Provenance Information for Biomedical Data and Workflows: Scoping Review.

BACKGROUND: The record of the origin and the history of data, known as provenance, holds importance. Provenance information leads to higher interpretability of scientific results and enables reliable collaboration and data sharing. However, the lack of comprehensive evidence on provenance approaches hinders the uptake of good scientific practice in clinical research. OBJECTIVE: This scoping review aims to identify approaches and criteria for provenance tracking in the biomedical domain. We reviewed the state-of-the-art frameworks, associated artifacts, and methodologies for provenance tracking. METHODS: This scoping review followed the methodological framework developed by Arksey and O'Malley. We searched the PubMed and Web of Science databases for English-language articles published from 2006 to 2022. Title and abstract screening were carried out by 4 independent reviewers using the Rayyan screening tool. A majority vote was required for consent on the eligibility of papers based on the defined inclusion and exclusion criteria. Full-text reading and screening were performed independently by 2 reviewers, and information was extracted into a pretested template for the 5 research questions. Disagreements were resolved by a domain expert. The study protocol has previously been published. RESULTS: The search resulted in a total of 764 papers. Of 624 identified, deduplicated papers, 66 (10.6%) studies fulfilled the inclusion criteria. We identified diverse provenance-tracking approaches ranging from practical provenance processing and managing to theoretical frameworks distinguishing diverse concepts and details of data and metadata models, provenance components, and notations. A substantial majority investigated underlying requirements to varying extents and validation intensities but lacked completeness in provenance coverage. Mostly, cited requirements concerned the knowledge about data integrity and reproducibility. Moreover, these revolved around robust data quality assessments, consistent policies for sensitive data protection, improved user interfaces, and automated ontology development. We found that different stakeholder groups benefit from the availability of provenance information. Thereby, we recognized that the term provenance is subjected to an evolutionary and technical process with multifaceted meanings and roles. Challenges included organizational and technical issues linked to data annotation, provenance modeling, and performance, amplified by subsequent matters such as enhanced provenance information and quality principles. CONCLUSIONS: As data volumes grow and computing power increases, the challenge of scaling provenance systems to handle data efficiently and assist complex queries intensifies, necessitating automated and scalable solutions. With rising legal and scientific demands, there is an urgent need for greater transparency in implementing provenance systems in research projects, despite the challenges of unresolved granularity and knowledge bottlenecks. We believe that our recommendations enable quality and guide the implementation of auditable and measurable provenance approaches as well as solutions in the daily tasks of biomedical scientists. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.2196/31750.

The Status of Data Management Practices Across German Medical Data Integration Centers: Mixed Methods Study.

BACKGROUND: In the context of the Medical Informatics Initiative, medical data integration centers (DICs) have implemented complex data flows to transfer routine health care data into research data repositories for secondary use. Data management practices are of importance throughout these processes, and special attention should be given to provenance aspects. Insufficient knowledge can lead to validity risks and reduce the confidence and quality of the processed data. The need to implement maintainable data management practices is undisputed, but there is a great lack of clarity on the status. OBJECTIVE: Our study examines the current data management practices throughout the data life cycle within the Medical Informatics in Research and Care in University Medicine (MIRACUM) consortium. We present a framework for the maturity status of data management practices and present recommendations to enable a trustful dissemination and reuse of routine health care data. METHODS: In this mixed methods study, we conducted semistructured interviews with stakeholders from 10 DICs between July and September 2021. We used a self-designed questionnaire that we tailored to the MIRACUM DICs, to collect qualitative and quantitative data. Our study method is compliant with the Good Reporting of a Mixed Methods Study (GRAMMS) checklist. RESULTS: Our study provides insights into the data management practices at the MIRACUM DICs. We identify several traceability issues that can be partially explained with a lack of contextual information within nonharmonized workflow steps, unclear responsibilities, missing or incomplete data elements, and incomplete information about the computational environment information. Based on the identified shortcomings, we suggest a data management maturity framework to reach more clarity and to help define enhanced data management strategies. CONCLUSIONS: The data management maturity framework supports the production and dissemination of accurate and provenance-enriched data for secondary use. Our work serves as a catalyst for the derivation of an overarching data management strategy, abiding data integrity and provenance characteristics as key factors. We envision that this work will lead to the generation of fairer and maintained health research data of high quality.

Prospective Evaluation of Antibiotic Management in Ureteral Stent and Nephrostomy Interventions.

