Instruments Used for the Assessment of SUI Severity in Urogynecologic Surgical Trials: A Scoping Review.

INTRODUCTION AND HYPOTHESIS: Various instruments are used to evaluate the severity of stress urinary incontinence (SUI) in clinical trials for SUI surgery. We conducted a scoping review with the primary aim of investigating the use of such instruments. METHODS: A comprehensive search in PubMed/MEDLINE, Cochrane Library, ClinicalTrials.gov, and WHO ICTRP was carried out. Inclusion criteria were studies including patients undergoing surgical intervention for SUI with assessment of SUI severity performed pre- and post-operatively. Exclusion criteria were nonprospective studies, nonrandomized studies, studies not in the English language, and the absence of reporting the methods of SUI severity evaluation in the study. RESULTS: In total, 8,886 articles were identified, yielding 100 papers for data extraction. The most frequent interventions were mid-urethral slings (85 studies), Burch colposuspension (10 studies), and the use of bulking agents (3 studies). The most frequently used instruments for objective evaluation of SUI were urodynamics (90 studies), nonvalidated cough stress test (83 studies), and 1-h pad test (28 studies). The most frequently used instruments for subjective evaluation were bladder diary (37 studies), Incontinence Impact Questionnaire-7 (26 studies), and Urinary Distress Inventory-6 (23 studies). There were three studies reporting results according to the severity of pre- and post-operative SUI. CONCLUSIONS: There is significant heterogeneity regarding the instruments used to evaluate the severity of SUI in surgical trials for female incontinence. There is a paucity of data regarding results according to the pre-operative severity of SUI. Hence, commonly agreed standardized methods for the assessment of SUI severity are needed to improve comparability between clinical trials for SUI surgery.

Impact of microbiota and host immunologic response on the efficacy of anticholinergic treatment for urgency urinary incontinence.

INTRODUCTION AND HYPOTHESIS: Studies within the past decade have suggested associations among composition of the urinary microbiota, local immune responses, and urinary incontinence symptoms. To investigate these relationships, we evaluated the structure of the urinary microbiome, local inflammatory markers, and patient responses prior to and at 6-weeks after treatment with anticholinergic medication for urgency urinary incontinence (UUI). METHODS: Using a prospective pilot study, we enrolled women who presented with UUI symptoms and were prescribed treatment with anticholinergics. Catheterized urine samples were collected from participants at their baseline and 6-week follow-up visits for microbiological (standard and 16S rRNA gene phylotyping analyses) and cytokine analysis along with the UDI-6 questionnaire and 2-day bladder diary. RESULTS: Patients were Caucasian, post- menopausal, with a median age of 64 and median BMI of 30.1 kg/m2. Among the patients, 75% had UUI symptoms for less than 2 years, but with a frequency of at least a few times a week or every day. Most women were prescribed 10 mg oxybutynin ER daily at enrollment. Patients had varied urinary microbiota by culture and 16S phylotyping, with species of Lactobacillus being the most common, in six samples, in addition to taxa associated with Enterococcus, Staphylococcus, and mixed flora. Cytokine levels showed no differences before and after treatment with anticholinergics, nor correlation with urinary bacteria or microbiome composition. CONCLUSIONS: Our pilot study suggests factors in addition to the urinary microbiome and local immune responses may be involved in patients' response to anticholinergics for UUI.

IMRT as an Alternative Technique for Intracavitary Brachytherapy in Patients with Carcinoma of the Cervix: A Feasibility Study Using Unified Dosimetric Index.

