The Expert Panel on Preventive Services: Continuing the Work of the U.S. Preventive Services Task Force

The Expert Panel on Preventive Services: Continuing the Work of the U.S. Preventive Services Task Force Steven H. Woolf, MD, MPH Harold C. Sox, Jr., MD

Clinical preventive services are an important part of primary care medicine. They include screening tests (e.g., mammography), counseling interventions (e.g., smoking cessation counseling), immunizations, and chemoprophylactic regimens (e.g., estrogen replacement therapy). For many years, however, clinicians have been uncertain about which preventive services to perform and how often to perform them. Fundamental questions have arisen about the evidence that preventive maneuvers effectively prevent disease and about the value of routine periodic health examinations. In addition, concerns have increased about ineffective or harmful preventive services that should be excluded from routine practice. Patients who receive preventive services are often in good health- by definition, they lack the conditions for which the maneuvers are intended. The chances that adverse effects, such as mislabeling or iatrogenic complications from diagnostic work-ups and treatment, will result in more harm than good may often be greater in persons who receive preventive services. Because such patients are often asymptomatic, clinicians face a special obligation to ensure that benefits outweigh risks. Identification of ineffective preventive maneuvers has also become important because of limited health care resources; money spent on ineffective preventive servicesroutine chest radiographs, for instance-may draw resources away from other services of more established value, such as smoking cessation counseling. In response to these needs, expert panels, 1- 3 medical organizations,4-6 and individual experts7- 10 began in the 1980s to issue guidelines on screening tests and other clinical preventive services. Often these recommendations reflected expert opinion. To provide a stronger science base for such recommendations, certain groups (e.g., Canadian Task Force on the Periodic From the Office of Disease Prevention and Health Promotion, U.S. Public Health Service, Washington, D.C. (Woolf), and the Department of Medicine, Dartmouth-Hitchcock Medical Center, Hanover, New Hampshire (Sox). Dr. Woolf is scientific advisor to and Dr. Sox is chairman of the Expert Panel on Preventive Services.

326 American Journal of Preventive Medicine, volume 7, number 5

Health Examination, the U.S. Preventive Services Task Force, American College of Physicians) developed special methods of guideline development that linked the strength of recommendations to the quality of supporting evidence. Preventive services were recommended only with evidence of effectiveness. These evidence-based programs used explicit methods to document the scientific rationale behind recommendations. The Canadian Task Force on the Periodic Health Examination was one of the first groups to introduce such methods. Its 1979 report introduced rules of evidence and codes to link the strength of recommendations with the quality of the underlying evidence.11 Subsequent updates12- 17 have followed the same approach. In 1984, the U.S. Public Health Service established the U.S. Preventive Services Task Force (USPSTF) to conduct a similar evaluation of clinical preventive services and to develop comprehensive guidelines on the periodic health examination. This 20member panel, aided by senior advisors, scientific support staff, and outside reviewers, worked over five years (1984-1 989) to review the evidence for 169 preventive services. The USPSTF published background papers on specific preventive services in the late 1980s.1S- 30 The full USPSTF report, Guide to Clinical Preventive Services,31 released in 1989, provided summaries of the evidence and comprehensive recommendations for the preventive care of children, adults, and pregnant women. The details of the USPSTF methodology appear elsewhere)l,32 The approach emphasized systematic methods for collecting evidence, evaluating the quality of studies, and translating science into clinical policy.33 When the USPSTF project ended in 1989, its recommendations clearly would eventually become outdated without an ongoing program of reevaluation and revision. There was also a need to address new topics that the USPSTF had not studied, such as certain preventive services for infants and children and fo r pregnant women.34 N ew data unavaila ble to the USPSTF and new technologies not yet introduced also required evaluation. In 1990, the U.S. Public Health Service established the Expert

