A systematic review of outcome and outcome-measure reporting in randomised trials evaluating surgical interventions for anterior-compartment vaginal prolapse: a call to action to develop a core outcome set

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Abstract

Introduction

We assessed outcome and outcome-measure reporting in randomised controlled trials evaluating surgical interventions for anterior-compartment vaginal prolapse and explored the relationships between outcome reporting quality with journal impact factor, year of publication, and methodological quality.

Methods

We searched the bibliographical databases from inception to October 2017. Two researchers independently selected studies and assessed study characteristics, methodological quality (Jadad criteria; range 1–5), and outcome reporting quality Management of Otitis Media with Effusion in Cleft Palate (MOMENT) criteria; range 1–6], and extracted relevant data. We used a multivariate linear regression to assess associations between outcome reporting quality and other variables.

Results

Eighty publications reporting data from 10,924 participants were included. Seventeen different surgical interventions were evaluated. One hundred different outcomes and 112 outcome measures were reported. Outcomes were inconsistently reported across trials; for example, 43 trials reported anatomical treatment success rates (12 outcome measures), 25 trials reported quality of life (15 outcome measures) and eight trials reported postoperative pain (seven outcome measures). Multivariate linear regression demonstrated a relationship between outcome reporting quality with methodological quality (β = 0.412; P = 0.018). No relationship was demonstrated between outcome reporting quality with impact factor (β = 0.078; P = 0.306), year of publication (β = 0.149; P = 0.295), study size (β = 0.008; P = 0.961) and commercial funding (β = −0.013; P = 0.918).

Conclusions

Anterior-compartment vaginal prolapse trials report many different outcomes and outcome measures and often neglect to report important safety outcomes. Developing, disseminating and implementing a core outcome set will help address these issues.

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Most cited references 96

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The prevalence of pelvic floor disorders and their relationship to gender, age, parity and mode of delivery.

Paul A. MacLennan, Stuart Taylor, Machelle D. Wilson (2000)

To define the prevalence of pelvic floor disorders in a non-institutionalised community and to determine the relationship to gender, age, parity and mode of delivery. A representative population survey using the 1998 South Australian Health Omnibus Survey. Random selection of 4400 households; 3010 interviews were conducted in the respondents' homes by trained female interviewers. This cross sectional survey included men and women aged 15-97 years. The prevalence of all types of self-reported urinary incontinence in men was 4.4% and in women was 35.3% (P 20 weeks), regardless of the mode of delivery, greatly increased the prevalence of major pelvic floor dysfunction, defined as any type of incontinence, symptoms of prolapse or previous pelvic floor surgery. Multivariate logistic regression showed that, compared with nulliparity, pelvic floor dysfunction was significantly associated with caesarean section (OR 2.5, 95% CI 1.5-4.3), spontaneous vaginal delivery (OR 3.4, 95% CI 2.4-4.9) and at least one instrumental delivery (OR 4.3, 95% CI 2.8-6.6). The difference between caesarean and instrumental delivery was significant (P<0.03) but was not for caesarean and spontaneous delivery. Other associations with pelvic floor morbidity were age, body mass index, coughing, osteoporosis, arthritis and reduced quality of life scores. Symptoms of haemorrhoids also increased with age and parity and were reported in 19.9% of men and 30.2% of women. Pelvic floor disorders are very common and are strongly associated with female gender, ageing, pregnancy, parity and instrumental delivery. Caesarean delivery is not associated with a significant reduction in long term pelvic floor morbidity compared with spontaneous vaginal delivery.

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MOMENT – Management of Otitis Media with Effusion in Cleft Palate: protocol for a systematic review of the literature and identification of a core outcome set using a Delphi survey

Nicola L Harman, Iain Bruce, Peter Callery … (2013)

Background Cleft palate (CP) has an incidence of approximately 1 in 700. Children with CP are also susceptible to otitis media with effusion (OME), with approximately 90% experiencing nontrivial OME. There are several approaches to the management of OME in children with CP. The Management of Otitis Media with Effusion in Children with Cleft Palate (MOMENT) study is a feasibility study that includes the development of a core outcome set for use in future trials of the management of OME in children with CP. Methods/Design The MOMENT study will include a systematic review of the literature to identify a list of outcomes that have previously been reported. This list of outcomes will be used in a Delphi study with cleft clinicians. The Delphi study is anticipated to include three rounds. The first round will ask clinicians to score the outcome list and to add any outcomes they think are relevant. The second round involves presentation of scores according to stakeholder group and the opportunity for participants to rescore outcomes. To ensure that the opinion of parents and children are sought, qualitative interviews will be completed with a purposive sample in parallel. In the final round of the Delphi process, participants will be shown the distribution of scores, for each outcome, for all stakeholder groups separately as well as a summary of the results concerning outcomes from the qualitative interviews with parents. A final consensus meeting will be held with all stakeholders, including parents and children, to review outcomes. Discussion A core outcome set represents the minimum that should be measured in a clinical trial for a particular condition. The MOMENT study will aim to identify a core outcome set that can be used in future trials of the management of OME, improving the consistency of research in this clinical area.