INTRODUCTION: Screening for and treating asymptomatic bacteriuria (ABU) or administering antibiotic prophylaxis is recommended during ureteral stent and nephrostomy interventions. This study investigates the frequency of postinterventional infectious complications to gain insight into the need for antibiotics. METHODS: Between September 2016 and June 2019, 168 insertions/exchanges of ureteral stents or nephrostomies were recorded in a prospective multicenter study. Patients without a symptomatic UTI did not receive antibiotic treatment/prophylaxis. Asymptomatic patients in whom their urologist already administered an antibiotic treatment served as a comparative group. Follow-up included postinterventional complications within 30 days. Symptoms were assessed by the Acute Cystitis Symptom Score (ACSS) before and after the intervention. Predictors of increasing postinterventional symptoms were analyzed by a multivariable logistic regression model. RESULTS: One hundred forty-five interventions were eligible. One hundred twenty-two (84.1%) interventions were performed without antibiotic treatment. Preinterventional ABU was detected in 54.4% and sterile urine in 22.8% (22.8% without culture). Postinterventional infectious complications did not differ between patients with versus without antibiotics. Transurethral interventions aggravate symptoms (p = 0.034) but do not increase infectious complications compared to percutaneous interventions. Patients without diabetes mellitus are at higher risk for increasing symptoms. CONCLUSION: Results indicate that peri-interventional antibiotic treatment may be omitted in patients without symptomatic UTI. Symptoms must be differentiated between infectious and procedure-associated origins.

Single- vs multiple-layer wound closure for flank incisions: results of a prospective, randomised, double-blinded multicentre study.

OBJECTIVE: To compare the incidence of postoperative flank bulges between patients with multiple-layer closure and single superficial-layer closure after retroperitoneal surgery via open flank incision in the SIngle versus MUltiple-LAyer wound Closure for flank incision (SIMULAC) trial. PATIENTS AND METHODS: The study was a randomised controlled, patient- and assessor-blinded, multicentre trial. Between May 2015 and February 2017, 225 patients undergoing flank incisions were randomised 1:1 to a multiple-layer closure (SIMULAC-I) or a single superficial-layer closure (SIMULAC-II) group. The primary outcome was the occurrence of a flank bulge 6 months after surgery. RESULTS: Overall, 177 patients (90 in SIMULAC-I, 87 in SIMULAC-II) were eligible for final assessment. The cumulative incidence of a flank bulge was significantly higher in the SIMULAC-II group (51.7%) compared to the SIMULAC-I group [34.4%; odds ratio (OR) 2.04, 95% confidence interval (CI) 1.11-3.73; P = 0.02]. Rate of severe postoperative complications (4.4% SIMULAC-I vs 10.3% SIMULAC-II; P = 0.21) or hernia (6.7% SIMULAC-I vs 10.3% SIMULAC-II; P = 0.59) was similar between the groups. There was no difference in pain (visual analogue scale) and the requirement for pain medication at 6 months postoperatively. Quality of life assessed with the European Quality of Life 5 Dimensions Questionnaire was higher in the SIMULAC-I group compared to the SIMULAC-II group at 6 months postoperatively, with a (median range) score of 80 (30-100) vs 75 (5-100) (P = 0.012). CONCLUSION: The overall risk of a flank bulge after flank incision is high. Multiple-layer closure after flank incision should be performed as a standard procedure.

Defining the target prior to prostate fusion biopsy: the effect of MRI reporting on cancer detection.

PURPOSE: Definition of targets in multiparametric MRI (mpMRI) prior to MRI/TRUS fusion prostate biopsy either by urologist or radiologist, as a prose report or by illustration is crucial for accurate targeted biopsies (TB). The objective was to analyze the effect of MRI reporting on target definition and cancer detection. METHODS: 202 patients underwent MRI/TRUS fusion biopsy with Artemis™ (Eigen, USA). mpMRI results were submitted in written form to urologists, who marked the targets in the proprietary software. An expert uroradiologist reviewed and marked mpMRI targets blinded to biopsy data. We compared number, localization and volume of targets between the observers and analyzed whether variations impaired TB results by bivariate and logistic regression models. RESULTS: Interobserver variability was moderate regarding number and low regarding localization of targets. Urologists overestimated target volumes significantly compared to radiologists (p = 0.045) and matching target volume between both observers was only 43.9%. Overall cancer detection rate was 69.8 and 52.0% by TB. A higher matching target volume was a significant predictor of cancer in TB (p < 0.001). Logistic regression revealed prostate volume and PI-RADS as independent predictors. Defining targets in incorrect T2w slices in the cranio-caudal axis are one presumable reason for missing cancer in TB. CONCLUSIONS: A high concordance of the target definition between radiologist and urologist is mandatory for accurate TB. Optimized ROI definition is recommended to improve TB results, preferably as contouring in MRI sequences by the radiologist or, if not feasible, by precise MRI reports including specific localization in sequence and slice as well as an illustration. High prostate volume and low PI-RADS score have to be considered as limiting factors for target definition.

Mapping the landscape of urology: A new media-based cross-sectional analysis of public versus academic interest.

