Personalized Surgical Management Offers Full Restitution and Unimpaired Quality of Life to Patients with Duplex Kidneys and Associated Pathologies: 30-year Follow-up at a Tertiary Referral Center.

Background: Duplex kidneys may be associated with additional pathologies with an indication for surgery. Various surgical approaches have been described. However, little is known about long-term outcomes and quality of life (QoL) for these patients. Objective: To present long-term outcomes and QoL data up to 30 yr after surgical treatment of duplex kidneys and associated pathologies. Design setting and participants: We collected clinical and operative data for all patients who underwent surgery for complicated duplex kidney at our institution from 1990 to 2018. All patients were invited for a follow-up examination or telephone interview. Outcome measurements and statistical analysis: We evaluated renal function, clinical outcomes, residual dilation of the upper urinary tract, and health-related QoL. Results and limitations: Of the 176 patients included, 173 were available for follow-up (mean 140.5 mo). Surgical treatment involved an upper-tract, lower-tract, or combined approach in 11%, 56%, and 33% of cases, respectively. Rates of perioperative complications (8%) and secondary surgery (10%) were low. Overall, 95% of our patients achieved full restitution. Renal function was preserved in all cases, with recurrent urinary tract infections reported by just 2% and urinary incontinence by 1%. Good health-related QoL was reported by 98% of patients. Those without full restitution included six patients who underwent total nephrectomy and two boys who underwent multiple surgeries and urinary diversion. Our results are limited by their retrospective nature, including partly incomplete data sets. Conclusions: Management of duplex kidneys and associated pathologies is complex and highly individual. By planning a personal approach for each patient it is possible to achieve full bodily integrity and good QoL for most of these patients. Patient summary: Almost all patients undergoing surgery for duplex kidneys and associated pathologies will lead a life without body impairment and good quality of life.This trial is registered in the German Clinical Trials Register as DRKS00022542.

Totally tubeless, tubeless, and tubed percutaneous nephrolithotomy for treating kidney stones.

