Register Entry Research Articles

How prospective trial registration can prevent selective outcome reporting and salami slicing?

BackgroundPre-registration of a clinical trial before the first participant is recruited can help to prevent selective outcome reporting and salami-slicing that can distort the evidence base for an intervention and result in people being offered care or treatment that is not effective. Rates of clinical trial registration in nursing and midwifery are low. AimTo use a hypothetical example from midwifery practice to illustrate how selective outcome reporting and salami-slicing can distort the evidence base. FindingsA trial of immersion in water during labour and birth is used to consider issues in outcome selection and how researchers may be drawn to switch primary outcomes or report different outcomes across multiple papers. DiscussionIn nursing and midwifery science, selective outcome and salami reporting are seemingly common. Prospective trial registration is intended to prevent these practices, enhancing the quality and integrity of the work. ConclusionClinical trials are a robust form of primary research evidence and directly impact clinical practice. Researchers must ensure their trials are correctly registered and editors need to reconcile submitted papers and registration entries as part of the review process.

Trial registration and selective outcome reporting in Endodontic Research: Evidence over a 5-year period.

To assess the prevalence of registration of clinical trials in endodontic research and to identify outcome reporting discrepancies between trial registration entries and respective final publications. Associations with publication characteristics, such as journal, year of publication, origin, number of centres and authors, funding and statistical significance of the findings, were also sought. All reports of endodontic randomized controlled trials (RCTs) published in 4 endodontic specialty and 4 general dental journals from 1 January 2016 to 31 December 2020 were identified. Trial registration frequency patterns were assessed for the included RCTs, whilst for the ones registered, outcome reporting discrepancies were recorded. Article characteristics such as year of publication, geographic region, number of centres, authors participating in the publication, funding, type of registration and others were identified. Descriptive statistics and univariable/multivariable logistic regression were performed to examine the effect of study characteristics on identified registration practices. One hundred and fifty-five RCTs were included, with the majority published in specialty journals (121/155; 78.1%). A total of 42.6% of the identified RCTs was registered (66/155), mostly retrospectively (38/66; 57.6%). There was strong evidence that each additional year for more recent publication accounted for 1.42 times higher odds of being registered (adjusted Odds Ratio=1.42; 95%CI: 1.11, 1.80; p=.004). More than 1/3 of registered RCTs presented outcome reporting discrepancies (24/66; 36.4%), whilst such inconsistencies were almost evenly distributed between primary and secondary outcomes. Trial registration policies in endodontic research should be reviewed and active endorsement of prospective registration practices should be prioritized for better clarity and transparency of the disseminated research. Outcome reporting discrepancies shall thus be eliminated, offering increased credibility in research findings and eliminating bias in this respect.

Smartphone application alerts for early trauma team activation: Millennial technology in healthcare

BackgroundData access through smartphone applications (apps) has reframed procedure and policy in healthcare, but its impact in trauma remains unclear. Citizen is a free app that provides real-time alerts curated from 911 dispatch data. Our primary objective was to determine whether app alerts occurred earlier than recorded times for trauma team activation and emergency department arrival. MethodsTrauma registry entries were extracted from a level one urban trauma center from January 1, 2018 to June 30, 2019 and compared with app metadata from the center catchment area. We matched entries to metadata according to description, date, time, and location then compared metadata timestamps to trauma team activation and emergency department arrival times. We computed percentage of time the app reported traumatic events earlier than trauma team activation or emergency department arrival along with exact binomial 95% confidence interval; median differences between times were presented along with interquartile ranges. ResultsOf 3,684 trauma registry entries, 209 (5.7%) matched app metadata. App alerts were earlier for 96.1% and 96.2% of trauma team activation and emergency department arrival times, respectively, with events reported median 36 (24–53, IQR) minutes earlier than trauma team activation and 32 (25–42, IQR) minutes earlier than emergency department arrival. Registry entries for younger males, motor vehicle-related injuries and penetrating traumas were more likely to match alerts (P < .0001). ConclusionApps like Citizen may provide earlier notification of traumatic events and therefore earlier mobilization of trauma service resources. Earlier notification may translate into improved patient outcomes. Additional studies into the benefit of apps for trauma care are warranted.