OBJECTIVES: To quantify public and academic interest in the urological field using a novel new media-based methodology. METHODS: We systematically measured public and academic interest in 56 urological keywords and combined in nine subspecialties. Public interest was quantified as video views on YouTube. Academic interest was quantified as article citations using Microsoft Academic Search. The public-to-academic interest ratio was calculated for a comparison of subspecialties as well as for diseases and treatments. RESULTS: For the selected 56 urological keywords, we found 226 617 591 video views on YouTube and 2 146 287 citations in the academic literature. The public-to-academic interest ratio was highest for the subspecialties robotic urology (ratio 6.3) and andrological urology (ratio 4.6). Prostate cancer was the central urological disease combining both a high public (20% of all video views) and academic interest (26% of all citations, ratio 0.8). Further diseases/treatments of high public interest were premature ejaculation (ratio 54.4), testicular cancer (ratio 11.4), erectile dysfunction (ratio 5.5) and kidney transplant (ratio 3.7). Urological treatments had a higher public-to-academic interest ratio (median ratio 0.25) than diseases (median ratio 0.05; P = 0.029). CONCLUSIONS: A quantification of academic and public interest in the urological field is feasible using a novel new media-based methodology. We found several mismatches in public versus academic interest in urological diseases and treatments, which has implications for research strategies, conference planning and patient information projects. Regular re-assessments of the public and academic interest landscape can contribute to detecting and proving trends in the field of urology.

Evaluating and Enhancing the Fitness-for-Purpose of Electronic Health Record Data: Qualitative Study on Current Practices and Pathway to an Automated Approach Within the Medical Informatics for Research and Care in University Medicine Consortium.

BACKGROUND: Leveraging electronic health record (EHR) data for clinical or research purposes heavily depends on data fitness. However, there is a lack of standardized frameworks to evaluate EHR data suitability, leading to inconsistent quality in data use projects (DUPs). This research focuses on the Medical Informatics for Research and Care in University Medicine (MIRACUM) Data Integration Centers (DICs) and examines empirical practices on assessing and automating the fitness-for-purpose of clinical data in German DIC settings. OBJECTIVE: The study aims (1) to capture and discuss how MIRACUM DICs evaluate and enhance the fitness-for-purpose of observational health care data and examine the alignment with existing recommendations and (2) to identify the requirements for designing and implementing a computer-assisted solution to evaluate EHR data fitness within MIRACUM DICs. METHODS: A qualitative approach was followed using an open-ended survey across DICs of 10 German university hospitals affiliated with MIRACUM. Data were analyzed using thematic analysis following an inductive qualitative method. RESULTS: All 10 MIRACUM DICs participated, with 17 participants revealing various approaches to assessing data fitness, including the 4-eyes principle and data consistency checks such as cross-system data value comparison. Common practices included a DUP-related feedback loop on data fitness and using self-designed dashboards for monitoring. Most experts had a computer science background and a master's degree, suggesting strong technological proficiency but potentially lacking clinical or statistical expertise. Nine key requirements for a computer-assisted solution were identified, including flexibility, understandability, extendibility, and practicability. Participants used heterogeneous data repositories for evaluating data quality criteria and practical strategies to communicate with research and clinical teams. CONCLUSIONS: The study identifies gaps between current practices in MIRACUM DICs and existing recommendations, offering insights into the complexities of assessing and reporting clinical data fitness. Additionally, a tripartite modular framework for fitness-for-purpose assessment was introduced to streamline the forthcoming implementation. It provides valuable input for developing and integrating an automated solution across multiple locations. This may include statistical comparisons to advanced machine learning algorithms for operationalizing frameworks such as the 3×3 data quality assessment framework. These findings provide foundational evidence for future design and implementation studies to enhance data quality assessments for specific DUPs in observational health care settings.

Designing interactive visualizations for analyzing chronic lung diseases in a user-centered approach.

OBJECTIVES: Medical practitioners analyze numerous types of data, often using archaic representations that do not meet their needs. Pneumologists who analyze lung function exams must often consult multiple exam records manually, making comparisons cumbersome. Such shortcomings can be addressed with interactive visualizations, but these must be designed carefully with practitioners' needs in mind. MATERIALS AND METHODS: A workshop with experts was conducted to gather user requirements and common tasks. Based on the workshop results, we iteratively designed a web-based prototype, continuously consulting experts along the way. The resulting application was evaluated in a formative study via expert interviews with 3 medical practitioners. RESULTS: Participants in our study were able to solve all tasks in accordance with experts' expectations and generally viewed our system positively, though there were some usability and utility issues in the initial prototype. An improved version of our system solves these issues and includes additional customization functionalities. DISCUSSION: The study results showed that participants were able to use our system effectively to solve domain-relevant tasks, even though some shortcomings could be observed. Using a different framework with more fine-grained control over interactions and visual elements, we implemented design changes in an improved version of our prototype that needs to be evaluated in future work. CONCLUSION: Employing a user-centered design approach, we developed a visual analytics system for lung function data that allows medical practitioners to more easily analyze the progression of several key parameters over time.

