care Policy and Research /a£lxun"\ ? HBRARY f 1 . Vmexny 3F (AJH‘WIIHA 1/ Agency for Health Care Policy and Research Report to Congress: Progress of Research on Outcomes of Health Care Services and Procedures U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES Public Health Service Agency for Health Care Policy and Research Rockville, Maryland AHCPR Pub. No. 91—0004 May 1991 U.S. Department of Health and Human Services , ' A ritxflli Louis W. Sullivan, M.D., Secretary Public Health Service James 0. Mason, M.D., Dr. P.H., Assistant Secretary for Health Agency for Health Care Policy and Research J. Jarrett Clinton, M.D., Administrator AHCPR AHEC CDC CMER CRDL DHHS DOD DVA GEC HCFA HRSA IHS IOM IPPB MEDTEP NCHSR NEl NHLBI NIH NLM OPM OSDD PHS POARP PORT RCT List of Acronyms Agency for Health Care Policy and Research Area Health Education Center Centers for Disease Control Center for Medical Effectiveness Research Center for Research Dissemination and Liaison Department of Health and Human Services Department of Defense Department of Veterans Affairs Geriatric Education Center Health Care Financing Administration Health Resources and Services Administration Indian Health Service Institute of Medicine Intermittent positive pressure breathing Medical Treatment Effectiveness Program National Center for Health Services Research and Health Care Technology Assessment National Eye Institute National Heart, Lung, and Blood Institute National Institutes of Health National Library of Medicine Office of Personnel Management Office of Science and Data Development Public Health Service Patient Outcome Assessment Research Program Patient Outcomes Research Team Randomized clinical trial iii Contents List of Acronyms ................................................... iii Executive Summary .............................................. ES—l Introduction and Overview ............................................. 1 Data Development ................................................... 5 Outcomes Research .................................................. 7 Practice Guideline Development ....................................... 11 Dissemination ...................................................... 13 Coordination of MEDTEP Activities .................................... 15 References ........................................................ l7 Appendices A. The Feasibility of Linking Research—Related Data Bases to Federal and Non-Federal Medical Administrative Data Bases: Report to Congress—Executive Summaiy ............. A—l B. MEDTEP Active Research Projects as of September 30, 1990 ......................................... B—l C. Practice Guideline Panels ..................................... C—l D. National Advisory Council for Health Care Policy, Research, and Evaluation .............................. D—l E. AHCPR Organizational Chart .................................. E—l Executive Summary Section 6103 of the Omnibus Budget Reconciliation Act of 1989 (Public Law 101—239), enacted on Decem— ber 19, 1989, added title IX to the Public Health Service Act and therein established the Agency for Health Care Policy and Research (AHCPR). The AHCPR is to en- hance the quality, appropriateness, and effectiveness of health care services through a broad program of scientif- ic research and information dissemination. Section 1 142 ofthe Social Security Act, as amended by the same section of PL. 101—239, established a program of re- search on outcomes of health care services and proce- dures to be carried out by the Secretary, acting through the Administrator of AHCPR. Section 1142(h) of the Social Security Act directs the Secretary to develop a re- port to Congress on the progress of the activities related to the program of research on outcomes of health care services and procedures. This report addresses the re— quirements of section 1142(h) by describing the out- comes research activities of AHCPR from December 1989 through January 1991. Building on earlier accomplishments by the Depart- ment, AHCPR elected to use the previously established Medical Treatment Effectiveness Program (MEDTEP) as the appropriate means to carry out the new statutory program on outcomes research and clinical guidelines. MEDTEP conducts and integrates four related activi- ties: data development, outcomes research, clinical guideline development, and dissemination. Taken to- gether, these activities provide scientific information about the most effective medical strategies for practi— tioners, consumers, employers, educators, and insurers, and they facilitate professional assimilation of scientifi- cally based medical practices. Data development is concerned with identifying, eva- luating, and expanding the usefulness of existing data bases to support research on patient outcomes. MEDTEP research is focused on patient outcomes and generation of scientific information on alternative strategies for the prevention, diagnosis, treatment, and management of patient conditions. Clinical practice guidelines are intended to specify how various health conditions are most effectively pre— vented, diagnosed, and treated in order to ensure effec— tive and appropriate use of medical resources. Dissemination refers to a broad array of activities to educate health care providers and consumers about re- search and guidelines and to promote the assimilation of this information into practice. The progress of AHCPR through January 1991 in ES—l meeting the requirements for aprogram on outcomes re- search, as implemented through MEDTEP, is summa- rized below. Data Development The Office of Science and Data Development (OSDD), which has primary responsibility for data de- velopment, held several planning meetings and work- shops to explore issues such as improving the uniformi- ty of research—related data and linking Federal and pri- vate sector data bases. The results of this first year of work are summarized in the report submitted to Con- gress entitled, “The Feasibility ofLinking Research—Re— lated Data Bases to Federal and Non—Federal Medical Administrative Data Bases.” Conclusions and future activities of AHCPR in data development are summa- rized in the Executive Summary of that report (appendix A of this document). Outcomes Research The Center for Medical Effectiveness Research guides MEDTEP research through both Patient Out— comes Research Team (PORT) projects and a variety of other grants, contracts, and intramural research. PORT projects involve large multisite and multidisciplinary teams that evaluate alternative services or procedures for managing specific clinical conditions. The specific clinical conditions chosen for study were selected to re— flect predominately the needs of the Medicare popula- tion as required by PL. 101—239. PORT projects have been initiated that address each of the following clinical conditions and procedures: Back pain, Total knee replacement, Acute myocardial infarction, Cataracts, Benign prostatic hypertrophy, Ischemic heart disease, Biliary tract disease, Hip fracture repair and osteoarthritis, Diabetes, Pneumonia, and Cesarean section and other obstetrical procedures. Practice Guidelines The Office of the Forum for Quality and Effective— ness in Health Care (the Forum) facilitates the develop- ment and review ofclinical practice guidelines. Practice guidelines and associated standards, performance mea— sures, and review criteria are based on the best available research and professional judgment. Multidisciplinary expert panels were convened to de- velop guidelines for seven priority areas ofclinical prac— tice, chosen with the assistance of the Institute of Medi- cine (IOM). These clinical practice areas were selected with a primary concern for the treatment needs of Medi- care beneficiaries. 0 Diagnosis and treatment of benign prostatic hyper- plasia, 0 Treatment of visual impairment due to cataracts in the aging eye, Treatment of urinary incontinence in adults, Prediction, prevention, and early treatment of pres— sure sores in adults, Management of acute postoperative pain, Diagnosis and treatment of depressed outpatients in primary care settings, and 0 Delivery of comprehensive care in sickle cell dis- ease. The Chairpersons, cochairs, and members of these panels are experts drawn from medicine, nursing, and allied health disciplines involved in the management of these clinical practice areas. Each panel has a consumer representative. The process of guideline development is systematic and rigorous, involving review and analy— sis of scientific evidence, potential benefits and risks, and expected patient outcomes. Three draft guidelines have been developed and were ready for peer review and pilot testing in January 1991. Dissemination The Center for Research Dissemination and Liaison (CRDL) serves as the focal point for disseminating MEDTEP-related and other research information. CRDL has undertaken several activities to ensure effec— tive dissemination of both practice guidelines and MEDTEP research. Extensive mailing lists of inter- ested individuals and groups have been developed. Regular periodic publications contain research updates, and special publications contain infonnation about all aspects of AHCPR’s activities. In addition, CRDL’s ES—2 State and Local User Liaison Program has been de- signed to meet the growing need for dissemination of better and more comprehensive information on the plan— ning, management, delivery, and financing of health care services. This program conveys research findings to policymakers, State and local elected health officials and programs, leaders of health care organizations, and purchasers of care in the private sector. Other dissemination efforts involve Area Health Edu— cation Centers (AHECs) and Geriatric Education Cen— ters (GECs), through an interagency agreement with the Health Resources and Services Administration (HRSA). In addition, an agreement with the National Institutes of Health’s National Library of Medicine (NLM), Office of Health Services Research Informa— tion, supports dissemination of MEDTEP research and clinical practice guidelines. In fiscal year 1990, AHCPR obligated $37.5 million to support MEDTEP activities related to data develop- ment, outcomes research, development of practice guidelines, and dissemination. Future Plans As AHCPR moves into its second year, activities will continue to focus on issues related to information acqui— sition and analysis, expanded MEDTEP research, the ongoing guideline development effort, enhanced dis- semination activities, and initiating evaluations. Plans are underway for workshops and conferences to refine further the outcomes research agendas. Collaborative efforts will continue with the Health Care Financing Ad- ministration (HCFA), other components of the Public Health Service (PHS), such as the National Institutes of Health (NIH), HRSA, and the Indian Health Service (IHS), and others. Practice guidelines will be dissemi- nated to providers and consumers, and their use and ef- fects will be evaluated. Quality and utilization review criteria associated with practice guidelines will be de- veloped during the coming year. In conclusion, MEDTEP is a multifaceted program to enhance the quality of health care by improving the scientific basis for medical practice and increasing the involvement of patients and consumers in decisionmak- ing regarding health care. MEDTEP builds on past re— search and significantly extends previous efforts to speed the effective dissemination of scientific informa— tion and promote its use in medical practice. The pro- gram represents a long-tenn commitment by the Depart- ment; significant progress has been achieved in the ini- tial year. lntroduction and Overview Section 6103 of the Omnibus Budget Reconciliation Act of 1989 (Public Law 101—239), enacted on Decem- ber 19, 1989, established under section 1142 of the S0— cial Security Act a program of research on outcomes of health care services and procedures. The same section of PL. 101—239 also added a new title IX to the Public Health Service Act and therein established the Agency for Health Care Policy and Research (AHCPR). The AHCPR is to enhance the quality, appropriateness, and effectiveness of health care services through a broad program of scientific research and information dissemi— nation. Section 1142(a) ofthe Social Security Act directs that the Secretary shall carry out the program of research on outcomes of health care services and procedures, acting through the Administrator of AHCPR. Section 1142(h) directs the Secretary to develop a report to Congress on the progress of activities related to the program of re— search on outcomes of health care services and proce— dures. This report addresses the requirements of section 1142(h) by describing the outcomes research activities of AHCPR from December 1989 through January 1991. Building on earlier accomplishments by the Depart— ment, AHCPR elected to use the previously established Medical Treatment Effectiveness Program (MEDTEP) as the appropriate means to carry out the new statutory program on outcomes research and clinical guidelines. MEDTEP conducts and integrates four related activi— ties: data development, outcomes research, clinical guideline development, and dissemination. Together, these activities provide scientific information about the most effective medical strategies for practitioners, con- sumers, employers, educators, and insurers, and they fa- cilitate professional assimilation of scientifically based medical practices. Historical Development The Department of Health and Human Services (DHHS) has supponed medical effectiveness research for two decades. Within the Public Health Service (PHS), the National Center for Health Services Re— search and Health Care Technology Assessment (NCHSR) funded research on small area variations in the 19705 and early 19805. The research demonstrated that differences in usage rates for surgical and medical procedures in different communities existed even when results were adjusted for variation in the populations. For example, in the early 1970s Dr. John Wennberg of Dartmouth Medical School examined the rate of tonsil- lectomies in several Vermont communities and found high rates in some areas and low rates in others. Chil- dren in the areas with low rates did not appear to experi— ence adverse health outcomes as a result of foregoing the procedure. Wennberg and others have since demon- strated additional examples of widely varying medical and surgical practices throughout the United States (Wennberg, 1986; Wennberg and others, 1988). Patient Outcome Assessment Research Program Findings from the early research, along with concern for rising health care costs, led to inclusion in the Omni- bus Budget Reconciliation Act of 1986 a directive that NCHSR establish a “patient outcome assessment re— search program to promote research with respect to pa- tient outcomes of selected medical treatments and surgi- cal procedures for the purpose of assessing their appro- priateness, necessity and effectiveness.” No funds were appropriated for the program in fiscal year 1987, but $1.9 million was appropriated and transferred from Medicare Trust Funds in fiscal year 1988, and $5.9 mil- lion was appropriated and transferred in fiscal year 1989. A portion of these funds was allocated to the support of 13 small research studies. The majority of the funds was targeted for support of four Patient Outcome Asses- sment Research Program (POARP) projects. POARPs are multiyear—funded assessment teams comprised of researchers, clinicians, economists, and other appropri- ate health care professionals. Fiscal year 1989 funding supported research on: 0 Prostate disease (Dr. John Wennberg, principal in— vestigator, Dartmouth Medical School), 0 Cataracts (Dr. Earl Steinberg, principal investiga- tor, Johns Hopkins University), 0 Myocardial infarction (Dr. Barbara McNeill, princi— pal investigator, Harvard Medical School), and 0 Low back pain (Dr. Richard Deyo, principal investi- gator, University of Washington). HCFA's Medical Effectiveness Initiative An article in the New England Journal of Medicine outlined the interest of Dr. William Roper, then Admin- istrator of the Health Care Financing Administration (HCFA), in evaluating and improving the quality of medical care by using population—based data bases to understand which practices are most effective. The re— search would focus on the measurement of medical out- comes with particular attention to quality-of—life mea- sures (Roper and others, 1988). Dr. Roper made these activities essential components of the HCFA medical effectiveness initiative and asked the Institute of Medicine (10M) to assist HCFA in priori- tizing topics for effectiveness research. The IOM re- sponded by proposing two tiers ofhigh-priority clinical conditions believed appropriate for evaluation. Tier one included acute myocardial infarction, angina, breast cancer, congestive heart failure, and hip fracture. Tier two included