The National Institute of Child Health and Human Development (NICHD), National Institutes of Health (NIH), and NIH's Office of Medical Applications of Research (OMAR) sponsored a workshop on Ultrasound Screening: Implications of the RADIUS Study, on December 3, 1993. A Technology Assessment Statement concerning the outcome of this workshop may be available in early 1995.

Draft Report

RADIUS--The Routine Antenatal Diagnostic Imaging Ultrasound Study--was a large randomized clinical trial to assess the effectiveness of routine ultrasound screening for women who are at low risk for poor pregnancy outcomes. The principal investigators designed the study in response to a recommendation by the 1984 NIH Consensus Development Conference on Diagnostic Ultrasound Imaging in Pregnancy for studies "to establish the clinical efficacy of ultrasound . . . [and] its contribution to reducing morbidity and mortality." The preliminary results of RADIUS have been reported in the American Journal of Obstetrics and Gynecology and in the New England Journal of Medicine in September 1993 (see below).

The NICHD, which sponsored RADIUS, and OMAR agreed to arrange a 1-day forum to address two important questions: (1) How will patients and obstetric care providers be likely to use the RADIUS results? and (2) What "economic scenarios" might be anticipated as a result of different policy interpretations of the RADIUS results? Accordingly, NICHD and OMAR held an interpretive workshop that brought together RADIUS investigators, research design methodologists, and representatives of health care providers and consumers, as well as experts on medical liability, biomedical ethics, and health care economics. The speakers and topics are listed below.

Workshop participants speculated on how the RADIUS results might affect public health and reimbursement policies on routine obstetric ultrasound screening. The development of a policy position was not an objective of the workshop. Rather, the participants sought to provide insight on routine ultrasound screening to decision- and policymakers from a wide variety of disciplines and organizations. For further information about the RADIUS results, refer to the articles cited below:

• Ewigman, B., Crane, J.P., Frigoletto, F.D., et al.
• Impact of prenatal ultrasound screening on perinatal outcome. N Engl J Med 1993 Sept 16;329:821-7.

• LeFevre, M., Bain, R., Ewigman, B., et al.
• A randomized trial of prenatal ultrasound screening: Impact on maternal management and outcome. Am J Obstet Gynecol 1993 Sept 15;169:483-9.

• Crane, J.P., LeFevre, M., Winborn, R., et al.
• A randomized trial of prenatal ultrasound screening: Impact on the detection, management and outcome of anomalous fetuses. Am J Obstet Gynecol 1994 August (in press).

Speakers

• Raymond P. Bain, Ph.D.
• RADIUS Investigator
• "Statistical Plan"
• Research Professor
• Statistics/Computer Information Systems, The Biostatistics Center
• George Washington University
• Rockville, Maryland

• Kathleen Belanger, Ph.D.
• "Critique of Design and Results"
• Associate Research Scientist
• Perinatal Epidemiology Unit Yale University School of Medicine
• New Haven, Connecticut

• Richard L. Berkowitz, M.D.
• "Providers' Perspective"
• Professor and Chairman
• Department of Obstetrics, Gynecology, and Reproductive Science
• Mount Sinai Medical Center
• New York, New York

• Sarah Brown, M.P.H.
• "Closing Remarks"
• Senior Study Director
• Health Promotion and Disease Prevention Institute of Medicine
• Washington, DC

• Charlotte Catz, M.D.
• "Opening Remarks"
• Chief,
• Pregnancy and Perinatology Branch
• National Institute of Child Health and Human Development
• National Institutes of Health
• Bethesda, Maryland

• James P. Crane, M.D.
• RADIUS Investigator
• "Ultrasound" "Detection of Anomalies"
• Professor
• Department of Obstetrics/Gynecology and Radiology
• Washington University School of Medicine
• St. Louis, Missouri

• Bernard Ewigman, M.D., M.S.P.H.
• RADIUS Investigator
• "Design"
• Associate Professor
• Family and Community Medicine
• University of Missouri School of Medicine
• Columbia, Missouri

• John Ferguson, M.D.
• "Opening Remarks"
• Director
• Office of Medical Applications of Research
• National Institutes of Health
• Bethesda, Maryland

• Frederic D. Frigoletto, M.D.
• RADIUS Investigator
• "Perinatal Outcome"
• Chief of Obstetrics
• Department of Obstetrics/Gynecology Massachusetts General Hospital
• Boston, Massachusetts

• Thomas J. Garite, M.D.
• "Critique of Design and Results"
• Professor and Chairman
• Department of Obstetrics/Gynecology University of California - Irvine
• Orange, California

• Gail Geller, Sc.D.
• "Ethical Issues"
• Assistant Professor
• Department of Pediatrics Johns Hopkins Medical Institutions
• Baltimore, Maryland

• Edgar O. Horger III, M.D.
• "Medical-Legal Issues"
• Professor and Chairman
• Department of Obstetrics and Gynecology
• University of South Carolina, School of Medicine
• Columbia, South Carolina

• Michael L. LeFevre, M.D.
• RADIUS Investigator
• "Maternal Management and Outcome"
• Associate Professor
• Family and Community Medicine
• University of Missouri School of Medicine
• Columbia, Missouri

• Donald McNellis, M.D.
• RADIUS Program Officer
• "Overview/Background" "Closing Remarks"
• Special Assistant for Obstetrics
• Pregnancy and Perinatology Branch Center for Research for Mothers and Children
• National Institute of Child Health and Human Development
• National Institutes of Health
• Bethesda, Maryland

• Sheryl Ruzek, Ph.D., M.P.H.
• "Consumers' Perspective"
• Professor
• Department of Health Education Temple University
• Philadelphia, Pennsylvania

• Kit N. Simpson, Dr.P.H.
• "Economic Issues"
• Assistant Professor
• Department of Health Policy and Administration
• University of North Carolina School of Public Health
• Chapel Hill, North Carolina

• Stephen B. Thacker, M.D., M.Sc.
• "Summary of Methodology and Results"
• Acting Director
• National Center for Environmental Health Centers for Disease Control and Prevention
• Atlanta, Georgia

About the NIH Technology Assessment Program

NIH Technology Assessment Conferences and Workshops are convened to evaluate available scientific information related to a biomedical technology. The resultant NIH Technology Assessment Statements and published reports are intended to advance understanding of the technology or issue in question and to be useful to health professionals and the public.

Some Technology Assessment Conferences and Workshops adhere to the NIH Consensus Development Conference (CDC) format because the process is altogether appropriate for evaluating highly controversial, publicized, or politicized issues. In the CDC format, NIH Technology Assessment Statements are prepared by a nonadvocate, non-Federal panel of experts, based on (1) presentations by investigators working in areas relevant to the consensus questions during a 1-1/2-day public session, (2) questions and statements from conference attendees during open discussion periods that are part of the public session, and (3) closed deliberations by the panel during the remainder of the second day and morning of the third. Each statement is an independent report of the panel and is not a policy statement of the NIH or the Federal Government. Other Technology Assessment Conferences and Workshops are organized around unique formats. Usually, speakers present findings or perspectives on the issue. Policy implications may be discussed. The public is invited to address questions to the speakers. A report of the findings can emerge in one of a variety of formats including publication in a clinical or scientific journal.

Preparation and distribution of these reports are the responsibility of the Office of Medical Applications of Research, National Institutes of Health, Federal Building, Room 618, Bethesda, MD 20892.

For making bibliographic reference to this workshop draft report in the electronic form displayed here, it is recommended that the following format be used: Ultrasound Screening: Implications of the RADIUS Study [draft summary]. NIH Technol Assess Statement Online 1993 Dec 3 [cited year month day];12:1-5.