TY - JOUR
T1 - Design of the PID Evaluation and Clinical Health (PEACH) Study
AU - Ness, Roberta B.
AU - Soper, David E.
AU - Peipert, Jeff
AU - Sondheimer, Steven J.
AU - Holley, Robert L.
AU - Sweet, Richard L
AU - Hemsell, David L.
AU - Randall, Hugh
AU - Hendrix, Susan L.
AU - Bass, Debra C.
AU - Kelsey, Sheryl F.
AU - Songer, Thomas J.
AU - Lave, Judith R.
PY - 1998/10
Y1 - 1998/10
N2 - 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. Copyright (C) 1998 Elsevier Science Inc.
AB - 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. Copyright (C) 1998 Elsevier Science Inc.
KW - Adnexitis
KW - Clinical trials
KW - Infertility
KW - Pelvic inflammatory disease
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U2 - 10.1016/S0197-2456(98)00022-1
DO - 10.1016/S0197-2456(98)00022-1
M3 - Article
C2 - 9741869
AN - SCOPUS:0032189964
VL - 19
SP - 499
EP - 514
JO - Controlled Clinical Trials
JF - Controlled Clinical Trials
SN - 0197-2456
IS - 5
ER -