From COTS Simulation Software to an Open-source Platform: A Use Case in the Medical Device Industry

AbstractThe implementation of Discrete Event Simulation (DES) – based decision support tools in complex manufacturing environments could prove of invaluable help to industrial practitioners involved in cross-functional decision processes at multiple hierarchical levels. The increasing number of decision variables, their stochastic nature and the non-linearity of their mutual relationships theoretically make simulation a preferred modelling approach for a great variety of manufacturing systems as strict simplifying assumptions are not necessarily required and the models’ detail level can be tuned according to the analysis purposes. However, recourse to Commercial Off-The-Shelf (COTS) simulation packages to develop and implement simulation-based solutions in real manufacturing environments usually presents significant cost-of-ownership (COO). Along with license costs, modelling flexibility and sustainability represent fundamental issues raised by industrial engineers that adopt COTS simulation packages. In order to promote the use of DES in production related decision making processes and reduce the associated COO for manufacturing companies, an open-source simulation platform, ManPy, has been developed. ManPy consists of a library of DES objects implemented in SimPy. ManPy's scope is to provide modellers with generic, highly customizable open-source simulation objects that can be connected to form a model in the same fashion of COTS simulation packages. ManPy's on-going development is based on guidelines provided by the analysis of real industrial use cases. Specific pilot models developed in SimPy are used to identify new objects and relevant features to be incorporated in ManPy in order to make it a highly flexible simulation tool. In this article, a use case based on a labour intensive serial production line operating in a medical device manufacturing plant is described. Insights for the transition from a COTS simulation model to a specific SimPy model and finally to generic ManPy objects are presented

Variations in the mineral content of bottled 'carbonated or sparkling' water across Europe : a comparison of 126 brands across 10 countries

Kidney stone disease is a common disease with high recurrence rates. Sufficient intake of water is the cornerstone in primary prevention of stone disease. However, the mineral composition of water can affect urinary minerals and influence stone formation. The aim of this study is to assess the variation in the mineral composition of bottled sparkling or carbonated drinking water across Europe. The two largest supermarket chains in each participating country were visited to obtain data on mineral composition regarding bicarbonate, calcium, magnesium, potassium, sodium and sulphates of sparkling or carbonated waters by reading the ingredient labels on the bottles supplied by the manufacturers. Alternatively, the web-shops of these supermarkets were consulted. In total, 126 sparkling water brands across ten European countries were analysed regarding mineral composition. The median concentrations per mineral varied greatly. The greatest variation in median mineral content was found for sodium and sulphates with levels ranging from 3.1 mg/l to 63.0 mg/l and 6.0 mg/l to 263.0 mg/l respectively. A wide distribution of calcium content was found in Switzerland, with calcium levels reaching up to 581.6 mg/l. This study confirms that the mineral composition of sparkling or carbonated water varies greatly across Europe. Patients with kidney stone disease should be aware that the mineral content of water may influence stone formation and be mindful of the great variation that exists between different water brands. Mineral water can be a source of potential promotors or inhibitors of stone formation and patients and urologists need to be mindful of this

The european urology residents education programme hands-on training format: 4 years of hands-on training improvements from the European School of Urology