BACKGROUND: Percutaneous nephrolithotomy (PNL) is the standard of care for removing large kidney stones (> 2 cm). Once the procedure is complete, different exiting strategies exist to manage the percutaneous tract opening, including placement of an external nephrostomy tube, placement of an internal ureteral stent, or no external or internal tube. The decision to place or not place a tube is handled differently among clinicians and may affect patient outcomes. OBJECTIVES: To assess the effects of tubeless PNL (with ureteral stenting), totally tubeless PNL (without ureteral stenting or nephrostomy), and standard PNL (nephrostomy only) for the treatment of kidney stones in adults. SEARCH METHODS: We performed a systematic literature search in multiple biomedical databases (CENTRAL, MEDLINE, Embase, Web of Science), as well as in two clinical trial registries. We also handsearched reference lists of relevant publications and conference proceedings. We applied no language restrictions. The latest search update was conducted in September 2022. SELECTION CRITERIA: We included randomized controlled and quasi-randomized controlled trials of adult patients who received tubeless, totally tubeless, or standard PNL for treating kidney stones. We defined tubeless PNL as no nephrostomy tube, but ureteral stenting, while totally tubeless PNL meant no nephrostomy tube or ureteral stenting. Both interventions were compared to standard PNL with placement of a nephrostomy tube (only). We considered access tubes of any sizes. We only considered unilateral PNL with single-tract access. There were no exclusions on stone composition, size, or location. DATA COLLECTION AND ANALYSIS: Two review authors independently screened the literature, extracted data, assessed risk of bias, and rated the certainty of evidence using GRADE. Primary outcomes were severe adverse events and postoperative pain, and secondary outcomes were operating time, length of hospital stay, and stone-free rate. We used the random-effects model for meta-analysis. MAIN RESULTS: We included 10 studies in the review. Participant age varied among studies, ranging from 20 to 60 years. Detailed information on stone characteristics was rarely presented. Tubeless PNL versus standard PNL We are very uncertain whether there is a difference in severe adverse events (SAEs) between tubeless PNL and standard PNL (risk ratio (RR) 1.53, 95% confidence interval (CI) 0.14 to 16.46; I2 = 42%; 2 studies, 46 participants; very low-certainty evidence). Tubeless PNL may have little to no effect on pain on postoperative day one (mean difference (MD) 0.56 lower, 95% CI 1.34 lower to 0.21 higher; I2 = 84%; 4 studies, 186 participants; low-certainty evidence), and probably results in little to no difference in operating room time (MD 0.40 longer (in minutes), 95% CI 4.82 shorter to 5.62 longer; I2 = 0%; 3 studies, 81 participants; moderate-certainty evidence). Tubeless PNL may reduce length of hospital stay (MD 0.90 shorter, 95% CI 1.45 shorter to 0.35 shorter; I2 = 84%; 6 studies, 238 participants; low-certainty evidence). We are very uncertain of the effect of tubeless PNL on blood transfusions (RR 0.64, 95% CI 0.16 to 2.52; I2 = 0%; 4 studies, 161 participants; very low-certainty evidence), sepsis or fever (RR 0.50, 95% CI 0.05 to 4.75; I2 = not applicable; 2 studies, 82 participants; very low-certainty evidence), or readmissions (RR 1.00, 95% CI 0.07 to 14.21; I2 = not applicable, 1 study, 24 participants; very low-certainty evidence). Totally tubeless versus standard PNL Totally tubeless PNL may result in lower SAE rates (RR 0.49, 95% CI 0.19 to 1.25; I2 = 0%; 2 studies, 174 participants; low-certainty evidence) and pain on postoperative day one (MD 3.60 lower, 95% CI 4.24 lower to 2.96 lower; I2 = Not applicable; 1 study, 50 participants; low-certainty evidence). Totally tubeless PNL may result in little to no difference in operating room time (MD 6.23 shorter (in minutes), 95% CI 14.29 shorter to 1.84 longer; I2 = 72%; 2 studies, 174 participants; moderate-certainty evidence) and sepsis or fever (RR 0.33, 95% CI 0.01 to 7.97; I2 = not applicable; 1 study, 90 participants; low-certainty evidence). Totally tubeless PNL likely shortens the length of hospital stay (MD 1.55 shorter, 95% CI 1.82 shorter to 1.29 shorter; I2 = 0%; 4 studies, 274 participants; moderate-certainty evidence). We are very uncertain of the effect of totally tubeless PNL on blood transfusions (RR 0.62, 95% CI 0.26 to 1.48; I2 = 0%; 4 studies, 274 participants; very low-certainty evidence) or readmissions (RR not estimable, 95% CI not estimable; I2 = not applicable; 1 study, 50 participants; very low-certainty evidence). We found no studies comparing tubeless mini versus standard mini-PNL or totally tubeless mini versus standard mini-PNL. AUTHORS' CONCLUSIONS: When comparing tubeless to standard PNL with regard to the predefined primary outcomes of this review, there may be little difference in early postoperative pain, while we are very uncertain of the effect on SAEs. People treated with tubeless PNL may benefit from a reduced length of stay compared to standard PNL. When comparing totally tubeless to standard PNL, early postoperative pain and severe adverse events may be reduced with totally tubeless PNL. The certainty of evidence by outcome was mostly very low (range: moderate to very low) for the comparison of tubeless to standard PNL and low (range: moderate to very low) for the comparison of totally tubeless to standard PNL. The most common reasons for downgrading the certainty of the evidence were study limitations, inconsistency, and imprecision. We did not find randomized trial evidence for other comparisons. Overall, further and higher-quality studies are needed to inform clinical practice.

Novel thiazolopyridine derivatives of diflapolin as dual sEH/FLAP inhibitors with improved solubility.