cataracts, depressive disorders, prostatic hypertrophy, and transient ischemic attack (IOM, 1989). Legislative Interest in Medical Effectiveness Increasing congressional support for effectiveness re— search resulted in the introduction of several bills during 1989. Key among these were the “Patient Outcomes Assessment Act of 1989” sponsored by Senator George Mitchell; “Medical Care Quality Research and Im— provement Act of 1989,” sponsored by Representative Willis D. Gradison; and “Health Care Research and Policy Act of 1989,” sponsored by Representative Henry A. Waxman. Establishment of MEDTEP Concurrent with introduction of legislation related to medical effectiveness research, the Secretary of Health and Human Services formally established MEDTEP in June 1989. Retaining the key elements of the earlier HCFA initiative, the Secretary designated PHS as pri- marily responsible for implementing a new expanded program that involves several DHHS components. In testimony before congressional committees con— sidering the bills introduced on medical effectiveness, both the Secretary of Health and Human Services and the Assistant Secretary for Health emphasized the im- portant role of MEDTEP in the Department’s efforts to ensure appropriate medical care. While the cost of health care is of major concern to the Department, the Secretary underscored his intent that the primary goal of MEDTEP was to enhance the quality of health care by increasing the scientific knowledge base of medical practice and ensuring wide dissemination and assimila- tion of this knowledge by all involved in provision of health care, including consumers. Establishment of AHCPR AHCPR was created by Congress in the Omnibus Budget Reconciliation Act of 1989 (PL. 101—239 (sec- tion 6103)). This action was the next significant step in the ongoing effort to harness the results of several de— cades of research and technological advances to answer fundamental questions about the relative value of medi— cal care in a comprehensive and coordinated manner. AHCPR elected to use MEDTEP as the vehicle to carry out the programs of effectiveness and outcome re— search and the development of clinical practice guide- lines. MEDTEP Components: A Brief Description MEDTEP consists of four components directed to- ward improvement of patient care through improving the scientific basis for clinical decisionmaking of health care providers and consumers. The four components are: Data development, Outcomes research, Practice guideline development, and Dissemination. A brief description of these four components follows. Pages 4—12 provide a detailed description. Data Development The goal of this program component is to increase the quantity and quality of administrative and clinical data available for health services research, with special em- phasis on patient outcomes research. This is primarily accomplished by identifying and evaluating the useful— ness of existing data bases to support research on patient outcomes. AHCPR’S Office ofScience and Data Devel- opment (OSDD) coordinates these efforts. OSDD’S efforts are focused on the establishment of standards for uniform methods of developing and col- lecting data and on investigating the feasibility of link— ing research-related data with data collected or main- tained by both Federal and non-Federal entities and by agencies within DHHS. Additional concerns of OSDD include developing uniform definitions of data, common reporting formats, and linkages, and ensuring the security, confidentiality, accuracy, and appropriate maintenance of data as speci- fied in section 1142(d) of the Social Security Act. Outcomes Research AHCPR’S Center for Medical Effectiveness Research (CMER) guides the research on patient outcomes and al- ternative strategies for the prevention, diagnosis, treat— ment, and management of clinical conditions. Outcom- es research is conducted through both large—scale multi- disciplinary studies called Patient Outcome Research Teams (PORTS), as well as through smaller grants, con- tracts, and intramural research. PORTS build on the earlier POARP model (page 1), by documenting, analyzing, and synthesizing scientific findings about the outcomes, effectiveness, and appro— priateness of alternative medical strategies. In addition, PORTS are concerned with the cost-effectiveness of clinical management strategies and with the dissemina— tion of conclusions on the basis of their findings. In accordance with section 1142(a) and (b) of the So- cial Security Act and section 914 of the PHS Act, clini- cal conditions that meet the following criteria are chosen for study: Large numbers of individuals are affected. There is uncertainty and/or controversy regarding effectiveness of treatment. 0 The associated risks and/or costs of treatment are high. The needs of Medicare beneficiaries are addressed. Data are available or can be readily developed. While MEDTEP research is responsive to medical conditions affecting the Medicare age group, it also con- siders medical conditions relevant to Medicaid and oth- er non-Medicare populations. MEDTEP’s smaller projects focus on a particular fac— et of the broader objectives of PORTS, for example, syn- thesizing literature on medical effectiveness, addressing methodological issues such as how to measure essential patient outcomes of care, or studying problems related to clinical guideline use or assimilation. Practice Guidelines AHCPR’s Forum for Quality and Effectiveness in Health Care (the Forum) is responsible for facilitating the development, review, and updating of clinical prac— tice guidelines. These guidelines are intended to im- prove decisionmaking by health care practitioners on how various health conditions are most effectively pre- vented, diagnosed, and treated. Additionally, practice guidelines are to be translated into forms useful to con— sumers, persons concerned with quality assurance mon— itoring, and education programs for health profession— als. Dissemination and Assimilation The dissemination and assimilation of research find- ings and practice guidelines is the primary focus of AHCPR’s Center for Research Dissemination and Liai— son (CRDL). This Center, along with the Forum and CMER, addresses an array of dissemination activities, ranging from evaluation of the most effective ways of encouraging physicians and other health care providers to Change their practice patterns to strategies for reach- ing particular audiences. CRDL is developing different information strategies for communication through journal publications, infor- mation networks, and conferences. CRDL also employs resources and expertise of the National Institutes of Health’s National Library of Medicine (NLM) for in- dexing, abstracting, and dissemination and the Health Resources and Services Administration (HRSA) for dis- semination to selected health professions education net- works. AHCPR has developed communication links with professional organizations, specialty societies, and State and local medical societies, and it has used educa- tional seminars at professional meetings and profession- al journals to inform practitioners about AHCPR’s prac- tice guidelines and: outcomes research findings. Summary MEDTEP is a multifaceted and multidisciplinary ap- proach to addressing the complex issues of health care delivery. The program uses large extant data bases, as well as primary research data, to study health care out- comes salient to patients. It includes, in addition to tra- ditional indicators of morbidity and mortality, patients’ subjective assessments of their health status, functional capacity, and quality of life. MEDTEP focuses on health conditions, diseases, or symptom complexes of high priority; translates research findings into clinical guidelines for practice; and ensures dissemination and promotes assimilation of this body of knowledge by both health care professionals and consumers. Data Development Data development efforts have focused on assessing the utility of data, identifying issues related to setting standards for data and problems of data access, and ex- ploring the feasibility of linking research-related data with administrative data from the Department of De— fense (DoD), Department of Veterans Affairs (DVA), the Office of Personnel Management (0PM), and the private sector. To accomplish this work, in mid-1990 the Office of Science and Data Development held a series of work- shops attended by researchers, data assemblers, and in— dividuals associated with linked data bases and repre— sentatives from professional groups, governmental agencies, and private businesses. Issues associated with promoting the creation and maintenance of data bases useful for medical effectiveness research, improving the uniformity and linking of data bases, and improving ac- cess by researchers to data were the foci of the first workshop. Defining common data elements, improving information flow, and grouping health-related data were the foci of the second workshop. In addition to the workshops, OSDD held a meeting with approximately 20 representatives of State health data programs to review summary information about State data bases and legal conditions of access to data. OSDD also sponsored an IOM workshop on overcom- ing barriers to patient record development and use. The purpose of this invitational workshop was to investigate the breadth and depth of support of members of the health care community for automating health care infor- mation systems, and to obtain their views on the estab- lishment of an organization for patient record develop— ment. The results of this first year of work are summarized in the Report to Congress, The Feasibility of Linkin g Re- search-Related Data Bases to Federal and Non-F ederal Medical Administrative Data Bases. Briefly, the report draws conclusions regarding the feasibility of linking data bases of DoD, DVA, 0PM, and selected non—Feder- al entities; the usefulness of secondary data sources for MEDTEP research; standards for data bases; and access and confidentiality of data. The specific conclusions and future activities of AHCPR in each of these areas are summarized in the Executive Summary of the Report to Congress (appendix A of this report). Research data useful to effectiveness and outcomes research must have each of the following five basic characteristics: Reflect the individual patient level, Include information about the health care received, Report data about patient outcomes or the results of care, 0 Contain information about other relevant factors that influence either a patient’s treatment or out- comes, and 0 Be linked over time. No one data base is optimal for all purposes or satis- factory in terms of all of the basic characteristics. Add- ing a standard patient identifier, such as Social Security number, would, by itself, greatly facilitate the linkage of administrative and clinical data sets and, thus, the appro- priateness of existing data bases for MEDTEP research. For the foreseeable future, however, MEDTEP research will require a combination of primary and secondary data sources, as well as information from a variety of data bases. Central to AHCPR’s data base development is a rap- idly evolving collaboration with HCFA. This effort fo— cuses on timely transfer of special HCFA data tapes to MEDTEP researchers, and development of both a longi- tudinal survey of the functional status of a sample of Medicare beneficiaries, and of a functional status mea- sure of Medicare beneficiaries after hospitalization. In fiscal year 1990, AHCPR obligated $6.1 million for data development. This figure includes $5.0 million transferred to HCFA to support HCFA’s activities in timely transfer of special data tapes to MEDTEP re- searchers and related efforts. Outcomes Research MEDTEP research is accomplished by PORT proj— ects and other, smaller, grants and contracts. AHCPR’S Center for Medical Effectiveness Research coordinates research under the program. PORT projects involve a multisite, multidisciplinary evaluation of the effectiveness of alternative services or procedures for managing specific clinical conditions. The management strategy may include any pertinent medical, surgical, nursing, or pharmacological inter— vention, including the possibilities of “watchful wait- ing” and the decision not to treat. PORT projects include a review and formal synthesis ofavailable research, which serves as the basis for Speci- fying research hypotheses and other components of the research process. Then, using both primary and second— ary data sources, PORTS collect and analyze data to identify and explain variations in clinical practice and patient outcomes. Conclusions and recommendations regarding the effectiveness and appropriateness of alter- native clinica] practices are developed, and the informa- tion is disseminated to health care providers and its ef- fectiveness assessed. The findings of PORTS contribute to the scientific ba- sis for the development of practice guidelines and iden- tification of gaps in knowledge that require additional study. MEDTEP studies also are conducted to identify effective strategies for producing desired changes in clinical practices, including alternative ways to present and disseminate information to various practitioners and the public and to evaluate subsequent changes in practice. In 1988 HCFA, under its Medical Effectiveness Ini- tiative, requested the IOM to identify clinical conditions of high research priority. PORT projects funded in fiscal year 1989 included three of the nine priority areas iden- tified by IOM: myocardial infarction, cataracts, and be- nign prostatic hypertrophy. In addition, PORTS have been awarded in fiscal year 1990 for low back pain, total knee replacement, chronic ischemic heart disease, bili- ary tract disease, hip fracture and replacement, pneumo— nia, and diabetes. Under a contract mechanism, a PORT has been established to examine cesarean section deliv— ery. AS of September 30, 1990, 11 PORT projects were awarded. These are listed in figure 1 and summarized in appendix B. While each of these 5-year projects represents a sub- stantial, long-term commitment, valuable interim prod- ucts have been produced. Examples of preliminary findings follow. Final results based on analyses of com- plete samples may differ from preliminary results re- ported here. Low Back Pain Study The literature reviewed in the PORT Study of the ef— fectiveness of medical and surgical interventions for low back pain documented that widely used diagnostic imaging procedures for low back pain yield limited in- formation, are costly, and occasionally are harmful (Deyo and others, 1989). The review further indicates that because most epi— sodes of low back pain improve rapidly with little or no intervention, few patients require plain radiography (X-rays), and even fewer patients need more sophisti- cated imaging techniques. Thus, plain radiographs (X—rays) and lumbar Spine X-rays are of little utility, es- pecially when taken early in the course of low back pain. Moreover, lumbar spine films are a source of high doses of gonadal irradiation, and their use contributes to the rising cost of medical care. Researchers recommend limiting plain radiography (X—rays) to patients with back pain with symptoms that might indicate an under- lying malignancy, infection, inflammatory process, or trauma. The researchers further recommend that special imaging studies such as myelography, computed tomo- graphy, or magnetic resonance imaging be reserved for patients such as those who are unresponsive to conser- vative treatment or those who may be potential candi- dates for surgery. Finally, the study team recommends that priority should be placed on conducting better studies of the in- dications for, and sequencing of, imaging tests because of the prevalence of low back pain and the high cost of diagnostic testing. Myocardial Infarction Study Using a small sample of 1986 HCFA data, prelimi— nary analysis of cardiac catheterization and cardiac by- pass surgery was conducted by the PORT studying acute myocardial infarction (heart attacks). Results suggest there is more than threefold variation (9—29 percent) among States in use of cardiac catheterization, with the lowest rate in the Northeast and the highest in the South- east and Great Plains areas. This large variation demon— strates a lack of consensus about when cardiac catheteri- zation should be used. The proportional variation re— garding use of bypass surgery was somewhat less (28—63 percent), indicating somewhat greater consen- sus regarding use of surgical procedures for revasculari- zation of the heart. Figure 1. MEDTEP Research: Patient Outcomes Research Teams (PORTS) Project Title “Back Pain Outcome Assessment Team” “Assessing and Improving Outcomes: Total Knee Replacements" “The Consequences of Variation in Treatment for Acute Myocardial Infarction" "Variations in Cataract Management: Patient and Economic Outcomes" “Assessing Therapies for