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Introduction: Translational research is important, especially in medicine where decisions affect people's lives. Clinical registries and the studies embedded in them allow the depiction of actual care practice under routine conditions. Translating the findings of health services research back into clinical research through prospective cohort studies has the potential to drive medical innovations faster, more effectively and, above all, in a more targeted manner. These must therefore be a central component of cutting-edge oncological research., Objective: The aim of the registry is the establishment of clinical cohorts and the provision of a comprehensive, high-quality data set for oncological diseases., Methods/design: The registry will prospectively record all patients treated for cancer at Dresden University Hospital (UKD). In addition to the data from the hospital information systems (ORBIS, TDS, GEPADO, etc.), monitoring of health-related quality of life (HRQOL) is to be carried out at regular intervals at the beginning and during the course of treatment. In addition, individual linkage with data from clinical cancer registries and health insurance companies (including AOK PLUS) is planned for a period of five years before and after inclusion. All these data will be merged in a registry database. The selection of variables and measurement time points is closely based on the guidelines for colorectal carcinoma of the international initiative ICHOM (International Consortium for Health Outcomes Measurement). The study management software (STeVe) separates personal identification characteristics (IDAT) and medical data (MDAT) at an early stage. The independent trust centre of the TU Dresden (Treuhandstelle) ensures that no personal data enter the registry database. It is thereby also ensured that the data owners involved (UKD, biobank, health insurance company, cancer registry, patient) only receive the personal data they need for allocation. The MOSAIC software tools recommended by the TMF (Technologie- und Methodenplattform für die vernetzte medizinische Forschung e.V.) are used to manage the pseudonyms., Discussion/conclusion: With the registry, previously missing evidence on the effectiveness, safety and costs of diagnostic and therapeutic measures can be made, taking into account long-term and patient-reported outcomes of routine care. The data potentially allow for the identification of barriers to and facilitators of innovative promising cancer diagnostics and therapies. They also enable generation of scientifically relevant hypotheses in the field of translational and outcomes research., Competing Interests: Unabhängig von dieser Studie erhielt JS institutionelle Förderung für von Forschern initiierte Forschung („investigator-initiated-research“) von Sanofi, Pfizer, Novartis und ALK und war als bezahlter Berater für Sanofi, Novartis, ALK und Lilly tätig. OS ist Mitglied in der Zertifizierungskommission „Hautkrebszentren“ der Deutschen Krebsgesellschaft. MB gab die Anstellung am UKD, Mitglied des NCT-Boards (Projektfinanzierung), Honorare und Reisekosten von den Firmen Jazz, Alexion, Novartis und Projektfinanzierung von AbbVie, Roche, sowie Ad-Board bei Jazz an. Die anderen Autoren erklären, dass sie sich in keinem Interessenkonflikt befinden., (The Author(s). This is an open access article published by Thieme under the terms of the Creative Commons Attribution-NonDerivative-NonCommercial-License, permitting copying and reproduction so long as the original work is given appropriate credit. Contents may not be used for commercial purposes, or adapted, remixed, transformed or built upon. (https://creativecommons.org/licenses/by-nc-nd/4.0/).)

The transfer of new insights from basic or clinical research into clinical routine is usually a lengthy and time-consuming process. Conversely, there are still many barriers to directly provide and use routine data in the context of basic and clinical research. In particular, no coherent software solution is available that allows a convenient and immediate bidirectional transfer of data between concrete treatment contexts and research settings. Here, we present a generic framework that integrates health data (e.g., clinical, molecular) and computational analytics (e.g., model predictions, statistical evaluations, visualizations) into a clinical software solution which simultaneously supports both patient-specific healthcare decisions and research efforts, while also adhering to the requirements for data protection and data quality. Specifically, our work is based on a recently established generic data management concept, for which we designed and implemented a web-based software framework that integrates data analysis, visualization as well as computer simulation and model prediction with audit trail functionality and a regulation-compliant pseudonymization service. Within the front-end application, we established two tailored views: a clinical (i.e., treatment context) perspective focusing on patient-specific data visualization, analysis and outcome prediction and a research perspective focusing on the exploration of pseudonymized data. We illustrate the application of our generic framework by two use-cases from the field of haematology/oncology. Our implementation demonstrates the feasibility of an integrated generation and backward propagation of data analysis results and model predictions at an individual patient level into clinical decision-making processes while enabling seamless integration into a clinical information system or an electronic health record., Competing Interests: The authors have declared that no competing interests exist., (Copyright: © 2023 Hoffmann et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.)