Prognostic Impact of Anemia and Hemoglobin Levels in Unselected Patients Undergoing Coronary Angiography.

Background/Objectives: This study investigates the prevalence and prognostic impact of concomitant anemia in unselected patients undergoing invasive coronary angiography (CA). The spectrum of patients undergoing CA has significantly changed during the past decades, related to ongoing demographic changes and improved treatment strategies for patients with cardiovascular disease. Methods: Consecutive patients undergoing invasive CA from 2016 to 2022 were retrospectively included at one institution. Patients with anemia (i.e., hemoglobin < 13.0 g/dL for males and <12.0 g/dL for females) were compared with patients without anemia (i.e., nonanemics). The primary endpoint was rehospitalization for heart failure (HF) at 36 months. Secondary endpoints comprised the risk of rehospitalization for acute myocardial infarction (AMI) and coronary revascularization. Statistical analyses included Kaplan-Meier, multivariable Cox proportional regression analyses, and propensity score matching. Results: From 2016 to 2022, 7645 patients undergoing CA were included with a median hemoglobin level of 13.2 g/dL. Anemics had a higher prevalence of coronary artery disease (CAD) (76.3% vs. 74.8%; p = 0.001), alongside an increased need for percutaneous coronary intervention (PCI) (45.3% vs. 41.5%; p = 0.001). At 36 months, the risk of rehospitalization for HF was higher in anemic patients (27.4% vs. 18.4%; p = 0.001; HR = 1.583; 95% CI 1.432-1.750; p = 0.001), which was still evident after multivariable adjustment (HR = 1.164; 95% CI 1.039-1.304; p = 0.009) and propensity score matching (HR = 1.137; 95% CI 1.006-1.286; p = 0.040). However, neither the risk of AMI (8.4% vs. 7.4%, p = 0.091) nor the risk of coronary revascularization at 36 months (8.0% vs. 8.5%, p = 0.447) was higher in anemic compared with nonanemic patients. Conclusions: In consecutive patients undergoing CA, concomitant anemia was independently associated with an increased risk of rehospitalization for HF, but not AMI or coronary revascularization. Patients with LVEF ≥ 35% and multivessel disease were especially susceptible to anemia-induced HF-related rehospitalization.

Prognostic significance of EGFR, AREG and EREG amplification and gene expression in muscle invasive bladder cancer.

Introduction: Muscle invasive bladder cancer (MIBC) remains a prevalent cancer with limited therapeutic options, obviating the need for innovative therapies. The epidermal growth factor receptor (EGFR) is a linchpin in tumor progression and presents a potential therapeutic target in MIBC. Additionally, the EGFR ligands AREG and EREG have shown associations with response to anti-EGFR therapy and improved progression-free survival in colorectal carcinoma. Materials and methods: We investigated the prognostic significance of EGFR, AREG, and EREG in MIBC. Gene expression and copy number analyses were performed via qRT-PCR on tissue samples from 100 patients with MIBC who underwent radical cystectomy at the University Hospital Mannheim (MA; median age 72, interquartile range [IQR] 64-78 years, 25% female). Results were validated in 361 patients from the 2017 TCGA MIBC cohort (median age 69, IQR 60-77 years, 27% female), in the Chungbuk and MDACC cohort. Gene expressions were correlated with clinicopathologic parameters using the Mann-Whitney test, Kruskal-Wallis- test and Spearman correlation. For overall survival (OS), cancer-specific survival (CSS) and disease-free survival (DFS) gene expression was analyzed with Kaplan-Meier and Cox-proportional hazard models. Results: Significant gene expression differences in EGFR, AREG, and EREG could be detected in all cohorts. In the TCGA cohort, EGFR expression was significantly elevated in patients with EGFR amplification and KRAS wildtype. High AREG expression independently predicted longer OS (HR = 0.35, CI 0.19 - 0.63, p = 0.0004) and CSS (HR = 0.42, CI 0.18 - 0.95, p = 0.0378) in the MA cohort. In the TCGA cohort, high EGFR, AREG, and EREG expression correlated with shorter OS (AREG: HR = 1.57, CI 1.12 - 2.20, p = 0.0090) and DFS (EGFR: HR = 1.91, CI 1.31 - 2.8, p = 0.0008). EGFR amplification was also associated with reduced DFS. Discussion: High EGFR and EREG indicate worse survival in patients with MIBC. The prognostic role of AREG should further be investigated in large, prospective series. Divergent survival outcomes between the four cohorts should be interpreted cautiously, considering differences in analysis methods and demographics. Further in vitro investigations are necessary to elucidate the functional mechanisms underlying the associations observed in this study.