OBJECTIVE: Intracavitary brachytherapy (ICBT) plays an important role in the management of carcinoma of the cervix. This study attempts to find the feasibility of intensity-modulated radiation therapy (IMRT) as a boost for patients who are not suitable for ICBT in order to improve their disease-free and overall survival. METHODS: Twenty patients with carcinoma of the cervix were included in this study. Nine fields of IMRT and ICBT plans were generated for PTVBoost. Various dosimetric indices like coverage, conformity, homogeneity, and gradient index were calculated, and the corresponding unified dosimetric index (UDI) values were generated. Plans were classified based on combined UDI, and the UDI values were compared with those of ICBT. In addition, rectum and bladder doses were compared. RESULTS: All the dosimetric indices were within acceptable limits except for the gradient index. The gradient index of the IMRT and ICBT plans were 8.77 ± 0.26 and 1.33 ± 0.06 respectively (p < 0.0001). The mean of combined UDI with standard deviation was 32.557 ± 8.940 and plan quality was calculated from these values. Rectum and bladder doses for ICBT were lesser than IMRT (p < 0.0001). CONCLUSION: ICBT is the gold standard for boost RT in carcinoma of the cervix patients. IMRT boost is feasible for patients who are unsuitable on medical grounds for brachytherapy.

In support of interoperability: A laboratory perspective.

Healthcare in the United States has become increasingly digital since the passage of the HITECH Act in 2009. As a result, there is a growing need to optimize healthcare IT to allow for the interoperable exchange of data. As a result, the Office of the National Coordinator for Health IT has implemented their Final Rule for the 21st Century Cures Act. This requires certified health IT systems to use modernized messaging standards for the safe and secure exchange of data within health information networks and also requires the use of terminology standards including LOINC, SNOMED CT, and UCUM for coding clinical and laboratory data. Given the critical importance of laboratory results in the delivery of healthcare, laboratorians must become familiar with these principles of interoperability. Their clinical laboratory expertise is needed to appropriately structure and code test results to safeguard against improper aggregation or misinterpretation by downstream users and systems.

Molecular Characterization of Non-Neurogenic and Neurogenic Lower Urinary Tract Dysfunction (LUTD) in SCI-Induced and Partial Bladder Outlet Obstruction Mouse Models.

We examined bladder function following spinal cord injury (SCI) by repeated urodynamic investigation (UDI), including external urethral sphincter (EUS) electromyography (EMG) in awake restrained mice and correlated micturition parameters to gene expression and morphological changes in the bladder. A partial bladder outlet obstruction (pBOO) model was used for comparison to elucidate both the common and specific features of obstructive and neurogenic lower urinary tract dysfunction (LUTD). Thirty female C57Bl/6J mice in each group received an implanted bladder catheter with additional electrodes placed next to the EUS in the SCI group. UDI assessments were performed weekly for 7 weeks (pBOO group) or 8 weeks (SCI group), after which bladders were harvested for histological and transcriptome analysis. SCI mice developed detrusor sphincter dyssynergia (DSD) one week after injury with high-pressure oscillations and a significantly increased maximal bladder pressure Pmax and were unable to void spontaneously during the whole observation period. They showed an increased bladder-to-bodyweight ratio, bladder fibrosis, and transcriptome changes indicative of extracellular matrix remodeling and alterations of neuronal signaling and muscle contraction. In contrast, pBOO led to a significantly increased Pmax after one week, which normalized at later time points. Increased bladder-to-bodyweight ratio and pronounced gene expression changes involving immune and inflammatory pathways were observed 7 weeks after pBOO. Comparative transcriptome analysis of SCI and pBOO bladders revealed the activation of Wnt and TGF-beta signaling in both the neurogenic and obstructive LUTD and highlighted FGF2 as a major upregulated transcription factor during organ remodeling. We conclude that SCI-induced DSD in mice leads to profound changes in neuronal signaling and muscle contractility, leading to bladder fibrosis. In a similar time frame, significant bladder remodeling following pBOO allowed for functional compensation, preserving normal micturition parameters.

Integrating real-world data to assess cardiac ablation device outcomes in a multicenter study using the OMOP common data model for regulatory decisions: implementation and evaluation.