Inflammatory responses are orchestrated by a plethora of lipid mediators, and perturbations of their biosynthesis or degradation hinder resolution and lead to uncontrolled inflammation, which contributes to diverse pathologies. Small molecules that induce a switch from pro-inflammatory to anti-inflammatory lipid mediators are considered valuable for the treatment of chronic inflammatory diseases. Commonly used non-steroidal anti-inflammatory drugs (NSAIDs) are afflicted with side effects caused by the inhibition of beneficial prostanoid formation and redirection of arachidonic acid (AA) into alternative pathways. Multi-target inhibitors like diflapolin, the first dual inhibitor of soluble epoxide hydrolase (sEH) and 5-lipoxygenase-activating protein (FLAP), promise improved efficacy and safety but are confronted by poor solubility and bioavailability. Four series of derivatives bearing isomeric thiazolopyridines as bioisosteric replacement of the benzothiazole core and two series additionally containing mono- or diaza-isosteres of the phenylene spacer were designed and synthesized to improve solubility. The combination of thiazolo[5,4-b]pyridine, a pyridinylen spacer and a 3,5-Cl2-substituted terminal phenyl ring (46a) enhances solubility and FLAP antagonism, while preserving sEH inhibition. Moreover, the thiazolo[4,5-c]pyridine derivative 41b, although being a less potent sEH/FLAP inhibitor, additionally decreases thromboxane production in activated human peripheral blood mononuclear cells. We conclude that the introduction of nitrogen, depending on the position, not only enhances solubility and FLAP antagonism (46a), but also represents a valid strategy to expand the scope of application towards inhibition of thromboxane biosynthesis.

Cross-Registry Benchmarking of Data Quality: Lessons Learned.

Feedback of data quality measures to study sites is an established procedure in the management of registries. Comparisons of data quality between registries as a whole are missing. We implemented a cross-registry benchmarking of data quality within the field of health services research for six projects. Five (2020) and six (2021) quality indicators were selected from a national recommendation. The calculation of the indicators was adjusted to the registries' specific settings. Nineteen (2020) and 29 results (2021) could be included in the yearly quality report. Seventy-four per cent (2020) and 79% (2021) of the results did not include the threshold in their 95%-confidence-limits. The benchmarking revealed several starting points for a weak-point analysis through a comparison of results with a predefined threshold as well as through comparisons among each other. In the future, a cross-registry benchmarking might be part of services provided through a health services research infrastructure.

Synthesis and structure-activity relationships for some novel diflapolin derivatives with benzimidazole subunit.

A series of derivatives of the potent dual soluble epoxide hydrolase (sEH)/5-lipoxygenase-activating protein (FLAP) inhibitor diflapolin was designed, synthesised, and characterised. These novel compounds, which contain a benzimidazole subunit were evaluated for their inhibitory activity against sEH and FLAP. Molecular modelling tools were applied to analyse structure-activity relationships (SAR) on both targets and to predict solubility and gastrointestinal (GI) absorption. The most promising dual inhibitors of these series are 5a, 6b, and 6c.

A nationwide registry for recurrent urolithiasis in the upper urinary tract - The RECUR study protocol.

BACKGROUND: Urinary stone disease is a widespread disease with tremendous impact on those affected and on societies around the globe. Nevertheless, clinical and health care research in this area seem to lag far behind cardiovascular diseases or cancer. This may be due to the lack of an immediate deadly threat from the disease and therefore less public and professional interest. However, the patients suffer from recurring, sometimes intense pain and often must be treated in hospital. Long-term morbidity includes doubled rates of chronic kidney disease and arterial hypertension after at least one stone-related event. Observational studies, more specifically, registries and other electronic data sets have been proposed as a means of filling critical gaps in evidence. We propose a nationwide digital and fully automated registry as part of the German Ministry for Education and Research (BMBF) call for the "establishment of model registries". METHODS: RECUR builds on the technical infrastructure of Germany's Medical Informatics Initiative. Local data integration centres (DIC) of participating medical universities will collect pseudonymized and harmonized data from respective hospital information systems. In addition to their clinical data, participants will provide patient reported outcomes using a mobile patient app. Scientific data exploration includes queries and analysis of federated data from DICs of eleven participating sites. All primary patient data will remain at the participating sites at all times. With comprehensive data from this longitudinal registry, we will be able to describe the disease burden, to determine and validate risk factors, and to evaluate treatments. Implementation and operation of the RECUR registry will be funded by the BMBF for five years. Subsequently, the registry is to be continued by the German Society of Urology without significant costs for study personnel. DISCUSSION: The proposed registry will substantially improve the structural and procedural framework for patients with recurrent urolithiasis. This includes advanced diagnostic algorithms and treatment pathways. The registry will help us identify those patients who will most benefit from specific interventions to prevent recurrences. The RECUR study protocol and the registry's technical architecture including full digitalization and automation of almost all registry-associated proceedings can be transferred to future registries. TRIAL REGISTRATION: This study is registered at the German Clinical Trial Register (Deutsches Register Klinischer Studien), DRKS-ID DRKS00026923 , date of registration January, 11th 2022.