Benign Prostatic Hypertrophy and Localized Prostate Cancer" "Outcome Assessment Program in lschemic Heart Disease" “Outcome Assessment of Patients with Biliary Tract Disease" “Analysis of Practices: Hip Fracture Repair and Osteoarthritis" “Variations in the Management and Outcomes of Diabetes" “Assessment of the Variation and Outcomes of Pneumonia" “Variation in Obstetric Practice and Patient Outcomes” Principal Investigator Richard A. Deyo, MD. University of Washington Seattle, WA Deborah A. Freund, Ph.D., M.P.H. Indiana University Indianapolis, lN Barbara J. McNeil, MD, Ph.D. Harvard Medical School Boston, MA Earl P. Steinberg, M.D. Johns Hopkins University Baltimore, MD John E. Wennberg, MD, MPH. Dartmouth Medical School Hanover, NH David B. Pryor, M.D. Duke University Medical Center Durham, NC J. Sanford Schwartz, MD. University of Pennsylvania Philadelphia, PA James I. Hudson, MD. University of Maryland College Park, MD Sheldon Greenfield, MD. New England Medical Center Boston, MA Wishwa N. Kapoor, MD. University of Pittsburgh Pittsburgh, PA Emmett Keeler, Ph.D. The RAND Corp. Santa Monica, CA Project Period 9/89—8/94 4/90—3/94 9/89—8/94 9/89—8/94 9/89—8/94 7/90—6/95 8/90—7/95 9/90—9/95 9/90—9/95 9/90—9/95 9/90—9/95 Cataract Study Significant variation in the use of cataract surgery also was found in the preliminary analysis conducted by the PORT studying use of such surgery to improve vi- sion. Using 1986—87 Medicare data, researchers found a threefold difference in age- and sex—adjusted rates of cataract surgery. While the factors explaining these pre— liminary findings have not been determined to date, the rates of cataract surgery for whites were significantly higher than for blacks (ratio for whites was 1.4 times that for blacks in 1986 and 1.25 in 1987), and these differ— ences persist across all census divisions and almost all States. Benign Prostatic Hypertrophy Study The PORT on benign prostatic hypertrophy and pros- tate cancer has developed an interactive video tape to as— sist physicians and patients in decisionmaking regard- ing the treatment of benign prostatic hypertrophy. The video disk on shared medical decisionmaking has been introduced into several clinical practices where it has been used as a tool for identifying potential outcomes and patient preferences. Results based on information from over 400 patients are being analyzed. Other Studies In addition to preliminary findings from PORT stu- dies, other MEDTEP research has contributed to en- hancing knowledge about the usefulness of methods for studying treatment effectiveness. For example, meta-analysis—the systematic evaluation and combi— nation of results from separate studies of a particular subject—can be useful when individual studies disagree in their findings or are too small to yield conclusive an- swers. Researchers supported by AHCPR recently tested the power of meta—analysis on endoscopic hemo- stasis, a nonsurgical therapy used to treat bleeding ul- cers. Many gastroenterologists consider the number of individual randomized clinical trials (RCTs) on endo- scopic hemostasis too small to yield conclusive results. In addition, a recent NIH-sponsored consensus confer- ence reported that there were not enough RCTs of endo- scopic hemostasis to draw firm conclusions about the technology’s clinical applications. The AHCPR-supported researchers found no short- age of RCTs evaluating endoscopic hemostasis (Sacks and others, 1990). They identified reports of 25 RCTs published in the English-language literature that met their criteria for inclusion in the meta-analysis. The meta-analysis confirmed the findings of two less com— plete meta-analyses published 2 years ago that there are enough RCT results to conclude that endoscopic hemos- tasis significantly reduces recurrent bleeding, the need for emergency surgery, and in-hospital mortality. More specifically, the new meta-analysis found that, relative to standard medical therapy, endoscopic hemos— tasis reduced recurrent or continued bleeding by 69 per— cent, emergency operations by 62 percent, and in-hospi— tal mortality by 30 percent. Although the results are most impressive when a blood vessel is seen bleeding, the review indicated that patients need to undergo en— doscopy early if the blood vessel is to be located and treated. The authors agree with the earlier consensus conference that a number of questions remain, including which endoscopic procedure is best. Another recently completed study illustrates the ef— fectiveness of computer-displayed messages in decreas— ing physician use of diagnostic tests. Diagnostic tests account for a significant portion of total health care ex- penditures, and often they are unnecessary. Research- ers have tried different ways of reducing unnecessary tests; however, most ofthese methods have proved time— consuming and expensive. But a relatively inexpensive software program designed to display onscreen mes- sages about charges for specific tests at the moment phy- sicians order them (via microcomputers) appears to be a step in the right direction. The software, which was de- veloped and tested with the support of AHCPR, also tells the physician the total charges for all tests ordered for the patient on the day of his or her visit. A randomized, controlled study of the effects of the experimental computer program on the ordering of out- patient tests found that physicians at a large, primary care outpatient clinic who used the special software or- dered 14 percent fewer tests per patient visit than physi- cians whose computers were not equipped with the pro— gram (Tierney and others, 1990). The reduction was even larger—l7 percent—for scheduled patients, who accounted for 80 percent of all visits. The intervention resulted in an average cost savings of nearly $7 per visit overall and over $8 per scheduled visit. If the reductions could have been applied to all 12,000 patients served by the clinic, they would have saved insurers and patients $250,000 during the 26 weeks that the intervention was conducted, according to the investigators. The decrease in the number of tests did not appear to be associated with any adverse out- comes. During the intervention and for 6 months after- ward, patients seen by the physicians who used the spe- cial computer program had about the same number of hospital admissions, emergency room visits, or subse— quent outpatient visits as patients seen by the control group doctors. The computer-display messages did not improve physician knowledge of test charges, as expected, nor were the effects long—lived. Once the messages were discontinued, the experimental group physicians or- dered only 7.7 percent fewer tests resulting in a mere 3.5 percent lowering of charges than their control group colleagues. The researchers speculate that con- tinued exposure to messages may be effective in chang- ing physician behavior. The computer system used in the study cost less than $40,000. However, office—management systems cost- ing under $5,000 are currently available and could be adapted to display charges when tests are ordered on mi- crocomputers, according to the researchers. To complement extramural MEDTEP research, AHCPR has supported intramural projects such as the review of functional disability scales. There is a grow— ing need among policymakers for reliable data on func— tional disability for use in establishing eligibility criteria for social and insurance programs. Measurement of functional disability has also taken on added importance as a tool for assessing outcomes of alternative medical treatments and for evaluating long-term care programs. To meet this need, researchers are increasingly turning to functional disability scales, which in the past were used primarily to supplement the standard medical eval— uation of geriatric patients. An AHCPR intramural review examined instruments whose reliability and validity have been studied and that have gained some acceptance in the clinical and health services research field (Spector, 1990). In addition to describing each scale and its reliability, validity, and re- sponsiveness, the review addresses each scale’s original purpose, newer applications, and advantages and disad- vantages. Among the instruments assessed are the Katz Index ofActivities of Daily Living, the Barthel Index [of activities of daily living], and the Pfeffer Functional Ac- tivity Questionnaire. MEDTEP research beyond the PORTs includes a wide variety of studies such as regional variations in pe— diatric hospitalization, prediction and outcomes in con- gestive heart failure, physician decisions regarding ce— rebral palsy referral, and the effectiveness of prenatal care. At the end of fiscal year 1990, 35 of these projects were underway. A list of principal investigators and projects is in appendix B. As findings continue to emerge from MEDTEP re~ search, the results will be used to further the develop- ment of practice guidelines and to further define future 10 research agendas. Efficiencies will be achieved by coordination of the activities of these various projects. For example, a second annual meeting to coordinate PORT work took place November 14—16, 1990. Repre- sentatives focused on themes common to all PORT pro j- ects such as meta—analysis, sources of data, and manag- ing conflict of interest. In April 1991, a conference is planned with clinical and social scientists to develop a long—term research agenda to shape the direction of the outcomes and effec- tiveness research program. This conference will deal with methodological and measurement issues, such as the measurement of functional status. Gaps in research identified by guideline development panels also will be used to highlight areas of need for future research. In fiscal year 1990, AHCPR obligated $21.7 million for outcomes research. This figure includes $12.9 mil— lion in funding for 11 PORTS plus other grants, con- tracts, and intra—agency agreements. Practice Guideline Development The Forum for Quality and Effectiveness in Health Care facilitates the development and review ofclinical practice guidelines. Guidelines are professionally derived statements intended to inform the clinical deci- sionmaking of providers and consumers regarding ap— propriate prevention, diagnosis, and treatment of se- lected health conditions. Practice guidelines and asso- ciated standards, performance measures, and review cri— teria are based on the best available research and profes— sional judgment regarding the effectiveness and appro— priateness of health care services and procedures. The Forum has sought extensive public and private sector involvement in the initial year of guideline devel— opment. Prior to convening the first guideline develop- ment panels, a letter was sent to over 500 organizations inviting their participation in the process. Multiple meetings were held to elicit assistance from special groups. Conferences were convened with leaders from nursing and allied health professions. A user liaison workshop for State and local govemment officials on medical effectiveness provided another arena for com— municating information about the guideline process. Multidisciplinary panels of qualified experts and health care consumers were named to develop practice guidelines for the following conditions and procedures: 0 Diagnosis and treatment of benign prostatic hyper- plasia, 0 Treatment of visual impairment due to cataracts in the aging eye, Treatment of urinary incontinence in adults, Prediction, prevention, and early treatment of pres- sure sores in adults, Management of acute postoperative pain, Diagnosis and treatment of depressed outpatients in primary care settings, and 0 Delivery of comprehensive care in sickle cell dis- ease. Panel membership is broadly representative of the numerous types ofproviders involved in treating a given medical condition. All panels include primary and spe- cialty physicians, nurses, selected allied health disci- plines as appropriate, and consumers. The panel chairs and cochairs are listed in figure 2; the membership of the panels is listed in appendix C. To provide technical assistance and advice on defin- ing the attributes of practice guidelines, and criteria for selection of conditions for research and guideline devel— opment, a study group was convened by the IOM. The committee completed its initial work and submitted a re- port in August 1990. The IOM provided working defi— nitions of guidelines, medical review criteria, perform- 11 ance measures, and standards. An additional 18-month project has been undertaken with IOM to provide fur- ther specification for the development, dissemination, assimilation, evaluation, and revision of clinical prac- tice guidelines. The IOM specified the following key attributes of practice guidelines: reliability, validity, clarity, multi- disciplinary involvement, clinical flexibility, clinical applicability, and scheduled review and documentation of procedures. IOM is developing these attributes into an instrument that may be used to evaluate practice guidelines. Additionally, selected issues related to eval- uation of the guideline development and implementa- tion processes are under exploration. Although the initial seven guideline panels are in var- ious stages of development, with some nearing the end and others still shaping their work, guidelines for man— agement of three clinical conditions were developed by January 1991. The initial three guidelines deal with the following conditions: diagnosis and treatment of be— nign prostatic hyperplasia, management of acute post- operative pain, and urinary incontinence in adults. These draft guidelines are being readied for peer review, pilot testing, dissemination, and evaluation. Methods to direct the guideline development process have been devised with the assistance of consultants and individuals with specialized expertise in areas such as research information synthesis. While the specifics of this methodology are being refined, all panels are using the same overall guideline development approach that includes the following basic steps: 0 Choose a clinical condition from priorities based on prevalence, morbidity/mortality, potential for bene— fit, variability in practice, high costs of treatment, and importance to Medicare beneficiaries and other populations of public health importance. 0 Clearly define the clinical condition or treatment to be considered for the development of a guideline and its intended users. 0 Review and analyze the literature and available scientific evidence of appropriateness and effec- tiveness. 0 Review estimates of outcomes important to patients that will be influenced by intervention. 0 Review benefits and harms from use of each inter— vention. 0 Review health outcomes and costs generated by the intervention. 