The objective of this study is to describe application of the Observational Medical Outcomes Partnership (OMOP) common data model (CDM) to support medical device real-world evaluation in a National Evaluation System for health Technology Coordinating Center (NESTcc) Test-Case involving 2 healthcare systems, Mercy Health and Mayo Clinic. CDM implementation was coordinated across 2 healthcare systems with multiple hospitals to aggregate both medical device data from supply chain databases and patient outcomes and covariates from electronic health record data. Several data quality assurance (QA) analyses were implemented on the OMOP CDM to validate the data extraction, transformation, and load (ETL) process. OMOP CDM-based data of relevant patient encounters were successfully established to support studies for FDA regulatory submissions. QA analyses verified that the data transformation was robust between data sources and OMOP CDM. Our efforts provided useful insights in real-world data integration using OMOP CDM for medical device evaluation coordinated across multiple healthcare systems.

ISO 15189 is a sufficient instrument to guarantee high-quality manufacture of laboratory developed tests for in-house-use conform requirements of the European In-Vitro-Diagnostics Regulation.

The EU In-Vitro Diagnostic Device Regulation (IVDR) aims for transparent risk-and purpose-based validation of diagnostic devices, traceability of results to uniquely identified devices, and post-market surveillance. The IVDR regulates design, manufacture and putting into use of devices, but not medical services using these devices. In the absence of suitable commercial devices, the laboratory can resort to laboratory-developed tests (LDT) for in-house use. Documentary obligations (IVDR Art 5.5), the performance and safety specifications of ANNEX I, and development and manufacture under an ISO 15189-equivalent quality system apply. LDTs serve specific clinical needs, often for low volume niche applications, or correspond to the translational phase of new tests and treatments, often extremely relevant for patient care. As some commercial tests may disappear with the IVDR roll-out, many will require urgent LDT replacement. The workload will also depend on which modifications to commercial tests turns them into an LDT, and on how national legislators and competent authorities (CA) will handle new competences and responsibilities. We discuss appropriate interpretation of ISO 15189 to cover IVDR requirements. Selected cases illustrate LDT implementation covering medical needs with commensurate management of risk emanating from intended use and/or design of devices. Unintended collateral damage of the IVDR comprises loss of non-profitable niche applications, increases of costs and wasted resources, and migration of innovative research to more cost-efficient environments. Taking into account local specifics, the legislative framework should reduce the burden on and associated opportunity costs for the health care system, by making diligent use of existing frameworks.

An evaluation of lower urinary tract symptoms in diabetic patients: a cross-sectional study.

BACKGROUND: Lower urinary tract symptoms (LUTS) are common among diabetic patients and represent hidden and mysterious morbidity. The pathophysiology of LUTS among diabetes mellitus (DM) patients is multifactorial. Importantly, LUTS is known to cause physical and psychological distress. Thus, this study describes LUTS among DM patients, investigates factors that may associate with it, and assesses the possible relationship between LUTS and the quality of life of diabetics. METHODS: Over 6 months, data were collected from 378 diabetic patients in primary health care clinics. Demographic and clinical characteristics, Urogenital Distress Inventory-6 (UDI-6), and Incontinence Impact Questionnaire-7 (IIQ-7) were used to collect data. Univariate and multivariate analyses were performed. RESULTS: Three hundred seventy-eight participants were included in this study. (29.9%) were (58-67) years old. 49% were female. Half of the cohort was overweight, and a third were obese. 81% were Type 2 DM. Almost all of them are on medical treatment. A median score of 5.50 (2.00-8.00) for the UDI-6 scale and a median score of 5 (0.00-10.00) for the IIQ-7 scale were reported. Multiple linear regression models showed that residency (p = 0.038) and regular exercise (p = 0.001) were significantly and negatively correlated with the UDI-6 score, while female gender (p = 0.042), insulin use (p = 0.009) and the presence of comorbidities (p = 0.007) were positively correlated with this score. Furthermore, age (p = 0.040) and body mass index (BMI) (p < 0.001) were significantly and positively associated with the IIQ-7 score. CONCLUSION: LUTS is significant morbidity among DM patients. Factors such as age, BMI, and co-morbidities exacerbate LUTS, which can be modified and controlled. On the other hand, regular exercise and weight loss strategies help diabetic patients to improve LUTS.