Panel on Preventive Services (EPPS) to continue . t he wor k of the USPSTF and to update its recommendat· · · d ver. . . . 10ns Wit h revise s10ns of the Guide to Clmzcal Preventive Services. Although the EPPS shares an important h1stoncal and philosophical relationship with its predecessor group, it differs from the USPSTF in composition, methodology, and overall mission. This article reviews the goals of the EPPS and provides a general overview of its process of reviewing evidence and developing recommendations. We do not discuss the details of the EPPS methodology, which will be described more fully in a methodology document now under development by the panel. Mission The mission of the EPPS is twofold : (1) to evaluate the efficacy and effectiveness of clinical preventive services not examined by the USPSTF; and (2) to reevaluate clinical preventive services examined by the USPSTF and for which there is new scientific evidence, new technologies that merit consideration, or other reasons to reevaluate the USPSTF recommendations. The EPPS will publish updated editions of the Guide that reflect new evidence and new assessments of preventive services. The project shares the commitment of the USPSTF to use systematic methods for developing guidelines, to base its recommendations on scientific evidence, and to document clearly its analytic criteria and rationale. Composition The members of the EPPS are listed at the end of this article. The 10 core members include two specialists each in internal medicine, family practice, pediatrics, and obstetrics-gynecology, respectively; the panel also includes an epidemiologist and a decision analyst. The core membership of the EPPS is supplemented by ad hoc content experts who serve on the panel during its evaluation of specific topics. A panel of senior advisors, including the former members of the USPSTF, also provides expertise on analytic methods and goals. On behalf of the U.S. Public Health Service, the Office of Disease Prevention and Health Promotion in Washington, D.C., provides staff support for the EPPS, including background research on specific topics. A network of experts on preventive medicine and specific clinical topics throughout academia, govern_ment, and the medical practice community provides peer reviews on content. The EPPS has established close liaison with related national medical organizations and federal health agencies. Each of the specialty societies and government agencies listed in Appendix 1 has appointed an EPPS staff liaison to attend meetings, to help develop guidelines, and to share information about ongoing projects. The EPPS continues the close binational relationship between the USPSTF and the Canadian Task Force on the Periodic Health Examination. The EPPS also maintains contact with the U.S. Preventive Services Coordinating Committee, which includes over 30 medical organizations, agencies, and specialty societies. The U.S. Department of Health and Human Services established this committee in 1989 to examine barriers to putting preventive services recommendations into practice (e.g., limited reimbursement, provider and public education, access to care). Topic Selection The topics of immediate interest to the EPPS are clinical preventive services that ( 1) are provided to asymptomatic per-

sons, who lack clinical evidence of the condition to be prevented, and (2) are offered in the clinical setting. The focus is therefore on primary and secondary prevention for patients in traditional primary care settings. Suggestions for potential topics derive from the panel itself; from outside organizations, agencies, and individuals; and from coalitions of organizations, such as the U.S. Preventive Services Coordinating Committee. The EPPS tries to avoid considering preventive services already under study or recently reviewed by other groups that use similar methodologies. Close liaisons between the EPPS and these groups allow information exchange to avoid duplication of effort and to avoid producing inconsistent recommendations on the same topics. The EPPS uses explicit criteria to determine the order of priority in which it examines candidate topics. These are the criteria reflecting the importance of the condition to patients and to society: (1) the severity and frequency of the target condition (burden of suffering); (2 ) uncertainty about appropriate practice that can be remedied by guidelines; (3 ) timeliness of the topic; (4) costs and other limited resources; (5 ) availability of scientific evidence; and (6 ) feasibility of the review. A quantitative methodology by which criteria scores are translated into ranking schemes and "topic cues" will be discussed in a subsequent article. The first topics to be examined by the EPPS are listed in Appendix 2. Analytic Criteria The EPPS does not recommend preventive services unless they meet explicit criteria of clinical effectiveness. The criteria vary, depending on the type of preventive service (Appendix 3 ). The criteria provide the framework for more detailed analyses of the benefits and harms associated with specific preventive services. Because patients receiving preventive services are generally asymptomatic, special attention is given to the potential adverse effects of preventive measures to ensure that the risks of a preventive practice do not outweigh its potential benefits. Review of Evidence The EPPS determines whether a preventive service meets its analytic criteria by carefully reviewing scientific evidence from published clinical research. Relevant evidence generally includes peer-reviewed clinical trials, observational studies, and other epidemiologic data on the effectiveness of the interventions under consideration. Other types of scientific evidence and outcomes data may also merit consideration. The evidence is collected by staff researchers or outside experts, who often draft background papers that summarize the evidence. The review process involves three steps: retrieval of the evidence, evaluation of individual studies, and synthesis of the results. Retrieval of evidence. The retrieval of evidence is comprehensive. EPPS staff attempt to gather all relevant studies and to document the process used to locate relevant evidence (e.g. , bibliographic sources, keywords, relevancy criteria ). This documentation allows readers to judge the thoroughness of the review and to duplicate it. Evaluation of individual studies. Evaluation involves a systematic assessment of the quality of the evidence. Study design features, such as sample size, selection bias, confounding variables, data analysis, and generalizability, are examined carefully for their effect on internal and external validity. The EPPS classifies general study design categories (e.g., randomized con-