Metadata Definition in Registries: What Is a Data Element?

Observational research benefits from a rich methodological foundation of registry development and operation published in international and national guidelines. Metadata management is an essential part of registry implementation based on concepts of data elements and value sets. The metadata from six German registries revealed vastly divergent interpretations of the concept of data elements. The different perspectives of research questions, data acquisition and data storage were all represented in the registries' catalogs of data elements. Consequently, the whole life cycle of a registry needs to be accompanied by a catalog of data elements, which has to be continuously adapted to the changing perspectives. A standard for the representation of those metadata is still missing. The FAIR Guiding Principles introduce important methodological requirements, but the tools for their fulfillment in respect to the management of metadata are still in its infancy.

Thermal effects of thulium: YAG laser treatment of the prostate-an in vitro study.

PURPOSE: To objectively determine whether there is potential thermal tissue damage during Tm:YAG laser-based LUTS treatment. METHODS: Our experimental model was comprised of a prostatic resection trainer placed in a 37 °C water bath. In a hollowed-out central area simulating the urethral lumen, we placed a RigiFib 800 fibre, irrigation inflow regulated with a digital pump, and a type K thermocouple. A second thermocouple was inserted 0.5/1 cm adjacently and protected with an aluminum barrier to prevent it from urethral fluid. We investigated continuous and intermittent 120 W and 80 W laser application with various irrigation rates in eight measurement sessions lasting up to 14 min. Thermal measurements were recorded continuously and in real-time using MatLab. All experiments were repeated five times to balance out variations. RESULTS: Continuous laser application at 120 W and 125 ml/min caused a urethral ∆T of ~ 15 K and a parenchymal temperature increase of up to 7 K. With 50 ml/min irrigation, a urethral and parenchymal ∆T of 30 K and 15 K were reached, respectively. Subsequently and in absence of laser application, prostatic parenchyma needed over 16 min to reach baseline body temperature. At 80 W lower temperature increases were reached compared to similar irrigation but higher power. CONCLUSIONS: We showed that potentially harming temperatures can be reached, especially during high laser power and low irrigation. The heat generation can also be conveyed to the prostate parenchyma and deeper structures, potentially affecting the neurovascular bundles. Further clinical studies with intracorporal temperature measurement are necessary to further investigate this potentially harming surgical adverse effect.

Feasibility of an Updated Randomised Controlled Trial on Surgical Urolithiasis Treatments: The Pilot Trial for the German Endoscopic versus Shock Wave Therapy Study (GESS).

Data comparing treatments for urolithiasis are often outdated, with inconsistent results or poor methodological and reporting quality. We report a pilot study in preparation for a larger multicentre randomised controlled trial (RCT) comparing shockwave therapy and ureteroscopy in patients with a single urinary stone of ≤20 mm in the upper urinary tract. Primary objectives included screening completeness, patients' willingness to participate, their remaining in the study, the suitability of the eligibility criteria, and the acceptability of the outcome measures. Screened individuals not invited to participate were those with no indication for active treatment among referred patients (n = 166), those who staff failed to screen (n = 99), and patients not meeting the inclusion criterion of a single stone (n = 422). Of the 176 patients invited, 116 refused to participate. Ultimately, we were able to recruit 60 patients within 34 mo. All patients underwent their allocated treatments. This pilot trial provides an in-depth analysis of the feasibility of an RCT on surgical treatments for upper urinary tract urolithiasis in a highly regulated health care system. The study procedures and outcome measures proved acceptable and feasible. On the basis of these data, we propose a pragmatic, multicentre RCT to deliver updated, high-level evidence on the efficacy of currently available treatments for urolithiasis. PATIENT SUMMARY: We performed a small pilot trial comparing current treatments in urolithiasis. We were able to prove the feasibility of a larger multi-institutional trial with regard to the time needed to recruit an adequate number of patients and the acceptability of the treatments and outcome measures.

