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Design of the PID Evaluation and Clinical Health (PEACH) Study
R B Ness1, D E Soper, J Peipert
1Department of Epidemiology, Graduate School of Public Health, University of Pittsburgh, Pennsylvania 15261, USA.
Insights
The PEACH study compares inpatient and outpatient antibiotic treatments for pelvic inflammatory disease (PID). This large trial evaluates effectiveness and cost-effectiveness to guide optimal PID treatment strategies.
Area of Science:
- Reproductive Health
- Infectious Diseases
- Clinical Trials
Background:
- Pelvic inflammatory disease (PID) is a common infection in women.
- Current treatment strategies include inpatient and outpatient antimicrobial regimens.
- The optimal treatment approach for PID requires further evaluation.
Purpose of the Study:
- To compare the effectiveness and cost-effectiveness of inpatient versus outpatient antimicrobial treatment for PID.
- To assess the impact of PID treatment on long-term health outcomes, including infertility, ectopic pregnancy, and chronic pelvic pain.
- To provide evidence-based guidance for selecting between inpatient and outpatient antibiotic therapy for PID.
Main Methods:
- A multicenter, randomized clinical trial (PEACH study) involving women with PID.
- Comparison of currently recommended antibiotic combinations for PID.
- Collection of data on patient selection, treatment adherence, follow-up, quality of life, and health outcomes.
- Statistical analyses to determine treatment effectiveness and cost-effectiveness.
Main Results:
- The PEACH study is the largest prospective study of PID in North America.
- Enrollment included 312 women in the first 11 months, with 59% consent rate.
- High follow-up rate (95%) achieved after a median of 5.5 months.
Conclusions:
- The PEACH study provides a rationale for choosing between inpatient and outpatient antibiotic treatment for PID.
- Findings will inform clinical decision-making for PID management.
- The study contributes significant data to the understanding of PID treatment outcomes.
Abstract:
This paper describes the PID Evaluation and Clinical Health Study (PEACH), a multicenter, randomized clinical trial designed to compare treatment with outpatient and inpatient antimicrobial regimens among women with pelvic inflammatory disease (PID). PEACH is the first trial to evaluate the effectiveness and cost-effectiveness of currently recommended antibiotic combinations in preventing infertility, ectopic pregnancy, chronic pelvic pain, recurrent PID, and other health outcomes. It is also the largest prospective study of PID ever conducted in North America. We describe the PEACH study's specific aims, study organization, patient selection criteria, conditions for exclusion, data collected upon entry, randomization and treatment, adherence measures, follow-up activities, quality-of-life measures, outcomes, and statistical analyses. In the first 11 months of enrollment (March 1996-January 1997), 312 women were randomized. Of eligible women, 59% consented to enroll. Participating women are primarily black (72%) and young (mean age 24 years). After a median of 5.5 months of follow-up, we were in contact with 95% of study participants. The PEACH study will provide a rationale for selecting between inpatient and outpatient antibiotic treatment, the two most common treatment strategies, for PID.