0 Conduct open forums to provide an opportunity to groups and individuals to present information and comments. Prepare first draft of the guideline. Revise draft guideline after analysis of guideline pretesting and of comments from external peer re— view. Prepare and disseminate guideline in appropriate forms for use by providers, consumers, and educa- tors. Evaluate assimilation of the guideline into clinical practice and revise as indicated. Other activities of the Forum have included outreach efforts to inform the public and private sectors about medical treatment effectiveness efforts of AHCPR in general and the practice guideline efforts in particular. In the past year more than 100 presentations have been made. Audiences have included general and specialist physicians, nurses, a wide range of allied health profes- sionals, consumers, Government decisionmakers, payers, researchers, educators, and professional organi— zations. This outreach effort will continue through fis- cal year 1991. In fiscal year 1990, AHCPR obligated $4.6 million to facilitate development of practice guidelines. Figure 2. Practice Guideline Panels: Names and Affiliations of Chairpersons Visual impairment due to cataracts in the aging eye Denis M. O‘Day, MD. Professor of Ophthalmology Director of Corneal and External Disease Service Vanderbilt University School of Medicine Nashville, TN 37232 Diagnosis and treatment of benign prostatic hyper- plasia John D. McConnell, MD. Assistant Professor of Urology Southwestern Medical Center University of Texas Dallas, TX 75235—9031 Management of acute postoperative pain Daniel B. Carr, MD. Associate Professor of Anesthesiology and Medicine Massachusetts General Hospital Harvard Medical School Boston, MA 02114 and Ada Jacox, Ph.D., R.N. Professor of Nursing Johns Hopkins University Baltimore, MD 21205 Diagnosis and treatment of depressed outpatients in primary care settings A. John Rush, M.D. Betty Jo Hay Chair in Mental Health Director, Mental Health Clinic Research Center Southwestern Medical Center University of Texas Dallas, TX 75235—9070 Delivery of comprehensive care in sickle cell disease Jeanne Smith, MD. Associate Professor of Clinical Medicine Columbia University/Harlem Hospital Center New York, NY 10037 and Thomas Kinney, MD. Associate Professor of Pediatrics Duke University Medical Center Durham, NC 27710 Prediction, prevention, and early treatment of pressure sores in adults Nancy Bergstrom, Ph.D., R.N., F.A.A.N. Professor, College of Nursing University of Nebraska Omaha, NE 68105 Urinary incontinence in adults Ananias C. Diokno, MD. Chief, Department of Urology William Beaumont Hospital Royal Oak, MI 48073 and Kathleen A. McCormick, Ph.D., R.N. Nursing Research Director NlH, NIA, LBS, GRC, 3806 Baltimore, MD 21224 Dissemination The Center for Research Dissemination and Liaison is the focal point for disseminating MEDTEP-related in- formation to a broad audience, including private and public decisionmakers, researchers, third—party payers, educators, legislators, health professionals of many types, and consumers. Effective dissemination of MEDTEP research and practice guidelines requires an active multifaceted ef— fort to provide information and encourage providers to change their behavior. There is considerable evidence that research information about new technologies and information about ineffective practices are slow to reach primary health care providers. Additionally, informa- tion alone often is not sufficient to change provider prac- tices. For example, the National Heart, Lung, and Blood In- stitute (NHLBI) initiated an evaluation of intermittent positive pressure breathing (IPPB) in response to calls for clinical trials. At the time, IPPB was commonly used to treat a variety of pulmonary conditions, even though substantial doubts about its efficacy and safety had been raised. Most experts believed that clinical trials would support the findings of earlier studies and that physi~ cians would respond to the information by stopping their use of the procedure. The experts were partly cor— rect. Results from the NHLBI clinical trials, released in 1983, showed that IPPB was generally not effective. Yet, significant use of IPPB continued 4 years after pub- lication of these results. While the frequency of IPPB use declined, there is no evidence that the rate ofdecline accelerated as a result of clinical trials. Analysis conducted by AHCPR’s Division of Provid- er Studies, Center for General Health Services Intramu— ral Research, found that certain factors seem to be asso- ciated with hospitals’ abandonment of this outmoded technology. Efficient hospitals, those with neighboring teaching hospitals, and hospitals located outside of the north central United States were more likely than others to have stopped using IPPB by 1980. By 1987, hospitals in areas with low physician/population ratios, those that are free-standing, those with severely ill chronic ob— structive pulmonary disease patients, and again, those with neighboring teaching hospitals were more likely to have abandoned IPPB. However, failure to abandon the outmoded IPPB technology was only partially ex— plained by hospital and market Characteristics (Duffy and Farley, 1990). Additional research will be needed to more fully understand why outmoded technologies con— tinue to be used. It is possible, for example, that hospi- tals may have little incentive to abandon a technology for reasons related to costs and retraining needs. As another example, knowledge of how best to treat breast cancer has grown and been refined over the last 13 20 years. The medical profession has recommended breast-conserving surgery with adjunct therapy (radi- ation and/or chemotherapy) as opposed to more radical surgery for early—stage breast cancer since the 1970s. A study conducted by AHCPR intramural researchers is examining how physicians in different settings changed their surgical practice between 1980 and 1987 in re- sponse to these recommendations of the medical com- munity. Based on data from over 400 hospitals and more than 22,000 patients discharged with early—stage breast can— cer, preliminary results suggest that information affect— ing the practice of medicine is assimilated relatively slowly (AHCPR, Center for General Health Services In- tramural Research, 1991). Some types of hospital set- tings are especially slow to accept the most recent rec- ommendations. By 1987, small hospitals (less than 60 beds) were about one—third as likely as larger institutions to use the lumpectomy alternative in treating cases of early-stage breast cancer. Rural hospitals, primarily be- cause oftheir size, were less than half as likely to choose lumpectomy. Hospitals preferring radical over conser— vative surgery also performed fewer breast cancer sur— geries of all types, suggesting that lack of experience may be an important factor in explaining why physi- cians in these institutions continue to perform radical breast cancer surgery when it is no longer recom— mended. This research continues to explore factors af— fectin g diffusion of breast-conserving surgery into other hospital settings. In recognition of the complexity of effective dissemi— nation and assimilation of new information, CRDL is developing multiple and diverse approaches to dissemi— nation, as well as plans to evaluate the effectiveness of various dissemination strategies. A specific and detailed dissemination strategy will be developed for each practice guideline. The guidelines will be disseminated via a variety of means including print, direct mail, computer search systems, videotape, the press, exhibits, presentations, and other formats. CRDL’S dissemination efforts will involve profes- sional groups, governmental agencies, consumer groups, professional education organizations, libraries, and targeted marketing efforts in selected communities. These dissemination strategies will be evaluated to de- termine the most effective means of communicating with AHCPR’s target audiences. For example, as prac- tice guidelines are ready for dissemination, they will be presented in print, computer search systems such as those developed by the NLM, video tape, and other me— dia and formats. Two special mechanisms for broad dissemination of clinical guidelines are being tested through the profes- sional education programs assisted by HRSA of the PHS. These are the Area Health Education Centers (AHECs), a nationwide system of primary care educa— tion focused at medical schools, and the Geriatric Edu- cation Centers (GECs), a nationwide set of educational programs to enhance providers’ capacity to treat aging patients. An interagency agreement has been signed with HRSA to transfer funds to ensure dissemination of clinical practice guidelines and test the effectiveness of this method of dissemination. The specific contracts to initiate this work are with the AHEC serving Arkansas and three GECs in the States of New York, Texas, and Alabama. These projects will be evaluated over an 18-month period to determine the efficacy of the dis— semination method used, the degree to which the guide- lines are assimilated into practice, and the barriers to dis- semination and assimilation. To develop the capability to retrieve research findings and facilitate guidelines dissemination through comput- er-based medical information systems, the NLM’s Of- fice of Health Services Research Information has ex— panded its information services to include these topics. A joint AHCPR—NLM committee is working to update the medical subject headings (MESH) and annotated subject headings. Additionally, as a part of the contract between AHCPR and NLM, NLM has provided litera— ture review assistance and support to the panels con— vened to develop clinical practice guidelines. AHCPR will continue to work with NLM to expand existing methods for dissemination of information and develop new ones. These mechanisms are critical both to support MEDTEP research and to facilitate dissemi- nation of MEDTEP research and practice guidelines. In the fall of 1991 a dissemination workshop will be held. This meeting will explore the state ofthe art in dis— semination techniques and technology for purposes of establishing a research agenda to further MEDTEP dis- semination activities. In fiscal year 1990, AHCPR obligated $2.5 million to strengthen and expand the dissemination and liaison ac- tivities. Coordination of MEDTEP Activities To facilitate Department—wide collaborative efforts related to effectiveness and outcomes research and the development ofclinical practice guidelines, two coordi- nation mechanisms have been established. PHS Committee The PHS Committee for the Medical Treatment Ef- fectiveness Program was established by the Assistant Secretary for Health. This Committee, chaired by the Administrator of AHCPR, consists of representatives from the: 0 Alcohol, Drug Abuse and Mental Health Adminis- tration, Centers for Disease Control, Food and Drug Administration, Health Resources and Services Administration, Indian Health Service, and National Institutes of Health. The Committee meets quarterly to review program progress, share information, and identify areas deserv- ing greater attention, coordination, or direct collabora— tion. For example, it was through this Committee that the interests of AHCPR and NIH’s National Heart, Lung, and Blood Institute in the area of asthma were identified. Duplication of effort was avoided, and a col- laborative mechanism was established to finance a ma— jor asthma research agenda development seminar in 1991. In the September 1990 meeting, the Committee fo- cused on diabetes,with presentations by the National Institute of Diabetes and Digestive and Kidney Disease, the Centers for Disease Control (CDC), and the National Eye Institute (NEI). The CDC is funding, with AHCPR’s assistance, a community-based diabetes complication prevention program; NEI has a long, pro- ductive history of identifying the best methods to treat the vision complications of diabetes. The relevance of MEDTEP to service programs as- sisted by the Indian Health Service and the Health Re— sources and Services Administration is highlighted in these meetings. Additionally, the research interests of NIH have played an important role in MEDTEP. For example, AHCPR is building on the research interests of the Na- tional Institute on Aging and the NHLBI by naming ex- pert panels to develop guidelines for adult incontinence and sickle cell disease. Further, the interest ofthe NEI in diabetic retinopathy has stimulated AHCPR financial 15 support for the diabetes complication prevention pro— gram of the CDC. Intradepartmental Committee In January 1990, the Secretary of Health and Human Services established the Department’s Intradepartmen- tal Committee for the Medical Treatment Effectiveness Program to ensure participation from senior policy offi- cials. This Committee, chaired by the Assistant Secretary for Health, includes the Administrator ofHCFA, the As— sistant Secretary for Management and Budget, the As- sistant Secretary for Planning and Evaluation, and the Administrator of AHCPR. Committee functions include: Establishment of long-term goals, 0 Development of annual and multiyear agenda and budget levels, 0 Identification of research priorities taking into consideration other advisory group recommenda- tions, and 0 Monitoring progress of research and guideline development and dissemination. The Committee meets quarterly and has served as a model coordination mechanism for a Department-wide effort. National Advisory Council The National Advisory Council for Health Care Policy, Research, and Evaluation has been established to make recommendations to the Secretary and the Ad- ministrator, AHCPR, on the quality, appropriateness, and effectiveness of health care services. The Secretary of Health and Human Services appointed the member- ship on September 19, 1990, consistent with statutory requirements. The Council’s membership with titles and affiliations is in appendix D. From the Council’s membership, a Subcouncil for Outcomes Research and Guideline Development has been established. These individuals also are noted in ap— pendix D. The first meeting of the National Advisory Council was on November 26—27, 1990. It served as the initial introduction to members of their responsibilities and provided an overview of AHCPR programs. Subse- quent meetings, held every 4 months. will review major research grants and contracts plus ongoing guideline de- velopment. References Agency for Health Care Policy and Research, Center for General Health Services Intramural Research. Unpub- lished data. 1991. Deyo, R., S. Bigos, and K. Maravilla. (1989). Diagnos— tic imaging procedures for the lumbar spine. Annals of Medicine 111, pp. 865—867. Duffy, S. and D. Farley. (1990, October). The pro— tracted demise of medical technology: The case of inter- mittent positive pressure breathing. Paper presented at the annual meeting of the American Public Health Asso- ciation, New York. Institute of Medicine. (1989). Eflectiveness Initiative: Setting Prioritiesfor Clinical Conditions. Washington, DC: National Academy Press. Roper, W. and others. (1988). Effectiveness in health care: An initiative to evaluate and improve medical practice. New England Journal of Medicine 319(18), pp. 1197—1202. 17 Sacks, H. and others. (1990). Endoscopic hemostasis: An effective therapy for bleeding peptic ulcers. Journal of the American Medical Association 264(4), pp. 494—499. Spector, W. (1990). Functional disability scales. In B. Spilker (Ed.). Quality of Life Assessments in Clinical Trials (pp. 115—129). New York: Raven Press. Tierney, W.,M. Miller, and C. McDonald. (1990). The effect of test ordering of informing physicians of the charges for outpatient diagnostic tests. New England Journal ofMedicine 322(21), pp. 1499—1504. Wennberg,]. (1986). Which rate is right? NewEngIand Journal ofMedicine 314, pp. 310—311. Wennberg, J. and others. (1988). An assessment of prostatectomy for benign urinary tract obstruction: Geographic variations and the evaluation of medical care. Journal oftlze American MedicalAssoc-iation 259, pp. 3027—3030. Appendix A Executive Summary The Feasibility of Linking Research-Related Data Bases to Federal and Non-Federal Medical Administrative Data Bases A Report to the United States Congress i_"4 4 Executive Summary The Feasibility of Linking Research-Related Data Bases to Federal and Non-Federal Medical Administrative Data Bases A Report to the United States Congress The Omnibus Budget Reconciliation Act (OBRA) of 1989 (Public Law 101—239), at section 6103, created the Agency for Health Care Policy and Research (AHCPR). This section also established a program of research on health care outcomes and procedures (at 42 USC l320b—12, section 1142 of the Social Security Act) and mandated that: Not later than one year after the date of the enactment of this Act, the Secretary of Health and Human Services shall report to the Congress on the feasibility of linking research—related data described in section 1142(d) of the Social Security Act (as added by paragraph (1) of this subsection) with similar data collected or maintained by non-Federal entities and by Federal Agencies other than the Department of Health and Human Services (including the Departments of Defense and Veterans Affairs and the Office of Personnel Management).1 The research—related data referred to will describe patient clinical and functional status for: . research with respect to the outcomes, effectiveness, and appropriateness of health care services and procedures in order to identify the manner in which diseases, disorders, and other health conditions can most effectively and appropriately be prevented, diagnosed, treated, and managed clinically; . . .2 The research referred to in this legislation is known as medical effectiveness research. Medical effectiveness research investigates the effects of alternative treatments of a given medical condition on the eventual lSection 6103(b) (2) ofPublic Law 101—239, the Omnibus Budget Reconciliation Act of 1989. 2The statutory objectives of the research program on outcomes of health care set out at section ll42(a)(l)(A) of the Social Security Act. A—l outcomes3 realized by the patient. Evaluating the effects of medical care on patient outcomes is not a new idea. However, it has recently received increased emphasis because of concerns for the quality and the cost of medical care. To address these concerns, Congress expects that clinical guidelines of care for use by health care practitioners will result from this research. In response to the legislation, AHCPR sponsored a series of planning meetings and workshop conferences with representatives from Federal and non-Federal organizations concerned with health care data. The issues and discussions that originated at these meetings, along with information obtained directly from the Department of Defense (DoD), Department of Veterans Affairs (DVA), Office of Personnel Management (0PM), and Federal and non—Federal entities, contributed to the preparation of this report. The report discusses the usefulness of data for medical effectiveness research, as well as the technical barriers and issues of access that determine whether two or more data files can be linked together. This discussion leads to development of the criteria upon which the feasibility of linking various data files can be determined. These criteria include the utility of the data in the data files for medical effectiveness research, the value of linking these data to other data, the technical capability to perform the linkage, and the ability to access the data. Chapter 2 focuses on the usefulness of secondary data, generally obtained from medical administrative records, for medical effectiveness research. Such records are generally used for program management and reimbursement purposes. To the extent that such files contain information on the use and content of health services, they may be useful in medical effectiveness research. However, they frequently lack critical clinical and patient level information. Another limiting factor is the absence of validation of many data elements. 