[RECUR - Establishment of An Automated Digital Registry for Patients with Recurrent Stones in the Upper Urinary Tract]. / RECUR ­ Aufbau eines automatisierten digitalen Registers für Patient*innen mit rezidivierenden Steinen des oberen Harntraktes.

Kidney stones, like cardiovascular diseases and diabetes mellitus, affect a large number of people. Patients suffer from acute pain, repeated hospitalizations and associated secondary diseases, such as arterial hypertension and renal insufficiency. This results in considerable costs for the society and its health care system. The recurrence rate is as high as 50%. The registry for RECurrent URolithiasis (RECUR) aims to fill existing evidence gaps. The prospective and longitudinal RECUR registry is funded by the German Ministry of Education and Science (BMBF). It is based on the digital infrastructure of the German Medical Informatics Initiative (MII). RECUR aims to include patients that have suffered from more than one stone occurrence and treated at any one of the ten participating university hospitals of the MIRACUM consortium. The intention is to obtain new information on risk factors and to evaluate different diagnosis and treatment algorithms. Along with the data form the patient's Electronic Health Records (EHR), the RECUR project will also collect Patient Reported Outcomes data from patients with recurrent kidney stones. These data will be collected at participating sites using digital questionnaires via a smartphone app. These data will be merged with medical data from the hospital information systems and saved in the MII research data repositories. The RECUR registry has a model character due to its fully federated, digital approach. This allows the recruitment of many patients, the collection of a wide range of data and their processing with low administrative and personnel costs.

Management and endovascular therapy of ureteroarterial fistulas: experience from a single center and review of the literature.

BACKGROUND: Ureteroarterial fistula (UAF) is a rare but potentially life threatening disease. The aim of this study was to evaluate the outcome of endovascular therapy for UAF treatment. METHODS: This retrospective case series evaluates a single center experience of percutaneous stent graft (SG) angioplasty and/or coil embolization for UAF. Patient follow-up included technical and early clinical success, complications and revisional procedures. We also conducted a systematic review of the literature reporting on endovascular UAF management. RESULTS: We identified 17 UAF in 16 patients (12 male, 4 female, mean age 69.8 ± 11.3 years) who underwent endovascular UAF therapy at our tertiary hospital. All patients presented with hematuria. 5/17 (29.4%) presented with flank pain, in 7 (41.2%) cases patients were in hypovolemic shock. Risk factors of UAF included chronic indwelling ureteral stents in all fistulas, major pelvic surgery in 13 cases (76.5%). In 6 cases (35.3%) SG were placed from the common iliac artery (CIA) to the external iliac artery (EIA) following coil embolization of the proximal internal iliac artery (IIA). SG placement without previous coil embolization was performed in 10 fistulas (58.8%). In one case only coil embolization of the IIA was performed. Mean follow-up was 654 (range: 1-3269) days. All procedures were technically successful and no procedure related deaths occurred during follow-up. During the initial hospital stay hematuria disappeared in 14/17 cases (82.4%). Overall, four patients suffered recurrent hematuria, which in three cases resolved after a secondary intervention. One recurrent UAF related death occurred during follow-up 229 days after initial treatment. A total of 152 UAF cases were additionally analyzed from our systematic literature review: SG placement with or without embolization was performed in 140 cases (92.1%) while embolization alone was done in 12 cases (7.9%). Complications included UAF recurrence (18/152, 11.8%), SG thrombosis (7/140, 5%), and SG infections (5/140, 3.6%) with an overall complications rate of 13.8%. Five patients died due to UAF (3.3%). CONCLUSION: Endovascular therapy offers high technical success rates and rapid bleeding control of UAF. Severe complications like SG occlusions or SG infections are rare but significant. Antibiotic treatment and single anti-platelet therapy improve SG durability as well as close and long follow-up to timely perform repeated endovascular or surgical treatment if necessary. EVIDENCE-BASED MEDICINE: Level 4, case series.

Radiation exposure during retrograde intrarenal surgery (RIRS): a prospective multicenter evaluation.