Background: The European School of Urology (ESU) started the European Urology Residents Education Programme (EUREP) in 2003 for final year urology residents, with hands-on training (HOT) added later in 2007. Objective: To assess the geographical reach of EUREP, trainee demographics, and individual quality feedback in relation to annual methodology improvements in HOT. Design, setting, and participants: From September 2014 to October 2017 (four EUREP courses) several new features have been applied to the HOT format of the EUREP course: 1:1 training sessions (2015), fixed 60-min time slots (2016), and standardised teaching methodology (2017). The resulting EUREP HOT format was verified by collecting and prospectively analysing the following data: total number of participants attending different HOT courses; participants’ age; country of origin; and feedback obtained annually. Results and limitations: A total of 796 participants from 54 countries participated in 1450 HOT sessions over the last 4 yr. This included 294 (20%) ureteroscopy (URS) sessions, 237 (16.5%) transurethral resection (TUR) sessions, 840 (58%) basic laparoscopic sessions, and 79 (5.5%) intermediate laparoscopic sessions. While 712 residents (89%) were from Europe, 84 (11%) were from non-European nations. Of the European residents, most came from Italy (16%), Germany (15%), Spain (15%), and Romania (8%). Feedback for the basic laparoscopic session showed a constant improvement in scores over the last 4 yr, with the highest scores achieved last year. This included feedback on improvements in tutor rating (p = 0.017), organisation (p < 0.001), and personal experience with EUREP (p < 0.001). Limitations lie in the difficulties associated with the use of an advanced training curriculum with wet laboratory or cadaveric courses in this format, although these could be performed in other training centres in conjunction with EUREP. Conclusions: The EUREP trainee demographics show that the purpose of the course is being achieved, with excellent feedback reported. While European trainees dominate the demographics, participation from a number of non-European countries suggests continued ESU collaboration with other national societies and wider dissemination of simulation training worldwide.EUREP is supported by educational grant from Olympus.info:eu-repo/semantics/acceptedVersio

Global Variations in the Mineral Content of Bottled Still and Sparkling Water and a Description of the Possible Impact on Nephrological and Urological Diseases

Kidney stone disease (KSD) is a complex disease. Besides the high risk of recurrence, its association with systemic disorders contributes to the burden of disease. Sufficient water intake is crucial for prevention of KSD, however, the mineral content of water might influence stone formation, bone health and cardiovascular (CVD) risk. This study aims to analyse the variations in mineral content of bottled drinking water worldwide to evaluate the differences and describes the possible impact on nephrological and urological diseases. The information regarding mineral composition (mg/L) on calcium, bicarbonate, magnesium, sodium and sulphates was read from the ingredients label on water bottles by visiting the supermarket or consulting the online shop. The bottled waters in two main supermarkets in 21 countries were included. The evaluation shows that on a global level the mineral composition of bottled drinkable water varies enormously. Median bicarbonate levels varied by factors of 12.6 and 57.3 for still and sparkling water, respectively. Median calcium levels varied by factors of 18.7 and 7.4 for still and sparkling water, respectively. As the mineral content of bottled drinking water varies enormously worldwide and mineral intake through water might influence stone formation, bone health and CVD risk, urologists and nephrologists should counsel their patients on an individual level regarding water intake

Global Variations in the Mineral Content of Bottled Still and Sparkling Water and a Description of the Possible Impact on Nephrological and Urological Diseases

Kidney stone disease (KSD) is a complex disease. Besides the high risk of recurrence, its association with systemic disorders contributes to the burden of disease. Sufficient water intake is crucial for prevention of KSD, however, the mineral content of water might influence stone formation, bone health and cardiovascular (CVD) risk. This study aims to analyse the variations in mineral content of bottled drinking water worldwide to evaluate the differences and describes the possible impact on nephrological and urological diseases. The information regarding mineral composition (mg/L) on calcium, bicarbonate, magnesium, sodium and sulphates was read from the ingredients label on water bottles by visiting the supermarket or consulting the online shop. The bottled waters in two main supermarkets in 21 countries were included. The evaluation shows that on a global level the mineral composition of bottled drinkable water varies enormously. Median bicarbonate levels varied by factors of 12.6 and 57.3 for still and sparkling water, respectively. Median calcium levels varied by factors of 18.7 and 7.4 for still and sparkling water, respectively. As the mineral content of bottled drinking water varies enormously worldwide and mineral intake through water might influence stone formation, bone health and CVD risk, urologists and nephrologists should counsel their patients on an individual level regarding water intake

Trends of 'urolithiasis: interventions, simulation, and laser technology' over the last 16 years (2000-2015) as published in the literature (PubMed): a systematic review from European section of Uro-technology (ESUT)

