OBJECTIVE: End points currently used in lupus nephritis (LN) clinical trials lack uniformity and questionably reflect long-term kidney survival. This study was undertaken to identify short-term end points that predict long-term kidney outcomes for use in clinical trials. METHODS: A database of 944 patients with LN was assembled from 3 clinical trials and 12 longitudinal cohorts. Variables from the first 12 months of treatment after diagnosis of active LN (prediction period) were assessed as potential predictors of long-term outcomes in a 36-month follow-up period. The long-term outcomes examined were new or progressive chronic kidney disease (CKD), severe kidney injury (SKI), and the need for permanent renal replacement therapy (RRT). To predict the risk for each outcome, hazard index tools (HITs) were derived using multivariable analysis with Cox proportional hazards regression. RESULTS: Among 550 eligible subjects, 54 CKD, 55 SKI, and 22 RRT events occurred. Variables in the final CKD HIT were prediction-period CKD status, 12-month proteinuria, and 12-month serum creatinine level. The SKI HIT variables included prediction-period CKD status, International Society of Nephrology (ISN)/Renal Pathology Society (RPS) class, 12-month proteinuria, 12-month serum creatinine level, race, and an interaction between ISN/RPS class and 12-month proteinuria. The RRT HIT included age at diagnosis, 12-month proteinuria, and 12-month serum creatinine level. Each HIT validated well internally (c-indices 0.84-0.92) and in an independent LN cohort (c-indices 0.89-0.92). CONCLUSION: HITs, derived from short-term kidney responses to treatment, correlate with long-term kidney outcomes, and now must be validated as surrogate end points for LN clinical trials.

• MeSH
• akutní poškození ledvin mortalita   terapie   MeSH
• biologické markery analýza   MeSH
• chronická renální insuficience mortalita   terapie   MeSH
• databáze faktografické MeSH
• dospělí MeSH
• klinické zkoušky jako téma MeSH
• kreatinin krev   MeSH
• lidé středního věku MeSH
• lidé MeSH
• longitudinální studie MeSH
• multivariační analýza MeSH
• náhrada funkce ledvin mortalita   MeSH
• nefritida při lupus erythematodes mortalita   terapie   MeSH
• prediktivní hodnota testů MeSH
• proporcionální rizikové modely MeSH
• proteinurie moč   MeSH
• reprodukovatelnost výsledků MeSH
• stupeň závažnosti nemoci * MeSH
• věkové faktory MeSH
• Check Tag
• dospělí MeSH
• lidé středního věku MeSH
• lidé MeSH
• mužské pohlaví MeSH
• ženské pohlaví MeSH
• Publikační typ
• časopisecké články MeSH
• práce podpořená grantem MeSH
• Research Support, N.I.H., Extramural MeSH
• Research Support, N.I.H., Intramural MeSH

Tento článek má za cíl posloužit jednak jako seznámení se základními principy moderní podoby hnutí Open Science a rovněž jako úvaha k nejvýraznějším silným a slabým stránkám jeho vybraných složek. V hlavní části textu autor rozebírá tři klíčové aspekty Open Science. Jedná se o otevřený přístup k výzkumným článkům, datům a informacím o metodologických a analytických procedurách. Všechny tyto aspekty s sebou přinášejí nové praktické postupy s možnými výhodami a nevýhodami, z nichž ty nejvýznamnější jsou v textu popisovány a diskutovány. Článek navíc stručně popisuje propojení Open Science s replikační krizi v psychologii a možné techniky pro zlepšení replikovatelnosti výzkumu. Příspěvek končí krátkým shrnutím a zvážením vhodnosti přejímání vybraných principů Open Science do tuzemské výzkumné praxe.

The aim of this article is to introduce the basic principles of the modern Open Science movement and to deliberate the most important advantages and disadvantages of its selected components. In the main part of the article, the author analyzes three key aspects of Open Science. They are, as follows: open access to research articles, open access to data, and open access to the information regarding methodical and analytical procedures. Each one of these components brings forth new practical procedures with their own pros and cons. The author describes and discusses the most important ones of them. In addition, the Open Science movement and its connection to the replication crisis in psychology and possible techniques for enhancing research replicability is discussed. The article ends with a brief recapitulation and a consideration on the suitability of adapting the selected Open Science principles into the local research practices.