From Fiscal Diversity to Fiscal Convergence: Franciscan Monasteries in the Sanjak of Bosna during the First Century of Ottoman Rule

Abstract The present contribution is an attempt to analyse and conceptualise all available information concerning the principal Franciscan monasteries in Central Bosnia from the Ottoman tax survey registers of the fifteenth and first half of the sixteenth centuries. Many features in the monks’ fiscal status at this period are shared with the müste’min or foreigner from abroad, a status which appears to be based on the ahdnames granted by Sultan Mehmed Fatih. Yet at the same time, individual monasteries can be shown to have been placed under different tax regimes. It is only towards the later period that a high degree of fiscal convergence can be observed, resulting in a stereotype wording of the relevant entries in the tax survey registers.

Farmers’ preferences for nature conservation compensation measures with a focus on eco-accounts according to the German Nature Conservation Act

Negative impacts on nature and landscape caused by development activity have to be offset within the framework of no-net-loss policies in many countries worldwide. In Germany this is legally anchored in the German Nature Conservation Act (BNatSchG). The relevant compensation measures or biodiversity offsets are often implemented by developers on agricultural land which is lost as a result of the offsetting activity. Therefore, conflicts of interest can arise between the actors involved. However, approaches like mitigation banking can give farmers the possibility to voluntarily carry out a compensation measure against payment by the intervener. Thus, they can control the location and type of measure themselves and counter land use by external interveners. By establishing the timing of the individual measures in advance, these can further be better planned and coordinated than before. This may also lead to greater benefits for nature conservation. Hence, we conducted a discrete choice experiment with 209 farmers at the federal level to analyse under what conditions farmers would be willing to voluntarily implement compensation measures and how acceptance could be improved. We found that farmers are generally willing to implement compensation measures. One major challenge is the form of legal protection of the measure in connection with whether the measure is permanent or only for a fixed period of time. A land register entry markedly reduces acceptance. In addition, the market value of an area and the associated potential loss of value are also relevant. Furthermore, we were able to show that, in general, farmers are most accepting of production-integrated compensation (PIC). However, we did identify a lower acceptance of PIC among organic farmers. Nevertheless, production-integrated compensation in particular, depending on the legal safeguards, can be a rather expensive alternative for the intervener who bears the costs. Hence, our analyses provide important information for policy makers in environmental legislation and for practical landscape planning and nature conservation. They likewise provide insights into the market for biodiversity offsets in Germany.

Subsequent criminal participation among young people first admitted to psychiatric inpatient care during early and middle adolescence

ABSTRACT Adolescents brought before court suffer excessively of mental disorders. Less is known about subsequent criminal participation of adolescent psychiatric inpatients. Our register study comprised all subjects that had between 1980 and 2010 been admitted to psychiatric inpatient care in Finland for the first time in their lives at ages 13–17 (n = 16 842), identified in the Care Register for Health Care and followed up for up to 10 years in the Register of Prosecutions, Sentences and Punishments. Incidence of register entry for any crime was 2.4/100 person-years, 4.0 in males and 1.9 in females. Incidence of violent crime was 0.9/100 person-years, 1.5 in males and 0.3 in females. Greatest risk for subsequent crime was associated with diagnoses of conduct, personality and substance use disorders (F90–92, F60–69, F10–19). Schizophrenia group diagnoses (F20–29) were associated with lowest risk. Later criminality was manifold among those who already had a crime register entry before the index treatment. Need for psychiatric inpatient care during adolescence associates with a great risk of antisocial development. Treatment needs to address this risk by systematically implementing evidence-based interventions. Health and social policies need to ensure resources and skills to these treatments.

Scout - sarcoidosis outcomes taskforce. A systematic review of outcomes to inform the development of a core outcome set for pulmonary sarcoidosis.