[Exploration and Thinking on Fine Management of Cost Accounting of Medical Consumables].

With the gradual advancement of The Reform Plan to Control High-value Medical Consumables published by the State Council, the reform policies such as purchase with quantity, charging consumables" zero bonus" were born, the operating pressure of medical institutions on medical consumables increased sharply, and the fine cost accounting management demands were improving. Due to the manage features of medical consumables, this will lead to the inaccurate and cross-cycle of cost accounting. In order to achieve the refined cost accounting management, the related business system and process adjustment are studied.

Analysis of the renewed European Medical Device Regulations in the frame of the non - EU regulatory landscape during the COVID facilitated change.

The term "Medical devices" includes technology-based devices or articles, both basic and complex. Due to these types of variations, a strict, robust, transparent, and sustainable regulatory framework is required. In recent clinical practice, incidents including the breast implant and the hip replacement crisis have made it necessary to improve the regulatory and compliance approaches for the industry to ensure the manufacturing and distribution of safe and innovative MDs within the EU. In response to this, the EU revised the laws governing medical devices and in vitro diagnostics to align with the developments of the sector, address critical safety issues and support innovation. The new regulation (EU) 2017/745 on Medical Devices (MDR) is now applicable from May 26 2021 and the In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746 will take effect from May 2022.In this review, we aim to provide an update on the new Medical Device Regulations in the context of the current medical needs of the world, and also to give a glimpse at the non-EU regulatory landscape. Finally, we take a look at the closed-system transfer devices (CSTD) and COVID facilitated changes promoting demand for continuous improvement and trends in the pharmaceutical and medical industry related areas.

The daily urban dynamic indicator: Gauging the urban dynamic in Porto during the COVID-19 pandemic.

The SARS-CoV-2 outbreak motivated the development of a myriad of weekly and daily indicators that track economic activity to estimate and predict the consequences of the pandemic. With some exceptions, these indicators are calculated at the country level and are mainly focused on tracking economic factors, disregarding local urban phenomena. To address this, we present the Urban Dynamic Indicator (UDI), a novel composite indicator designed to measure a city's daily urban dynamic. The UDI is applied to Porto municipality, in Portugal, and it corresponds to a latent factor obtained through a factor analysis over seasonal adjusted daily data regarding traffic intensity, public transportation usage, internet usage in public buses, NO2 emissions and noise level. The UDI's values show that, by the end of 2020, despite the approach of economic activity to its pre-pandemic values, as suggested by the Portuguese Daily Economic Indicator (DEI), Porto urban dynamic did not recover completely. The UDI enriches the information available for Porto city planners and policymakers to respond to crisis situations and to gauge the application of local policies that contribute to urban sustainable planning. Furthermore, the methodology defined in this work can be followed for the development of daily urban dynamic indicators elsewhere.

[Design and Implementation of Medical Consumables Management Information Systems Based on Cloud Server].

There are common problems in realistic medical consumables management such as inconsistent material names, irregular billing, extensive management of sub-warehouse. It is necessary to use information systems to achieve full-process, refined, traceable management of medical consumables. A cloud-based information management system of medical consumables is introduced, which connects consumables access, acceptance, consumption and settlement by matching UDI code, charge code and medical insurance code. The system connects to external systems such as charging system. The system realizes traceable management of full-process from manufacture, supplier to hospital material management department, and finally to consumption department. The management efficiency of medical consumables supply chain is improved.

Advancing Patient Safety Surrounding Medical Devices: A Health System Roadmap to Implement Unique Device Identification at the Point of Care.