PURPOSE: Retrograde intrarenal surgery (RIRS) may require extensive X-ray usage. We evaluated the impact of preoperative surgeon briefing regarding the inclusion and evaluation of fluoroscopy time (FT) and dose area product (DAP) in a multicenter study on the applied X-ray usage. METHODS: A prospective multicenter study of 6 tertiary centers was performed. Each center recruited up to 25 prospective patients with renal stones of any size for RIRS. Prior to study´s onset, all surgeons were briefed about hazards of radiation and on strategies to avoid high doses in RIRS. Prospective procedures were compared to past procedures, as baseline data. FT was defined as the primary outcome. Secondary parameters were stone-free rate (SFR), complications according to the Clavien, SATAVA and postureteroscopic lesion scale. Results were analyzed using T test, chi-squared test, univariate analysis and confirmed in a multivariate regression model. RESULTS: 303 patients were included (145 retro- and 158 prospective). Mean FT and DAP were reduced from 130.8 s/565.8 to 77.4 s/357.8 (p < 0.05). SFR was improved from 85.5% to 93% (p < 0.05). Complications did not vary significantly. Neither stone position (p = 0.569), prestenting (p = 0.419), nor surgeons' experience (> 100 RIRS) had a significant impact on FT. Significant univariate parameters were confirmed in a multivariate model, revealing X-ray training to be radiation protective (OR - 44, p = 0.001). CONCLUSIONS: Increased surgeon awareness of X-ray exposure risks has a significant impact on FT and DAP. This "awareness effect" is a simple method to reduce radiation exposure for the patient and OR staff without the procedures´ outcome and safety being affected.

Thermal effects of Ho:YAG laser lithotripsy during retrograde intrarenal surgery and percutaneous nephrolithotomy in an ex vivo porcine kidney model.

PURPOSE: To evaluate the thermal effect of high-power holmium:yttrium-aluminum-garnet (Ho:YAG) laser lithotripsy in flexible/semirigid ureteroscopy (fURS/sURS) and percutaneous nephrolithotomy (PNL) in a standardized ex vivo porcine kidney model with real-time temperature assessment. METHODS: The experimental setup consisted of three models designed to evaluate the thermal effects of Ho:YAG laser lithotripsy in fURS, sURS and PNL, respectively. In all setups, a postmortem porcine kidney was placed in a 37 °C water bath. Three thermocouples were inserted into the renal parenchyma while a flexible thermocouple was placed 3-4 mm proximal to the laser fiber to measure temperature variations in the collecting system. The thermal impact was evaluated in relation to laser power between 5 and 100 W and various irrigation rates (37 °C, 0-100 ml/min). RESULTS: In all three experimental setups, sufficient irrigation was required to prevent potentially damaging temperatures into the renal pelvis and parenchyma. Even 5 W in fURS can lead to a potentially harming temperature rise if insufficient irrigation is applied. Particularly, high-power settings ≥ 30 W carry an elevated risk for critical temperature rises. The results allow the definition of a specific irrigation threshold for any power setting to prevent critical temperatures in the present study design. CONCLUSIONS: Ho:YAG laser lithotripsy bears the risk of thermal damages to the urinary tract even at low-power settings if inadequate irrigation is applied. Sufficient irrigation is mandatory to perform safe Ho:YAG laser lithotripsy. Based on the results, we developed a formula calculating the approximate ΔT for irrigation rates ≥ 30 ml/min: ΔT = 15 K × (power [W]/irrigation [ml/min]).

Stone-Free Rate after Treating Kidney Stones Exceeding 10 mm via Flexible Ureteroscopy: Can Endoscopic Assessment Replace Low-Dose Computed Tomography Control?

INTRODUCTION: It is unclear whether endoscopic assessment of the stone-free rate after flexible ureteroscopy (fURS) is as effective as assessment with low-dose computed tomography (CT) scan. METHODS: Prospective documentation of patients with kidney stones > 10 mm diameter from 2 different centers (Freiburg, Regensburg), who underwent fURS and were declared to be endoscopically completely stone-free. Low-dose CT control performed 4-8 weeks postoperatively. RESULTS/CONCLUSION: Thirty-eight patients were treated between October 2015 and August 2016 (12 F, 26 M). Average age was 55.9 years (range 19-82, SD 17.24), and body mass index was 29.7 kg/m2 (range 23.5-42.5, SD 4.37). There were 2.0 (range 1-7, SD 1.55) stones with a mean diameter of 15 mm (range 10-40, SD 6.78) per kidney. Mean surgery time was 74 min (range 38-124, SD 24.28), and lithotripsy was necessary in 33 cases. CT was performed 5.4 weeks afterwards (range 4-8, SD 1.43). One patient had a 2 mm residual which was extracted by URS. Strictly speaking, endoluminal stone removal control failed in only that patient, yielding a negative predictive value of 97%. A routine postoperative CT scan would thus appear unnecessary in the case of negative endoscopic control for residual fragments and should be avoided to reduce radiation exposure. Further investigations with larger patient populations are necessary.