3“Outcomes" are what happens to the patient and may include the patient’s health status, functional status. quality ol'lil‘e. or the pres- ence or absence of disease. Additional outcome measures include mortality, readmission to the hospital. or repeat surgery. Issues of data standards and access to data are addressed in the third and fourth chapters, respectively. There is a lack of coordination in the development of standards for medical data, and there are multiple laws, regulations, rules, and contractual arrangements controlling access to data. The establishment and implementation of standards and the resolution of access issues will contribute to the general availability of data for medical effectiveness research. Chapter 5 deals with the specific feasibility question posed by the Congress. While it is technically feasible to link medical administrative data bases ofthe DoD and the DVA with other, research-related data and while these data are similar in content, the lack of common standards and definitions make combinations of and comparisons among these data files difficult. Furthermore, the DoD and DVA data files are composed of populations that are different from the general US. population, as are the systems of medical care delivery. Nonetheless, the linkage of individuals’ records within these systems may prove valuable. Access is possible for researchers within these Departments and may be possible for researchers from other Federal agencies. Whether or not access will be given to researchers outside the Federal system will be decided on a case-by—case basis. Data collected by non-Federal organizations have proven useful to medical effectiveness researchers. Although it is feasible to link data from non-Federal entities to research data bases, the practicality of doing this will depend on whether the linkage adds information necessary for answering the research question. Access to the data will continue to be decided by these entities on a case—by-case basis and will depend on whether the release of data is consistent with the goals, objectives, and proprietary concerns of the unit that controls the data. The sixth chapter describes various approaches to increase the availability of secondary data for medical effectiveness research. Improving existing data sources, especially State data systems, and encouraging the development of the automated patient record and the standards that must precede it, will contribute to the short- and long—term improvement in data for medical effectiveness research. Chapter 7 contains the conclusions and planned actions resulting from this report. Two summary points on the use of secondary data are particularly important. The first is that the collection ofdata will be driven by the primary reason for its collection. For instance, items collected for the processing of claims will be collected only ifthey are of value forthat purpose. This may limit their utility for effectiveness research. The second is that the usefulness of secondary data sources will be enhanced by the development and use of standards and by specification of the strengths and limitations of those secondary sources. There are not “one or two items” that can be added to these administrative data bases that will dramatically increase the utility ofthe information they contain. Furthermore, unless there is sufficient motivation for those persons recording the data to do so accurately. the quality of the data will be less than desirable. The Feasibility of Linking Federal and Non-Federal Data to Research-Related Data Conclusions 0 It is technically feasible to link medical and administrative data bases of the DoD and the DVA to other research-related data bases utilized in medical effectiveness research. However, the usefulness of doing this should be determined by careful pilot studies. 0 It is not technically feasible at this time to link OPM health care data because they are held by insurance claims processors. There are no consistent, uniform directions for the collection and coding of these data. 0 Data collected by non—Federal organizations have been linked to research-related data bases. The utility of linking these data will depend on whether the linkage contributes information necessary for the research. Access to the data will depend on whether the release of data is consistent with the goals, objectives, and proprietary concerns of the entity that controls the data. Activity To Be Undertaken by AHCPR 1. AHCPR will encourage joint studies with DoD, DVA, 0PM, and non-Federal entities to determine the usefulness of their data for medical effectiveness research. Secondary Data Sources Conclusions 0 Administrative data and other secondary data sources will not supply all the data needs of medical effectiveness research. However, administrative data files will remain efficient sources of information from which to develop research models, refine hypotheses, and determine patterns of utilization and variation in medical practice. The files will also serve as population sampling frames. Secondary data sources are often employed in research without the documentation of strict analytic protocols and validation of data elements found in studies that rely on primary data collection. Activities To Be Undertaken by AHCPR AHCPR will develop grant announcements and requests for contract proposals describing funding opportunities to undertake studies and to sponsor conferences and workshops to: 1. Identify the availability of existing sources of data and their strengths and weaknesses for medical effectiveness research. 2. Assess the validity of the data elements of the secondary data sources used in medical treatment effectiveness research. 3. Determine the completeness of the secondary data sources and the data elements contained in these data bases. Standards Conclusions 0 The exchange of information among different medical information systems is inhibited by the lack of uniform message and vocabulary standards. In particular, the use of a common, unique individual identifier is critical to link medical records longitudinally and to determine individual patient outcomes. 0 A unique personal identifier, such as the Social Security number (SSN), would improve the technical feasibility of linking research—related data if used on all patient-care-related data. 0 Comprehensive security standards, if developed and implemented by all parties that process confidential patient—level data, including researchers, would increase the privacy of and potentially the access to patient-care-related data. Standards developed for and applied to the processing of health insurance claims would increase the uniformity and accuracy of information derived from administrative claims data describing a patient’s episode of illness. Development of a standard list of treatment and procedure codes that comprehensively covers and unambiguously identifies the care provided in both inpatient and ambulatory settings would increase the uniformity and accuracy of medical effectiveness data. 0 The standardization of medical nomenclature, patient care data, and the coding, storage, and transmission of the data would enhance the data available for medical effectiveness research. Activities To Be Undertaken by AHCPR AHCPR will work with the National Center for Health Statistics and other components of the Department of Health and Human Services (DHHS) and will develop grant announcements and requests for contract proposals describing funding opportunities to: 1. Promote the exchange of information among standard-setting groups and users of medical information standards. 2. Assess the state of the art in medical information standards and in systems that can use these standards. 3. Encourage the development of standard methods for the linkage, security, and maintenance of patient care data. AHCPR will continue to work with the National Center for Health Statistics, the National Committee on Vita] and Health Statistics, and other components of DHHS to encourage the development, evaluation, and use of minimum data sets. AHCPR will continue to undertake liaison with the National Academy of Sciences, Committee on National Statistics, Panel on Confidentiality to fully develop issues of data confidentiality. 4. Encourage the development of uniform treatment and procedure codes. 5. Investigate how the complete, secure transfer of patient care data files can be accomplished and how efficiency in transfer may be promoted by exploring various capabilities for compacting the data. 6. Investigate the development of methods that would permit the storage and analysis of individual-level data used in research in the Medical Treatment Effectiveness Program (MEDTEP), yet ensure that output from these systems would not identify individuals. Evaluate the implementation of these methods, and the protection provided by systems implementing these methods, as well as the potential for securely distributing data within these systems. Access and Confidentiality of Data Conclusions The issue of access to data useful for medical effectiveness research and the linking of those data is complex and requires the analyses of multiple Federal and State laws in addition to addressing proprietary concerns. Some nongovernmental organizations, such as hospitals, trade and industry associations, insurers, and commercial data compilers, may be reluctant to share data with medical effectiveness researchers, particularly clinically relevant information. It is possible that sharing could be encouraged by providing incentives to such organizations. The best incentive could be the perception that medical effectiveness research is in the public interest and that a particular disclosure of data to researchers would further medical effectiveness and not harm individuals. Activities To Be Undertaken by AHCPR 1. AHCPR will develop generic model agreements for data access, confidentiality, security, transfers, and linkages that will facilitate the use of research-related data from Federal and State Governments and the private sector. A—4 Ex) Representatives of AHCPR, in consultation with the Office ofthe General Counsel (OGC), will meet with representatives of agencies having data relevant to MEDTEP research to discuss how disclosure would further MEDTEP’s work and how it might be done within the constraints of the Privacy Act and other special authorizations. AHCPR, with OGC consultation, will draft routine use models for other agencies to consider for incorporation in their systems notices. These could allow data disclosures to AHCPR while limiting the Agency’s uses of the data to specific purposes. Development of Future Data Bases Conclusion Potentially valuable secondary data sources for medical effectiveness research could be developed by standardizing and linking State health care utilization data files and by automation of part or all of the patient’s medical record. Activities To Be Undertaken by AHCPR AHCPR will develop grant announcements and requests for contract proposals describing funding opportunities to undertake studies and to sponsor conferences and workshops to: 1. Investigate the development of State data files, including the development of longitudinal records, minimum data sets, and the establishment of Medicaid claims data files. Investigate the development and evaluation of automated patient care information. Appendix B Medical Treatment Effectiveness Program (MEDTEP) Active Research Projects as of September 30, 1990 Medical Treatment Effectiveness Program (MEDTEP) Active Research Projects as of September 30, 1990 Patient Outcomes Research Team Projects Patient Outcomes Research Team (PORT) projects are designed to identify and analyze the outcomes and costs of alternative practice patterns for a specific condition, determine the best strategy for treatment or clinical management, and develop and test methods for reduc— ing inappropriate variations in practice. PORTS evalu- ate the effectiveness and cost-effectiveness of altema- tive services or procedures for the prevention, diagno- sis, treatment, and management of specific clinical con- ditions. Considered in the analysis are any pertinent medical, surgical, nursing, or pharmacological inter- ventions, including the possibilities of “watchful wait- ing” and decisions not to treat. Patient outcomes to be addressed include objectively measured clinical out— comes as well as patients’ perceptions of their functional ability, health status, and quality of life. PORT projects generally include the following compo- nents: Review and formal synthesi s. The team conducts a com— prehensive review and formal synthesis, such as meta—analysis, of available research findings. This is the basis for the refinement of research hypotheses; specifi— cation of needed data; and finalization of instruments, measures, and procedures to collect the data. Collection and analysis of data. PORTS acquire the data needed to identify and explain variations in clinical practice and in outcomes. Sources of secondary data in- clude enrollment and claims data maintained by the Health Care Financing Administration, hospital dis- charge abstracts, State health department records, pa- tient registries, and insurance records. These data are supplemented by primary data collected via surveys of patients and providers or by abstracting patient records. Dissemination of findings and recommendations. PORTS draw conclusions and make recommendations regarding the effectiveness and appropriateness of alter- native clinical practices. Methods and materials are de— signed to disseminate findings and recommendations to health care providers and the public. PORT findings contribute to improved clinical decisionmaking by pro- viders and patients and to the scientific basis for the de— velopment of practice guidelines and identification of remaining gaps in knowledge. Dissemination methods include print, audiovisual, and video productions for students and specialized groups of health professionals as well as presentations for patients and lay audiences. Evaluation of eflects on clinical practice. PORTS con— duct studies to identify effective strategies for produc— ing desired changes in clinical practice (reductions in unwarranted variations). This includes testing altema— tive methods to present and disseminate information to various audiences and evaluating subsequent changes in practice or, when possible, changes in patient outcomes. As of September 30, 1990, ll PORTS have been awarded. Brief summaries of the PORTS follow. Back Pain Outcome Assessment Team Principal Investigator: Richard A. Deyo, MD. University of Washington Seattle, WA Grant Number: HS 06344 Project Period: 9/89—8/94 Back pain is a prevalent and expensive condition, ranked as the second leading cause of all physician vis- its. The costs, both for associated health care and dis- ability compensation, are high. Geographic variations in the use of hospitalization and surgery have been well documented, while the efficacy and effectiveness of some treatments have not. This PORT will assess alternative types of lumbar spine surgery (fusion, laminectomy, and discectomy), a vari- ety of nonsurgical interventions (traction and various therapeutic injections), and diagnostic tests (including myelography, computed tomography, magnetic reso— nance imaging, and thermography) commonly used for patients with back pain, especially pain due to spinal ste— nosis, the most common diagnosis leading to surgery among elderly patients. National and state wide hospital discharge data, Medicare claims data, and surveys of pa- tients and physicians will be the basis for the formal analysis of the surgical decision that will incorporate probabilities, patient preferences for various health states, and costs. Findings will be disseminated via tar- geted feedback to physicians and hospitals in high use areas and by means of Special materials for