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

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 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

Health Education Practice in Libya; Professional Opinions

The aim of this study is to assess the perceptions of Libyan health professionals of their role in the provision of health education to the general public. It is also to identify barriers to effective health education and to suggest actions for a more effective role. A closedend questionnaire was distributed to 500 health professionals in five Libyan localities. Participants were requested to answer questions covering the responsibilities, importance and effectiveness of the existing role of health professionals in health education. Participants were also asked to indicate their perceptions of various barriers to the delivery of effective health education. A list of related suggested solutions for improving the practice was also presented. Nearly two thirds out of 500 health professionals responded to the questionnaire. A large majority perceived that they are responsible for providing health education and almost all (98.9%) considered this role very important or important. The effectiveness of their existing role was assessed differently. Participants perceived that lack of educational aids and materials and low priority for health education were the main barriers that should be overcome in order to improve services

Optimisation of resources deployment in a call centre by using stochastic data in simulation models

In recent years, call centres have been considered as an integral part of the modern businesses, since they play an important role in providing service delivery functions to their customers. A well-managed call centre, therefore, is crucial to ensure high level of customer satisfaction in today’s competitive market. In order to achieve a high standard, managers of call centres face a very difficult set of challenges. At the top level, they must strike a balance between two powerful competing interests: low operating costs and high service quality. On a day-to-day basis, while simultaneously keeping low costs and high service quality, those managers must also employ appropriate techniques and tools in order to evaluate the true performance of their operations accurately. Such tools play a vital role in understanding the current system performance, evaluation of any proposed enhancement scenarios, and optimising operations management decisions under any unexpected operating conditions. One of traditional operations management challenges for call centre managers is to tackle the multi-period human resources allocation problem. In this thesis, the staffing and staff scheduling decisions in single-skill inbound call centres were studied. These decisions are normally made under strict service level constrain in the presence of highly uncertain operations and demand of call centre services. Neglecting such uncertainty may lead to unrealistic decisions. The objective of this research thesis was to propose a framework to enhance the call centre performance through taking realistic optimal staffing and scheduling decisions. Realistic optimisation requires realistic modeling (evaluation) of call centre operations which is the main focus and contribution of this research. The proposed framework has combined statistical, simulation, and Integer Programming (IP) techniques in achieving realistic optimisation. The framework begins by developing stochastic statistical data models for call centre operations parameters which are divided into service demand (arrival volumes) and service quality (service times, abandonment volumes, and patience time) parameters. These data models are then fed into a simulation model which was developed to determine the minimum staffing levels in daily an-hour periods. Finally, these staffing levels are considered as input to an IP model that optimally allocates the service agents to the different operating shifts of a typical working day. Application of the proposed framework to a call centre in Libya will also be presented to illustrate how its staffing and scheduling decisions could be improved by using the model

Do we need a core outcome set for childbirth perineal trauma research? A systematic review of outcome reporting in randomised trials evaluating the management of childbirth trauma

Background Selecting appropriate outcomes to reflect both beneficial and harmful effects is a critical step in designing childbirth trauma trials. Objective To evaluate the outcomes and outcome measures reported in randomised controlled trials evaluating interventions for childbirth trauma. Search strategy Randomised trials were identified by searching bibliographical databases including the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, and EMBASE. Selection criteria Randomised trials evaluating the efficacy and safety of different techniques in the management of perineal lacerations. Data collection and analysis Two researchers independently assessed studies for inclusion, evaluated methodological quality, and extracted the relevant data. Spearman's ρ correlation and multivariate linear regression analysis using the backward stepwise model were used for analysis. Main results Forty‐eight randomised trials, reporting data from 20 308 women, were included. Seventeen different interventions were evaluated. Included trials reported 77 different outcomes and 50 different outcome measures. Commonly reported outcomes included pain (34 trials; 70%), wound healing (20 trials; 42%), and anorectal dysfunction (16 trials, 33%). In the multivariate analysis, no relationship was demonstrated between the quality of outcome reporting and year of publication (P = 0.31), journal impact factor (P = 0.49), and methodological quality (P = 0.13). Conclusion Outcome reporting in childbirth trauma research is heterogeneous. Developing, disseminating, and implementing a core outcome set in future childbirth trauma research could help address these issues.</p