Concept to gain trust for a German personal health record system using public cloud and FHIR.

OBJECTIVE: Although a national Personal Health Record (PHR) infrastructure was supposed to have been introduced in Germany by law in 2006 and different providers are entering the market, no system has yet been widely adopted in Germany. There is also little information available on how current technical advancements affect German patients' and physicians' trust in PHR systems. METHODS: Supporting scenarios obtained from clinicians, this study proposes a concept for a German PHR system using a public cloud infrastructure, smartphone access and focusing on trust, privacy, and interoperability. In advance to an eventual implementation, a multi-center questionnaire study has been conducted to predict patients' and physicians' intention to use that system and evaluate their trust in different providers of such a system. RESULTS: Our results show that both patients and physicians are highly likely to use the PHR based on the present concept. Trust in healthcare providers exceeds trust in other institutions like private companies, health insurance companies, or even governmental institutions when offering such a PHR system. CONCLUSIONS: We recommend the implementation of this PHR system. To maximize patients' and physicians' trust in the system, it should be offered to patients by their healthcare provider. Further evaluation regarding its actual adoption and expected improvement in patient outcome based on the scenarios is advisable.

Synthesis, Biological Evaluation and Structure-Activity Relationships of Diflapolin Analogues as Dual sEH/FLAP Inhibitors.

A series of derivatives of the potent dual soluble epoxide hydrolase (sEH)/5-lipoxygenase-activating protein (FLAP) inhibitor diflapolin was designed, synthesized, and characterized by 1H NMR, 13C NMR, and elemental analysis. These novel compounds were biologically evaluated for their inhibitory activity against sEH and FLAP. Molecular modeling tools were applied to analyze structure-activity relationships (SAR) on both targets. Results show that even small modifications on the lead compound diflapolin markedly influence the inhibitory potential, especially on FLAP, suggesting very narrow SAR.

How to compete with Google and Co.: big data and artificial intelligence in stones.

PURPOSE OF REVIEW: To elucidate the keywords big data and artificial intelligence and corresponding literature in the field of urolithiasis. RECENT FINDINGS: Numbers of publications on big data and artificial intelligence in the field of urolithiasis are rising, but still low. Most publications describe the development, testing, and validation of automated computational analyses of clinical data sets and/or images in a preclinical setting. SUMMARY: In the field of digital health services, there is a discrepancy between the enormous commitment of large private companies and investments of public funds. This situation means a still small number of medical publications on this topic in the urolithiasis field. Nevertheless, as doctors and scientists, we should try to provide our patients with secure and worthwhile digital services.

Validating Automated Kidney Stone Volumetry in CT and Mathematical Correlation with Estimated Stone Volume Based on Diameter.

OBJECTIVES: To validate AutoMated UroLithiasis Evaluation Tool (AMULET) software for kidney stone volumetry and compare its performance to standard clinical practice. MATERIALS AND METHODS: Maximum diameter and volume of 96 urinary stones were measured as reference standard by three independent urologists. The same stones were positioned in an anthropomorphic phantom and CT scans acquired in standard settings. Three independent radiologists blinded to the reference values took manual measurements of the maximum diameter and automatic measurements of maximum diameter and volume. An "expected volume" was calculated based on manual diameter measurements using the formula: [Formula: see text] Results: Ninety-six stones were analyzed in the study. We had initially aimed to assess 100. Nine were replaced during data acquisition due of crumbling and four had to be excluded because the automated measurement did not work. Mean reference maximum diameter was 13.3 mm (5.2-32.1 mm). Correlation coefficients among all measured outcomes were compared. The correlation between the manual and automatic diameter measurements to the reference was 0.98 and 0.91, respectively (p < 0.001). Mean reference volume was 1200 mm3 (10-9000 mm3). The correlation between the "expected volume" and automatically measured volume to the reference was 0.95 and 0.99, respectively (p < 0.001). CONCLUSIONS: Patients' kidney stone burden is usually assessed according to maximum diameter. However, as most stones are not spherical, this entails a potential bias. Automated stone volumetry is possible and significantly more accurate than diameter-based volumetric calculations. To avoid bias in clinical trials, size should be measured as volume. However, automated diameter measurements are not as accurate as manual measurements.