educating patients whose decisionmaking role is especially impor— tant in these usually elective procedures. Assessing and Improving Outcomes: Total Knee Replacements Principal Investigator: Deborah A. Freund, Ph.D., M.P.H. Indiana University Indianapolis, IN Grant Number: HS 06432 Project Period: 4/90—3/94 Progressive forms of arthritis are common, especially in the Medicare population, which will receive about 70 percent of the estimated 175,000 total knee replace- ments (TKRs) performed in the United States in 1990. Rates of TKR are highly variable and appear to be in- creasing very rapidly despite the serious lack of infor- mation about the correlates of good outcome. This PORT will determine and explain variations in rates and outcomes ofTKR for patients with a diagnosis of rheumatoid or osteoarthritis. The team will construct and analyze a comprehensive decision model to aid phy— sicians and patients in deciding whether to undertake TKR. Findings will be disseminated to physicians and patients with the aim of reducing the wide treatment variation that currently exists. Analysis will focus on areas of greatest controversy, as determined by a sys- tematic synthesis of the literature and a survey of prac— ticing physicians regarding the relationships between outcome and practice variables. Comparisons of out- comes will be made between TKR and nonsurgical treatment for patients presenting with different degrees of pain, disability, and comorbidity. Outcomes will be assessed in terms of functional and symptomatic relief, clinical complications, costs, and associated patient util- ity. The PORT will create the first comprehensive data base for TKR consisting ofclinical and claims data from public (especially Medicare) and private sources for the United States, Indiana, Western Pennsylvania, and On— tario, Canada. The Consequences of Variation in Treatment for Acute Myocardial Infarction Principal Investigator: Barbara J. McNeil, M.D., Ph.D. Harvard Medical School Boston, MA GrantNumber: HS 06341 Project Period: 9/89—8/94 Each year, at least 750,000 Americans have an acute myocardial infarction (MI). Medicare patients, who ac- count for about 40 percent of these cases, have a cumu— lative mortality of 40 percent. Variations in treatment B—2 are well documented, and the relative benefits of numer— ous new treatments remain controversial, especially in elderly patients. This PORT aims to establish a national center for the in— tegration of information about medical technologies and processes of care for patients with acute MI. Four specific areas of study (or foci of treatment variation) have been selected based on meta—analyses and recom— mendations ofa national advisory panel. These foci in— clude predischarge diagnostic tests for risk stratification (such as coronary angiography, exercise tolerance tests, echocardiography, Holter monitoring), acute interven- tions (especially thrombolytic therapy, streptokinase therapy, and percutaneous transluminal coronary an gio— plasty, PTCA, rehospitalization within 3 to 6 months following MI, and alternative procedures and medica- tions used immediately following M1 to reduce compli— cations and recurrence (coronary arteriography, PTCA, aspirin, and cholesterol-lowering drugs). Primary data will be obtained from an inception cohort of patients. Resource utilization, outcomes, and cost will be studied using Medicare data plus comparable data from the De— partment of Veterans Affairs (VA). Recommendations will be developed and disseminated by means of direct physician education and distribution of printed materi- als in a series of interventions that target whole States, parts of States, and/or regions of the VA health care sys— tem. Variations in Cataract Management: Patient and Economic Outcomes Principal Investigator: Earl P. Steinberg, M.D. Johns Hopkins University Baltimore, MD Grant Number: HS 06280 Project Period: 9/89—8/94 Cataracts are associated with serious visual and func— tional impairment. Extraction of cataracts is the single most common surgical procedure performed on Medi— care beneficiaries, with more than a million of these pro- cedures undertaken each year. This PORT will assess variations in short-term and long-temt outcomes and costs for treatment of cataracts. The analysis will include comparisons of the timing and type of surgical intervention (intracapsular cataract ex— traction, extracapsular extraction, and phacoemulsifica— tion), diagnostic procedures (including ultrasound and speculomicroscopy), and differences in followup care. Anticipated changes in demographic characteristics of the population over the next 25 years will be incorpo— rated into the development of a model to project the clin- ical and economic impact ofaltemative strategies for the management of cataracts. Data will include Medicare enrollment and claims files plus chart reviews and sur— veys of cataract patients and physicians in three sites. A panel of experts will define optimal management strate— gies for specified categories of cataract patients. Assessing Therapies for Benign Prostatic Hypertrophy and Localized Prostate Cancer Principal Investigator: John E. Wennberg, M.D., MPH. Dartmouth Medical School Hanover, NH Grant Number: HS 06336 Project Period: 9/89—8/94 Enlargement of the prostate affects eight out of every 10 men by the age of 80, and about 400,000 prostatecto- mies are performed in the United States every year. Un- ceitainty regarding both the natural history of prostate disease and the efficacy and effectiveness of alternative treatments has led to wide variations in practice. This PORT will assess a variety of surgical and nonsur- gical interventions for benign prostatic hyperplasia (BPH) and localized adenocarcinoma (cancer) of the prostate. For BPH, assessment will include variations in use and outcomes associated with transurethral resec- tion, open prostatectomy, balloon dilation, bladder neck incision, transurethral incision of the prostate, prostato- tomy, microwave diathermy, medical therapy, and watchful waiting. For cancer of the prostate, early diag— nostic screening, radiation, radical prostatectomy, and watchful waiting will be compared. Outcome variables emphasize the full range of outcomes that are relevant to patients, such as survival, morbidity, symptoms, and self-assessed functional status and quality of life. Deci— sion models based on probabilities of outcomes and as- sociated patient utility will be developed and used to analyze the effectiveness and cost-effectiveness of treatment alternatives for subgroups of patients. Find- ings will be incorporated into materials produced to contribute clinical decisionmaking, practice guidelines, research, and health care policy. Outcome Assessment Program in Ischemic Heart Disease Principal Investigator: David B. Pryor, M.D. Duke University Medical Center Chapel Hill, NC HS 06503 7/90—6/95 Grant Number: Project Period: Coronary artery disease (CAD) remains the primary cause of death and a major cause of morbidity in the United States. Significant clinical manifestations of CAD are seen in one of every three men and one of every 10 women by the age of 60. This PORT will identify inappropriate sources of varia— tion in diagnostic and treatment strategies for chronic is- chemic heart disease (such as stable CAD), with the goal of maximizing health outcomes and efficient use of health resources. Alternative procedures to be studied include cardiac catheterization and revascularization with either percutaneous transluminal coronary angio- plasty (PTCA) or coronary artery bypass graft (CABG) surgery. Analysis of patient outcomes and preferences regarding potential outcomes will help to define appro- priate indications for these procedures. The project will also devise new approaches and methods for outcomes assessment, including integration of detailed clinical data bases with claims data bases. Patient-specific feed- back and educational programs for regional groups of physicians will be employed to demonstrate the feasibil- ity of affecting voluntary change in physician practice patterns. Outcome Assessment of Patients with Biliary Tract Disease Principal Investigator: J. Sanford Schwartz, MD. University of Pennsylvania Philadelphia, PA Grant Number: HS 06481 Project Period .‘ 8/90—7/95 While gallbladder disease affects an estimated 20 mil- lion Americans, and each year between 300,000 and 450,000 persons undergo cholecystectomy, the condi- tion has received little attention. This PORT will assess alternative procedures for the evaluation and management of patients with suspected or documented biliary tract (gallstone) disease. Out— comes will be compared for patients who receive alter— native surgical procedures (especially cholecystecto— my), medical therapy, and no therapy. In addition, the use and value of alternative diagnostic tests (endoscopic retrograde cholangiopancreatography (ERCP) and in- traoperative cholangiography) will be assessed. A com— bination of administrative and clinical data bases, plus surveys of patients and physicians, will lead to assess- ment of outcomes and development of recommenda- tions related to the quality and efficiency of care for bil- iary tract disease both in hospital and outpatient settings. Findings will be disseminated to physicians by their peers in an intervention that permits comparisons across Pennsylvania communities. The impact of interven- tions will be measured in terms of changes in appropri- ateness of services, referral patterns, health outcomes, Medicare expenditures, and physician charges. Analysis of Practices: Hip Fracture Repair and Osteoarthritis Principal Investigator: James 1. Hudson, MD. University of Maryland Baltimore, MD HS 06658 9/90-9/95 Among Americans over 65, more than 220,000 hip fractures are recorded annually. The burden of this con— dition is measurable in terms of disability, dysfunction, dependence, and death, and associated annual expen- ditures are estimated at $7.3 billion. Osteoarthritis (0A), which can affect the hands, feet, spine, knees, or hips, is the most common form of joint disorder and can be seen in virtually all adults by the age of 70. Total hip replacement has become a major mode of treat— ment for severe OA of the hip. Grant Number: Project Period: This PORT will assess the effectiveness of alternative management pathways for hip fracture and total hip re- placement. The analysis of variations in management and outcomes will focus on immediate surgery versus delay for stabilization (in cases of hip fracture), altema— tive types of surgery, and the role of rehabilitation thera- py, comorbid conditions, hospital volume, and length of stay. Data will be collected for the period between 1984 and 1994 for all Medicare patients in the State of Mary- land having hip fracture repair or total hip replacement. Probabilities will be estimated based on retrospective analysis of secondary data and prospective analysis of primary data. The primary data will come from the eight Maryland hospitals that account for the highest volume of procedures under study and one-fourth of all orthopedic surgeons in the State. The investigators will develop practice recommendations, disseminate them to physicians and the public, and measure the impact of these recommendations on physician attitudes, practice patterns, and Medicare costs. Variations in the Management and Outcomes of Diabetes Principal Investigator: Sheldon Greenfield, MD. New England Medical Center Boston, MA Grant Number: HS 06665 Project Period: 9/90—9/95 Diabetes is a chronic illness that presents a major source of health care costs and disease burden. The annual inci- dence of Type II diabetes is approximately 320 per 134 100,000 in persons over 20 and approximately 8,800 per 100,000 in persons over 65. In 1982, diabetes accounted for 35,000 deaths and 5,800 new cases of blindness. It is associated with a high proportion of end-stage renal disease and nontraumatic amputations, as well as a sharply increased risk of hypertension and ischemic heart disease. This PORT aims to develop a comprehensive, prospec- tive, longitudinal data base tailored to the requirements of medical effectiveness in chronic disease, specifically Type II diabetes. Research on chronic diseases is com- plex because care extends over many years; patients use multiple, mostly outpatient, providers and a variety of health care resources; and quality of care depends heavi- ly on interpersonal (educational, motivational) as well as technical aspects of care. The data system will be im- plemented in three large health care delivery organiza- tions located in Boston, Indianapolis, and Portland, Ore— gon, where a total of approximately 6,000 patients will be enrolled and followed for4 years. A combination of survey data, medical records, and claims data will be linked for analysis of variations in practice, utilization, expenditures, and patient outcomes. Based on literature review, decision analysis, and analysis of the data base, the PORT will develop practice recommendations re- garding optimal technical and interpersonal care asso— ciated with the outcome of principal interest—patient quality of life. Educational interventions, planned as randomized controlled trials, will aim to improve spe— cific physician practices with respect to utilization, ex- penditures, and technical and interpersonal quality of care. Assessment of the Variation and Outcomes of Pneumonia Principal Investigator: Wishwa N. Kapoor, M.D., MPH. University of Pittsburgh Pittsburgh, PA Grant Number: HS 06468 Project Period: 9/90—9/95 Community—acquired pneumonia affects over 3 million persons annually and is the sixth leading cause of death in the United States. In the elderly population, pneumo- nia is particularly prevalent, dangerous, and costly. It is the fourth leading cause of death among persons over 65 and accounts for $1.5 billion in Medicare inpatient ex- penditures. This PORT focuses on variations in the treatment of community—acquired pneumonia in adults, especially variations in rates of hospitalization, diagnostic, and therapeutic interventions (such as choice of antimicro- bial agents). Two major aims are to evaluate geographic variation in hospitalization rates and to test the hypothe- sis that hospitalizations, intensive care unit (ICU) ad— missions, diagnostic tests, therapeutic maneuvers, and cost can be reduced without increasing morbidity or mortality. A comprehensive literature review will be undertaken, and variations in treatment and outcomes will be assessed using discharge rates and outcomes available from Medicare and other claims data for resi— dents of Pennsylvania, Massachusetts, and Nova Scotia. In order to obtain more detailed data about treatments and outcomes for ambulatory as well as hospitalized pa- tients, claims data will be supplemented by a prospec— tive cohort study of patients in Pittsburgh, Boston, and Halifax. Cohort data will be accrued over 30 months from approximately 2,500 patients who are followed for 90 days. A substudy of physicians will provide detail about factors influencing clinical decisions. Economic analysis will consider both direct and indirect costs of care and comparisons across communities. Using deci— sion analysis, cost effectiveness analysis, and an adviso- ry panel, the team will develop clinical recommenda- tions. Educational interventions will be implemented with the collaboration of the Pennsylvania Medical So- ciety and Peer Review Organizations, and their impact will be evaluated. Variations in Obstetric Practice and Patient Outcomes Principal Investigator: Emmett Keeler, Ph.D. The RAND Corporation Santa Monica, CA Contract Number 282—90—0039 Project period: 9/90—9/95 The rate of cesarean section (c-section) has increased steadily over the past two decades. The procedure is now performed in one out of every four deliveries, mak- ing it the most common inpatient surgical procedure in the United States. Despite consensus conferences and publication of practice guidelines, wide variations in rates continue to exist across geographic areas and pop- ulation groups, and clinical controversies surrounding appropriate indications for c-section and other obstetri- cal procedures remain unresolved. This PORT will identify appropriate indications for the use of cesarean section versus its alternatives (oxytocin, trial of labor, assisted vaginal delivery) and analyze variations and correlates of specific diagnostic and treatment procedures utilized in the course of labor and delivery. The emphasis will be on maternal outcomes and on determining factors that influence physician and patient decisionmaking. Work will include a compre— hensive review and analysis of existing literature and guidelines; collection of survey data from pregnant women, new mothers, and obstetricians; and analysis of State data linking birth, death, and hospital records. The investigators will develop clinical recommendations and a series of interventions for disseminating informa- tion to distinct audiences of patients and physicians. Fi- nal steps include evaluation of the impact of these inter- ventions on practice and the preparation of public use data files to support further research. Other Medical Effectiveness/Patient Outcomes Projects Other AHCPR medical effectiveness/patient outcomes research projects address specific health conditions or interventions; develop methods, data, or measures for effectiveness research; or synthesize available research findings. The projects described in this section are di- vided into four categories: variations in practice and outcomes, comparative treatment effectiveness analysis (condition- or procedure-specific), methods and mea- sures, and dissemination and related evaluation. 