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.
N1 - Funding Information:
This study was funded by the Agency for Health Care Policy & Research (AHCPR). We would like to thank the following people who were actively involved in the PEACH Study. Data Coordinating Center, Pittsburgh, PA: Linda S. Kalka, Mark Kamlet, PhD, Becky Meehan, RD, Sara Scholle, MD, Richard Schulz, PhD; Emory University, Atlanta, GA: Marsha Scott, CRNP, Pat Nichols, Lisa Williams; Magee-Women’s Hospital, Pittsburgh, PA: Rajnikant Amin, MD, Antonio Amortegui, MD, Sharon L. Hillier, MD, Susie Kostilnik, Ingrid Macio, PA-C, Tara Pealer, Anne Rideout, CRNP, Harold C. Wiesenfeld, MD. Medical University of South Carolina, Charlestown, SC: Faye LeBoeuf, MSN, CNM, Erna Lundgren; University of Alabama School of Medicine, Birmingham, AL: Kim Miller, RN, Amanda Murphy, RN, Allison Northern, BSN, Diane Strong; University of Pennsylvania, Philadelphia, PA: Connie Mulhern, RN, Margarite Patzer, CRNP, Poxie Jackson-Reid, Kelly Timbers, CRNP, Suzanne Shepard, MD; UT Southwestern Medical Center, Dallas, TX: Audrey Baum, Ellie Corley, Molly Heard, Brenda Nobles, CNM, George Windel, MD; Wayne State University, Detriot, MI: Sara Barrett, RN, S. Gene McNeeley, MD, Joy Mowery, RN; Women & Infants Hospital, Providence, RI: Lori Boardman, MD, Amy Cooper, CRNP, Rebecca Johnson, Ann Meers, RN, Andrea Montagno, RN; Data Safety and Monitoring Board: Kathryn Chaloner, PhD, Bert Peterson, MD, Peter Rice, MD; AHCPR: Heddy Hubbard, RN, MPH.
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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UR - http://www.scopus.com/inward/citedby.url?scp=0032189964&partnerID=8YFLogxK
U2 - 10.1016/S0197-2456(98)00022-1
DO - 10.1016/S0197-2456(98)00022-1
M3 - Article
C2 - 9741869
AN - SCOPUS:0032189964
SN - 0197-2456
VL - 19
SP - 499
EP - 514
JO - Controlled Clinical Trials
JF - Controlled Clinical Trials
IS - 5
ER -