Background:Clinical trials evaluating different management strategies for pulmonary sarcoidosis may measure different outcomes. This heterogeneity in outcomes can lead to waste in research due to the inability to compare and combine data. Core outcome sets (COS) have the potential to address this issue and here we describe a systematic review of outcomes as the first step in the development of a COS for pulmonary sarcoidosis research.Methods:A search of clinical trial registries for phase II, III and IV trials of pulmonary sarcoidosis was undertaken along with a rapid review of the patient perspective literature. Each study was screened for eligibility and outcomes extracted verbatim from the registry entry or publication then reviewed, grouped and categorised using the COMET taxonomy.Results:36 trial registry entries and 6 studies on patients’ perspective of pulmonary sarcoidosis were included reporting 56 and 82 unique outcomes respectively across 23 domains. The most frequently reported outcome domain was “respiratory, thoracic and mediastinal outcomes”. However, the patients’ perspective literature identified outcomes in the “personal circumstances” and “societal/carer burden” domains that were not reported in any of the included trial registrations.Conclusions:Using both clinical trial registry data and published literature on patients’ perspective has allowed rapid review of outcomes measured and reported in pulmonary sarcoidosis research. The use of multiple sources has led to the development of a comprehensive list of outcomes that represents the first step in the development of a COS for use in future pulmonary sarcoidosis research.

Restitution of court decisions on restoration of the entry in the unified state register of rights to real property

Restitution of court decisions on restoration of the entry in the unified state register of rights to real property

A Retrospective Analysis of Intracranial Meningiomas in a Tertiary Health Care Facility in North Central Nigeria

<i>Introduction/Aim: </i>There is scanty detailed published literature on meningiomas in Nigeria and other parts of Africa. This study is aimed at exploring the demographics, histopathology and presenting symptoms/signs of meningioma in our tertiary health facility and comparing it with other published literature. <i>Methodology: </i>This is a hospital based retrospective study of all histopathologically diagnosed meningioma cases at the department of histopathology of the Jos University Teaching Hospital in plateau state North-Central Nigeria. The period of review is between the 1st of January 2012 to the 31st of December 2020. Materials utilized for this research consisted of Archival histopathology glass slides, paraffin wax tissue blocks, electronic surgical pathology result data base, electronic cancer registry entries and hard copies of patient case files. The age, sex, intracranial location, histomorphological variant, grade and presenting symptom/sign was documented for all cases and analyzed.<i> Results:</i> Thirty-four (34) cases of meningioma out of 87 primary intracranial neoplasms were histopathologically diagnosed over the 9 years of review. There was a female predominance, with a M:F of 1:1.61. The peak age of diagnoses occurred in the 5^th and 6^th decades for females and males respectively. The commonest histomorphological variant was the Meningothelial type with the commonest intracranial site of diagnosis being the convexities. The most frequently occurring presenting symptom/sign were headache, seizures and visual impairment. <i>Conclusion:</i> Meningioma is the commonest intracranial tumour diagnosed at the Jos University teaching Hospital, In North central Nigeria. This tumour occurs at a relatively younger age in our environment. The sex distribution, variants, grades and symptoms/signs of this tumour in our study conforms to what is obtainable in other parts of the world.

The Uncompleted Privatization of Functional Land in Slovenia and Attempts at its Re-nationalization

The article discusses the unsettled ownership status of many tracts of urban land in Slovenian cities that persists as a consequence of the disorderly transition from the socialist into the market institutional environment. Problems arising from the privatization of real estate, which can be detected all over the former Yugoslavia, typically affect functional land, i.e. land directly intended for the regular use and functioning of a building. Frequently, the land register does not show the rightful ownership status of such plots, leading to disputes and lengthy court proceedings for the determination of ownership. This is particularly the case with shared outdoor parts of residential neighborhoods, which are often subject to unfounded ownership claims based on obsolete entries in the land register. Even some municipal authorities have attempted to bring such land into public domain under this pretense, which would, if successful, amount to a 21st-century nationalization.

