Do we need a core outcome set for childbirth perineal trauma research? A systematic review of outcome reporting in randomised trials evaluating the management of childbirth trauma

Pergialiotis, Vasilios; Durnea, Constantin M.; Elfituri, Abdullatif; Duffy, James M N; Doumouchtsis, Stergios K.; Urogynaecology, Standards in

doi:10.1111/1471-0528.15408

Cited by 35 publications

(38 citation statements)

References 76 publications

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“…To our knowledge, this is the first systematic review evaluating the quality of randomized controlled trials and analyzing these outcomes and outcome measures. We followed a rigorous search strategy and the assessment of the studies was as standardized as possible following the methodology of previous publications in this field …”

Section: Discussionmentioning

confidence: 99%

“…A protocol including explicitly defined objectives, study selection criteria, and data extraction methods was developed. The protocol was informed by other evaluations in pre‐eclampsia, endometriosis, obstetrics, and urogynecology . Ethical approval for this study was not required.…”

Section: Methodsmentioning

confidence: 99%

“…CHORUS is an International Collaboration for Harmonizing Outcomes, Research and Standards in Urogynaecology and Women's Health (http://i-chorus.org), aiming to address such issues in all areas of urogynaecology, female pelvic medicine, and reconstructive surgery. We have recently published relevant papers on childbirth trauma and anterior prolapse surgery …”

Section: Introductionmentioning

confidence: 99%

“…We have recently published relevant papers on childbirth trauma and anterior prolapse surgery. 3,4 Therefore, the aim of the present study was to assess the consistency in outcome and outcome measure reporting among randomized trials evaluating surgical interventions using synthetic mesh for pelvic organ prolapse.…”

Section: Introductionmentioning

confidence: 99%

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A systematic review on reporting outcomes and outcome measures in trials on synthetic mesh procedures for pelvic organ prolapse: Urgent action is needed to improve quality of research

Lourenço¹,

Pergialiotis

Duffy

et al. 2018

Neurourology and Urodynamics

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The use of synthetic mesh in pelvic organ prolapse surgery is being closely scrutinized because of serious concerns regarding life‐changing complications such as erosion, pain, infection, bleeding, dyspareunia, organ perforation, and urinary problems. Randomized trials and their syntheses in meta‐analysis offer a unique opportunity to assess efficacy and safety. However, outcomes and outcome measures need to be consistently selected, collected, and reported across randomized trials to be effectively combined in systematic reviews. Aims We evaluated outcome and outcome measure reporting across randomized controlled trials on surgical interventions using synthetic mesh for pelvic organ prolapse. Methods Systematic review of randomized controlled trials using synthetic mesh for the treatment of pelvic organ prolapse. The selected studies were evaluated using Jadad and MOMENT criteria. Outcomes and outcome measures were systematically identified and categorized. Results Seventy‐one randomized trials were included. Twenty‐four different types of mesh were identified. Included trials reported 110 different outcomes and 60 outcome measures. Erosion (40 trials, 78%), pain (29 trials, 56%), bleeding (31 trials, 61%), and dyspareunia (25 trials, 49%) were the most frequently reported outcomes. The longest follow up was 74 months. Conclusions Most randomized trials evaluating surgical interventions using synthetic mesh for pelvic organ prolapse failed to report on clinically important outcomes and to evaluate efficacy and safety over the medium‐ and long‐term. Developing and implementing a minimum data set, known as a core outcome set, in future vaginal prolapse trials could help address these issues.

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Section: Discussionmentioning

confidence: 99%

Section: Methodsmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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A systematic review on reporting outcomes and outcome measures in trials on synthetic mesh procedures for pelvic organ prolapse: Urgent action is needed to improve quality of research

Lourenço¹,

Pergialiotis

Duffy

et al. 2018

Neurourology and Urodynamics

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“…The recent investigation of variation in outcome reporting across studies evaluating treatments for twin‐to‐twin transfusion syndrome (TTTS) highlighted the high variability in the outcomes reported and their definition. Similar heterogeneity in outcome reporting has been identified in studies of other conditions related to women's and newborns' health, including pre‐eclampsia, childbirth trauma and endometriosis. There is a need for a focused effort to improve the quality of research studies on multiple pregnancy complications and their treatment.…”

Section: Characteristics Of 39 Studies Evaluating Interventions For Smentioning

confidence: 99%

Variation in outcome reporting across studies evaluating interventions for selective fetal growth restriction

Sileo

Duffy

Townsend

et al. 2019

Ultrasound in Obstet & Gyne

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The recent investigation of variation in outcome reporting in studies of twin-to-twin transfusion syndrome has highlighted the problem of variable and inconsistently defined outcome reporting in studies of twin-to-twin transfusion syndrome (TTTS).(1) Similar heterogeneity in outcome reporting has been identified across women's and newborn health including pre-eclampsia, childbirth trauma and endometriosis.(2-8) This article is protected by copyright. All rights reserved.

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A systematic review of reported outcomes and outcome measures in randomized trials evaluating surgical interventions for posterior vaginal prolapse to aid development of a core outcome set

Lourenço

Pergialiotis

Durnea

et al. 2020

Intl J Gynecology & Obste

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Background: Recent systematic reviews have demonstrated wide variations on outcome measure selection and outcome reporting in trials on surgical treatments for anterior, apical and mesh prolapse surgery. A systematic review of reported outcomes and outcome measures in posterior compartment vaginal prolapse interventions is highly warranted in the process of developing core outcome sets. Objective: To evaluate outcome and outcome measures reporting in posterior prolapse surgical trials. Search strategy: We searched MEDLINE, EMBASE and the Cochrane Central Register of Controlled Trials (CENTRAL). Selection criteria: Randomized trials evaluating the efficacy and safety of different surgical interventions for posterior compartment vaginal prolapse.Data collection and analysis: Two researchers independently assessed studies for inclusion, evaluated methodological quality, and extracted relevant data. Methodological quality, outcome reporting quality and publication characteristics were evaluated.

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Do we need a core outcome set for childbirth perineal trauma research? A systematic review of outcome reporting in randomised trials evaluating the management of childbirth trauma

Abstract: Developing @coreoutcomes for childbirth trauma research could help to reduce #research waste.

Cited by 35 publications

References 76 publications

A systematic review on reporting outcomes and outcome measures in trials on synthetic mesh procedures for pelvic organ prolapse: Urgent action is needed to improve quality of research

A systematic review on reporting outcomes and outcome measures in trials on synthetic mesh procedures for pelvic organ prolapse: Urgent action is needed to improve quality of research

Variation in outcome reporting across studies evaluating interventions for selective fetal growth restriction

A systematic review of reported outcomes and outcome measures in randomized trials evaluating surgical interventions for posterior vaginal prolapse to aid development of a core outcome set

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