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

The association between the prevalence of restless leg syndrome, fatigue, and sleep quality in patients undergoing hemodialysis

Objective: To determine the prevalence of restless legs syndrome (RLS) in patients with chronic renal failure (CRF) and to compare CRF patients with or without RLS in terms fatigue and sleep quality. Methods: A cross-sectional study was conducted on 220 patients (18-75 years) who were undergoing dialysis 3 times weekly in Çorum Province, Corum, Turkey, between January 2014 and January 2016. The diagnosis of RLS was based on the diagnostic form proposed by the international RLS study group. Sleep quality was evaluated using the Pittsburgh sleep quality index (PSQI), and severity of fatigue was determined by using fatigue severity scale (FSS). Results: Of all the participants, 16.8% (n= 37) (Group 1) were found to have RLS, while 183 patients had no RLS (Group 2). The mean ages were similar between groups. With respect to laboratory analyses, a p-value of 0.05 was considered in Group 1 than in Group 2. Restless legs syndrome was mild (7.1%), moderate (46.4%) and severe (39.3%) in patients with RLS. Factors associated with the severity of RLS included weight, duration of dialysis, anuria, iron, total iron binding capacity, calcium and transferrin saturation. The PSQI and FSS scores were significantly worse in Group 1 (p0.001). Conclusion: Restless legs syndrome is a common condition in patients undergoing hemodialysis; the results of our study confirm the adverse effects of RLS in terms of many aspects of sleep quality and fatigue. © 2018, Saudi Arabian Armed Forces Hospital. All rights reserved