Abstract 14806: Circumstances Surrounding End of Life in Pediatric Heart Transplant: A Report From the Pediatric Heart Transplant Society

Introduction: The Institute of Medicine called for scientific investigation and the development of guidelines to improve end of life care for pediatric patients with serious illnesses. Despite high morbidity and mortality in pediatric heart transplantation (HTx), research on the end of life care needs of this population is extremely limited. Aims: This study aimed to describe the circumstances surrounding death of pediatric HTx patients and examine associations between location of death and technological interventions at end-of-life with demographic, disease, and HTx-related factors. Methods: This retrospective analysis of the Pediatric Heart Transplant Society registry utilized descriptive statistics and standard univariate analysis to examine associations between location of death and patient factors. Results: Of 9,217 registry entries, 2,804 (30%) deaths occurred; 1,310 while awaiting HTx; 1,494 post-HTx. Location of death was only recorded for 1,113 patients which included 804 waitlist deaths; 89% occurred in the hospital, primarily in ICU settings (74%) with most requiring mechanical ventilation (77%). A subset (39%) were supported by ECMO/VAD at time of death with 69% receiving inotrope support. Location of death was captured for 309 post-HTx patients with only 22% occurring in hospital; primarily in the ICU (74%) with half receiving mechanical ventilation (52%) and a smaller proportion supported by ECMO/VAD (18%) or inotropes (21%) at time of death. Overall, location of death was not associated with patient sex, race, ethnicity, insurance type, or primary etiology. Out of hospital death was associated with older patient age (p&lt;0.01). Family decision to withdraw life-sustaining interventions was included as a contributing cause of death in 5.4% of waitlist cases and 3.5% of post-HTx cases. Conclusions: Death occurred in ~1/3 of patients captured in this pediatric HTx registry. ICU deaths with high use of technological interventions were common, particularly in waitlisted patients, but family decision to discontinue interventions was infrequently cited. Findings underscore the need for palliative care interventions and improved research strategies to better understand end of life in pre- and post-HTx pediatric populations.

German and international studies on SARS-CoV-2 seroprevalence.

Since the beginning of the year 2020, the SARS-CoV-2 coronavirus has spread globally at a tremendous pace. Studies on the prevalence of SARS-CoV-2 antibodies in the population help estimate the number of people that have already been infected. They also allow an estimate of the number of undetected infections i.e. infections that do not appear in data on officially reported cases. The interpretation of study results needs to consider bias from selective sampling and the diagnostic test properties. To promote networking and co-operation between scientists, the Robert Koch Institute has compiled an overview of the seroepidemiological studies conducted in Germany on its website, which is regularly updated. The RKI conducts searches, for example of press releases, study registry entries or preprint server publications, and contacts the lead investigators of these studies. Of the 40 studies contacted so far, 24 have already provided information (as of 25.06.2020). We can differentiate between studies of the general population, of selected population groups such as healthcare workers, or of ongoing cohorts. This article provides an overview of such studies from Germany, but also of selected international studies. A special focus is set on studies of children and adolescents, which are now of particular interest due to the planned reopening of childcare facilities and schools.

People with intellectual disabilities as heirs. Part 3

The article is another one in the series on people with intellectual disabilities as heirs. It discusses next steps that heirs need to take after an inheritance is accepted and a court confirmation of inheritance acquisition or a notarial deed of succession certification is received to be able to dispose of the property they acquired from the testator. It presents issues relating to inheritance division based on an agreement between the heirs and inheritance division by a court order, claiming the legitime, reporting the inheritance to the tax office to be entitled to inheritance tax exemption, as well as making an entry in the land register, reporting the acquisition of a car, notifying the homeowner association or the housing cooperative, changing the parties to contracts on services that are currently provided, etc. Practical difficulties that may arise when heirs with intellectual disabilities are taking these steps are listed along with the best methods to overcome them.

Female Youth Soccer Participation and Continued Engagement: Associations With Community Size, Community Density, and Relative Age.