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Anterior colporrhaphy versus transvaginal mesh for pelvic-organ prolapse.

Susanne M. Axelsen, M Ellstrøm-Engh, Tapio Väyrynen … (2011)

The use of standardized mesh kits for repair of pelvic-organ prolapse has spread rapidly in recent years, but it is unclear whether this approach results in better outcomes than traditional colporrhaphy. In this multicenter, parallel-group, randomized, controlled trial, we compared the use of a trocar-guided, transvaginal polypropylene-mesh repair kit with traditional colporrhaphy in women with prolapse of the anterior vaginal wall (cystocele). The primary outcome was a composite of the objective anatomical designation of stage 0 (no prolapse) or 1 (position of the anterior vaginal wall more than 1 cm above the hymen), according to the Pelvic Organ Prolapse Quantification system, and the subjective absence of symptoms of vaginal bulging 12 months after the surgery. Of 389 women who were randomly assigned to a study treatment, 200 underwent prolapse repair with the transvaginal mesh kit and 189 underwent traditional colporrhaphy. At 1 year, the primary outcome was significantly more common in the women treated with transvaginal mesh repair (60.8%) than in those who underwent colporrhaphy (34.5%) (absolute difference, 26.3 percentage points; 95% confidence interval, 15.6 to 37.0). The surgery lasted longer and the rates of intraoperative hemorrhage were higher in the mesh-repair group than in the colporrhaphy group (P<0.001 for both comparisons). Rates of bladder perforation were 3.5% in the mesh-repair group and 0.5% in the colporrhaphy group (P=0.07), and the respective rates of new stress urinary incontinence after surgery were 12.3% and 6.3% (P=0.05). Surgical reintervention to correct mesh exposure during follow-up occurred in 3.2% of 186 patients in the mesh-repair group. As compared with anterior colporrhaphy, use of a standardized, trocar-guided mesh kit for cystocele repair resulted in higher short-term rates of successful treatment but also in higher rates of surgical complications and postoperative adverse events. (Funded by the Karolinska Institutet and Ethicon; ClinicalTrials.gov number, NCT00566917.).

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Author and article information

Contributors

Constantin M. Durnea: +44 1372 735 735 , costea.durnea@gmail.com

Stergios K. Doumouchtsis: sdoum@yahoo.com

Journal

Journal ID (nlm-ta): Int Urogynecol J

Journal ID (iso-abbrev): Int Urogynecol J

Title: International Urogynecology Journal

Publisher: Springer London (London )

ISSN (Print): 0937-3462

ISSN (Electronic): 1433-3023

Publication date (Electronic): 22 October 2018

Publication date PMC-release: 22 October 2018

Publication date (Print): 2018

Volume: 29

Issue: 12

Pages: 1727-1745

Affiliations

[1 ]GRID grid.419496.7, Department of Obstetrics and Gynaecology, , Epsom and St Helier University Hospitals NHS Trust, ; Rowan House, Dorking Road, Epsom, London, KT18 7EG UK

[2 ]ISNI 0000 0004 0581 2008, GRID grid.451052.7, Nortwick Park Hospital, , London North West University Healthcare NHS Trust, ; London, UK

[3 ]ISNI 0000 0001 2155 0800, GRID grid.5216.0, Laboratory of Experimental Surgery and Surgical Research N.S. Christeas, , Athens University Medical School, ; Athens, Greece

[4 ]ISNI 0000 0004 1936 8948, GRID grid.4991.5, Nuffield Department of Primary Care Health Sciences, , University of Oxford, ; Oxford, UK

[5 ]ISNI 0000 0004 1936 8948, GRID grid.4991.5, Balliol College, , University of Oxford, ; Oxford, UK

[6 ]ISNI 0000 0000 8546 682X, GRID grid.264200.2, St George’s University of London, ; London, UK

Article

Publisher ID: 3781

DOI: 10.1007/s00192-018-3781-5

PMC ID: 6244754

PubMed ID: 30350116

SO-VID: 9b60224b-5190-48b0-ab44-df3dd7e644d9

License:

Open Access This article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made.

History

Date received : 7 May 2018

Date accepted : 12 July 2018

Funding

Funded by: St. George's University of London

Custom metadata

ScienceOpen disciplines: Obstetrics & Gynecology

Keywords: anterior repair,colporrhaphy,core outcome sets,cystocele,outcomes,outcome measures

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ScienceOpen disciplines: Obstetrics & Gynecology

Keywords: anterior repair, colporrhaphy, core outcome sets, cystocele, outcomes, outcome measures

A systematic review of outcome and outcome-measure reporting in randomised trials evaluating surgical interventions for anterior-compartment vaginal prolapse: a call to action to develop a core outcome set

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Most cited references 96

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MOMENT – Management of Otitis Media with Effusion in Cleft Palate: protocol for a systematic review of the literature and identification of a core outcome set using a Delphi survey

Anterior colporrhaphy versus transvaginal mesh for pelvic-organ prolapse.

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