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A protocol for developing, disseminating, and implementing a core outcome set (COS) for childbirth pelvic floor trauma research.

Doumouchtsis, SK; Rada, MP; Pergialiotis, V; Falconi, G; Haddad, JM; Betschart, C (2020) A protocol for developing, disseminating, and implementing a core outcome set (COS) for childbirth pelvic floor trauma research. BMC Pregnancy Childbirth, 20 (1). p. 376. ISSN 1471-2393 https://doi.org/10.1186/s12884-020-03070-z
SGUL Authors: Doumouchtsis, Stergios

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Abstract

BACKGROUND: More than 85% of women sustain different degrees of trauma during vaginal birth. Randomized controlled trials on childbirth pelvic floor trauma have reported a wide range of outcomes and used different outcome measures. This variation restricts effective data synthesis, impairing the ability of research to inform clinical practice. The development and use of a core outcome set (COS) for childbirth pelvic floor trauma aims to ensure consistent use of outcome measures and reporting of outcomes. METHODS: An international steering group, within CHORUS, an International Collaboration for Harmonising Outcomes, Research and Standards in Urogynaecology and Women's Health, including academic community members, researchers, healthcare professionals, policy makers and women with childbirth pelvic floor trauma will lead the development of this COS. Relevant outcome parameters will be identified through comprehensive literature reviews. The selected outcomes will be entered into an international, multi-perspective online Delphi survey. Subsequently and based on the results of the Delphi surveys consensus will be sought on 'core' outcomes. DISCUSSION: Dissemination and implementation of the resulting COS within an international context will be supported and promoted. Embedding the COS for childbirth pelvic floor trauma within future clinical trials, systematic reviews, and clinical practice guidelines is expected to enrich opportunities for comparison of future clinical trials and allow better synthesis of outcomes, and will enhance mother and child care. The infrastructure created by developing a COS for childbirth pelvic floor trauma could be leveraged in other settings, for example, advancing research priorities and clinical practice guideline development.

Item Type: Article
Additional Information: © The Author(s). 2020 Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated in a credit line to the data.
Keywords: Birth-related injuries, Childbirth pelvic floor trauma, Core outcome measures in effectiveness trials (COMET), Core outcome set (COS), International collaboration for Harmonising outcomes (CHORUS), Levator Ani muscle (LAM), Obstetric anal sphincter injury (OASIS), Recommendations for interventional trials (SPIRIT), Urinary incontinence (UI), Childbirth pelvic floor trauma, Birth-related injuries, Obstetric anal sphincter injury (OASIS), Urinary incontinence (UI), Levator Ani muscle (LAM), International collaboration for Harmonising outcomes (CHORUS), Core outcome measures in effectiveness trials (COMET), Core outcome set (COS), Recommendations for interventional trials (SPIRIT), Obstetrics & Reproductive Medicine, 1114 Paediatrics and Reproductive Medicine, 1117 Public Health and Health Services, 1110 Nursing
SGUL Research Institute / Research Centre: Academic Structure > Institute of Medical & Biomedical Education (IMBE)
Academic Structure > Institute of Medical & Biomedical Education (IMBE) > Centre for Clinical Education (INMECE )
Journal or Publication Title: BMC Pregnancy Childbirth
ISSN: 1471-2393
Language: eng
Dates:
DateEvent
26 June 2020Published
19 June 2020Accepted
Publisher License: Creative Commons: Attribution 4.0
PubMed ID: 32591018
Web of Science ID: WOS:000545747300002
Go to PubMed abstract
URI: https://openaccess.sgul.ac.uk/id/eprint/112348
Publisher's version: https://doi.org/10.1186/s12884-020-03070-z

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