Research design characteristics of published pharmacologic randomized clinical trials for irritable bowel syndrome and chronic pelvic pain conditions: an ACTTION systemic review

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...

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Main Authors: Gewandter, J, Chaudari, J, Iwan, K, Kitt, R, As-Sanie, S, Bachmann, G, Clemens, Q, Lai, H, Tu, F, Verne, N, Vincent, K, Wesselmann, U, Zhou, Q, Turk, D, Dworkin, R, Smith, S
Format: Journal article
Published: Elsevier 2018
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author Gewandter, J
Chaudari, J
Iwan, K
Kitt, R
As-Sanie, S
Bachmann, G
Clemens, Q
Lai, H
Tu, F
Verne, N
Vincent, K
Wesselmann, U
Zhou, Q
Turk, D
Dworkin, R
Smith, S
author_facet Gewandter, J
Chaudari, J
Iwan, K
Kitt, R
As-Sanie, S
Bachmann, G
Clemens, Q
Lai, H
Tu, F
Verne, N
Vincent, K
Wesselmann, U
Zhou, Q
Turk, D
Dworkin, R
Smith, S
author_sort Gewandter, J
collection OXFORD
description 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 endpoints 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 endpoints were identified for only (57%) of trials. These endpoints, 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.
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spelling oxford-uuid:22219535-1b28-4d13-8dc6-6c26696748672022-03-26T11:37:02ZResearch design characteristics of published pharmacologic randomized clinical trials for irritable bowel syndrome and chronic pelvic pain conditions: an ACTTION systemic reviewJournal articlehttp://purl.org/coar/resource_type/c_dcae04bcuuid:22219535-1b28-4d13-8dc6-6c2669674867Symplectic Elements at OxfordElsevier2018Gewandter, JChaudari, JIwan, KKitt, RAs-Sanie, SBachmann, GClemens, QLai, HTu, FVerne, NVincent, KWesselmann, UZhou, QTurk, DDworkin, RSmith, SChronic 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 endpoints 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 endpoints were identified for only (57%) of trials. These endpoints, 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.
spellingShingle Gewandter, J
Chaudari, J
Iwan, K
Kitt, R
As-Sanie, S
Bachmann, G
Clemens, Q
Lai, H
Tu, F
Verne, N
Vincent, K
Wesselmann, U
Zhou, Q
Turk, D
Dworkin, R
Smith, S
Research design characteristics of published pharmacologic randomized clinical trials for irritable bowel syndrome and chronic pelvic pain conditions: an ACTTION systemic review
title Research design characteristics of published pharmacologic randomized clinical trials for irritable bowel syndrome and chronic pelvic pain conditions: an ACTTION systemic review
title_full Research design characteristics of published pharmacologic randomized clinical trials for irritable bowel syndrome and chronic pelvic pain conditions: an ACTTION systemic review
title_fullStr Research design characteristics of published pharmacologic randomized clinical trials for irritable bowel syndrome and chronic pelvic pain conditions: an ACTTION systemic review
title_full_unstemmed Research design characteristics of published pharmacologic randomized clinical trials for irritable bowel syndrome and chronic pelvic pain conditions: an ACTTION systemic review
title_short Research design characteristics of published pharmacologic randomized clinical trials for irritable bowel syndrome and chronic pelvic pain conditions: an ACTTION systemic review
title_sort research design characteristics of published pharmacologic randomized clinical trials for irritable bowel syndrome and chronic pelvic pain conditions an acttion systemic review
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