Environmental context can impact youth engagement in sport and athlete development. Previous work has examined the population size of the birthplace of elite athletes; commonly known as the birthplace or community size effect. Community density has also been recognized as an important variable. Exact estimates for the ideal community characteristics and a thorough understanding of the underlying mechanisms has been somewhat elusive. Existing studies are cross-sectional in nature and there is evidence to suggest that significant variation exists within imposed categories. An athlete's birthdate position in a similar-age cohort can also impact development and has been associated with (dis)advantages resulting from subtle age differences (i.e., the relative age effect); it remains unknown if this variable is associated with population density. The objective of this study was to establish longitudinal participation trends among female youth soccer players in Ontario Canada, with consideration of community size, community density, and relative age. Within-category variation and associations between the variables were assessed. Registration entries at age 10 years (n = 9,826) and 16 years (n = 2,305) were isolated for analysis. Odds ratio analyses were conducted within each community size and density category for all 10 year old registrants; 95% confidence intervals were obtained. This procedure was repeated for all registrants at 16 years of age using the expected distribution at age 10 years to examine continued engagement. Findings suggest medium-sized communities (i.e., 10,000–249,999 inhabitants) provide the best odds of participation and continued engagement. Less densely populated communities (i.e., 50–<400 population/km2) appeared to be ideal for facilitating participation at age 10 years, but not for engagement at age 16 years. However, within-category variation was evident when each community was inspected individually. Consistent with previous attempts to find an association between community size and the relative age effect, there did not appear to be an association between community density and birth quartile distribution. Observations from this study show that community size and community density are truly unique and separate variables. Future studies should consider the underlying contributions to both low and high participation and continued engagement, while being mindful of within-category variation.

Zasady przenoszenia praw z akcji w spółce akcyjnej. Odrębność regulacji kodeksu spółek handlowych względem kodeksu cywilnego w dobie dematerializacji papierów wartościowych

Ustawodawca 30 sierpnia 2019 roku dokonał zasadniczej zmiany przepisów kodeksu spó- łek handlowych w odniesieniu do akcji oraz zasad przenoszenia z nich praw w spółce akcyjnej. Nowo wprowadzone przepisy, które mają wejść w życie od 1 stycznia 2021 roku, przewidują bowiem obligatoryjność dematerializacji akcji oraz utworzenie rejestru akcjonariuszy, którego celem jest zastąpienie księgi akcyjnej. Zamiarem ustawodawcy było również dokonanie ujednolicenia reżimu przenoszenia praw z akcji imiennych i na okaziciela, który ma się opierać na założeniach analogicznych do tych dotyczących przenoszenia praw z papierów wartościowych regulowanych w ustawie o obrocie instrumentami finansowymi. W niniejszym artykule podjęto próbę analizy uchwalonych przepisów i mogących pojawiać się na tle ich stosowania wątpliwości interpretacyjnych. Celem dokonanej analizy było także określenie, czy uchwalone przepisy wprowadzające nowe zasady przenoszenia praw z akcji w kodeksie spółek handlowych mają charakter zupełny i odrębny względem przepisów kodeksu cywilnego.

A systematic review of trial registry entries for randomized clinical trials investigating COVID-19 medical prevention and treatment.