Am

J Prev

Med 1991;7(5) 327

trolled trials, cohort studies, case-control studies) using the codes developed in 1984 by the Canadian Task Force and the USPSTf.35 Synthesis of evidence. Synthesis summarizes available data narratively and in evidence tables. More formal methods of information synthesis, such as meta-analysis, decision analysis, and other forms of modeling are used when appropriate. The EPPS documents the logic by which evidence is translated into guidelines. Factors Other Than Clinical Evidence Expert opinion based on clinical experience plays an important role in judging appropriateness, because high-quality scientific evidence is often lacking to determine the benefits and harms of preventive interventions. The EPPS makes recommendations based on scientific evidence. It refrains from advocating preventive practices when there are no convincing data or when there is conflicting evidence. The EPPS occasionally makes recommendations despite poor evidence (e.g., for interventions without substantial health risks or costs). In such cases, the EPPS states that the source of the recommendation is expert opinion and not scientific evidence. The recommendations of other groups are also identified, and efforts are made to achieve consistency. The costs and resource implications of offering preventive services are important factors for recommendations. Although formal cost-effectiveness analysis of preventive services is difficult,36 the EPPS often reviews available information about the direc~ nd indirect costs of preventive measures. This review may include published cost assessments. The EPPS generally does not perform its own cost-effectiveness analyses. Peer Review The EPPS distributes literature reviews and draft recommendations for critical review by outside content experts and by relevant organizations and agencies. Selected content experts may work more closely with the EPPS to provide detailed written reviews, to discuss preventive services at panel meetings, and to serve as ad hoc panel members on topics that require more extensive input. The U.S. Preventive Services Coordinating Committee is also asked to review EPPS documents. The EPPS sends early drafts of recommendations to interested organizations to provide advance notice of impending recommendations and to obtain suggestions for further revisions. Publications Many EPPS recommendations on individual preventive services will be published periodically in peer-reviewed journals. Comprehensive recommendations for all age groups will be provided in updated editions of the Guide. Joint recommendations with the Canadian Task Force on the Periodic Health Examination may also be issued. Implementation of Recommendations The publication of guidelines, by itself, does not ensure implementation in clinical practice.J 7,38 Additional measures are often necessary to familiarize clinicians and patients with the recommendations and to change attitudes about standards of care. Chart inserts, flow sheets, and office computer systems are often necessary as reminders of when to provide preventive services. Other barriers to the delivery of preventive services,

328 American Journal of Preventive Medicine, volume 7, number 5

such as inadequate emphasis on preventive medicine in clinical training, lack of reimbursement by third-party payers, and time constraints in the clinical setting, are described in detail elsewhere.39 The EPPS is not charged with developing implementation programs or devising strategies for practitioners to put preventive care guidelines into practice. However, it works closely with other groups that are attempting to address these issues, including medical specialty societies and projects aimed at developing implementation tools, such as the "Put Prevention Into Practice" campaign40 to be launched in 1991 by the U.S . Public Health Service.