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.</p

Childhood urolithiasis in North-Western Libya

The study reviews causes of urolithiasis and its manifestations in North-West (NW) Libya. Libyan childhood urolithiasis accounted for 3.6% of nephrology out-patient work load. There were 59 children with urolithiasis, including 34 boys and 25 girls with a mean age of 2.8 ± 2.42 years. Urolithiasis was more common among younger age groups (P = 0.001) and in boys with primary oxaluria and infective etiology. The causes of urolithiasis included metabolic stones in 64%, infective in 26%, and it was idiopathic in 10%. Overall, family history of renal stone disease was elicited in 59%; it was 92% in patients with primary oxaluria. The main presenting features were abdominal pain (27%), gross hematuria (22%), associated urinary tract infection (UTI; 24%), and stone release in 19%. Stone location was bilateral in 64%, multiple in 68%, and in the upper tract in 93% (P = 0.05). Important complications encountered included chronic renal failure (13%), hydronephrosis (34%), systemic hypertension (8%), and rickets in 17%. Calcium oxalate was the most prominent constituent, seen in 41% of the calculi, followed by struvite (21%), uric acid (10%), carbapatite (7%), and cystine (3.5%). Diagnostically helpful findings were family history, age at presentation, UTI by urease producing organisms, rickets, imaging and chemical analysis of calculi. Early detection and prompt treatment helps in preventing long-term sequelae in patients with urolithiasis

Do we need a core outcome set for childbirth perineal trauma research? A systematic review of outcome reporting in randomised trials evaluating the management of childbirth trauma

BackgroundSelecting appropriate outcomes to reflect both beneficial and harmful effects is a critical step in designing childbirth trauma trials. ObjectiveTo evaluate the outcomes and outcome measures reported in randomised controlled trials evaluating interventions for childbirth trauma. Search strategyRandomised trials were identified by searching bibliographical databases including the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, and EMBASE. Selection criteriaRandomised trials evaluating the efficacy and safety of different techniques in the management of perineal lacerations. Data collection and analysisTwo researchers independently assessed studies for inclusion, evaluated methodological quality, and extracted the relevant data. Spearman’s correlation and multivariate linear regression analysis using the backward stepwise model were used for analysis. Main resultsForty-eight randomised trials, reporting data from 20 308 women, were included. Seventeen different interventions were evaluated. Included trials reported 77 different outcomes and 50 different outcome measures. Commonly reported outcomes included pain (34 trials; 70%), wound healing (20 trials; 42%), and anorectal dysfunction (16 trials, 33%). In the multivariate analysis, no relationship was demonstrated between the quality of outcome reporting and year of publication (P = 0.31), journal impact factor (P = 0.49), and methodological quality (P = 0.13). ConclusionOutcome reporting in childbirth trauma research is heterogeneous. Developing, disseminating, and implementing a core outcome set in future childbirth trauma research could help address these issues. Tweetable abstractDeveloping @coreoutcomes for childbirth trauma research could help to reduce #research waste. Tweetable abstract Developing @coreoutcomes for childbirth trauma research could help to reduce #research waste. This paper includes Author Insights, a video abstract available a

A systematic review on outcome reporting in randomised controlled trials on surgical interventions for female stress urinary incontinence: a call to develop a core outcome set

BACKGROUND Several meta-analyses have identified methodological limitations in female stress urinary incontinence (SUI) trials, precluding the synthesis of primary studies and high-quality evidence. OBJECTIVES Evaluation of outcome measure selection and outcome reporting in randomised controlled trials (RCTs) on surgery for SUI. SEARCH STRATEGY Systematic review of RCTs identified from bibliographical databases, including Medline, Cochrane, and EMBASE. SELECTION CRITERIA Randomised controlled trials evaluating the efficacy and safety of surgical interventions for the management of female SUI. DATA COLLECTION AND ANALYSIS Two researchers independently assessed the included studies and documented outcomes. MAIN RESULTS Overall, 108 studies were identified that included 422 reported outcomes and 119 outcome measures. The three most common outcomes were cure rates (87 studies), quality of life (85 studies), and overactive bladder (78 studies). The median methodological quality rating was 3 (range 0-3) and the outcome reporting quality rating was 3 (range 0-5). Multinomial logistic regression analysis revealed that the methodological quality and use of validated questionnaire were significant predictors of the quality of outcome reporting (β = 0.538, P < 0.001; β = 0.218, P = 0.011, respectively). CONCLUSIONS Outcome reporting in SUI trials is highly variable. Until a core outcome set is developed and implemented, we propose an interim use of three commonly reported outcomes in each domain (treatment success rate - complete cure, partial improvement, or failure of response; urodynamic evaluation outcomes - overactive bladder (OAB), voiding dysfunction, and urodynamic stress incontinence; patient-reported outcomes - quality of life, sexual dysfunction, and patient satisfaction) with the use of validated questionnaires for patient-reported outcomes and subjective success rates. Complications should be also explicitly and comprehensively reported using validated outcome measures. TWEETABLE ABSTRACT There is significant variation in outcome reporting in SUI trials. Our systematic review findings aim to form the basis for the development of a core outcome set