TY - JOUR
TI - A systematic review of reported outcomes and outcome measures in
randomized controlled trials on apical prolapse surgery
AU - de Mattos Lourenco, Thais Regina
AU - Pergialiotis, Vasilis
AU - Durnea,
AU - Constantin
AU - Elfituri, Abdullatif
AU - Haddad, Jorge Milhem and
AU - Betschart, Cornelia
AU - Falconi, Gabriele
AU - Doumouchtsis, Stergios K.
AU - and CHORUS Int Collaboration Harmonis
JO - International Journal of Gynecology and Obstetrics
PY - 2019
VL - 145
TODO - 1
SP - 4-11
PB - Wiley
SN - 0020-7292
TODO - 10.1002/ijgo.12766
TODO - Apical prolapse; Core outcome sets; Outcome variation; Pelvic organ
prolapse; Uterine prolapse; Vault prolapse
TODO - 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.
ER -