TY - JOUR
TI - 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
AU - de Mattos Lourenco, T.R.
AU - Pergialiotis, V.
AU - Duffy, J.M.N.
AU - Durnea, C.
AU - Elfituri, A.
AU - Haddad, J.M.
AU - Betschart, C.
AU - Falconi, G.
AU - Doumouchtsis, S.K.
JO - Neurourology and Urodynamics
PY - 2019
VL - 38
TODO - 2
SP - 509-524
PB - John Wiley and Sons Inc
SN - 0733-2467, 1520-6777
TODO - 10.1002/nau.23871
TODO - abdominal surgery;  clinical outcome;  clinical practice;  functional assessment;  functional status;  gynecologic surgery;  human;  outcome assessment;  pelvic organ prolapse;  pelvis surgery;  postoperative complication;  quality control;  Review;  symptom;  systematic review;  treatment failure;  treatment response;  urinary tract disease;  urodynamics;  clinical trial (topic);  female;  middle aged;  pelvic organ prolapse;  procedures;  research;  surgical mesh;  treatment outcome;  uterus prolapse;  vagina, Clinical Trials as Topic;  Female;  Gynecologic Surgical Procedures;  Humans;  Middle Aged;  Outcome Assessment, Health Care;  Pelvic Organ Prolapse;  Research;  Surgical Mesh;  Treatment Outcome;  Uterine Prolapse;  Vagina
TODO - The use of synthetic mesh in pelvic organ prolapse surgery is being closely scrutinized because of serious concerns regarding life-changing complications such as erosion, pain, infection, bleeding, dyspareunia, organ perforation, and urinary problems. Randomized trials and their syntheses in meta-analysis offer a unique opportunity to assess efficacy and safety. However, outcomes and outcome measures need to be consistently selected, collected, and reported across randomized trials to be effectively combined in systematic reviews. Aims: We evaluated outcome and outcome measure reporting across randomized controlled trials on surgical interventions using synthetic mesh for pelvic organ prolapse. Methods: Systematic review of randomized controlled trials using synthetic mesh for the treatment of pelvic organ prolapse. The selected studies were evaluated using Jadad and MOMENT criteria. Outcomes and outcome measures were systematically identified and categorized. Results: Seventy-one randomized trials were included. Twenty-four different types of mesh were identified. Included trials reported 110 different outcomes and 60 outcome measures. Erosion (40 trials, 78%), pain (29 trials, 56%), bleeding (31 trials, 61%), and dyspareunia (25 trials, 49%) were the most frequently reported outcomes. The longest follow up was 74 months. Conclusions: Most randomized trials evaluating surgical interventions using synthetic mesh for pelvic organ prolapse failed to report on clinically important outcomes and to evaluate efficacy and safety over the medium- and long-term. Developing and implementing a minimum data set, known as a core outcome set, in future vaginal prolapse trials could help address these issues. © 2018 Wiley Periodicals, Inc.
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