PURPOSE: To look at the bibliometric publication trends on 'Urolithiasis' and aspects of treatment and training associated with it over a period of 16 years from 2000 to 2015. To this end, we conducted this study to look at the publication trends associated with urolithiasis, including the use of simulation, laser technology, and all types of interventions for it.MATERIALS AND METHODS: We performed a systematic review of the literature using PubMed over the last 16 years, from January 2000 to December 2015 for all published papers on 'Urolithiasis'. While there were no language restrictions, English language articles and all non-English language papers with published English abstracts were also included. Case reports, animal and laboratory studies, and those studies that did not have a published abstract were excluded from our analysis. We also analyzed the data in two time periods, period-1 (2000-2007) and period-2 (2008-2015).RESULTS: During the last 16 years, a total of 5343 papers were published on 'Urolithiasis', including 4787 in English language and 556 in non-English language. This included papers on URS (n = 1200), PCNL (n = 1715), SWL (n = 887), open stone surgery (n = 87), laparoscopic stone surgery (n = 209), pyelolithotomy (n = 35), simulation in Endourology (n = 82), and use of laser for stone surgery (n = 406). When comparing the two time periods, during period 2, the change was +171% (p = 0.007), +279% (p &lt; 0.001), and -17% (p = 0.2) for URS, PCNL, and SWL, respectively. While there was a rise in laparoscopic surgery (+116%), it decreased for open stone surgery (-11%) and pyelolithotomy (-47%). A total of 82 papers have been published on simulation for stone surgery including 48 papers for URS (67% rise in period-2, p = 0.007), and 34 papers for PCNL (480% rise in period-2, p &lt; 0.001). A rising trend for the use of laser was also seen in period 2 (increase of 126%, p &lt; 0.02, from 124 papers to 281 papers).CONCLUSIONS: Published papers on intervention for Urolithiasis have risen over the last 16 years. While there has been a steep rise of URS and minimally invasive PCNL techniques, SWL and open surgery have shown a slight decline over this period. A similar increase has also been seen for the use of simulation and lasers in Endourology.</p

Prevalence and characteristics of genetic disease in adult kidney stone formers.

BACKGROUND Molecular mechanisms of kidney stone formation remain unknown in most patients. Previous studies showed high a heritability of nephrolithiasis, but data on prevalence and characteristics of genetic disease in unselected adults with nephrolithiasis are lacking. This study was conducted to fill this important knowledge gap. METHODS We performed whole exome sequencing in 787 participants of the Bern Kidney Stone Registry, an unselected cohort of adults with ≥ 1 past kidney stone episode (KSF), and 114 non-stone-forming individuals (NKSF). An exome-based panel of 34 established nephrolithiasis genes was analyzed and variants assessed according to ACMG criteria. Pathogenic (P) or likely pathogenic (LP) variants were considered diagnostic. RESULTS Mean age of KSF was 47±15 years, and 18% were first time KSF. A Mendelian kidney stone disease was present in 2.9% (23 of 787) of KSF. The most common genetic diagnoses were cystinuria (SLC3A1, SLC7A9; n=13), Vitamin D-24 hydroxylase deficiency (CYP24A1; n=5) and primary hyperoxaluria (AGXT, GRHPR, HOGA1; n=3). 8.1% (64 of 787) of KSF were monoallelic for LP/P variants predisposing to nephrolithiasis, most frequently in SLC34A1/A3 or SLC9A3R1 (n=37), CLDN16 (n=8) and CYP24A1 (n=8). KSF with Mendelian disease had a lower age at the first stone event (30±14 years vs. 36±14 years, p=0.003), were more likely to have cystine stones (23.4% vs. 1.4%) and less likely to have calcium oxalate monohydrates stones (31.9% vs. 52.5%) compared to KSF without genetic diagnosis. The phenotype of KSF with variants predisposing to nephrolithiasis was subtle and showed significant overlap with KSF without diagnostic variants. In NKSF, no Mendelian disease was detected, and LP/P variants were significantly less prevalent compared to KSF (1.8% vs. 8.1%). CONCLUSION Mendelian disease is uncommon in unselected adult KSF, yet variants predisposing to nephrolithiasis are significantly enriched in adult KSF

Implementation of a deidentified federated data network for population-based cohort discovery.