CONCLUSIONS The EPPS is one of many groups developing practice guidelines on preventive services. Medical specialty societies, agencies, and private organizations regularly issue recommendations on screening, counseling, and immunizations. New initiatives to develop practice guidelines, such as those by the recentlyestablished Agency for Health Care Policy and Research, include preventive services among the topics for which guidelines are being prepared. 41 Other federal agencies (e.g., Centers for Disease Control, National Institutes of Health) also issue preventive care recommendations. In addition, guidelines relevant to preventive care are part of other recently established national practice guideline projects, such as the American Medical Association, RAND Corporation, and Academic Medical Center Consortium projects.42 The Canadian Task Force on the Periodic Health Examination continues to issue recommendations on specific topics and is currently developing a comprehensive update on preventive services for all age groups. The American College of Physicians recently issued recommendations on common screening tests43 and published a summary of current recommendations on preventive services.44 Central to these projects is a strong emphasis on scientific evidence and documentation of methods as the foundation for practice recommendations. The emphasis on systematic methods that has characterized recent preventive medicine guidelines played an important role in the adoption of similar approaches for practice guidelines in other areas of medicine (i.e., diagnosis and treatment).45 The trend toward more explicit methods of guideline development is likely to improve the quality of practice recommendations. Ultimately, studies of clinical outcomes will be necessary to demonstrate that the development and implementation of such guidelines effectively improve the quality of care received by patients. The core members of the Expert Panel on Preventive Services are Harold C. Sox, Jr., MD (chairman), Dartmouth-Hitchcock Medical Center; Donald M. Berwick, MD, MPP (vice-chairman), Harvard Medical School; Alfred 0. Berg, MD, MPH, University of Washington; Paul S. Frame, MD, Tri-County Family Medicine; Dennis G. Fryback, PhD, University of Wisconsin-Madison; David A. Grimes, MD, University of Southern California; Robert S. Lawrence, MD, Harvard Medical School; Robert B. Wallace, MD, University of Iowa; A. Eugene Washington, MD, MSc, University of California, San Francisco; and Modena E.H. Wilson, MD, MPH, Johns Hopkins University. Other members are identified according to the topic under consideration.

Questions about the EPPS and suggestions about new topics to be examined by the panel shouJ-d be directed to the author at the following address: Steven H. Woolf, MD, MPH, Scientific Advisor, Expert Panel on Preventive Services, Office of Disease Prevention and Health Promotion, U.S. Public Health Service, 330 C Street, S.W., Room 2132, Washington, D.C. 20201. Since this article was prepared, the Expert Panel on Preventive Services has been renamed the U.S. Preventive Services Task Force in order to avoid confusion.

APPENDIX 1. LIAISON MEMBERS OF THE EPPS Medical Specialty Societies American Academy of Family Physicians American Academy of Pediatrics American College of Obstetricians and Gynecologists American College of Physicians Federal Agencies Agency for Health Care Policy and Research Alcohol, Drug Abuse, and Mental Health Administration Centers for Disease Control Health Resources and Services Administration Indian Health Service Food and Drug Administration National Institutes of Health Other Organizations Canadian Task Force on the Periodic Health Examination

APPENDIX 2. FIRST TOPICS TO BE ASSESSED BY THE EPPS Screening for adolescent idiopathic scoliosis Routine iron supplementation during pregnancy Measles vaccinationa Haemophilus influenza type b vaccinationa Hormone replacement therapya Home monitoring for premature labor Screening for prostate cancera Screening for human immunodeficiency virus infectiona Screening for abdominal aortic aneurysms aTopics previously addressed by the USPSTF and now being reexamined because of new evidence or new preventive technologies and interventions.

