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Clinton Administration Supports Major Study of
Outpatient Treatment for Pelvic Inflammatory Disease
Press Release Date: December 19, 1995
The Agency for Health Care Policy and Research today announced
the award of a $6 million
grant to study the effectiveness of outpatient treatment for
pelvic inflammatory disease (PID), an
infection of the pelvic tract caused by sexually transmitted
pathogens. The five-year study, to be
conducted by researchers at the University of Pittsburgh, will
involve the first clinical trial to
compare directly the effectiveness and cost-effectiveness of
outpatient and inpatient therapies
recommended for treating PID.
AHCPR administrator Clifton R. Gaus, Sc.D., said, "Pelvic
inflammatory disease affects over one
million American women every year. It frequently results in
infertility, ectopic pregnancy, and
chronic pelvic pain. The costs associated with PID and its
consequences have been estimated at
over $4 billion per year. Information to be gained from this
study is crucial for the success of
efforts to prevent the costly, and often clinically devastating
consequences of PID."
Lynn Yeakel, mid-Atlantic director for the Department of Health
and Human Services, said the
Clinton administration is especially anxious to bolster research
in the area of women's health.
"Historically, women have been underrepresented in health
research, and diseases like PID, which
affects so many American women, have been largely ignored in
clinical trials," she said.
Treatment for more than three quarters of women diagnosed with
PID currently consists of
antibiotics to be taken on an outpatient basis. However, the
effectiveness of outpatient treatment
in comparison to antibiotic treatment administered parenterally
(by injection) to patients who
remain hospitalized, has not been tested. Outpatient treatment
is initially less costly than inpatient
treatment, but there has been no systematic assessment of the
long-term costs of PID relative to
the effectiveness of each treatment.
Roberta B. Ness, M.D., assistant professor at the University of
Pittsburgh's department of
epidemiology and principal investigator said, "Clinicians
currently often work under the untested
assumption that intensive inpatient therapy for PID, while more
expensive, may be more effective
in treating the disease. This study, by focusing on both
clinical outcomes and quantification of
costs associated with each treatment, will allow us to develop
rational treatment guidelines."
Dr. Ness said 1,200 women at five medical centers who are
suspected of having PID will be
randomly assigned to parenteral or oral antibiotic therapy
provided in either inpatient or
outpatient settings. The primary comparison of interest between
the two treatment groups will be
the time it takes for women to attain fertility and the rates of
involuntary infertility. Women
assigned to the two treatment groups will also be compared from
the standpoint of disease-related
direct and indirect costs, taking into account the benefits and
burdens of each of the outcomes.
For additional information, contact AHCPR Public Affairs: Karen Migdail, (301) 427-1855.