To identify investigated interventions for COVID-19 prevention or treatment via trial registry entries on planned or ongoing randomised clinical trials. To assess these registry entries for recruitment status, planned trial size, blinding and reporting of mortality. We identified trial registry entries systematically via the WHO International Clinical Trials Registry Platform and 33 trial registries up to June 23, 2020. We included relevant trial registry entries for randomized clinical trials investigating medical preventive, adjunct or supportive therapies and therapeutics for treatment of COVID-19. Studies with non-random and single-arm design were excluded. Trial registry entries were screened by two authors independently and data were systematically extracted. We included 1303 trial registry entries from 71 countries investigating 381 different single interventions. Blinding was planned in 47% of trials. Sample size was >200 participants in 40% of trials and a total of 611,364 participants were planned for inclusion. Mortality was listed as an outcome in 57% of trials. Recruitment was ongoing in 54% of trials and completed in 8%. Thirty-five percent were multicenter trials. The five most frequent investigational categories were immune modulating drugs (266 trials (20%)), unconventional medicine (167 trials (13%)), antimalarial drugs (118 trials (9%)), antiviral drugs (100 trials (8%)) and respiratory adjuncts (78 trials (6%)). The five most frequently tested uni-modal interventions were: chloroquine/hydroxychloroquine (113 trials with 199,841 participants); convalescent plasma (64 trials with 11,840 participants); stem cells (51 trials with 3,370 participants); tocilizumab (19 trials with 4,139 participants) and favipiravir (19 trials with 3,210 participants). An extraordinary number of randomized clinical trials investigating COVID-19 management have been initiated with a multitude of medical preventive, adjunctive and treatment modalities. Blinding will be used in only 47% of trials, which may have influence on future reported treatment effects. Fifty-seven percent of all trials will assess mortality as an outcome facilitating future meta-analyses.

Ocular Demodex: a systematic review of the clinical literature.

There is increasing clinical and research interest in the potential contribution of Demodex to ocular surface disease. The aim of this systematic review was to summarise and synthesise current clinical evidence relating to the aetiology, diagnosis and treatment of ocular Demodex. A comprehensive literature search was performed in OVID Medline, OVID Embase, and clinical trial registries, for studies published between 1990 and August 2019, examining Demodex on the ocular surface. The review included primary clinical research studies and systematic reviews of primary clinical research studies, where Demodex was considered in the context of the ocular surface and/or adnexa. Studies were categorised using the National Health and Medical Research Council evidence hierarchy. Risk of bias assessment was performed using validated tools for studies categorised as providing Level I or II evidence. A total of 87 studies were eligible for inclusion, including two systematic reviews. Most studies (60%) were observational, describing the prevalence of ocular Demodex in different clinical populations. There was a high degree of variability in the epidemiological data derived from cross-sectional aetiology studies. There was mostly consistent evidence to support an association between ocular Demodex and chronic blepharitis. Seven diagnostic test-accuracy studies were identified, which considered a range of techniques, including slit lamp examination for cylindrical eyelash collarettes and/or eyelash manipulation techniques, light microscopic evaluation of epilated eyelashes and in vivo confocal microscopy. There is currently no accepted gold-standard diagnostic method for ocular Demodex. For intervention studies, there was one systematic review, 11 published randomised trials, six trial registry entries, and nine case series. Despite a number of recent trials, the appropriate treatment regimen for ocular Demodex (including the optimal criteria and timing of an intervention) is not clearly established. This comprehensive narrative synthesis has captured the landscape of clinical evidence relating to the prevalence, aetiology, diagnosis and treatment of ocular Demodex. There remain opportunities to enhance understanding of its role in ocular surface disease, best diagnostic approaches and optimal treatment protocols.

Provision of security of the Unified Federal Information Register Containing Data on the Population of the Russian Federation

The object of this research is the public relations with regards to processing of information in the Unified Federal Information Register Containing Data on the Population of the Russian Federation n. Besides the Federal Law &amp;ldquo;On the Unified Federal Information Register Containing Data on the Population of the Russian Federation&amp;rdquo;, the subject of this research is legislation in the area of personal data and legislation on the critical information infrastructure. Based on the main formal and substantive aspects, the author defines the indicated register as a variety of register-based information; substantiates the relevance of application of the principles of framework regulation of information law in the context of creating the register; raises the question on the need to recognize the information system that processes data contained in the register as a valuable object of critical information infrastructure. The novelty of this research consists in the fact that this article is one of the first works dedicated to provision of legal security of the Unified Federal Information Register Containing Data on the Population of the Russian Federation. The following conclusions and proposals on improvement of legislation are formulated: 1) The principles of legal regulation established by legislation with regards to information as the object of legal regulation should be applied to the created register; any unauthorized actions with a separate register entry should be viewed as violation of integrity of the entire object. 2) Due to critical importance of the data contained in the register, it is essential to set confidentiality restrictions, and recognize the federal nformation system that processes data contained in the register as a valuable object of critical information infrastructure. 3) In the text of the Law &amp;ldquo;On the Unified Federal Information Register Containing Data on the Population of the Russian Federation&amp;rdquo;, it is necessary to specify the responsibilities of operator of the federal information system who maintains the federal register and compliance with the requirements of legislation on the security of critical information infrastructure. It is also necessary to clarify the provisions of the Decree of the Government of the Russian Federation that establishes a list of criteria of importance of the objects of critical information infrastructure of the Russian Federation and their value.