• MeSH
• databáze jako téma MeSH
• přístup k informacím MeSH
• publikování v režimu Open Access MeSH
• reprodukovatelnost výsledků MeSH
• věda trendy   MeSH
• výzkum * trendy   MeSH

Background The effect of racial/ethnic group on survival in upper tract urothelial carcinoma (UTUC) is unknown. We tested this concept in non-metastatic UTUC patients treated with radical nephroureterectomy (RNU) and hypothesized that important differences may exist according to racial/ethnic groups. Material and Methods We relied on the Surveillance Epidemiology and End Results database (2004-2016). We relied on Propensity-score matching (ratio 1:4). Subsequently, cumulative incidence plots and multivariable competing risks regression models (CRR) addressed cancer-specific mortality (CSM). Results Of 9129 assessable patients, 7454 (81.7%) were Caucasian vs. 665 (7.3%) Hispanic vs. 584 (6.4%) Asian vs. 426 (4.7%) African-American. No statistically significant differences were recorded for tumor grade or T-stage, between all racial/ethnic groups. However, within patents who received lymph-node dissection (n = 2694, 29.5%), Asians exhibited the highest rate of more than 2 positive lymph nodes at RNU (19.0%, followed by 17.1% African-Americans, 15.0% Caucasians and 12.6% Hispanics, P < 0.001). After PS-matching and multivariable CRR, Asian race/ethnicity independently predicted higher CSM, relative to Caucasians (Hazard ratio: 1.29, P < 0.01). No statistically significant differences according to CSM was recorded in the remaining races/ethnicities comparisons (all P ≥ 0.1) Conclusion Important CSM differences may exist according to race/ethnicity in non-metastatic UTUC patients treated with RNU. However, these differences only apply to Asian patients, who account for 6% of the overall non-metastatic UTUC cohort treated with RNU. In consequence, in clinical practice Asian patients should be given particular attention with the intent of reducing the CSM disadvantage that cannot be clearly explained by stage and/or grade disadvantage at diagnosis.

• MeSH
• databáze faktografické normy   MeSH
• etnicita MeSH
• lidé MeSH
• nádory močového měchýře epidemiologie   mortalita   MeSH
• program SEER MeSH
• senioři nad 80 let MeSH
• senioři MeSH
• staging nádorů MeSH
• Check Tag
• lidé MeSH
• mužské pohlaví MeSH
• senioři nad 80 let MeSH
• senioři MeSH
• ženské pohlaví MeSH
• Publikační typ
• časopisecké články MeSH

PURPOSE: Data about optimal management of plasmacytoid (PCV) bladder cancer patients are extremely scarce and limited by sample size. We focused on PCV bladder cancer patients to explore the effect of radical cystectomy (RC) and chemotherapy in non-metastatic (T 2-4N0-3M0), as well as in metastatic (TanyNanyM1) subgroups. METHODS: Using the Surveillance, Epidemiology and End Results database (2000-2016), we identified 332 PCV patients with muscle-invasive disease or higher (≥ T2N0M0). Kaplan-Meier plots and Cox regression models addressed cancer-specific mortality (CSM). RESULTS: In 332 PCV patients, median age was 68 years (Interquartile range [IQR]:58-76). Of those, 252 were non-metastatic patients (76%) vs 80 were metastatic patients (24%), at presentation. Of non-metastatic patients, 142 (56%) underwent RC and 131 (52%) underwent chemotherapy. Chemotherapy did not improve CSM in non-metastatic PCV. Conversely, RC was associated with lower CSM (hazard ratio [HR]: 0.51, p = 0.002). Median CSM-free survival was 48 vs 38 months for RC treated vs RC not treated. Of metastatic patients, 22 (28%) underwent RC and 42 (52%) underwent chemotherapy. Both chemotherapy and RC improved CSM in metastatic PCV. Median CSM-free survival was 12 vs 7 months for RC treated vs RC not treated (HR: 0.27, p < 0.001). Median CSM-free survival was 11 vs 4 months for chemotherapy exposed vs chemotherapy naïve (HR: 0.32, p = 0.002). CONCLUSIONS: Although RC resulted in lower CSM, chemotherapy failed to show that effect in non-metastatic PCV patients. Conversely, both chemotherapy and RC resulted in statistically significantly lower CSM in metastatic PCV patients.

