A systematic review of outcome and outcome-measure reporting in randomised trials evaluating surgical interventions for anterior-compartment vaginal prolapse: a call to action to develop a core outcome set

INTRODUCTION: We assessed outcome and outcome-measure reporting in randomised controlled trials evaluating surgical interventions for anterior-compartment vaginal prolapse and explored the relationships between outcome reporting quality with journal impact factor, year of publication, and methodological quality. METHODS: We searched the bibliographical databases from inception to October 2017. Two researchers independently selected studies and assessed study characteristics, methodological quality (Jadad criteria; range 1-5), and outcome reporting quality Management of Otitis Media with Effusion in Cleft Palate (MOMENT) criteria; range 1-6], and extracted relevant data. We used a multivariate linear regression to assess associations between outcome reporting quality and other variables. RESULTS: Eighty publications reporting data from 10,924 participants were included. Seventeen different surgical interventions were evaluated. One hundred different outcomes and 112 outcome measures were reported. Outcomes were inconsistently reported across trials; for example, 43 trials reported anatomical treatment success rates (12 outcome measures), 25 trials reported quality of life (15 outcome measures) and eight trials reported postoperative pain (seven outcome measures). Multivariate linear regression demonstrated a relationship between outcome reporting quality with methodological quality (β = 0.412; P = 0.018). No relationship was demonstrated between outcome reporting quality with impact factor (β = 0.078; P = 0.306), year of publication (β = 0.149; P = 0.295), study size (β = 0.008; P = 0.961) and commercial funding (β = -0.013; P = 0.918). CONCLUSIONS: Anterior-compartment vaginal prolapse trials report many different outcomes and outcome measures and often neglect to report important safety outcomes. Developing, disseminating and implementing a core outcome set will help address these issues

Prevalence and risk factors for mesh erosion after laparoscopic-assisted sacrocolpopexy

Introduction and hypothesis: The purpose of this study is to identify risk factors for mesh erosion in women undergoing minimally invasive sacrocolpopexy (MISC). We hypothesize that erosion is higher in subjects undergoing concomitant hysterectomy. Methods: This is a retrospective cohort study of women who underwent MISC between November 2004 and January 2009. Demographics, operative techniques, and outcomes were abstracted from medical records. Multivariable regression identified odds of erosion. Results: Of 188 MISC procedures 19(10%) had erosions. Erosion was higher in those with total vaginal hysterectomy (TVH) compared to both post-hysterectomy (23% vs. 5%, p = 0.003) and supracervical hysterectomy (SCH) (23% vs. 5%, p = 0.109) groups. In multivariable regression, the odds of erosion for TVH was 5.67 (95% CI: 1.88-17.10) compared to post-hysterectomy. Smoking, the use of collagen-coated mesh, transvaginal dissection, and mesh attachment transvaginally were no longer significant in the multivariable regression model. Conclusion: Based on this study, surgeons should consider supracervical hysterectomy over total vaginal hysterectomy as the procedure of choice in association with MISC unless removal of the cervix is otherwise indicated. © 2010 The Author(s)

Outcome measures to assess anatomy and function of the posterior vaginal compartment.

Introduction and hypothesisOptimal measures for assessing anatomy and defecatory symptoms related to posterior compartment prolapse are unknown. Our objectives were: (1) to test the inter- and intrarater reliability of commonly used or reported anatomic measures of posterior compartment prolapse performed in the clinic setting and under anesthesia; and (2) to examine the correlation between posterior compartment anatomy and defecatory symptoms prior to surgical intervention.MethodsA prospective cohort of women with pelvic floor disorders was assessed using a variety of validated questionnaires and standardized examination measures at baseline, at a preoperative visit, and intraoperatively. Inter- and intrarater reliability for anatomic measures were assessed by two separate examiners at the initial visit and repeated by one of the original examiners at a preoperative visit. Reliability was measured using kappa or intraclass correlations according to data type. Symptom and anatomic measure correlations were analyzed using Spearman rank tests.ResultsMean age of the 120 women recruited was 57 ± 15 years, 49 (41 %) had a point Bp ≥ 0; 59 % reported at least moderate bother from at least one obstructed defecation symptom on the Pelvic Floor Distress Inventory (PFDI). At baseline, most anatomic measures showed at least moderate to good inter/intrarater reliability (> 0.5). There were no moderate or better correlations between any symptom and anatomic measure (all r <  0.27).ConclusionsMost anatomic measures of posterior compartment prolapse are reliable and reproducible; however, they do not correlate well with defecatory symptoms

Outcome measures to assess anatomy and function of the posterior vaginal compartment.

Introduction and hypothesisOptimal measures for assessing anatomy and defecatory symptoms related to posterior compartment prolapse are unknown. Our objectives were: (1) to test the inter- and intrarater reliability of commonly used or reported anatomic measures of posterior compartment prolapse performed in the clinic setting and under anesthesia; and (2) to examine the correlation between posterior compartment anatomy and defecatory symptoms prior to surgical intervention.MethodsA prospective cohort of women with pelvic floor disorders was assessed using a variety of validated questionnaires and standardized examination measures at baseline, at a preoperative visit, and intraoperatively. Inter- and intrarater reliability for anatomic measures were assessed by two separate examiners at the initial visit and repeated by one of the original examiners at a preoperative visit. Reliability was measured using kappa or intraclass correlations according to data type. Symptom and anatomic measure correlations were analyzed using Spearman rank tests.ResultsMean age of the 120 women recruited was 57 ± 15 years, 49 (41 %) had a point Bp ≥ 0; 59 % reported at least moderate bother from at least one obstructed defecation symptom on the Pelvic Floor Distress Inventory (PFDI). At baseline, most anatomic measures showed at least moderate to good inter/intrarater reliability (> 0.5). There were no moderate or better correlations between any symptom and anatomic measure (all r <  0.27).ConclusionsMost anatomic measures of posterior compartment prolapse are reliable and reproducible; however, they do not correlate well with defecatory symptoms