Peritoneal Flap for Lymphocele Prophylaxis Following Robotic-assisted Radical Prostatectomy with Lymph Node Dissection: The Randomised Controlled Phase 3 PELYCAN Trial.

BACKGROUND: Symptomatic lymphoceles (SLCs) after transperitoneal robotic-assisted radical prostatectomy with pelvic lymph node dissection (PLND) are common. Evidence from randomised controlled trials (RCTs) on the impact of peritoneal flaps (PFs) on lymphocele (LC) reduction is inconclusive. OBJECTIVE: To show that addition of PFs leads to a reduction of postoperative SLCs. DESIGN, SETTING, AND PARTICIPANTS: An investigator-initiated, prospective, parallel, double-blinded, adaptive, phase 3 RCT was conducted. Recruitment took place from September 2019 until December 2021; 6-month written survey-based follow-up was recorded. Stratification was carried out according to potential LC risk factors (extended PLND, diabetes mellitus, and anticoagulation) and surgeons; 1:1 block randomisation was used. Surgeons were informed about allocation after completion of the last surgical step. INTERVENTION: To create PFs, the ventral peritoneum was incised bilaterally and fixated to the pelvic floor. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: The primary endpoint was SLCs. Secondary endpoints included asymptomatic lymphoceles (ALCs), perioperative parameters, and postoperative complications. RESULTS AND LIMITATIONS: In total, 860 men were screened and 551 randomised. Significant reductions of SLCs (from 9.1% to 3.7%, p = 0.005) and ALCs (27.2% to 10.3%, p < 0.001) over the follow-up period of 6 mo were observed in the intention-to-treat analysis. Operating time was 11 min longer (p < 0.001) in the intervention group; no significant differences in amount (80 vs 103, p = 0.879) and severity (p = 0.182) of postoperative complications (excluding LCs) were observed. The survey-based follow-up might be a limitation. CONCLUSIONS: This is the largest RCT evaluating PF creation for LC prevention and met its primary endpoint, the reduction of SLCs. The results were consistent among all subgroup analyses including ALCs. Owing to the subsequent reduction of burden for patients and the healthcare system, establishing PFs should become the new standard of care. PATIENT SUMMARY: A new technique-creation of bilateral peritoneal flaps-was added to the standard procedure of robotic-assisted prostatectomy for lymph node removal. It was safe and decreased lymphocele development, a common postoperative complication and morbidity. Hence, it should become a standard procedure.

Randomized Controlled Feasibility Trial of Robot-assisted Versus Conventional Open Partial Nephrectomy: The ROBOCOP II Study.

BACKGROUND: There is no evidence from randomized controlled trials (RCTs) comparing robot-assisted partial nephrectomy (RAPN) and open partial nephrectomy (OPN). OBJECTIVE: To assess the feasibility of trial recruitment and to compare surgical outcomes between RAPN and OPN. DESIGN, SETTING, AND PARTICIPANTS: ROBOCOP II was designed as single-center, open-label, feasibility RCT. Patients with suspected localized renal cell carcinoma referred for PN were randomized at a 1:1 ratio to either RAPN or OPN. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: The primary outcome was the feasibility of recruitment, assessed as the accrual rate. Secondary outcomes included perioperative and postoperative data. Data were analyzed descriptively in a modified intention-to-treat population consisting of randomized patients who underwent surgery. RESULTS AND LIMITATIONS: A total of 50 patients underwent RAPN or OPN (accrual rate 65%). In comparison to OPN, RAPN had lower blood loss (OPN 361 ml, standard deviation [SD] 238; RAPN 149 ml, SD 122; difference 212 ml, 95% confidence interval [CI] 105-320; p < 0.001), less need for opioids (OPN 46%; RAPN 16%; difference 30%, 95% CI 5-54; p = 0.024), and fewer complications according to the mean Comprehensive Complication Index (OPN 14, SD 16; RAPN 5, SD 15; difference 9, 95% CI 0-18; p = 0.008). OPN has a shorter operative time (OPN 112 min, SD 29; RAPN 130 min, SD 32; difference -18 min, 95% CI -35 to -1; p = 0.046) and warm ischemia time (OPN 8.7 min, SD 7.1; RAPN 15.4 min, SD 7.0; difference 6.7 min, 95% CI -10.7 to -2.7; p = 0.001). There were no differences between RAPN and OPN regarding postoperative kidney function. CONCLUSIONS: This first RCT comparing OPN and RAPN met the primary outcome of the feasibility of recruitment; however, the window for future RCTs is closing. Each approach has advantages over the other, and both remain safe and effective options. PATIENT SUMMARY: For patients with a kidney tumor, open surgery and robot-assisted keyhole surgery are both feasible and safe approaches for partial removal of the affected kidney. Each approach has known advantages. Long-term follow-up will explore differences in quality of life and cancer control outcomes.

