Prospective versus retrospective recordings of comorbidities and complications in bladder cancer patients undergoing radical cystectomy - a randomized controlled trial.

BACKGROUND: Patients undergoing radical cystectomy are predominantly elderly with many comorbidities and high risk of complications. Studies on comorbidity and complications following cancer surgery are often based on data collected retrospectively from records. However, prospective registration is often considered a more valid source of information. Therefore, it is relevant to investigate if the amount and severity of complications and comorbidities is valid when using retrospective registration compared to a more meticulous prospective registration. OBJECTIVE: To investigate the difference in registered comorbidities and complications between prospective and retrospective data collection in patients with bladder cancer undergoing radical cystectomy. METHOD: Seventy-three bladder cancer patients undergoing radical cystectomy were randomized to receive prospective or retrospective collection of data regarding comorbidities and complications. Data in the prospective arm was collected daily during hospitalization, 14-days after discharge and 90-days postoperatively. In the retrospective arm, medical records were reviewed retrospectively at 90-days. Comorbidities were compared using the Charlson Comorbidity Index (CCI) and complications were reported as overall, minor and major dependent on Clavien Dindo Classification (CDC). The primary endpoint was the difference in overall complication rate. RESULTS: No statistically significant difference in CCI was observed with median [IQR] 2[0;3] and 1[0;2] (p = 0.21). No statistically significant difference was found regarding all, minor (CDC I-II) or major (CDC III-V) complications at all three time points. CONCLUSION: No statistically significant difference in comorbidity and complications between retrospectively and prospectively collected data was observed. We find that retrospective collected data is reliable when strict reporting guidelines are used in this single-centre study.

Mesenchymal Stromal Cells Are Retained in the Porcine Renal Cortex Independently of Their Metabolic State After Renal Intra-Arterial Infusion.

The regenerative capacities of mesenchymal stromal cells (MSCs) make them suitable for renal regenerative therapy. The most common delivery route of MSC is through intravenous infusion, which is associated with off-target distribution. Renal intra-arterial delivery offers a targeted therapy, but limited knowledge is available regarding the fate of MSCs delivered through this route. Therefore, we studied the efficiency and tissue distribution of MSCs after renal intra-arterial delivery to a porcine renal ischemia-reperfusion model. MSCs were isolated from adipose tissue of healthy male pigs, fluorescently labeled and infused into the renal artery of female pigs. Flow cytometry allowed MSC detection and quantification in tissue and blood. In addition, quantitative polymerase chain reaction was used to trace MSCs by their Y-chromosome. During infusion, a minor number of MSCs left the kidney through the renal vein, and no MSCs were identified in arterial blood. Ischemic and healthy renal tissues were analyzed 30 min and 8 h after infusion, and 1-4 × 104 MSCs per gram of tissue were detected, predominantly, in the renal cortex, with a viability >70%. Confocal microscopy demonstrated mainly glomerular localization of MSCs, but they were also observed in the capillary network around tubuli. The infusion of heat-inactivated (HI) MSCs, which are metabolically inactive, through the renal artery showed that HI-MSCs were distributed in the kidney in a similar manner to regular MSCs, suggesting a passive retention mechanism. Long-term MSC survival was analyzed by Y-chromosome tracing, and demonstrated that a low percentage of the infused MSCs were present in the kidney 14 days after administration, while HI-MSCs were completely undetectable. In conclusion, renal intra-arterial MSC infusion limited off-target engraftment, leading to efficient MSC delivery to the kidney, most of them being cleared within 14 days. MSC retention was independent of the metabolic state of MSC, indicating a passive mechanism.

Child-Centered Design: Developing an Inclusive Letter Writing App.

Everywhere there are children, there are screens, and child-computer interaction is ubiquitous. Despite their omnipresence, research on the impact of screens on children's learning lags behind the development of digital tools. Apple's App Store has an abundance of "educational" apps, but many of these apps' claims are unsubstantiated. Organizations responsible for vetting quality products for young people, such as the American Library Association, are developing resources to help identify the best digital products available, but they remain difficult to find, and there is limited guidance for app designers when it comes to designing apps for younger audiences. Our interdisciplinary, empirical study was inspired by "co-creation" (Sanders and Stappers, 2008) and "cooperative inquiry" (Druin, 2005). Starting with a seed grant from Kent State University's College of Communication and Information, our team sought to create a high-quality and inclusive alphabet app with haptic interactions and simplified gamification to reinforce the basic letter writing skills of young children. The app rewards a child's successful handwriting with an animation of a verb that corresponds with the letter they traced. Concrete animations and digital and verbal demonstrations connect the typographic letter to the handwritten counterpart. Librarian Claudia Haines' rubric (Haines, 2016) and the Dig Checklist (Kidmap, 2018.) guided our definition of "quality," and children served as co-designers in two qualitative user studies. Our young designers tested prototypes, completed task booklets, and were interviewed about their preferences and their feedback informed our design. Additionally, a focus group interview with kindergarten and preschool teachers provided further feedback about the typographic design, stroke order, and gaming rewards. To be inclusive, children in both our app design and user studies were selected from a diverse pool. Our research contributes to work on co-design and cooperative inquiry in the fields of User Experience Design, human-computer interaction, human information behavior, information science, interface design, motion design, typeface design and typography for children, and early literacy development. A post-study is planned upon completion of the app.