APPENDIX 3. GENERAL CRITERIA OF EFFECTIVENESSa Screening Tests Accuracy and reliability of screening tests Effectiveness of early detection A. Treatment efficacy B. Asymptomatic period C. Benefits of early detection D. Acceptability

Counseling Interventions Efficacy of behavior change in risk reduction Efficacy and effectiveness of counseling patients about health behaviors Immunizations I Chemoprophylaxis Efficacy and effectiveness of agent Efficacy and effectiveness of counseling

aThe EPPS has developed detailed guidelines that clarify each of the general criteria listed here. This complete list of criteria will be provided in a forthcoming methodology document.

REFERENCES 1. National Cancer Institute. Working guidelines for early cancer detection: rationale and supporting evidence to decrease mortality. Bethesda, Maryland: National Cancer Institute, 1987. 2. Report of the National Cholesterol Education Program Expert Panel on detection, evaluatio n, and treatment of high blood cholesterol in adults. Arch Intern Med 1988;148 :36-69. 3. American Heart Association. Cardiovascular and risk factor evaluation of healthy American adults: a statement for physicians by an ad hoc committee appointed by the steering committee. Circulation 1987;75:1340A-62A. 4. American Cancer Society. Report on the cancer-related health checkup. CA 1980;30:194- 240. 5. American College of Physicians. Periodic health examination: a guide for designing individualized preventive care in the asymptomatic patient. Ann Intern Med 1981 ;95:729-32. 6. American College of Physicians. Common diagnostic tests: use and interpretation. Philadelphia: American College of Physicians, 1987. 7. Frame PS. A critical review of adult health maintenance. Part I. Prevention of atherosclerotic diseases. J Fam Pract 1986;22:341- 6. 8. Frame PS. A critical review of adult health maintenance. Part 2. Prevention of infectio us diseases. J Fam Pract 1986;22:41 7-22. 9. Frame PS. A critical review of adult health maintenance. Part 3. Prevention of cancer. J Fam Pract 1986;22:5 11-20. 10. Frame PS. A critical review of adult health maintenance. Part 4. Prevention of metabolic, behavioral, and miscellaneous conditions. J Fam Pract 1986;23 :29-39. 11. Canadian Task Force on the Periodic Health Examination. The periodic health examination. Can Med Assoc J 1979;121:1194-254. 12. Canadian Task Force on the Periodic Health Examination. The periodic health examination: 1984 update. Can Med Assoc J 1984;130:1278- 85. 13. Canadian Task Force on the Periodic Health Examination. The periodic health examination: 1986 update. Can Med Assoc J 1986;134: 721-9. 14. Canadian Task Force on the Periodic Health Examination. The periodic health examination: 1988 update. Can Med Assoc J 1988;138:61 7- 26. 15. Canadian Task Force on the Periodic Health Examination. The periodic health examination: 1989 update. Can Med Assoc J 1989;141:205-16.

Am J Prev M ed 1991; 7(5) 329

16. Canadian Task Force on the Periodic Health Examination. Periodic health examination: 1990 update. Can Med Assoc J 1990;142:955-61. 17. Canadian Task Force on the Periodic Health Examination. Periodic health examination: 1991 update. Can Med Assoc J 1991 ;144:42531. 18. O'Malley MS, Fletcher SW. Screening for breast cancer with breast self-examinatio n: a critical review. JAMA 1987;257:2197-2203. 19. Laforce FM. Immunizations, immunoprophylaxis, and chemoprophylaxis to prevent selected infections. JAMA 1987;257:2464-70.

31. U.S. Preventive Services Task Force. Guide to clinical preventive services: an assessment of the effectiveness of 169 interventions. Baltimore: Williams and Wilkins, 1989. 32. Woolf SH, Battista RN, Anderson GM, Logan AG, Wang E. Assessing the clinical effectiveness of preventive maneuvers: analytic principles and systematic methods in reviewing evidence and developing clinical practice recommendations. J Clin Epidemiol 1990;43:891-905. 33. Lawrence RS, Mickalide AD, Kamerow DB, Woolf SH. Report of the U.S. Preventive Services Task Force. JAMA 1990;263:436- 7. 34. Harvey B. Dr. Harvey examines pros, cons of task force reco mmendations. AAP News, February 1990;2.