Microbial colonization and ureteral stent-associated storage lower urinary tract symptoms: the forgotten piece of the puzzle?

PURPOSE: Ureteral stents are frequently associated with side effects. Most patients suffer from storage lower urinary tract symptoms (LUTS). Storage LUTS are commonly attributed to the irritation of the trigone, smooth muscle spasm or a combination of factors. The relationship between microbial ureteral stent colonization (MUSC) and de novo or worsening storage LUTS has not been investigated yet. METHODS: Five hundred ninety-one polyurethane ureteral stents from 275 male and 153 female patients were prospectively evaluated. The removed stents were sonicated to dislodge adherent microorganisms. Urine flow cytometry was performed to detect pyuria. A standardized urinary symptom questionnaire was given to all patients. RESULTS: Thirty-five per cent of male and 28% of female cases showed de novo or worsened storage LUTS. MUSC was more common in patients with storage LUTS compared to patients without storage LUTS (men: 26 vs. 13%, respectively, P < 0.05; women: 63 vs. 48%, respectively, P = 0.13). Pyuria was significantly more common in patients with storage LUTS compared to patients without storage LUTS (men: 55 vs. 40%, respectively, P < 0.05; women: 70 vs. 45%, respectively, P < 0.05). No significant correlation was observed between the detected genera of microorganisms and storage LUTS. CONCLUSIONS: Our data show a significant association between MUSC- and stent-related de novo experienced or worsened storage LUTS in men. The incidence of MUSC is most common in both female and male patients with storage LUTS and accompanying pyuria. In these patients, a combination of antibiotics and anti-inflammatory drugs may be regarded as treatment option.

Aquagenic pruritus in polycythemia vera: characteristics and influence on quality of life in 441 patients.

Aquagenic pruritus (AP) is a symptom typical for polycythemia vera, but very little is known about its exact frequency, characteristics, influence on quality of life, and proper treatment. Therefore, we investigated these aspects in a large cohort of German patients with polycythemia vera using a patient directed questionnaire. Our analysis revealed that 301 of 441 analyzed patients suffered from AP. In 64.8%, AP occurred on average 2.9 years prior to diagnosis of polycythemia vera. Only in 15.4% did this lead to a hematological investigation. AP occurs primarily on the trunk and proximal parts of the extremities. Most patients complain about itching (71.8%), the remainder about tickling, stinging, or burning sensations. Forty-four patients (14.6%) classified the pruritus as "unbearable." Patients with AP reported reduced global health status and higher fatigue, pain, and dyspnea. Only 24% of patients received pruritus specific treatment for pruritus consisting mostly of histamine antagonists, which ameliorated symptoms in about half of the patients. In 5.6% of patients, polycythemia vera directed therapy (phlebotomy/cytoreduction) resolved the symptoms. In summary, AP is a serious symptom in patients with polycythemia vera, which until recently was difficult to treat. The advent of the novel JAK2 inhibitors, however, may open new ways for therapy.

Traceable Research Data Sharing in a German Medical Data Integration Center With FAIR (Findability, Accessibility, Interoperability, and Reusability)-Geared Provenance Implementation: Proof-of-Concept Study.

BACKGROUND: Secondary investigations into digital health records, including electronic patient data from German medical data integration centers (DICs), pave the way for enhanced future patient care. However, only limited information is captured regarding the integrity, traceability, and quality of the (sensitive) data elements. This lack of detail diminishes trust in the validity of the collected data. From a technical standpoint, adhering to the widely accepted FAIR (Findability, Accessibility, Interoperability, and Reusability) principles for data stewardship necessitates enriching data with provenance-related metadata. Provenance offers insights into the readiness for the reuse of a data element and serves as a supplier of data governance. OBJECTIVE: The primary goal of this study is to augment the reusability of clinical routine data within a medical DIC for secondary utilization in clinical research. Our aim is to establish provenance traces that underpin the status of data integrity, reliability, and consequently, trust in electronic health records, thereby enhancing the accountability of the medical DIC. We present the implementation of a proof-of-concept provenance library integrating international standards as an initial step. METHODS: We adhered to a customized road map for a provenance framework, and examined the data integration steps across the ETL (extract, transform, and load) phases. Following a maturity model, we derived requirements for a provenance library. Using this research approach, we formulated a provenance model with associated metadata and implemented a proof-of-concept provenance class. Furthermore, we seamlessly incorporated the internationally recognized Word Wide Web Consortium (W3C) provenance standard, aligned the resultant provenance records with the interoperable health care standard Fast Healthcare Interoperability Resources, and presented them in various representation formats. Ultimately, we conducted a thorough assessment of provenance trace measurements. RESULTS: This study marks the inaugural implementation of integrated provenance traces at the data element level within a German medical DIC. We devised and executed a practical method that synergizes the robustness of quality- and health standard-guided (meta)data management practices. Our measurements indicate commendable pipeline execution times, attaining notable levels of accuracy and reliability in processing clinical routine data, thereby ensuring accountability in the medical DIC. These findings should inspire the development of additional tools aimed at providing evidence-based and reliable electronic health record services for secondary use. CONCLUSIONS: The research method outlined for the proof-of-concept provenance class has been crafted to promote effective and reliable core data management practices. It aims to enhance biomedical data by imbuing it with meaningful provenance, thereby bolstering the benefits for both research and society. Additionally, it facilitates the streamlined reuse of biomedical data. As a result, the system mitigates risks, as data analysis without knowledge of the origin and quality of all data elements is rendered futile. While the approach was initially developed for the medical DIC use case, these principles can be universally applied throughout the scientific domain.

