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

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.

Contributors

Lourenco, T. R. M. Pergialiotis, V. Durnea, C. M. Elfituri, A. Haddad, J. M. Betschart, C. Falconi, G. Nygaard, C. C. Bergstrom, L. Pattel, M. Doumouchtsis, S. K.

Publication

Journal: Int J Gynaecol Obstet
Volume:
Issue:
Pages: -
Year: 2019
DOI: 10.1002/ijgo.13079

Further Study Information

Current Stage: Not Applicable
Date:
Funding source(s):

---

Method(s)

- Systematic review

Linked Studies

• Developing a core outcome set for female pelvic floor disorders (urinary incontinence, pelvic organ prolapse, childbirth perineal trauma and pelvic pain syndromes)
• 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
• 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
• 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 of reported outcomes and outcome measures in randomized controlled trials on apical prolapse surgery
• A systematic review on outcome reporting in randomised controlled trials on surgical interventions for female stress urinary incontinence: a call to develop a core outcome set
• An arm-based network meta-analysis on treatments for vulvar lichen sclerosus and a call for development of core outcome sets: Treatment options for vulvar lichen sclerosus
• A systematic review and meta-synthesis of qualitative studies on pelvic organ prolapse for the development of core outcome sets
• Analysis of primary and secondary outcome domains reported in randomised trials on surgery for female stress urinary incontinence. A systematic review
• Outcome reporting in trials on conservative interventions for Pelvic Organ Prolapse: A systematic review for the development of a core outcome set
• A meta-synthesis of qualitative studies on stress urinary incontinence in women for the development of a Core Outcome Set: A systematic review
• Outcome reporting in randomized controlled trials (RCTs) on the pharmacological management of idiopathic overactive bladder (OAB) in women; a systematic review for the development of core outcome sets (COS)
• Developing a core outcome set for childbirth-related perineal trauma: delphi survey
• Reported outcomes and outcome measures in RCTs of laparoscopic and robotic interventions for pelvic organ prolapse in women: a systematic review

Related Links

No related links