Chronic urinary tract infections in patients with spinal cord lesions - biofilm infection with need for long-term antibiotic treatment.

Patients suffering from spinal cord injuries resulting in complete or incomplete paraplegia or tetraplegia are highly disposed to frequent, recurrent or even chronic urinary tract infections (UTIs). The reason for the increased risk of acquiring UTIs is multifactorial, including reduced sensation of classical UTI symptoms, incomplete bladder emptying, frequent catheterizations or chronic urinary tract catheters. Biofilms in relation to UTIs have been shown both on catheters, on concrements or as intracellular bacterial communities (IBCs). Due to the increased risk of acquiring recurrent or chronic UTIs and frequent antibiotic treatments, patients experience an increased risk of being infected with antibiotic-resistant bacteria like extended-spectrum ß-lactamase-producing Escherichia coli or Klebsiella spp., but also bacteria like Pseudomonas aeruginosa inherently resistant to several antibiotics. Diagnosing the UTI can also be challenging, especially distinguishing harmless colonization from pathogenic infection. Based on a previous study showing activation of humoral immune response toward UTI pathogens in patients with spinal cord lesions (SCL), the present mini review is an evaluation of using antibody response as an indicator of chronic biofilm UTI. In addition, we evaluated the effect of long-term treatment with antibiotics in patients with SCLs and chronic UTI, defined by culturing of a uropathogen in the urine and elevated specific precipitating antibodies against the same uropathogen in a blood sample. Elimination of chronic UTI, decrease in specific precipitating antibody values and avoiding selection of new multidrug-resistant (MDR) uropathogens were the primary markers for effect of treatment. The results of this evaluation suggest that the long-term treatment strategy in SCL patients with chronic UTI may be effective; however, randomized prospective results are needed to confirm this.

Development of simulated arthroscopic skills.

BACKGROUND AND PURPOSE: Previous studies have shown that there is a correlation between arthroscopic experience and performance on a virtual-reality (VR) unit. We analyzed the development inexperienced surgeons went through during VR training of shoulder arthroscopy. METHODS: 14 inexperienced surgeons from Silkeborg Regional Hospital were randomized into an intervention group and a control group. 7 experienced surgeons constituted another control group. All were tested twice on insightMIST-an advanced arthroscopic VR trainer-within a period of 6-15 days. The intervention group also received a 5-hour training program on the VR unit. RESULTS: The average time for the arthroscopy in the intervention group was reduced from 720 (SD 239) seconds to 223 (SD 114) seconds (p = 0.03 compared to the inexperienced control group). Distance travelled by the camera was reduced from 367 (SD 151) cm to 84 (SD 44) cm in the intervention group (p = 0.02 compared to the inexperienced control group). Depth of collisions was also significantly reduced, whereas distance travelled by the probe and number of collisions were improved in the intervention group, although not statistically significantly. INTERPRETATION: VR training is a possible way for young and inexperienced surgeons to achieve basic navigation skills necessary to perform arthroscopic surgery. Further studies regarding the transferability of the skills acquired on the VR unit to the operating theater are desirable.

Clinical efficacy and safety of once-daily dosing of a novel, prolonged-release oral morphine tablet compared with twice-daily dosing of a standard controlled-release morphine tablet in patients with cancer pain: a randomized, double-blind, exploratory crossover study.

CONTEXT: Recently, a new oral prolonged-release formulation of morphine sulfate for once-daily dosing has been developed based on an injection-molded matrix (abuse-deterrent, prolonged-release erodible matrix [ADPREM]). OBJECTIVES: The objective of this double-blind, randomized, exploratory crossover study was to assess the efficacy and safety of once-daily ADPREM compared with twice-daily controlled-release morphine (CRM; MST ContinusNapp Pharmaceuticals, Cambridge, UK). METHODS: Thirty-eight adult cancer pain patients participated in the study, which consisted of a run-in period for stabilization and two consecutive fixed-dose treatment periods of two weeks' duration each. Rescue medication, immediate-release morphine sulfate, was available during the entire study for treatment of breakthrough pain (BTP). RESULTS: There was no difference between the treatments in use of rescue medication. The medians of the average number of rescue doses per day were 1.0 and 0.7 during the ADPREM and CRM treatment periods, respectively, with an estimated median difference of 0.07 dose/day (95% confidence interval: -0.21, 0.29). Likewise, no differences between treatments were found for the number of BTP episodes per day or morning and evening ratings of pain intensity (current, average, minimum, and maximum). Median assessment of the drugs was "good" for both treatments, and neither of the treatments was preferred. Steady-state trough concentrations of morphine and its metabolites in plasma before morning dosing were similar after either treatment period. The adverse events were as expected in an opioid-treated cancer population and showed no differences between ADPREM and CRM. CONCLUSION: In this study, dosing with ADPREM at intervals of 24 hours was therapeutically equivalent to CRM dosed at intervals of 12 hours.