BACKGROUND: The US Food and Drug Administration's Unique Device Identification System Rule of 2013 mandated manufacturers to assign unique device identifiers (UDIs) to their medical devices. Most high-risk (Class III), moderate-risk (Class II) and implantable devices now have UDIs. To achieve the necessary next step for a comprehensive UDI-enabled system for patient safety, UDIs must be electronically documented during patient care, a process not routinely done. The purpose of this research was to study the implementation experiences of diverse health systems in order to develop a roadmap for UDI implementation at the point of care. METHODS: Semi-structured interviews were conducted with personnel at health systems that had implemented UDI for implantable devices in their cardiac catheterization labs or operating rooms. Interviews were audio-recorded, transcribed, and analyzed using the framework methodology of Ritchie and Spencer. Data interpretation involved development of a conceptual model and detailed recommendations for UDI implementation. An expert panel evaluated and provided input on the roadmap. RESULTS: Twenty-four interviews at ten health systems were conducted by phone. Participants described implementation steps, factors and barriers impacting implementation. Findings populated a UDI implementation roadmap, that includes Foundational Themes, Key Components, Key Steps, UDI Use, and Outcomes. CONCLUSIONS AND IMPLICATIONS: The UDI implementation roadmap provides a framework for health systems to address the necessary steps and multilevel factors that underpin UDI implementation at the point of care. It is intended to guide and advance routine electronic documentation of UDIs for devices used during clinical care, the critical next step for a comprehensive UDI-enabled system to enhance medical device safety and effectiveness for patients.

Feasibility of capturing real-world data from health information technology systems at multiple centers to assess cardiac ablation device outcomes: A fit-for-purpose informatics analysis report.

OBJECTIVE: The study sought to conduct an informatics analysis on the National Evaluation System for Health Technology Coordinating Center test case of cardiac ablation catheters and to demonstrate the role of informatics approaches in the feasibility assessment of capturing real-world data using unique device identifiers (UDIs) that are fit for purpose for label extensions for 2 cardiac ablation catheters from the electronic health records and other health information technology systems in a multicenter evaluation. MATERIALS AND METHODS: We focused on data capture and transformation and data quality maturity model specified in the National Evaluation System for Health Technology Coordinating Center data quality framework. The informatics analysis included 4 elements: the use of UDIs for identifying device exposure data, the use of standardized codes for defining computable phenotypes, the use of natural language processing for capturing unstructured data elements from clinical data systems, and the use of common data models for standardizing data collection and analyses. RESULTS: We found that, with the UDI implementation at 3 health systems, the target device exposure data could be effectively identified, particularly for brand-specific devices. Computable phenotypes for study outcomes could be defined using codes; however, ablation registries, natural language processing tools, and chart reviews were required for validating data quality of the phenotypes. The common data model implementation status varied across sites. The maturity level of the key informatics technologies was highly aligned with the data quality maturity model. CONCLUSIONS: We demonstrated that the informatics approaches can be feasibly used to capture safety and effectiveness outcomes in real-world data for use in medical device studies supporting label extensions.

[Packaging Related Terms and Their Application in Unique Device Identification System].

This article introduces the significance of packaging for the implementation of Unique Device Identification System (UDI system) and some key terms associated with it. It is further supported by analyzing the important role it plays in building a successful UDI system. This article provides a reference for the related stakeholders to meet the requirement and implement UDI system.

Identification of the Urogenital Distress Inventory-6 and the Incontinence Impact Questionnaire-7 cutoff scores in urinary incontinent women.

