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Research Design Characteristics of Published Pharmacologic Randomized Clinical Trials for Irritable Bowel Syndrome and Chronic Pelvic Pain Conditions: An ACTTION Systematic Review
Journal article   Peer reviewed

Research Design Characteristics of Published Pharmacologic Randomized Clinical Trials for Irritable Bowel Syndrome and Chronic Pelvic Pain Conditions: An ACTTION Systematic Review

Jennifer S. Gewandter, Jenna Chaudari, Katarzyna B. Iwan, Rachel Kitt, Sawsan As-Sanie, Gloria Bachmann, Quentin Clemens, H. Henry Lai, Frank Tu, G. Nicholas Verne, …
The journal of pain, Vol.19(7), pp.717-726
07/2018
DOI: 10.1016/j.jpain.2018.01.007
PMID: 29412183
url
https://doi.org/10.1016/j.jpain.2018.01.007View
Published (Version of record) Open Access

Abstract

•Clinical trial design for abdominal and pelvic pain conditions is challenging.•A review of randomized clinical trial entry criteria and end points is provided.•Encouraged future research areas to inform trial design are discussed. Chronic pain conditions occurring in the lower abdomen and pelvis are common, often challenging to manage, and can negatively affect health-related quality of life. Methodological challenges in designing randomized clinical trials (RCTs) for these conditions likely contributes to the limited number of available treatments. The goal of this systematic review of RCTs of pharmacologic treatments for irritable bowel syndrome and 3 common chronic pelvic pain conditions are to: 1) summarize the primary end points and entry criteria, and 2) evaluate the clarity of reporting of important methodological details. In total, 127 RCTs were included in the analysis. The most common inclusion criteria were a minimum pain duration (81%), fulfilling an established diagnostic criteria (61%), and reporting a minimum pain intensity (42%). Primary end points were identified for only 57% of trials. These end points, summarized in this article, were highly variable. The results of this systematic review can be used to inform future research to optimize the entry criteria and outcome measures for pain conditions occurring in the lower abdomen and pelvis, to increase transparency in reporting to allow for proper interpretation of RCT results for clinical and policy applications, and to facilitate the aggregation of data in meta-analyses. This article summarizes entry criteria and outcome measures and the clarity of reporting of these important design features in RCTs of irritable bowel syndrome and 3 common chronic pelvic pain conditions. These results can be used to improve design of future trials of these largely unaddressed pain conditions.
 bladder pain syndrome chronic pelvic pain syndrome chronic prostatitis Interstitial cystitis randomized clinical trial reporting vulvodynia

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