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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, Thais R M; Pergialiotis, Vasilios; Durnea, Constantin M; Elfituri, Abdullatif; Haddad, Jorge M; Betschart, Cornelia; Falconi, Gabriele; Nygaard, Christiana C; Bergstrom, Lina; Pattel, Mittal; Doumouchtsis, Stergios K (2020). 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. International Journal of Gynaecology and Obstetrics, 148(3):271-281.

Abstract

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.

MAIN RESULTS

Twenty-seven interventional and four follow-up trials were included. Seventeen studies enrolled patients with posterior compartment surgery as the sole procedure and 14 with multicompartment procedures. Eighty-three reported outcomes and 45 outcome measures were identified. The most frequently reported outcomes were blood loss (20 studies, 74%), pain (18 studies, 66%) and infection (16 studies, 59%).

CONCLUSIONS

Wide variations in reported outcomes and outcome measures were found. Until a core outcome set is established, we propose an interim core outcome set that could include the three most commonly reported outcomes of the following domains: hospitalization; intraoperative, postoperative urinary, gastrointestinal, vaginal and sexual outcomes; clinical effectiveness.

Abstract

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.

MAIN RESULTS

Twenty-seven interventional and four follow-up trials were included. Seventeen studies enrolled patients with posterior compartment surgery as the sole procedure and 14 with multicompartment procedures. Eighty-three reported outcomes and 45 outcome measures were identified. The most frequently reported outcomes were blood loss (20 studies, 74%), pain (18 studies, 66%) and infection (16 studies, 59%).

CONCLUSIONS

Wide variations in reported outcomes and outcome measures were found. Until a core outcome set is established, we propose an interim core outcome set that could include the three most commonly reported outcomes of the following domains: hospitalization; intraoperative, postoperative urinary, gastrointestinal, vaginal and sexual outcomes; clinical effectiveness.

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Additional indexing

Contributors:CHORUS: An International Collaboration for Harmonising Outcomes, Research and Standards in Urogynaecology and Women's Health
Item Type:Journal Article, refereed, original work
Communities & Collections:04 Faculty of Medicine > University Hospital Zurich > Clinic for Gynecology
Dewey Decimal Classification:610 Medicine & health
Language:English
Date:1 March 2020
Deposited On:29 Jan 2020 14:08
Last Modified:18 Feb 2020 10:26
Publisher:Elsevier
ISSN:0020-7292
OA Status:Closed
Publisher DOI:https://doi.org/10.1002/ijgo.13079
PubMed ID:31814121

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