• MeSH
• cystektomie metody   MeSH
• karcinom z přechodných buněk * farmakoterapie   chirurgie   MeSH
• lidé MeSH
• močový měchýř patologie   MeSH
• nádory močového měchýře * farmakoterapie   chirurgie   MeSH
• program SEER MeSH
• senioři MeSH
• Check Tag
• lidé MeSH
• senioři MeSH
• Publikační typ
• časopisecké články MeSH

INTRODUCTION: Controversy regarding cancer-specific mortality (CSM) of elderly and very elderly patients with muscle-invasive, non-metastatic, urothelial carcinoma of the urinary bladder (UCUB) undergoing radical cystectomy (RC) vs radiotherapy (RT) still exists. MATERIALS AND METHODS: In the 2004-2016 Surveillance, Epidemiology and End Results (SEER) database, we identified 2663 UCUB patients aged 75-79 (1808 RC vs 855 RT) and 3569 UCUB patients aged 80-89 (1551 RC vs 2018 RT). After stratification for concomitant chemotherapy, propensity score matching (PSM) between RC and RT was applied and competing-risks regression models addressed CSM and OCM. RESULTS: In the cohort aged 75-79, five-year CSM rates were 22.0 vs 49.0% for RC only vs RT only and yielded a HR of 0.41 (95% confidence interval (CI) 0.30-0.57, p<0.001) favoring RC only. Five-year CSM rates were 28.3 vs 44.3% for RC with chemotherapy vs trimodal therapy (TMT) and yielded a HR of 0.48 (95% CI 0.35-0.65, p<0.001) favoring RC with chemotherapy. In the cohort aged 80-89, five-year CSM rates were 24.2 vs 48.9% for RC only vs RT only and yielded a HR of 0.42 (95% CI 0.33-0.52, p<0.001) favoring RC only. Five-year CSM rates were 19.6 vs 43.2% for RC with chemotherapy vs TMT and yielded a HR of 0.43 (95% CI 0.28-0.67, p<0.001) favoring RC with chemotherapy. CONCLUSIONS: In elderly and very elderly patients, radical cystectomy is associated with virtually half the CSM rate than radiotherapy, regardless of concomitant chemotherapy administration.

• MeSH
• cystektomie metody   MeSH
• karcinom z přechodných buněk * farmakoterapie   chirurgie   MeSH
• lidé MeSH
• močový měchýř patologie   MeSH
• nádory močového měchýře * radioterapie   chirurgie   MeSH
• program SEER MeSH
• senioři MeSH
• Check Tag
• lidé MeSH
• mužské pohlaví MeSH
• senioři MeSH
• ženské pohlaví MeSH
• Publikační typ
• časopisecké články MeSH

BACKGROUND: We relied on the most contemporary Surveillance, Epidemiology, and End Results (SEER) database and tested the hypothesis that chemotherapy may improve survival in metastatic urachal carcinoma (m-UraC). MATERIAL AND METHODS: Within the SEER database (2004-2016), we identified m-UraC patients aged ≥ 18 years. Propensity score matching (PSM: cystectomy status, age and sex), Kaplan-Meier plots, cumulative incidence plots, Cox regression models and competing risks regression (CRR) models addressed overall mortality (OM) and cancer-specific mortality (CSM). RESULTS: Overall, 274 m-UraC patients were identified with a median age of 70 years. Most were male (66%) and Caucasian (72%). Overall, 32% received chemotherapy. Chemotherapy-exposed patients were younger (62 vs. 73 years, p<0.001) and more frequently underwent cystectomy (19 vs. 8%, P = 0.014). In 274 m-UraC patients, median OM and CSM were 6 (4 -10) months and 8 (6 -14) months, respectively. After 1:1 PSM, chemotherapy-exposed patients exhibited lower OM (median 16 vs. 3 months; multivariable HR 0.38, P <0.001) and lower CSM (median 17 vs. 4 months; multivariable CRR HR 0.52, P = 0.001). The association between chemotherapy and better survival was even stronger in younger (≤70 years) patients (OM HR: 0.23, P <0.001; CSM CRR HR: 0.42, P = 0.001), but not in older (≥71 years) patients (OM HR: 0.61, P = 0.2; CSM CRR HR: 1.02, P = 1), after PSM and multivariable adjustments. CONCLUSION: Overall, we validated the very aggressive nature of UraC, when distant metastases are present, and observed that m-UraC patients exposed to chemotherapy exhibited lower OM and CSM.