Data Quality- and Utility-Compliant Anonymization of Common Data Model-Harmonized Electronic Health Record Data: Protocol for a Scoping Review.

BACKGROUND: The anonymization of Common Data Model (CDM)-converted EHR data is essential to ensure the data privacy in the use of harmonized health care data. However, applying data anonymization techniques can significantly affect many properties of the resulting data sets and thus biases research results. Few studies have reviewed these applications with a reflection of approaches to manage data utility and quality concerns in the context of CDM-formatted health care data. OBJECTIVE: Our intended scoping review aims to identify and describe (1) how formal anonymization methods are carried out with CDM-converted health care data, (2) how data quality and utility concerns are considered, and (3) how the various CDMs differ in terms of their suitability for recording anonymized data. METHODS: The planned scoping review is based on the framework of Arksey and O'Malley. By using this, only articles published in English will be included. The retrieval of literature items should be based on a literature search string combining keywords related to data anonymization, CDM standards, and data quality assessment. The proposed literature search query should be validated by a librarian, accompanied by manual searches to include further informal sources. Eligible articles will first undergo a deduplication step, followed by the screening of titles. Second, a full-text reading will allow the 2 reviewers involved to reach the final decision about article selection, while a domain expert will support the resolution of citation selection conflicts. Additionally, key information will be extracted, categorized, summarized, and analyzed by using a proposed template into an iterative process. Tabular and graphical analyses should be addressed in alignment with the PRISMA-ScR (Preferred Reporting Items for Systematic Reviews and Meta-Analyses Extension for Scoping Reviews) checklist. We also performed some tentative searches on Web of Science for estimating the feasibility of reaching eligible articles. RESULTS: Tentative searches on Web of Science resulted in 507 nonduplicated matches, suggesting the availability of (potential) relevant articles. Further analysis and selection steps will allow us to derive a final literature set. Furthermore, the completion of this scoping review study is expected by the end of the fourth quarter of 2023. CONCLUSIONS: Outlining the approaches of applying formal anonymization methods on CDM-formatted health care data while taking into account data quality and utility concerns should provide useful insights to understand the existing approaches and future research direction based on identified gaps. This protocol describes a schedule to perform a scoping review, which should support the conduction of follow-up investigations. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/46471.

German Version of the mHealth App Usability Questionnaire in a Cohort of Patients With Cancer: Translation and Validation Study.

BACKGROUND: Good usability is important for the adoption and continued use of mobile health (mHealth) apps. In particular, high usability can support intuitive use by patients, which improves compliance and increases the app's effectiveness. However, many usability studies do not use adequate tools to measure perceived usability. The mHealth App Usability Questionnaire (MAUQ) was developed specifically for end users in a medical context. MAUQ is a relatively new but increasingly used questionnaire to evaluate mHealth apps, but it is not yet available in German. OBJECTIVE: This study aims to translate MAUQ into German and determine its internal consistency, reliability, and construct validity. METHODS: This validation study was conducted as part of a usability evaluation project for an mHealth app used as a therapy support tool during breast cancer chemotherapy. MAUQ was translated into German through a rigorous forward-backward translation process, ensuring semantic and conceptual equivalence. Patient responses to MAUQ and System Usability Scale (SUS) were analyzed for validation. Descriptive analysis was performed for the MAUQ subscales and SUS standard scores. Significance tests and correlation coefficients assessed the relationship between the SUS and MAUQ results, confirming construct validity. Internal consistency was assessed for item reliability and consistency in measuring the target construct. Free-text questions assessed translation comprehensibility, with responses analyzed descriptively and qualitatively using content analysis. RESULTS: In this study, 133 participants responded to the questionnaire, and the validation analysis showed substantially positive correlations between the overall MAUQ score and its subscales: ease of use (r=0.56), interface and satisfaction (r=0.75), and usefulness (r=0.83). These findings support the construct validity of MAUQ and emphasize the importance of these subscales in assessing the usability of the Enable app. The correlation coefficients ranging from 0.39 to 0.68 for the items further validate the questionnaire by aligning with the overall score and capturing the intended concept. The high internal consistency reliability of MAUQ (Cronbach α=.81) and its subscales further enhances the instrument's robustness in accurately evaluating the usability of mHealth apps. CONCLUSIONS: We successfully validated the German translation of the MAUQ for stand-alone apps using a standardized approach in a cohort of patients with breast cancer. In our validation study, MAUQ exhibited strong internal consistency reliability (Cronbach α=.81) across its subscales, indicating reliable and consistent measurement. Furthermore, a significant positive correlation (P<.001) was found between the subscales and the overall score, supporting their consistent measurement of the intended construct. Therefore, MAUQ can be considered a reliable instrument for assessing the usability of mHealth apps among German-speaking adults. The availability of the German version of MAUQ will help other researchers in conducting usability studies of mHealth apps in German-speaking cohorts and allow for international comparability of their results.