1. Variations in Practice and Outcomes A Comparison of Practice Styles and Health Outcomes Principal Investigator: Klea D. Bertakis, M.D., M.P.H. University of California Davis, CA Grant Number: HS 06167 Project period: 4/89—4/92 This project utilizes a randomized trial design to investi- gate differences in practice styles and outcomes for pa- tients cared for by residents in internal medicine and in family practice. Physician—patient interaction behav- iors, costs, changes in health status, and patient satisfac— tion will be compared. Diagnostic Uncertainty and Variation in Use of Services Principal Investigator: Lee A. Green, MD. University of Michigan, Ann Arbor, MI Grant Number: HS 06409 Project Period: 9/90—9/92 The investigators will utilize medical records data for two Michigan communities to examine how the uncer- tainty of diagnostic indications contributes directly to the variations in admission rates for acute ischemic heart disease (AIHD) observed in clinical practice. Variations in Physicians’ Practice Style and Outcomes of Care Principal Investigator: Sheldon M. Greenfield, MD. New England Medical Center Boston, MA Grant Number: HS 06073 Project Period: 1/88—12/90 This grant supplements data collection and analysis ac— tivities of the ongoing Medical Outcomes Study, which aims to determine the extent of, reasons for, and out- comes related to variations in treatment across alterna— tive care systems (HMO, multispecialty group, or solo fee-for-service) for patients with selected chronic con- ditions, such as hypertension, diabetes, heart disease, and depression. Volume, Outcome, Market Share, and Admission Rates Principal Investigator: Harold S. Luft, Ph.D. University of California San Francisco, CA Grant Number: HS 06216 Project Period: 4/90—3/92 This project examines the possibility that physicians in- creasingly restrict their practice by concentrating on certain types of patients. The effects that this type of “specialization” may have on quality of care, access, and utilization of services will be discussed. Effects of Stressful Life Events on Health Outcomes Principal Investigator: Lisa S. Meredith, MA. The RAND Corporation Santa Monica, CA Grant Number: HS 06622 (Dissertation) Project Period: 9/90—8/91 This project is designed to study the effects of stressful life events upon health outcomes, particularly in the e]- derly and the chronically ill. Variation in Physician Drug Prescribing in Rest Homes ‘ Principal Investigator: Eleanor M. Perfetto, MS. University of North Carolina Chapel Hill, NC Grant Number: HS 06597 (Dissertation) Project Period: 8/90—7/91 The objective of this research is to identify the source of variation in physician drug prescribing in a domiciliary care setting and how prescribing behavior affects pa- tient outcome. ‘ Regional Variation in Pediatric Hospitalization Principal ' Investigator: James M. Perrin, MD. Massachusetts General Hospital Boston, MA Grant Number: HS 06060 Project period: 9/90—8/93 This study seeks to identify and explain documented variations in rates of pediatric hospitalization for five common childhood illnesses (meningitis, asthma and lower respiratory disease, head injury, toxic ingestion, and acute abdominal pain) in three Northeast cities. A Study of the Causes of Variations in Medical Care Principal Y Investigator: Charles E. Phelps, Ph.D. University of Rochester Rochester, NY Grant Number: HS 06366 Project Period: 3/90—2/93 The purpose of this project is to explain regional varia- tions in medical practice as a function of physician char— acteristics, including age, board status, sources of infor- mation, and propensities to use certain types of medical resources. Practice Variation and Outcomes in Ambulatory Care Principal Investigator: Barbara Starfield, M.D., M.P.H. Johns Hopkins University Baltimore, MD Grant Number: HS 06170 Project Period: 3/89—8/91 This project is utilizing Medicaid claims data and medi- cal record reviews to examine small area variations in ambulatory care in the State of Maryland. The relation- ship of variations to characteristics of the population served, provider attributes, and indicators of quality of care will be examined. 2. Comparative Treatment Effectiveness Analysis (Condition- or Procedure-Specific) Biliary Tract Disease Evaluation of Clinical Outcomes in Small Areas of Michigan Principal Investigator: Laurence F. McMahon, J r., M.D., MPH. University of Michigan Ann Arbor, M I Grant Number: HS 06486 Project period: 8/90—7/92 This study will examine small area variations in per- formance of cholecystectomy in Michigan to determine correlations with demographic, clinical, and socioeco- nomic variables. Generalizability of the results will be assessed by comparing local variability with that found nationally using Medicare data. Cardiovascular Disease Equation-Based Severity Measures for Revascularization Principal Investigator: Arthur J. Hartz, M.D., PhD. Medical College of Wisconsin Milwaukee, WI Grant Number: HS 06285 Project Period: 9/89—8/91 The investigators will develop and test the utility of a new measure of illness severity for patients undergoing coronary artery revascularization procedures. The mea- sure may be used to identify high-risk versus low-risk patients and to evaluate quality of care. CNNC & Outcomes in Cardiovascular Surgical Population Principal Investigator: Mary E. Kerr, M.N. Case Western Reserve University Cleveland, OH Grant Number: HS 06611 (Dissertation) Project Period: 8/90—7/91 This project will examine the usefulness ofa taxonomy ofnursing diagnoses (Conditions that Necessitate Nurs- ing Care, CNNC) in predicting selected patient out— comes following cardiovascular surgery. Primary Care Lipid Practice and Policy in Hypertension Principal Investigator: William E. Neighbor, MD. University of Washington Seattle, WA Grant Number: HS 06574 Project Period: 9/90—9/93 This study will examine primary care physicians’ knowledge, attitudes, and clinical practice policies re- garding the management ofhypercholesterolemia in hy- pertensive patients and the extent to which these con- structs are reflected in actual clinical practice. An edu- cational intervention will be developed based on case policy feedback as a means of modifying physician practice behavior. Predictions and Outcomes in Congestive Heart Failure Principal Im'estigator: Roy M. Poses, M.D. Virginia Commonwealth University, Richmond, VA HS 06274 12/89—11/93 Grant Number: Project Period: Investigators will examine the ability of physicians’ un— aided predictions to distinguish between patients with congestive heart failure who do and do not need inten- sive care. Observational data from emergency room physicians will be utilized and analyzed. Aggregated predictions will be compared with predictions of indi- vidual clinicians and examined against outcome. An MI Thrombolytic Therapy Outcome Predictive Instrument Principal Inthigator: Harry P. Selker, MD. New England Medical Center Boston, MA Grant Number: HS 06208 Project Period: 9/89—9/91 The purpose of this study is to develop a real-time pre- dictive instrument (TPI or thrombolytic therapy predic- tive instrument) to determine which patients in the emergency room setting are most likely to benefit from thrombolytic therapy. C erebrovascular Disease Physicians’ Decisions Regarding Cerebral Palsy Referral Principal Investigator: Suzann K. Campbell, Ph.D. University of Illinois, Chicago, IL Grant Number: HS 06429 Project Period: 4/90—3/91 This grant supports a survey of physicians to determine their attitudes regarding the efficacy of long-term physi— cal therapy (PT) for children with cerebral palsy and other conditions causing motor dysfunction. Differ— ences in referral patterns, according to patient and phy- sician characteristics will be examined. Cost/Utility of Stroke Prevention Principal Investigator: Theodore G. Ganiats, MD. University of California San Diego, CA Grant Number: HS 06098 Project Period: 3/89—12/91 This project, appended onto the NIH-supported study, Stroke Prevention in Arterial Fibrillation (SPAF), eval- uates the functional status and quality of life of individu- als receiving different types of anticoagulation therapy to prevent stroke. Diabetes Community Health Care Models for Diabetes Prevention and Control Principal Investigator: Ty Hartwell, PhD. Research Triangle Institute Durham, NC Intro-Agency Agreement Number: AHCPR 90—16 (with CDC) Project Period: 7/90—6/95 This project seeks to establish whether health care and health promotion activities that are thought to be effec- tive in diabetes prevention and control are in fact effec— tive in preventing morbidity and mortality, especially in communities with large minority populations. HIV-Related Illness Cost-Effective Management of HIV-Related Illnesses Principal Investigator: Anna Tosteson, Sc.D. Brigham and Women’s Hospital Boston, MA Grant Number: HS 06694 Project Period: 7/90—6/92 This project will develop models of the costs and quality of life gained from a broad range of strategies to care for 5 HIV—infected patients with specific symptoms of central nervous system (CNS) disease. My The Hysterectomy Decision: Assessment of Outcomes Principal Investigator: Buell A. Miller, MD. Maine Medical Assessment Foundation Manchester, ME . Grant Number: HS 06121 Project Period: 4/89—3/92 The effectiveness and appropriateness of hysterecto— mies will be examined with the overall goal of improv- ing decisions regarding hysterectomy versus alternative treatment for individual patients. Iatrogenic Illness Detection and Origins of Geriatric Drug-Related Hospitalizations Principal Investigator: Helene L. Lipton, Ph.D. University of California San Francisco, CA Grant Number: HS 06443 Project Period: 4/90—9/91 The purpose of this study is to characterize and quantify drug-related adverse events associated with admission of elderly patients to community hospitals. Pediatric Gastroenteritis Gastroenteritis Patient Outcome Research Principal Investigator: Christy Moynihan, PhD. SysteMetrics/ McGraw—Hill, Inc. Santa Barbara, CA Contract Number: 282—90~0043 Project Period: 9/90—9/93 The contractor will evaluate the available literature and data on pediatric gastroenteritis and collect and analyze data to evaluate variations in treatment, outcomes, and resource use. The study population will include Ameri- can Indian and Alaskan Native populations. Clinical recommendations will be developed based on findings. Pregnancy Effectiveness of Prenatal Care: Two Approaches Principal Investigator: Betsy J. Brach, M.S.N., M.P.H. Johns Hopkins University Baltimore, MD Grant Number: HS 06605 (Dissertation) Project Period: 8/90—7/91 The goal of this project is to delineate better the role and content of comprehensiveness, continuity, and coordi- nation of prenatal care on patient outcomes. Well-being of infants and mothers receiving care at sites that differ with respect to staffing, hours, and links with child care and family planning will be compared. The Impact of Litigation Risk on Cesarean Section Rates Principal Investigator: Arthur R. Localio, M.P.H. Harvard University Boston, MA Grant Number: HS 06677 Project Period .‘ 9/90—3/91 The investigators will undertake a 6—month, cross—sec- tional study designed to test the hypothesis that a higher risk oflitigation faced by providers of obstetrical care is associated with higher cesarean section rates. Practice Variations in Prenatal and Intrapartum Care Principal Investigator: Roger A. Rosenblatt, MD. University of Washington Seattle, WA Grant Number: HS 06166 Project Period: 7/89—6/92 This project involves a study of variations in obstetrical care for women with low-risk pregnancies in Washing— ton State with special attention to the effects of geo- graphic location and provider type, the impact of varia- tions on charges, and the extent to which actual practice conforms to recommended standards. 3. Methods and Measures Longitudinal Comparison of Measures for Health Outcomes Principal Investigator: Dennis G. Fryback, Ph.D. University of Wisconsin Madison, WI Grant Number: HS 06491 Project Period: 9/90—8/95 This study will compare alternative measures of health status for a general population. The major comparison is between the General Health Survey, a short form of the Medical Outcomes Study, and the Quality of Well-Be- ing Scale. The study will be conducted in collaboration with an ongoing epidemiologic study in Beaver Dam, WI. Screening Quality of Care Using Administrative Data Principal Investigator: Lisa I. Iezzoni, M.D. Beth Israel Hospital Boston, MA Grant Number: HS 06512 Project Period: 9/90—3/92 This project will develop and evaluate computerized al— gorithms to screen for substandard care and poor out— comes in hospital patients using readily available ad- ministrative data. Methodologic Studies on APACHE III Principal Investigator: William A. Knaus, M.D. George Washington University Washington, DC Grant Number: HS 05787 Project Period: 1/88—12/92 This project is designed to further understand and refine a severity of illness index, the Acute Physiology And Chronic Health Evaluation (APACHE) III. APACHE III is an update of the earlier APACHE (I and II) tools that were developed to quantify degree of illness and risk of death for patients in intensive care units across disease and illness categories. History of the Randomized Clinical Trial Principal Investigator: Marcia L. Meldrum,M.B.A., M.A. Stony Brook, NY Grant Number: HS 06792 (Dissertation) Project Period: 9/90—8/91 This project will investigate the process that led to the acceptance of randomized clinical trials as the “gold standard” for the evaluation of effectiveness of medical products and procedures. Meta-Analysis for Medicine: Application and Methods Principal Investigator: Frederick Mosteller, Ph.D. Harvard School of Public Health Boston, MA Grant Number: HS 05936 Project Period: 7/88-6/91 This project will carry out new meta—analyses and up— date previous meta—analyses for certain diagnostic and therapeutic procedures, thus contributing both to knowledge of the effectiveness of procedures and to methods for future evaluations. Evaluating Outcomes of Hospital Care Using Claims Data Principal Investigator: John E. Wennberg, M.D., MPH, Dartmouth College Hanover, NH Grant Number: HS 05745 Project Period: 7/87—6/90 The purpose of this study is to evaluate the utility of claims data from Medicare and from the Manitoba Health Commission for evaluation of outcomes asso- ciated with selected surgical procedures and medical ad- missions. The study will extend previous work to a broader range of causes for hospitalization, a more di- verse set of outcomes and a larger population base. 4. Dissemination and Related Evaluation Evaluation of Guidelines for Prescribing Dental X-Rays Principal Investigator: Kathryn A. Atchison, D.D.S. University of California Los Angeles, CA Grant Number: HS 06670 Project Period: 8/90—7/93 An experiment will be conducted to evaluate the effec— tiveness of current guidelines for dental radiographs to detect dental disease. Diagnoses based on the guide- lines will be compared with diagnoses made based on complete mouth radiographs. Conference: Effectiveness/Cutcomes—Health Care Services Principal Investigator: Karen S. O’Connor, M.A., R.N. American Nurses’ Association, Kansas City, MO Grant Number: HS 06662 Project period: 5/90—4/91 The purposes of the conference are (l) to share informa- tion with key nursing leaders about current public and private developments regarding the effectiveness and appropriateness of and payment for health care services, and (2) to further clarify methods to coordinate, devel— op, disseminate, and evaluate practice guidelines. Symposium and Short Courses on Health Outcomes Research Principal Investigator: Edward H. Shortliffe, M.D. Society for Medical Decision Making, Lebanon, NH HS 06647 8/90—7/91 Grant Number: Project Period: This project will augment the annual meeting ofthe So— ciety for Medical Decision Making with a series of ac- tivities targeted to the subject of health outcomes re— search. The meeting was held November 11—14, 1990. B—lO Asthma Care Effectiveness—A Proposed Workshop Principal Investigator: Kevin B. Weiss, M. D. George Washington