Analysis of articles directly related to randomized trials finds poor protocol availability and inconsistent linking of articles

ObjectivesInterpreting a randomized trial requires access to more than the main results paper. We aimed to determine the (1) proportion of trials referring to the protocol in the trial report and their accessibility, (2) proportion of protocols accessible from trial registry entry and by trial registration number search, and (3) types of additional publications associated with trial reports. Study Design and SettingA previously gathered sample of randomized trials of nonpharmacological interventions published in 2009 was used. Trial reports and registry entries were searched for protocol mentions and obtained when possible. Related publications were identified using citation searching. ResultsOf 133 trials, 96 (72%) mentioned the protocol within the report, 61 (64%) contained details about protocol acquisition, with 48 (36%) protocols obtainable. Of the 129 registered trials, 32 (25%) had protocols obtainable from registry entry. Citation tracking identified 1,030 related publications, most common were secondary analyses and qualitative studies. ConclusionTrial protocols facilitate good trial conduct and interpretation. However, they are often not linked to the main report or registry and can be difficult to obtain. Many trials have related publications that are inconsistently linked. Trial registries and registration numbers could facilitate the threading of articles related to a trial, but currently do not.

MP24-15 RENAL MORBIDITY FOLLOWING RADICAL CYSTECTOMY IN PATIENTS WITH BLADDER CANCER

INTRODUCTION AND OBJECTIVE: For patients diagnosed with muscle invasive bladder cancer, baseline kidney function plays a significant role in selecting chemotherapy regimens and the type of urinary reconstruction at the time of cystectomy. We sought to characterize baseline kidney function among patients undergoing radical cystectomy, as well as long term kidney function following surgery. METHODS: We identified patients diagnosed with bladder cancer between 2004 and 2018 in the Veterans Health Administration. We linked cancer registry entries with diagnosis and procedure codes to characterize the type of reconstruction (ileal conduit vs. neobladder). We measured baseline kidney function using outpatient serum creatinine values within one year prior to surgery. We estimated post-operative kidney function using outpatient creatinine values starting 30 days after surgery to minimize the effect of surgical complications or acute kidney injury following cystectomy. RESULTS: We identified 3,361 bladder cancer patients that underwent radical cystectomy with 2,983 (89%) undergoing ileal conduit reconstruction and 378 (11%) undergoing neobladder reconstruction. Comorbidity was similar by reconstruction type (Charlson Comorbidity Index 2.4 +/- 2.0 in neobladder vs. 2.8 +/- 2.3 in ileal conduit cohorts). Mean baseline eGFR was 70.2 for neobladder patients vs. 66.7 in the ileal conduit group. Kidney function declined at 3 months post surgery to 55.1 and 54.2 for neobladder and ileal conduit groups, respectively. The median time to reach clinically significant renal disease (eGFR <30) was shorter in the ileal conduit group at 14.8 months vs. 20.1 months in the neobladder cohort. For patients with normal baseline kidney function (eGFR>60) 73% of neobladder and 67% of ileal conduit patients experienced at least one eGFR <60, raising concern about eligibility for cisplatin-based adjuvant chemotherapy after radical cystectomy. CONCLUSIONS: Kidney function declines after radical cystectomy with either neobladder or ileal conduit urinary diversion. Many patients experience renal morbidity that may increase their risk of cardiovascular events and affect adjuvant treatment selection.Source of Funding: none