Lightweight Visual Transformers Outperform Convolutional Neural Networks for Gram-Stained Image Classification: An Empirical Study.

We aimed to automate Gram-stain analysis to speed up the detection of bacterial strains in patients suffering from infections. We performed comparative analyses of visual transformers (VT) using various configurations including model size (small vs. large), training epochs (1 vs. 100), and quantization schemes (tensor- or channel-wise) using float32 or int8 on publicly available (DIBaS, n = 660) and locally compiled (n = 8500) datasets. Six VT models (BEiT, DeiT, MobileViT, PoolFormer, Swin and ViT) were evaluated and compared to two convolutional neural networks (CNN), ResNet and ConvNeXT. The overall overview of performances including accuracy, inference time and model size was also visualized. Frames per second (FPS) of small models consistently surpassed their large counterparts by a factor of 1-2×. DeiT small was the fastest VT in int8 configuration (6.0 FPS). In conclusion, VTs consistently outperformed CNNs for Gram-stain classification in most settings even on smaller datasets.

Triptychon: Usability evaluation and implementation of a web-based application for patients' lab and vital parameters.

Background: A major challenge in healthcare is the interpretation of the constantly increasing amount of clinical data of interest to inpatients for diagnosis and therapy. It is vital to accurately structure and represent data from different sources to help clinicians make informed decisions. Objective: We evaluated the usability of our tool 'Triptychon' - a three-part visualisation dashboard of essential patients' medical data provided by a direct overview of their hospitalisation information, laboratory, and vital parameters over time. Methods: The study followed a cohort of 20 participants using the mixed-methods approach, including interviews and the usability questionnaires, Health Information Technology Usability Evaluation Scale (Health-ITUES), and User Experience Questionnaire (UEQ). The participant's interactions with the dashboard were also observed. A thematic analysis approach was applied to analyse qualitative data and the quantitative data's task completion time and success rates. Results: The usability evaluation of the visualisation dashboard revealed issues relating to the terminology used in the user interface and colour coding in its left and middle panels. The Health-ITUES score was 3.72 (standard deviation (SD) = 1.0), and the UEQ score was 1.6 (SD = 0.74). The study demonstrated improvements in intuitive dashboard use and overall satisfaction with using the dashboard daily. Conclusion: The Triptychon dashboard is a promising new tool for medical data presentation. We identified design and layout issues of the dashboard for improving its usability in routine clinical practice. According to users' feedback, the three panels on the dashboard provided a holistic view of a patient's hospital stay.

Radical Prostatectomy on YouTube: Education or Disinformation?

BACKGROUND: YouTube is the second most popular website worldwide. It features numerous videos about radical prostatectomy. The aim of this study was to assess the quality of these videos and screen their benefit for patients and doctors. METHODS: All videos on YouTube about radical prostatectomy were analysed using a specially developed software (python 2.7, numpy). According to a predefined selection process most relevant videos were analyzed for quality and reliability using Suitability Assessment of Materials (SAM)-Score, Global Quality Score and others. RESULTS: Out of 3520 search results, 179 videos were selected and analysed. Videos were watched a median of 5836 times (interquartile range (IQR): 11945.5; 18-721546). The median duration was 7.2 minutes (min). 125 of the videos were about robotic prostatectomy. 69 videos each were directly addressed to patients and doctors. Medical content generally was of low quality, while technical quality and total quality were at a high level. Reliability was good. CONCLUSIONS: Videos on radical prostatectomy on YouTube allow for patient information. While technical quality and reliability are classified as acceptable, medical content was low and warranted preselection. In contrast to Loeb et al. we did not observe a negative correlation between number of views and scientific quality in different scores. Our findings support the need for preselection of videos on YouTube as the potential benefit may vary between videos with the significant risk of low medical quality.