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Ultrasound Screening: Implications of the Radius Study 

NIH Technology Assessment Workshop,
Rockville, MD
December 3, 1993

This statement is more than five years old and is provided solely for historical purposes. Due to the cumulative nature of medical research, new knowledge has inevitably accumulated in this subject area in the time since the statement was initially prepared. Thus some of the material is likely to be out of date, and at worst simply wrong. For reliable, current information on this and other health topics, we recommend consulting the National Institutes of Health's MedlinePlus http://www.nlm.nih.gov/medlineplus/.

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. 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.


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, Bldg 31, Room 1B03, Bethesda, MD 20892.

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