University Washington, DC Grant Number: HS 06782 Project Period: 9/90 —5/91 The purpose of this two—day workshop, scheduled for March 14—16, 1991, is to define new and significant areas of research on problems of asthma health care de- livery. Papers will be commissioned for the workshop proceedings synthesizing the state of the science for asthma care and detailing health services research is- sues. Appendix C Practice Guideline Panels Practice Guideline Panels Benign Prostatic Hyperplasia Guideline Panel Name Michael Barry, MD. General Internal Medicine Unit Bulfinch One Massachusetts General Hospital Boston, MA Reginald C. Bruskewitz, MD. University of Wisconsin Hospital & Clinics Madison, WI Anton J. Bueschen, MD. University of Alabama at Birmingham Division of Urology Birmingham, AL Sherwood E. Denton, MD. Phoenix, AZ H. Logan Holtgrewe, MD. Annapolis, MD John L. Lange, MD. Holt-Krock Clinic Fort Smith, AR Bruce McClennan, MD. Director, Abdomen Imaging Section Mallinckrodt Institute of Radiology Washington University School of Medicine St. Louis, MO Specialty Internal medicine Urology Urology Urology Urology Urology Radiology Name John D. McConnell, MD. (Chairman) UT Southwestern Medical Center Division of Urology Dallas, TX Winston K. Mebust, MD. Kansas University Surgical Association Kansas City, KS Nancy J. Reilly, BS, MS, RN. Maple Shade, NJ Richard G. Roberts, M.D., J.D. The University of Wisconsin Madison, WI Stephen A. Sacks, MD. Cedars—Sinai Medical Office Towers Los Angeles, CA John Wasson, MD. VA Hospital White River Juction, VT Alan J. Wein, MD. Pennsylvania University Hospital Urology Division Philadelphia, PA Specialty Urology Urology Nursing Family practice Urology Internal medicine Urology Name Anthony J. Adams, O.D., Ph.D. Professor of Optometry and Physiological Optics Assistant Dean School of Optometry University of California Berkeley, CA Edwin H. Cassem, M.D. Acting Chief, Psychiatry Service Department of Psychiatry Massachusetts General Hospital Boston, MA Donald J. Doughman, MD. Professor Department of Ophthalmology University of Minnesota Hospital and Clinic Minneapolis, MN Catherine Glynn-Milley, R.N. President Specialty Nursing Agency, Inc. Santa Clara, CA Harry L. Knopf, MD. Associate Professor of Clinical Ophthalmology Washington University School of Medicine St. Louis, MO Emest L. Mazzaferri, MD. Professor and Chairman Department of Internal Medicine Ohio State University Columbus, OH Stephen A. Obstbaum, MD. Professor of Ophthalmology Cornell University New York, NY Cataract Guideline Panel Specialty Optometry Psychiatry Ophthalmology Nursing, home health Ophthalmology Internal medicine Ophthalmology Name Denis M. O’Day, M.D. (Chairman) Michael J. Hogan Professor of Ophthalmology and Director of Corneal and External Disease Service Vanderbilt University School of Medicine Department of Ophthalmology Vanderbilt University Medical Nashville, TN Eva Skinner Los Angeles, CA Alfred Sommer, M.D. Dean The Johns Hopkins School of Hygiene and Public Health Baltimore, MD Arlo C. Terry, MD. Associate Clinical Professor of Ophthalmology University of Texas San Antonio, TX James R. Weber, MD. Assistant Clinical Professor Department of Family and Com- munity Medicine College of Medical Sciences University of Arkansas Jacksonville, AR Von Best Whitaker, RN, PhD. Assistant Professor University of Texas Health Science Center School of Nursing San Antonio, TX Ira A. Wong, MD. Chief of Ophthalmology Kaiser Permanente Medical Center Redwood City, CA Specialty Ophthalmology Consumer rep- resentation, retired nurse Ophthalmology Ophthalmology Family practice Nursing, public health Ophthalmology Name Joyce Colling, RN, PhD, F.A.A.N. Professor and Chairperson Community Health Care Systems Department School of Nursing Oregon Health Sciences University Portland, OR Ananias C. Diokno, M.D. (Cochair) Chief Department of Urology William Beaumont Hospital Royal Oak, MI J. Andrew Fantl, MD. Professor Department of Obstetrics and Gynecology Medical College of Virginia Richmond, VA Richard Loughery, B.A., F.A.C.H.A. Consultant National Museum of Health and Medicine Washington, DC Kathleen McCormick, Ph.D., R.N.,F.A.A.N. (Cochair) Nursing Research Director Laboratory of Behavioral Sciences Gerontology Research Center National Institute on Aging, NIH Baltimore, MD Diane Newman, R.N. Vice President Golden Horizons, Inc. Newtown Square, PA Urinary Incontinence Guideline Panel Specialty Nursing Urology Obstetrics, gynecology Hospital admin— istration, consumer representation Nursing Nursing Name Specialty Joseph G. Ouslander, MD. Medical Director Jewish Homes for the Aging Associate Professor Multicampus Division of Geriatric Medicine and Gerontology UCLA School of Medicine Reseda, CA Geriatrics Betty Pearson, Ph.D., R.N. Associate Professor School of Nursing University of Wisconsin—Milwaukee Milwaukee, WI Nursing Shlomo Raz, MD. Professor Surgery/Urology Los Angeles, CA Urology Neil Resnick, MD. Chief of Geriatrics Brigham and Women’s Hospital Boston, MA Geriatrics Thomas Rohner, MD. Chief Division of Urology Penn State University Hershey Medical Center Hershey, PA Urology John Schnelle, Ph.D. Professor in Residence Borun Center for Gerontological Research UCLA School of Medicine Los Angeles, CA Psychology, gerontology Vernon Urich, M.D. Instructor in Urology University of Michigan Urological Services Flint, MI Urology Urinary Incontinence Guideline Panel (continued) Name Specialty Name Specialty Michael S. Vernon, MD. Family practice Jeanette M. Tries, M.S., O.T.R. Occupational Director of Geriatrics Sacred Heart Rehabilitation therapy, Associate Professor Hospital psychology Department of Family Medicine Milwaukee, WI School of Medicine East Carolina University Greenville, NC C—4 Name Beverly Ames 4427 23rd Parkway, Apt. T1 Temple Hills, MD Kwame Anyane-Yeboa, MD. Assistant Professor Pediatrics, Columbia University Director, Genetics Program Babies Hospital New York, NY Samuel Charache, MD. Professor of Laboratory Medicine Johns Hopkins Hospital Baltimore, MD Melvin Gerald, MD. Family Practitioner Washington, DC Serena Gilbert, M.S.W. Director Department of Social Work Prince George’s Hospital Center Cheverly, MD Thomas Kinney, M.D. (Cochair) Associate Professor of Pediatrics Duke University Medical Center Durham, NC David Phoenix, Dr.P.H. Assistant Professor Department of Management Appalachian State University Boone, NC Peter Rowley, MD. Rochester School of Medicine Chairman, Division of Genetics Rochester, NY Sickle Cell Guideline Panel Specialty Consumer representation, parent of child with sickle cell Pediatrics, genetics Internal medicine Family practice Medical social work Pediatrics Health planning Internal medicine, pediatrics, genetics Name Specialty Jeanne Smith, M.D., MPH. (Cochair) Associate Professor of Clinical Medicine Columbia University Director, Comprehensive Sickle Cell Center Harlem Hospital New York, NY hmmm medicine Ruby LaVeme Wesley, Ph.D. Lecturer College of Nursing Wayne State University Detroit, MI Nursing Doris Wethers, MD. Associate Professor Pediatrics, Columbia University Director, Comprehensive Sickle Cell Center St. Lukes/Roosevelt Hospital New York, NY Pediatrics Charles Whitten, MD. Associate Dean for Curricular Affairs Wayne State University School of Medicine Program Director, Comprehensive Sickle Cell Center Wayne State University Detroit, MI Pediatrics Iola Williams, R.N., P.N.P Coordinator Sickle Cell Disease Department of Hematology/Oncology Childrens National Medical Center Washington, DC Nursing (practitioner) Pressure Sores Guideline Panel Name Specialty Internal medicine, geriatrics Richard M. Allman, MD. Assistant Professor of Medicine General and Preventive Medicine University of Alabama at Birmingham Birmingham, AL Nancy Bergstrom, PhD, RN, F.A.A.N. (Chairman) Professor College of Nursing University of Nebraska Medical Center Omaha, NE Nursing, nutrition Carolyn E. Carlson, PhD, RN. Professor of Nursing Cedarville College Associate Director of Nursing for Research and Evaluation Rehabilitation Institute of Chicago Chicago, IL Nursing, rehabilitation William H. Eaglstein, MD. Professor and Chairman University of Miami School of Medicine Department of Dermatology and Cutaneous Surgery Miami, FL Dermatology Rita A. Frantz, PhD, RN. Associate Professor College of Nursing University of Iowa Iowa City, IA Nursing, psychology Susan L. Garber, M.A., O.T.R. Assistant Director for Research Department of Occupational Therapy Institute for Rehabilitation and Research Houston, TX Occupational therapy Name Davina Gosnell, Pli.D., R.N., F.A.A.N. Professor and Dean School of Nursing Kent State University Kent, OH Bettie S. Jackson, Ed.D., M.B.A., F.A.A.N, Director for Professional Services Department of Nursing Moses Division Montefiore Medical Center Bronx, NY Mildred G. Kemp, Ph.D., R.N., C.E.T.N. Associate Professor Rush University College of Nursing Practitioner/Teacher Department of Operating Room and Surgical Nursing Rush—Presbyterian-St. Luke’s Medical Center Chicago, IL Thomas A. Krouskop, PhD. Professor of Rehabilitation and Physical Medicine Baylor College of Medicine Institute for Rehabilitation and Research Houston, TX Elena M. Marvel, M.A., M.S.N., R.N. State Coordinator for Health Services/AARP Shorthills, NJ George T. Rodeheaver, Ph.D. Director Plastic Surgery Research University of Virginia School of Medicine Charlottesville, VA George C. Xakellis, MD. Assistant Professor University of Iowa College of Medicine Iowa City, IA C—6 Specialty Nursing Nursing Nursing Biomedical engineering Nursing, consumer representation Organic chemistry Family practice Name Daniel Carr, M.D. (Cochair) Associate Director Anesthesia Pain Unit Massachusetts General Hospital Boston, MA Richard Chapman, Ph.D. Professor, Anesthesiology University of Washington Department of Anesthesiology Seattle, WA Howard L. Fields, M.D., PhD. Department of Neurology University of California San Francisco, CA George Heidrich, III, R.N., MA. University of Wisconsin Medical School Department of Neurology Madison, WI Nancy K. Hester, RN, PhD. Associate Professor School of Nursing University of Colorado Health Sciences Center Denver, CO C. Stratton Hill, Jr., MD. Associate Professor MD Anderson Hospital Houston, TX Ada Jacox, RN, PhD. (Cochair) Professor School of Nursing The Johns Hopkins University Baltimore, MD Arthur G. Lipman, PharmD Professor of Clinical Pharmacy College of Pharmacy University of Utah Salt Lake City, UT Pain Management Guideline Panel Specialty Internal medicine, anesthesiology, endocrinology Psychology Neurology, neurophysiology Nursing Nursing General medicine Nursing, health pohcy Pharmacy Name Specialty Charles L. McGarvey, M.S. Chief, Physical Therapy Service Department of Rehabilitation Medicine National Institutes of Health Bethesda, MD Physical therapy Christine Miaskowski, RN, PhD. Nursing, Clinical Nurse Scholar physiology School of Nursing Department of Physiological Nursing San Francisco, CA David Stevenson Mulder, MD. Chief of Surgery McGill University Montreal General Hospital Montreal, Quebec Surgery Richard Payne, MD. Associate Professor of Neurology University of Cincinnati Medical Center Cincinnati, OH Neurology Neil Schechter, MD. Director Development of Behavioral Pediatrics St. Francis Hospital Medical Center Hartford, CT Pediatrics Rev. Robert Smith Director, Institute for Medicine in Contemporary Society State University Medical Center at Stony Brook Stony Brook, NY Religion, ethics Carole V. Tsou, M.D. Santa Monica, CA Family practice Loretta Vecchiarelli Consumer Rehabilitation Hospital of representation, Western New England rehabilitation Ludlow, MA Name William E. Golden, MD. Director, General Internal Medicine University of Arkansas for Medical Sciences Little Rock, AR Gladys Walton Hall, PhD. Washington, DC Col. Moses Herrera, MD, Family Practice Clinic Warner Robins Hospital Warner Robins, GA Artie Houston Fort Worth, TX Roger Kathol, MD. University of Iowa Hospital and Clinics Iowa City, IA Wayne Katon, MD. Department of Psychiatry University of Washington Medical Center Seattle, WA Catherine L. Matchett, MD. Grapevine, TX Depression Guideline Panel Specialty Internal medicine Medical social work Family practice Consumer representation Internal medicine, psychiatry Psychiatry Family practice Name Fred Petty, M.D., PhD. Department of Psychiatry Department of Veterans Affairs Medical Center Dallas, TX A. John Rush, MD. (Chairman) Betty Jo Hay Chair in Mental Health Director, Mental Health Clinical Research Center University of Texas Southwestern Medical Center Dallas, TX Herbert C. Schulberg, PhD. Professor of Psychiatry, Psychology & Medicine University of Pittsburgh School of Medicine Western Psychiatric Institute and Clinic Pittsburgh, PA G. Richard Smith, Jr., MD. Associate Professor of Psychiatry University of Arkansas for Medical Sciences Little Rock, AR Gail Wiscarz Stuart, PhD., RN. Medical University of South Carolina Charleston, SC Specialty Psychiatry, biology Psychiatry Psychology Psychiatry Psychiatric nursing Appendix D National Advisory Council for Health Care Policy, Research, and Evaluation National Advisory Council for Health Care Policy, Research, and Evaluation Members are appointed by the Secretary for staggered 3—year terms: dates when terms end are noted for each member. List of Members Linda H. Aiken, Ph.D. Trustee Professor of Nursing Professor of Sociology Director, Center of Health Services in Policy Research University of Pennsylvania School of Nursing Philadelphia, PA (1993) George A. Beller, M.D. Head, Division of Cardiology and Professor of Medicine University of Virginia Health Sciences Center Post Office Box 158 Charlottesville, VA (1991) Edward C. Bessey President, Chief Executive Officer Pfizer Hospital Products Group 235 East 42nd Street New York, NY (1991) Joseph F. Boyle, M.D. Executive Vice President American Society of Internal Medicine 1101 Vermont Avenue, N.W., Suite 500 Washington, DC (1992) Linda Burnes Bolton, Dr.P.H., R.N. Director, Nursing Research and Development Department of Nursing Research and Development Cedars—Sinai Medical Center 8700 Beverly Boulevard Los Angeles, CA (1992) Joseph T. Curti, MD. President, North America Operations SEARLE 5200 Old Orchard Road Skokie, IL (1991) Gary L. Filennan, Ph.D. President Association of University Programs in Health Administration 1911 North Fort Myer Drive, Suite 503 Arlington, VA (1992) Juanita W. Fleming, Ph.D., R.N., F.A.A.N. Professor of Nursing & Associate Vice Chancellor for Academic Affairs University of Kentucky Health Science Learning Center, Room 307 Lexington, KY (1992) David E. Hayes-Bautista, Ph.D. Director, Chicano Studies Research Center University of California Chicano Studies Research Center 405 Hilgard Avenue Los Angeles, CA (1991) William S. Kiser, M.D. (Chairman) Member, Resident Emeritus Staff The Cleveland Clinic 9500 Euclid Avenue Cleveland, OH (1992) Kermit B. Knudsen, MD. President & Chief of Staff, Scott & White Clinic Scott and White Memorial Hospital and Clinic 2401 South 31th Street Temple, TX (1993) Norma M. Lang, PhD. Dean and Professor University of Wisconsin School of Nursing 1921 East Hartford Avenue Milwaukee, WI (1993) Walter J. McNerney Herman Smith Professor of Health Policy Northwestem University Kellogg Graduate School of Management Leverone Hall 2001 Sheridan Rd. Evanston, IL (1992) Lawrence H. Meskin, DDS, PhD. Dean of the Graduate School University of Colorado Health Science Center 4200 East 9th Avenue Campus Box C—296 Denver, CO (1993) Barbara Starfield, MD. Professor and Head, Division of Health Policy Johns Hopkins University School of Hygiene and Public Health Hampton House, Room 452 624 North Broadway, Baltimore, M (1993) Sister Mary E. Wilhelm President/Chief Executive Officer Mercy Medical Corporation 101 Villa Drive Daphne, AL (1991) Ex-Officio Members David S. Kessler, M.D., J.D. Commissioner Food and Drug Administration Parklawn Building, Room 14—71 Rockville, MD Frederick K. Goodwin, M.D. Administrator Alcohol, Drug Abuse, and Mental Health Administration Parklawn Building, Room 12—105 Rockville, MD James W. Holsinger, Jr., MD. Chief Medical Director Department of Veterans Affairs 810 Vermont Avenue, NW. (10) Washington, DC Enrique Mendez, Jr., MD. Assistant Secretary of Defense (Health Affairs) Pentagon Building, Room 3E—346 Washington, DC William F. Raub, PhD. Acting Director National Institutes of Health 9000 Rockville Pike Building 1, Room 126 Bethesda, MD William L. Roper, MD. Director Centers for Disease Control 1600 Clifton Road, NE. Building 1, Room 2000 Atlanta, GA Gail Wilensky, Ph.D. Administrator Health Care Financing Administration Humphrey Building, Room 314G Washington, DC Appendix E AHCPR Organizational Chart Gar. moccE .< 55992 mOkowma 2024.... DZ< ZO_.F> .>> cmEBZ mOhomEo Iommww I._.._mmm Ih4FOmmum ._ meocH EOPOwEO hzwimmwwm< >OOJOZIQwh 1.54;... “.0 moiuo 952 39...; ES $9890 wmFomumw Dz< >P_-_mo 0_._On_ wm<0 Ih._Ozm6< w0_>mmm I.Smmm 252:: QZ< I._..._