TY - JOUR
TI - 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
AU - Lourenco, Thais R. M.
AU - Pergialiotis, Vasilis
AU - Durnea, Constantin
AU - M.
AU - Elfituri, Abdullatif
AU - Haddad, Jorge M.
AU - Betschart, Cornelia
AU - and Falconi, Gabriele
AU - Nygaard, Christiana C.
AU - Bergstrom, Lina and
AU - Pattel, Mittal
AU - Doumouchtsis, Stergios K.
AU - CHORUS
JO - International Journal of Gynecology and Obstetrics
PY - 2020
VL - 148
TODO - 3
SP - 271-281
PB - Wiley
SN - 0020-7292
TODO - 10.1002/ijgo.13079
TODO - Core outcome set; Enterocele; Outcome variation; Pelvic organ prolapse;
Posterior vaginal wall prolapse; Rectocele
TODO - 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.
PROSPERO: CRD42017062456.
ER -