The Intersectoral Coordination Unit for the Sustainable Intensification of Peritoneal Dialysis in Schleswig-Holstein (SKIP-SH) cohort study.

BACKGROUND: Peritoneal dialysis (PD) remains underutilised in Germany, prompting the initiation of the Sustainable Intensification of Peritoneal Dialysis in Schleswig-Holstein (SKIP-SH) project. The SKIP-SH cohort study aims to demonstrate the presumed benefits of PD, including enhanced quality of life and reduced healthcare personnel requirements, and to generate data to strengthen the use of PD. METHODS: The prospective SKIP-SH cohort study recruits patients with advanced chronic kidney disease (CKD) and their caregivers. Comprehensive data, including demographic information, medical history, clinical course, laboratory data, and quality-of-life assessments, are collected. Additionally, biomaterials will be obtained. Primary study objectives are documenting the clinical course and complications, time on therapy for new dialysis patients, reasons influencing treatment modality choices, circumstances at the initiation of dialysis, and quality of life for patients with CKD and their caregivers. The collected biomaterials will serve as a basis for further translational research. Secondary objectives include identifying factors impacting disease-related quality of life, clinical complications, and therapy dropout, estimating ecological footprints, and evaluating healthcare costs and labour time for initiating and sustaining PD treatment. DISCUSSION: PD is notably underutilised in Germany. The current therapy approach for advanced CKD often lacks emphasis on patient-focused care and quality-of-life considerations. Furthermore, adequate explorative research programs to improve our knowledge of mechanisms leading to disease progression and therapy failure in PD patients are scarce. The overarching goal of the SKIP-SH cohort study is to address the notably low PD prevalence in Germany whilst advocating for a shift towards patient-focused care, quality-of-life considerations, and robust translational research. TRIAL REGISTRATION: This study was registered with the German trial registry (Deutsches Register klinischer Studien) on November 7, 2023, under trial number DRKS00032983.

Potential and Uncertainties of RejectClass in Acute Kidney Graft Dysfunction: An Independent Validation Study.

BACKGROUND: Kidney graft rejections are classified based on the Banff classification. The RejectClass algorithm, initially derived from a cohort comprising mostly protocol biopsies, identifies data-driven phenotypes of acute rejection and chronic pathology using Banff lesion scores. It also provides composite scores for inflammation activity and chronicity. This study independently evaluates the performance of RejectClass in a cohort consisting entirely of indication biopsies. METHODS: We retrospectively applied RejectClass to 441 patients from the German TRABIO (TRAnsplant BIOpsies) cohort who had received indication biopsies. The primary endpoint was death-censored graft failure during 2 y of follow-up. RESULTS: The application of RejectClass to our cohort demonstrated moderately comparable phenotypic features with the derivation cohort, and most clusters indicated an elevated risk of graft loss. However, the reproduction of all phenotypes and the associated risks of graft failure, as depicted in the original studies, was not fully accomplished. In contrast, adjusted Cox proportional hazards analyses substantiated that both the inflammation score and the chronicity score are independently associated with graft loss, exhibiting hazard ratios of 1.7 (95% confidence interval, 1.2-2.3; P = 0.002) and 2.2 (95% confidence interval, 1.8-2.6; P < 0.001), respectively, per 0.25-point increment (scale: 0.0-1.0). CONCLUSIONS: The composite inflammation and chronicity scores may already have direct utility in quantitatively assessing the disease stage. Further refinement and validation of RejectClass clusters are necessary to achieve more reliable and accurate phenotyping of rejection.

Patient-focused outcomes after initiation of dialysis for ESRD: mortality, hospitalization and functional impairment.