20. Horsburgh CR, Douglas JM, Laforce FM. Preventive strategies in sexually transmitted diseases for the primary care physician. JAMA 1987;258:8 15-21.

35. Lawrence RS, Mickalide AD. Preventive services in clinical practice: designing the periodic health examination. JAMA 1987;257:2205-7.

21. Polen MR, Friedman GD. Automobile injury: selected risk factors and prevention in the health care setting. JAMA 1988 ;259:76- 80.

36. Russell LB. Is prevention better than cure? Washington, DC: Brookings Institution, 1986.

22. Kottke TE, Battista RN, DeFriese GH, et al. Attributes of successful smoking cessation interventions in medical practice: a metaanalysis of 39 controlled trials. JAMA 1988;259:2882-9.

37. Kosecoff J, Kanouse DE, Rogers WH, McCloskey L, Winslow CM, Brook RH. Effects of the Natio nal Institutes of H ealth Consensus Development Program o n physician practice. JAMA 1987;258:2708-13 .

23. Knight KK, Fielding JE, Battista RN. Occult blood screening for colorectal cancer. JAMA 1989;261:595-602.

38. Lomas J, Anderson GM, Dominick-Pierre K, Vayda E, Enkin MW, Hannah WJ. Do practice guidelines guide practice? The effect of a consensus statement on the practice of physicians. N Engl J Med 1989;321:1306-11.

24. Selby JV, Friedman GD. Sigmoidoscopy in the periodic health examination. JAMA 1989;261 :595- 602. 25. Harris SS, Caspersen CJ, DeFriese GH, et al. Physical activity counseling for healthy adults as a primary preventive intervention in the clinical setting: report for the U.S. Preventive Services Task Force. JAMA :i.?89;261 :3590-8. 26. Greene JC, Louis R, Wycoff SJ. Preventive dentistry. I. Dental caries. JAMA 1989;262:3459-63. 27. Greene JC, Louis R, Wycoff SJ. Preventive dentistry. IL Periodontal diseases, malocclusion, trauma, and oral cancer. JAMA 1990;263:4215. 28 . Woolhandler S, Pels RJ, Bor DH, Himmelstein DU, Lawrence RS. Dipstick urinalysis screening of asymptomatic adults for urinary tract disorders. I. Hematuria and proteinuria. JAMA 1989;262:1214-19. 29. Pels BJ, Bor DH, Woolhandler S, Himmelstein DU, Lawrence RS. Dipstick urinalysis screening of asymptomatic adults for urinary tract disorders. II. Bacteriuria. JAMA 1989;262:1221-4. 30. Goldbloo m RB, Lawrence RS, eds. Preventing disease: beyond the rhetoric. New York: Springer-Verlag, 1990.

330 American journal of Preventive Medicine, volume 7, number 5

39. Battista RN, Lawrence RS, eds. Implementing preventive services. New York: Oxford University Press, 1988. 40. Kamerow DB. Prevention : how to practice what we preach. J Fam Pract 1991 ;32:461-2. 41. Agency for Health Care Policy and Research. Clinical guideline development. AH CPR program note. Rockville, Maryland: Agency for Health Care Policy and Research, 1990. 42. Woolf SH. Practice guidelines: a new reality in medicine. I. Recent developments. Arch Intern Med 1990;150:1811-8 . 43. American College of Physicians. Common Screening Tests. Philadelphia: American College of Physicians, 1991. 44. Hayward RS, Steinberg EP, Ford DE, Roizen MF, Roach KW. Preventive care guidelines: 1991. Ann Intern Med 1991;114:758-83. 45 . Field MJ, Lohr KN, eds. Institute of Medicine, Committee to Advise the Public Health Service on Clinical Practice Guidelines. Clinical practice guidelines: directions for a new program. Washington, DC: National Academy Press, 1990.