• MeSH
• cystektomie MeSH
• karcinom z přechodných buněk * patologie   MeSH
• lidé MeSH
• nádory močového měchýře * patologie   MeSH
• program SEER MeSH
• senioři MeSH
• Check Tag
• lidé MeSH
• mužské pohlaví MeSH
• senioři MeSH
• ženské pohlaví MeSH
• Publikační typ
• časopisecké články MeSH

OBJECTIVE: Ascertain platelet inhibition and patient outcomes (PLATO) trial conduct. METHODS: We examined information from the FDA complete response review. RESULTS: FDA Medical Review indicated that (1) patients on ticagrelor monitored by the study sponsor had a lower odds ratio for the primary endpoint (p = 0.0004) versus ticagrelor patients monitored by a third party Clinical Research Organisation (CRO) independent of the study sponsor, (2) a significant interaction existed between ticagrelor and regions monitored by the study sponsor for all cause mortality through study end in favor of ticagrelor (p = 0.006), (3) ticagrelor faired worse than clopidogrel when regions were monitored independent of the study sponsor by a third party Contract Research Organisation (United States, Russia and Georgia), (OR = 1.21, 95% CI: 0.91 to 1.59, p = 0.2022), (4) 46% of all primary endpoint events favoring ticagrelor came from just two countries (Poland and Hungary), (5) PLATO was easy to unblind by breaking open a clopidogrel/dummy clopidogrel tablet with at least 452 patients being unblinded prior to the database lock, (6) significantly more cardiac events submitted for clopidogrel counted in the primary analysis as a myocardial infarction (MI) compared to those submitted for ticagrelor (p < 0.0001), (7) significantly more ticagrelor subjects hospitalized after an index event/hospitalization were not being reported as having a primary event compared to clopidogrel (p = 0.002 in favor of ticagrelor), (8) site-reported MI was not significantly reduced with ticagrelor versus clopidogrel, (9) an estimated 23 definite or possible cardiovascular events or deaths on ticagrelor were either not submitted for adjudication, inactivated, deleted or were downgraded to "softer" endpoints (this was not shown in the FDA review for clopidogrel), and (10) four FDA reviewers voted for non-approval of ticagrelor. DISCUSSION: The FDA report highlights what appear to be multiple serious deficiencies in the reporting of the PLATO results, which clinicians will not have gleaned from the primary publication alone. Individual clinicians may therefore wish to carefully reconsider their practice of ticagrelor prescription for this indication. Guideline bodies should also evaluate the information in its totality.

• MeSH
• adenosin analogy a deriváty   terapeutické užití   MeSH
• akutní koronární syndrom diagnóza   farmakoterapie   epidemiologie   MeSH
• antagonisté purinergních receptorů P2Y terapeutické užití   MeSH
• inhibitory agregace trombocytů terapeutické užití   MeSH
• lidé MeSH
• reprodukovatelnost výsledků MeSH
• stanovení cílového parametru metody   normy   MeSH
• Úřad Spojených států pro potraviny a léky normy   MeSH
• výsledek terapie MeSH
• Check Tag
• lidé MeSH
• Publikační typ
• časopisecké články MeSH
• randomizované kontrolované studie MeSH
• Geografické názvy
• Spojené státy americké MeSH