BACKGROUND: Outcome data regarding clinically relevant endpoints after starting dialysis for end-stage renal disease (ESRD) are sparse, and early events after starting dialysis are particularly underestimated. The aim of this study was to describe patient-focused outcomes in ESRD patients starting from first dialysis. METHODS: The data basis for this retrospective observational study were anonymized healthcare data from Germany's largest statutory health insurer. We identified ESRD patients who initiated dialysis in 2017. Deaths, hospitalizations and occurrence of functional impairment within 4 years after starting dialysis were recorded starting from first treatment. Hazard ratios in dialysis patients compared with an age- and sex-matched reference population without dialysis were generated, stratified by age. RESULTS: The dialysis cohort included 10 328 ESRD patients who started dialysis in 2017. First dialysis was performed in-hospital for 7324 patients (70.9%), and 865 of these died during the same hospitalization. One-year mortality for ESRD patients initiating dialysis was 33.8%. Functional impairment occurred in 27.1% of patients, while 82.8% of patients required hospitalization within 1 year. Hazard ratios of dialysis patients compared with the reference population for mortality, functional impairment and hospitalization at 1-year were 8.6, 4.3 and 6.2. Dialysis patients <50 years were disproportionately affected, with >40-fold increased risk of adverse events compared with their peers. CONCLUSIONS: The emergence of morbidity and mortality after starting dialysis for ESRD is significant, especially in younger patients. Patients have a right to be informed about the prognosis associated with their condition.

Study protocol: the TRAnsplant BIOpsies (TRABIO) study - a prospective, observational, multicentre cohort study to assess the treatment of kidney graft rejections.

INTRODUCTION: Despite continued efforts, long-term outcomes of kidney transplantation remain unsatisfactory. Kidney graft rejections are independent risk factors for graft failure. At the participating centres of the TRAnsplant BIOpsies study group, a common therapeutic standard has previously been defined for the treatment of graft rejections. The outcomes of this strategy will be assessed in a prospective, observational cohort study. METHODS AND ANALYSIS: A total of 800 kidney transplantation patients will be enrolled who undergo a graft biopsy because of deteriorating kidney function. Patients will be stratified according to the Banff classification, and the influence of the treatment strategy on end points will be assessed using regression analysis. Primary end points will be all-cause mortality and graft survival. Secondary end points will be worsening of kidney function (≥30% decline of estimated Glomerular Filtration Rate [eGFR] or new-onset large proteinuria), recurrence of graft rejection and treatment response. Baseline data and detailed histopathology data will be entered into an electronic database on enrolment. During a first follow-up period (within 14 days) and subsequent yearly follow-ups (for 5 years), treatment strategies and clinical course will be recorded. Recruitment at the four participating centres started in September 2016. As of August 2020, 495 patients have been included. ETHICS AND DISSEMINATION: Ethical approval for the study has been obtained from the ethics committee of Kiel (AZ B 278/16) and was confirmed by the committees of Munich, Mainz and Stuttgart. The results will be reported in a peer-reviewed journal, according to the Strengthening the Reporting of Observational Studies in Epidemiology criteria. TRIAL REGISTRATION NUMBER: ISRCTN78772632; Pre-results.

Evaluation of underidentification of potential organ donors in German hospitals.

BACKGROUND: Since 2010, the number of organ donations in Germany has decreased by one third, mostly due to undetected organ donors. It is unclear, how the undetected potential donor pool is distributed among the different German hospital categories (A = university hospital, B = hospitals with neurosurgery, C = hospitals without neurosurgery) and region types. METHODS: We performed a nationwide secondary data analysis of all German inpatient cases of the year 2016 (n = 20,063,689). All fatalities were regarded as potential organ donors, in which primary or secondary brain damage was encoded and organ donation was not excluded by a contraindication or a lack of ventilation therapy. RESULTS: In 2016, 28,087 potential organ donors were identified. Thereof 21% were found in category A, 28% in category B and 42% in category C hospitals. The contact rate (= organ donation related contacts/ potential organ donors) and realization rate (= realized organ donations/ potential organ donors) of category A, B and C hospitals was 10.6% and 4.6%, 10.9% and 4.8% and 6.0% and 1.7%, respectively. 58.2% of the donor potential of category C hospitals was found in the largest quartile of category C hospitals. 51% (n = 14,436) of the potential organ donors were treated in hospitals in agglomeration areas, 28% (n = 7,909) in urban areas and 21% (n = 5,742) in rural areas. The contact- and realization rate did not significantly differ between these areas. CONCLUSIONS: The largest proportion of potential organ donors and the lowest realization rate are found in category C hospitals. Reporting and donation practice do not differ between urban and rural regions.