Quality assessment of outcome reporting, publication characteristics and overall methodological quality in trials on synthetic mesh procedures for the treatment of pelvic organ prolapse for development of core outcome sets.

INTRODUCTION AND HYPOTHESIS: Variations in outcome measures and reporting of outcomes in trials on surgery for pelvic organ prolapse (POP) using synthetic mesh have been evaluated and reported. However, the quality of outcome reporting, methodology of trials and their publication parameters are important considerations in the process of development of Core Outcome Sets. We aimed to evaluate these characteristics in randomized controlled trials on surgery for POP using mesh. METHODS: Secondary analysis of randomized controlled trials on surgical treatments using synthetic mesh for POP previously included in a systematic review developing an inventory of reported outcomes and outcome measures. The methodological quality was investigated with the modified Jadad criteria. Outcome reporting quality was evaluated with the MOMENT criteria. Publication parameters included publishing journal, impact factor and year of publication. RESULTS: Of the 71 previously reviewed studies published from 2000 to 2017, the mean JADAD score was 3.59 and the mean MOMENT score was 4.63. Quality of outcomes (MOMENT) was related to methodological quality (JADAD) (rho = 0.662; p = 0.000) and to year of publication (rho = 0.262; p = 0.028). CONCLUSIONS: Methodological quality and outcome reporting quality appear correlated. However, publication characteristics do not have strong associations with the methodological quality of the studies. Evaluation of the quality of outcomes, methodology and publication characteristics are all an indispensable part of a staged process for the development of Core Outcome and Outcome Measure Sets.

A multicenter, randomized trial comparing pelvic organ prolapse surgical treatment with native tissue and synthetic mesh: A 5-year follow-up study.

INTRODUCTION: The aim of this study was to compare long-term outcomes in patients who underwent either native tissue repair or monofilament macroporous polypropylene mesh. METHODS: This multicenter, randomized trial included-at the end of 5 years follow-up-122 women with severe pelvic organ prolapse, who were randomly assigned to undergo surgical treatment using native tissue repair (native tissue group, n = 59) or synthetic mesh repair (mesh group, n = 63). Cure criterion was when pelvic organ prolapse-quantification (POP-Q) point was ≤0. Quality of life was assessed using the prolapse quality-of-life questionnaire and sexual function with the quality of sexual function. RESULTS: Groups were homogeneous preoperatively with the exception of the previous pelvic surgery variable, which was higher in mesh (P = .019). Cure rate was significantly better for mesh group in the anterior compartment (P = .002) and in the combination of all compartments (P = .001). Native tissue group was significantly better when there was prolapse in the posterior and apical compartment (P = .031). In the quality of life analysis, mesh group showed a significant improvement compared with native tissue group (P = .004). Complications were significantly higher in mesh and recurrence in native tissue. Regarding the reoperation rate, there was no difference between groups, but native tissue had a higher reoperation rate due to recurrence (P = .031). CONCLUSIONS: Outcomes in women with severe POP were better with mesh use than native tissue repair, both in the anterior compartment and in the multicompartmental prolapse after 5-year follow-up. Complications were more common in the mesh group and recurrences were more frequent in the native tissue group.

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.

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.

Biomarkers in the diagnosis and symptom assessment of patients with bladder pain syndrome: a systematic review.

INTRODUCTION AND HYPOTHESIS: Bladder pain syndrome (BPS) is a disease of unknown etiology defined as an unpleasant sensation related to the bladder, associated with lower urinary tract symptoms of more than 6 weeks' duration, in the absence of any identifiable causes. Despite its impact on quality of life (QoL) and socioeconomic burden, there are no objective methods for the diagnosis or assessment of therapeutic response. We systematically reviewed biomarkers associated with BPS to update the current knowledge on this issue. METHODS: A systematic review of the Cochrane Library, Embase, PubMed/MEDLINE, LILACS, SCOPUS, and ClinicalTrials.gov databases was conducted following the PRISMA statement. Original articles investigating biomarkers for the diagnosis or symptom assessment of patients with BPS were assessed; no language restrictions were applied. Animal or post-mortem studies were excluded. RESULTS: Of the 478 records retrieved, 11 articles were included. MIF, NGF, Etio-S, APF, and a combined methylhistamine/Il-6 model were increased in BPS urine samples versus controls. Also increased were glyceraldehyde in stool, in addition to the expression of some genes (ARID1A, ARF, CHAT, eNOS, GLI-1, iNOS, MCP-1, NGF, WNT-8A, WNT-10A), nerve density, IL-16, VCAM-1, and ICAM-1 in bladder tissue specimens. In contrast, some fecal bacteria, expression of other genes (CHT, HB-EGF, OCT-1, SMRT-1, WNT11) in the bladder urothelium, and urinary DNA methylation in CpG-sites, MCP-3, G5P1, and HB-EGF were decreased in BPS. As none of the biomarkers was studied more than once, a Forest plot could not be constructed. Only 4 articles reported the relation of biomarkers to symptom scores. CONCLUSIONS: Potential biomarkers for BPS in urine, stool, and bladder biopsy specimens are described. Further research is needed before their use in clinical practice.

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

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.

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.

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.