Thermal effects of Ho: YAG laser lithotripsy: real-time evaluation in an in vitro model.

PURPOSE: To evaluate the thermal effect of Ho:YAG laser lithotripsy in a standardized in vitro model via real-time temperature measurement. METHODS: Our model comprised a 20 ml test tube simulating the renal pelvis that was immersed in a 37 °C water bath. Two different laser fibers [FlexiFib (15-45 W), RigiFib 1000 (45-100 W), LISA laser products OHG, Katlenburg-Lindau, Germany] were placed in the test tube. An Ho:YAG 100 W laser was used in all experiments (LISA). Each experiment involved 120 s of continuous laser application, and was repeated five times. Different laser settings (high vs. low frequency, high vs. low energy, and long vs. short pulse duration), irrigation rates (0 up to 100 ml/min, realized by several pumps), and human calcium oxalate stone samples were analyzed. Temperature data were acquired by a real-time data logger with thermocouples (PICO Technology, Cambridgeshire, UK). Real-time measurements were assessed using MatLab®. RESULTS: Laser application with no irrigation results in a rapid increase in temperature up to ∆28 K, rising to 68 °C at 100 W. Low irrigation rates yield significantly higher temperature outcomes. Higher irrigation rates result immediately in a lower temperature rise. High irrigation rates of 100 ml/min result in a temperature rise of 5 K at the highest laser power setting (100 W). CONCLUSIONS: Ho:YAG laser lithotripsy might be safe provided that there is sufficient irrigation. However, high power and low irrigation resulted in potentially tissue-damaging temperatures. Laser devices should, therefore, always be applied in conjunction with continuous, closely monitored irrigation whenever performing Ho:YAG laser lithotripsy.

Combined prostatic urethral lift and remodeling of the prostate and bladder neck: a modified transurethral approach in the treatment of symptomatic lower urinary tract obstruction.

PURPOSE: The aim of the study was to evaluate the feasibility and safety of combining prostatic urethral lift (PUL) and a limited resection of the prostatic middle lobe or bladder neck incision in the treatment of lower urinary tract symptoms (LUTS) secondary to benign prostatic hyperplasia (BPH). METHODS: Twenty-eight patients were treated at two tertiary centers and followed prospectively. Patient evaluations included patient characteristics, relief of LUTS symptoms, erectile and ejaculatory function, continence, operative time and adverse events. Patients were followed for a mean of 10.9 months. RESULTS: Patient characteristics were as follows: age 66 years (46-85), prostate volume 39.6 cc (22-66), preoperative IPSS/AUASI 20 (6-35)/QoL 3.9 (1-6)/peak flow 10.5 mL/s (4.0-19)/post-void residual volume (PVR) 123 mL (0-500). Mean operating time was 31 min (9-55). Postoperative complications were minor except for the surgical retreatment of one patient for blood clot retention (Clavien 3b). One patient required catheterization due to urinary retention. Reduction of symptoms (IPSS - 59.6%), increase in QoL (+ 49.0%), increase in flow (+ 111.5%), and reduction of PVR (- 66.8%) were significant. Antegrade ejaculation was always maintained. CONCLUSION: Our data suggest that a combination of PUL and transurethral surgical techniques is feasible, safe, and effective. This approach may be offered to patients with moderate size prostates including those with unfavorable anatomic conditions for PUL. This procedure is still 'minimally invasive' and preserves sexual function. In addition, it may add to a higher functional efficacy compared to PUL alone. STUDY REGISTER NUMBER: DRKS00008970.