Core Outcome Measures in Effectiveness Trials

A systematic review of reported outcomes and outcome measures in randomized controlled trials on apical prolapse surgery

General Information

Abstract:
BACKGROUND: Evidence on efficacy and safety of pelvic organ prolapse interventions is variable, and methodological flaws preclude meaningful synthesis of primary research data. OBJECTIVE: To evaluate variations in reported outcomes and outcome measures in randomized controlled trials (RCTs) on apical prolapse surgical interventions. SEARCH STRATEGY: We searched Cochrane, EMBASE, MEDLINE, and Scopus for English-language articles published from inception to September 30, 2017, using the terms "management", "repair", "operation", and "pelvic organ prolapse". SELECTION CRITERIA: RCTs on apical prolapse surgical treatment. DATA COLLECTION AND ANALYSIS: Outcomes and outcome measures were identified and categorized into domains. Studies were evaluated for quality of outcomes. Descriptive statistics were used to calculate frequencies. MAIN RESULTS: Forty-three RCTs were included. Seventy-six outcomes and 66 outcome measures were identified. Bladder and ureteric injury were the most commonly reported intraoperative complications (19/31 studies; 61%). Quality of life was assessed by 19 different instruments and questionnaires. Fourteen (45%) of 31 studies used recurrence of prolapse as a postoperative anatomical outcome. CONCLUSIONS: Substantial variation in reported outcomes and outcome measures was confirmed, precluding comparisons across trials and synthesis of the results. Development of a core outcome set will enable high-quality meta-analyses to be performed in the future. PROSPERO registration: CRD42017062456.

Authors:
de Mattos Lourenco, T. R. Pergialiotis, V. Durnea, C. Elfituri, A. Haddad, J. M. Betschart, C. Falconi, G. Doumouchtsis, S. K. Chorus: An International Collaboration for Harmonising Outcomes, Research Standards in, Urogynaecology Women's, Health

Publication

Journal:
Int J Gynaecol Obstet
Volume:
Issue:
Pages:
-
Year:
2019
DOI:
Further Study Information

Date:
Funding source(s):

Health Area

Disease Category
Gynaecology

Disease Name
Pelvic organ prolapse (POP)
Prolapse, incontinence, overactive bladder

Target Population

Age Range
-

Sex
Female


Nature / type of Intervention
Surgery

Method(s)

Systematic review

Search strategy: We searched Cochrane, EMBASE, MEDLINE, and Scopus for English-language articles published from inception to September 30, 2017, using the terms “management”, “repair”, “operation”, and “pelvic organ prolapse”.

Selection criteria: RCTs on apical prolapse surgical treatment.

Data collection and analysis: Outcomes and outcome measures were identified and categorized into domains. Studies were evaluated for quality of outcomes. Descriptive statistics were used to calculate frequencies.


Stakeholders Involved

Study investigators

Study Type

Systematic review of outcome measures/measurement instruments
Systematic review of outcomes measured in trials

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