Purpose: Radical cystectomy in people with spinal cord injury (SCI) provides numerous additional difficulties, compared to able-bodied people. Therefore, it is important to obtain information from an experienced team about optimally managing these patients., Methods: Surgical procedures, based on the experience of 12 radical cystectomies in SCI patients with bladder cancer between January 1st, 2001, and December 31st, 2020, were recorded and the operative and perioperative clinical data were evaluated. Surgery was performed in a high-volume center by the surgeon most experienced in radical cystectomies, assisted by the neuro-urologist, involved in the care of the patient from the spinal cord center. Furthermore, a checklist based on the experience of the surgeon and the assisting neuro-urologist was developed., Results: SCI patients mostly suffered from an advanced disease and were always operated by the same team. The hospital stays ranged from 23 to 134 days (median 42 days). Four of the patients suffered from a postoperative paralytic ileus. Otherwise, both the operation time and the intraoperative blood loss as well as intraoperative and postoperative complications were basically comparable with those in able-bodied patients. The special features of radical cystectomy in SCI bladder cancer patients are described. Furthermore, a checklist addressing preoperative red flags, intra-operative challenges and post-operative challenges is presented., Conclusion: Radical cystectomy in SCI patients should be performed in a high-volume department by the most experienced surgical team. The inclusion of the urologist caring for the patient from the spinal cord injury center is highly recommended., (© 2022. The Author(s), under exclusive licence to Springer-Verlag GmbH Germany, part of Springer Nature.)

Urinary bladder cancer is the second most common tumour disease after lung cancer leading to death in people with a spinal cord injury. This paper provides a comprehensive overview of the differences relevant to urologists between urinary bladder tumours in this population compared with urinary bladder tumours in the general population.People with a spinal cord injury are 1 to 2 decades younger on average at the time of tumour diagnosis than patients without a spinal cord injury. Histopathologic findings at the initial diagnosis of urinary bladder cancer in people with a spinal cord injury are much less favourable than for urinary bladder cancers in the general population. Muscle-invasive tumours and tumours with poor differentiation are much more common, and the proportion of squamous cell carcinomas is significantly higher. The incidence rises after more than 10 years of paralysis. Urinary bladder cancer mortality is significantly elevated and increases with the duration of paralysis. In diagnostic procedures and, in particular, in radical cystectomy, clinically important features have to be considered. For example, urodynamic examinations or cystoscopy may trigger autonomic dysreflexia with hypertensive crises and the risk of life-threatening bradycardia.In the case of radical cystectomy, frequent adhesions and callosities of the urinary bladder, among other things, must be taken into account intraoperatively. Severe paralysis, prolonged intestinal atony and other conditions are frequently observed after the surgical procedure due to neurogenic bowel dysfunction. Correct positioning of the patient immediately after surgery to avoid decubitus and to support breathing, as well as bowel management specific to spinal cord injury, must be strictly observed.Other special features of paraplegic patients with urinary bladder cancer that should also be considered in clinical practice, as well as considerations for screening for urinary bladder tumors, are presented in the article., Competing Interests: Die Autorinnen/Autoren geben an, dass kein Interessenkonflikt besteht., (Thieme. All rights reserved.)

Purpose: Life expectancy for people with traumatic spinal cord injury (SCI) is increasing due to advances in treatment methods and in neuro-urology. Thus, developing urinary bladder cancer (UBC) is gaining importance., Methods: Single-centre retrospective evaluation of consecutive in- and out-patient data with spinal cord injury between January 1st, 1998 and December 31st, 2018 was carried out and data were compared with UBC data of the German population from the German Centre for Cancer Registry Data at Robert Koch Institute., Results: A total of 37 (4 female, 33 male) out of 7004 patients with SCI were diagnosed with histologically proven UBC (median follow-up 85 months). Median age at UBC diagnosis was 54.0 years (general population: 74 years). The SCI patients had significantly (p < 0.0001, each) more frequent muscle-invasive tumors (81% ≥ T2) and unfavorable grading (76% G3), compared to the general population. Median survival was 13 months for transitional cell carcinoma (n = 31) and 4 months for squamous cell carcinoma (n = 5) (p = 0.0039), resp. The median survival of the 24 cystectomized patients was 15.0 months. Long-term suprapubic or indwelling catheterization was found in only eight patients for a total of only 5.09% (median 15.5 months) of the latency of all patients. No significant differences for T category and grading were observed between the bladder emptying methods intermittent catheterisation and catheter-free voiding., Conclusion: The results indicate that in patients with SCI bladder management even without permanent catheterization represents a considerable risk for the development of UBC.