PURPOSE: Urogenital Distress Inventory-6 (UDI-6), Incontinence Impact Questionnaire-7 (IIQ-7) and The International Consultation on Incontinence (ICIQ-SF) Short Form are used to diagnose individuals with urinary incontinence (UI) and to assess the impact of the dysfunction on patient quality of life. While ICIQ-SF has fixed cutoff values-UDI-6 and IIQ-7 do not. We aimed to find the cutoff scores for UDI-6 and IIQ-7 in women with UI. METHODS: The study involved 205 women aged between 31 and 83 years-155 with, and 50 without UI symptoms. All participants completed all three questionnaires: ICIQ-SF, UDI-6 and IIQ-7. Patients were categorized according to their ICIQ-SF scores, as symptomatic ICIQ-SF ≥ 6 (n = 134) and asymptomatic ICIQ < 6 (n = 60). The Receiver Operating Characteristics (ROC) curve was used to test how well UDI-6 allowed a discrimination between patients suffering from UI and those who do not. Area under Curve (AUC) statistic was calculated to measure the UDI-6 and IIQ-7 Total Score efficiency. RESULTS: The cutoff values were selected. On the basis of the ROC curve analysis, the UDI-6 Total Score of 33.33 and IIQ-7 Total Score of 9.52 were determined to be the optimal cutoff for distinguishing between symptomatic and asymptomatic women (AUC = 0.94-UDI-6 and 0.91-IIQ-7). CONCLUSIONS: For UDI-6 scores more than 33.33 indicate higher distress caused by UI symptoms. Moreover, the higher impact of UI on health- related quality of life is seen in women who scored 9 or more in the IIQ-7 questionnaire, and such women felt impaired quality of life. Trial registration number NCT04433715, 11.06.2020 "retrospectively registered".

[Application Practice to Determine Structure of UDI-PI in Implementation of UDI System].

The purpose of UDI-PI and related international regulations/guidelines is analyzed. The application practice for the registrant/filing applicant to determine the composition of UDI is given. The article provides reference for the related stakeholders to implement UDI system.

Effects of opioids and benzodiazepines on bladder function of awake restrained mice.

OBJECTIVE: We aimed to study the effects of anaesthetics on bladder function using repeated urodynamic investigation (UDI) including external urethral sphincter (EUS) electromyography (EMG) in awake restrained mice. MATERIALS AND METHODS: Female C57Bl/6J mice underwent either bladder catheter (n=6) or bladder catheter plus electrodes (n=10) implantation next to the EUS. A control group (n=3) was included for histological analysis. Following awake UDI, the effects of midazolam (5 mg/kg) and opioids (fentanyl (50 µg/kg) and hydromorphine (250 µg/kg)) on bladder function were studied. Mice were allowed to recover from drug application for at least one day before being subjected to the next drug and UDI. Bladder weight was assessed and fibrotic changes were analysed by Masson's trichrome staining. RESULTS: EUS-EMG activity during voiding was reduced compared to before and after voiding in baseline measurements. Threshold and maximal detrusor pressure were significantly increased in both midazolam and the opioids. The opioids lead to either a significantly increased bladder filling volume and micturition cycle duration (hydromorphine) or a complete loss of the voiding phase leading to overflow incontinence (fentanyl). Bladder-to bodyweight ratio was significantly increased in both groups with an implanted catheter compared to controls. No differences were observed between the groups with- or without implanted electrodes regarding bladder-to bodyweight ratio, bladder fibrosis and urodynamic parameters. CONCLUSIONS: Repeated UDIs combined with EUS-EMG are feasible in the awake mouse model. The presence of electrodes next to the EUS does not obstruct the bladder outlet. Opioids and benzodiazepines severely interfere with physiological bladder function: fentanyl and hydromorphine disrupted the voiding phase evidenced by the reduced coordination of EUS activity with detrusor contraction, while bladder emptying under midazolam was achieved by EUS relaxation only.

[Design and Development of Medical Equipment Lifecycle Management System Based on Structured Information Flow Architecture].

This paper introduces the design and development of a light-weighted medical equipment management system in hospital based on structured information flow architecture, to collect and analyze data in medical equipment lifecycle management processes. It applies co-operative work flows both online and off-line to achieve high quality data collection, and to increase the efficiency for clinical personals and clinical engineers. This system manages to apply the UDI system, implements the intelligent access to medical equipments, uses data analysis to provide intelligent services. It will boost the quality control management and information construction synchronously.