ObjectiveThe Cross-Institutional Clinical Translational Research project explored a federated query tool and looked at how this tool can facilitate clinical trial cohort discovery by managing access to aggregate patient data located within unaffiliated academic medical centers.MethodsThe project adapted software from the Informatics for Integrating Biology and the Bedside (i2b2) program to connect three Clinical Translational Research Award sites: University of Washington, Seattle, University of California, Davis, and University of California, San Francisco. The project developed an iterative spiral software development model to support the implementation and coordination of this multisite data resource.ResultsBy standardizing technical infrastructures, policies, and semantics, the project enabled federated querying of deidentified clinical datasets stored in separate institutional environments and identified barriers to engaging users for measuring utility.DiscussionThe authors discuss the iterative development and evaluation phases of the project and highlight the challenges identified and the lessons learned.ConclusionThe common system architecture and translational processes provide high-level (aggregate) deidentified access to a large patient population (&gt;5 million patients), and represent a novel and extensible resource. Enhancing the network for more focused disease areas will require research-driven partnerships represented across all partner sites

Implementation of a deidentified federated data network for population-based cohort discovery.

ObjectiveThe Cross-Institutional Clinical Translational Research project explored a federated query tool and looked at how this tool can facilitate clinical trial cohort discovery by managing access to aggregate patient data located within unaffiliated academic medical centers.MethodsThe project adapted software from the Informatics for Integrating Biology and the Bedside (i2b2) program to connect three Clinical Translational Research Award sites: University of Washington, Seattle, University of California, Davis, and University of California, San Francisco. The project developed an iterative spiral software development model to support the implementation and coordination of this multisite data resource.ResultsBy standardizing technical infrastructures, policies, and semantics, the project enabled federated querying of deidentified clinical datasets stored in separate institutional environments and identified barriers to engaging users for measuring utility.DiscussionThe authors discuss the iterative development and evaluation phases of the project and highlight the challenges identified and the lessons learned.ConclusionThe common system architecture and translational processes provide high-level (aggregate) deidentified access to a large patient population (&gt;5 million patients), and represent a novel and extensible resource. Enhancing the network for more focused disease areas will require research-driven partnerships represented across all partner sites

Variations in the Mineral Content of Bottled "Still" Water Across Europe: Comparison of 182 Brands Across 10 Countries

Introduction: Kidney stone disease (KSD) is a highly prevalent disease worldwide. As water intake and its mineral content influence stone formation and recurrence, patients and physicians must be aware of the mineral content of drinkable water. We analyzed commercial bottled still water within Europe to assess the variation in its mineral composition across different manufacturers and countries. Materials and Methods: Data on the mineral composition of bottled still water regarding bicarbonate, calcium, magnesium, potassium, sodium, and sulfate concentration (mg/L) were collected from ten European countries. To collect the data, the two main supermarket chains in each participating country were either visited to check for the ingredient label on bottles or the online shop was consulted through the website of the supermarket in question. Descriptive statistics such as simple boxplots were used to illustrate the variation in mineral content. Results: One hundred eighty-two different commercial water brands were analyzed. Up to a fivefold variation in average concentrations per mineral between countries was observed. For calcium, a wide distribution was found in France and Switzerland compared with other countries with calcium levels ranging from 10.5 to 565 mg/L and 8.4 to 579 mg/L, respectively. By consuming 2 L of water with such high calcium levels, the daily reference intake for calcium is already achieved. Conclusions: The mineral content of bottled still water across Europe varies greatly. For patients with KSD it is important to be aware of the mineral content of the water they drink, as it might influence stone recurrence rates and necessitate alterations of their diet