Background: There is to date no convincing literature that has assessed the association between traumatic spinal cord injury (SCI) and the later development of urinary bladder cancer. The aim of this work is to present medical experts as well as the national accident insurance and the social courts decision-making aids based on the latest medical scientific knowledge, for assessment of this causal association., Materials and Methods: A study conducted between April 1998 and March 2017 in the BG Trauma Hospital Hamburg forms the basis for the decision-making aids. Urinary bladder cancer was diagnosed in 32 out of 6432 treated outpatient and inpatient SCI patients. Furthermore, relevant published literature was taken into consideration for the decision-making aids., Results: It was found that urinary bladder cancer in SCI patients occurs at a considerably younger age as compared to the general population, more frequently shows muscle invasive carcinoma with a higher grade at first diagnosis and a higher proportion of the more aggressive squamous cell carcinoma than that of the general population. Correspondingly, the survival time is extremely unfavorable. For medical experts a matrix was compiled where the various influencing factors, either for or against the recognition of an association between SCI and urinary bladder cancer, were weighted according to their relevance., Conclusion: The results showed that urinary bladder cancer in SCI patients differs considerably from that of able-bodied patients. These differences drastically shorten the survival time. A study on patients with spina bifida, i.e., a congenital spinal cord disorder, corroborates these observations. They indicate histopathological differences that have so far been intangible.

Introduction and Objectives:  Life expectancy for people with spinal cord injury/disease (SCI/D) is increasing, due to modern advances in treatment methods and in neuro-urology. However, with the increased life expectancy the risk of developing urinary bladder cancer is gaining importance. How is this patient group different from the general population?, Methods:  Single-centre retrospective evaluation of consecutive patient data with spinal cord injury and proven urinary bladder cancer., Results:  Between January 1st 1998 and March 31st 2017, 32 (3 female, 29 male) out of a total of 6432 patients with SCI/D were diagnosed with bladder cancer.The average age at bladder cancer diagnosis was 54.5 years, which is well below the average for bladder cancer cases in the general population (male: 74, female: 75).Twenty-seven patients suffered from urodynamically confirmed neurogenic detrusor overactivity, while five patients (all male) had detrusor acontractility.The median latency period between the onset of SCI/D and tumor diagnosis was 29.5 years. Temporary indwelling catheterisation was found in four patients for only 1.61 % of the overall latency period of all patients.The majority of the patients (n = 27) had transitional cell carcinoma, while five had squamous cell carcinoma. Of the 32 patients, 25 (78 %) had muscle invasive bladder cancer at ≥ T2 at the time of diagnosis. Regarding tumour grading, 23 out of 32 patients showed a histologically poorly differentiated G3 carcinoma; two patients each had G2 and G1 tumours repectively (no information on tumour grading was available in five patients).The median survival for all patients was 11.5 months. The prognosis of patients with squamous cell carcinoma was even worse; 4 out of 5 died within 7 months (median 4 months)., Conclusions:  The significantly younger age at onset and the frequency of invasive, poorly differentiated tumour at diagnosis indicate that SCI/D influences both bladder cancer risk and prognosis significantly. The latency period between paralysis and tumour disease seems to be a decisive risk parameter.The type of neurogenic bladder dysfunction and the form of bladder drainage do not appear to influence the risk. Long-term indwelling catheter drainage played only a minor role in the investigated patients.Early detection of bladder cancer in patients with spinal cord injury remains a challenge., Competing Interests: Die Autoren geben an, dass keine Interessenkonflikte vorliegen., (© Georg Thieme Verlag KG Stuttgart · New York.)