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.