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A systematic review of reported outcomes and outcome measures in randomized controlled trials on apical prolapse
Thais Regina de Mattos Lourenço1, Vasilis Pergialiotis2, Constantin Durnea3
1Department of Obstetrics and Gynaecology, Urogynaecology Division, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, São Paulo, Brazil.
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.
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