PURPOSE: Unmarried status is an established risk factor for worse cancer control outcomes in various malignancies. Moreover, several investigators observed worse outcomes in unmarried males, but not in females. This concept has not been tested in upper tract urothelial carcinoma and represents the topic of the study. METHODS: Within Surveillance, Epidemiology and End Results database (2004-2016), we identified 8833 non-metastatic upper tract urothelial carcinoma patients treated with radical nephroureterectomy (5208 males vs. 3625 females). Kaplan Meier plots and multivariable Cox regression models predicting overall mortality, other-cause mortality and cancer-specific mortality were used. RESULTS: Overall, 1323 males (25.4%) and 1986 females (54.8%) were unmarried. Except for lower rates of chemotherapy in unmarried males (15.6 vs. 19.6%, P = 0.001) and unmarried females (13.8 vs. 23.6%, P < 0.001), no clinically meaningful differences were recorded between males and females. In multivariable Cox regression models, unmarried status was an independent predictor of higher overall mortality in both males (Hazard ratio [HR]: 1.33, 95% confidence interval [CI]: 1.19-1.48, P < 0.001) and females (HR: 1.13, 95%CI: 1.00-1.27, P = 0.04), as well as of higher other-cause mortality in both males (HR: 1.53, 95%CI: 1.26-1.84,P < 0.001) and females (HR: 1.43, 95%CI: 1.15-1.78,P < 0.01). However, higher cancer-specific mortality was only recorded in unmarried males (HR: 1.24, 95%CI: 1.08-1.42, P < 0.01), but not in females (HR: 1.02, 95%CI: 0.89-1.17, P = 0.7). CONCLUSION: Unmarried status is a marker of worse survival in both males and females and should be flagged as an important risk factor at diagnosis, in both sexes. In consequence, unmarried patients represent candidate for interventions aimed at decreasing the survival gap relative to married counterparts.

• MeSH
• analýza přežití MeSH
• databáze faktografické normy   MeSH
• lidé MeSH
• manželský stav * MeSH
• nádory močového měchýře mortalita   chirurgie   MeSH
• nefroureterektomie metody   MeSH
• program SEER normy   MeSH
• rizikové faktory MeSH
• senioři MeSH
• Check Tag
• lidé MeSH
• mužské pohlaví MeSH
• senioři MeSH
• ženské pohlaví MeSH
• Publikační typ
• časopisecké články MeSH

Cíl studie: Zjistit nejen incidenci vybraných těhotenských komplikací v celostátní populaci, alei jejich závažnost ve vztahu ke klinickému stavu plodu a novorozence.Typ studie: Celostátní retrospektivní srovnávací epidemiologická studie.Název a sídlo pracoviště: Ústav pro péči o matku a dítě, Praha-Podolí; Ústav zdravotnických informacía statistiky ČR, Praha.Předmět a metoda: Srovnání výskytu vybraných těhotenských komplikací podle doporučení WHOa perinatální úmrtnosti u těchto rodiček z údajů evidovaných v inovované „Zprávě o rodičce“a uložených v databázi ÚZIS v r. 2000.Výsledky: Těhotenské komplikace se vyskytovaly v r. 2000 u 17,6 % všech těhotných a podílely sena 47,1 % celkové perinatální úmrtnosti, která činila 4,4 %. Jejich incidence v populaci těhotnýchkolísala od 0,2 % pro vcestné lůžko až po 5,6 % pro hrozící předčasný porod. Jejich závažnost,hodnocená specifickou perinatální úmrtností a vypočtená samostatně pro každou jednotlivoukomplikaci, kolísala od 2,6 ‰ pro gestační hypertenzi až po 103,5 ‰ pro předčasné odlučovánílůžka. U každé šesté ženy se vyskytovala více než jedna komplikace, nejčastěji v kombinaci hrozícíhopředčasného porodu s jinou komplikací. S věkem těhotné výskyt komplikací přibývá, stejnějako se snižujícím se gestačním stářím novorozence. Komplikace vedoucí k poruše placentárnífunkce jsou spíše příčinou mrtvorozenosti, zatímco komplikace, jež jsou častou příčinou předčasnéhoporodu, vedou spíše k časné novorozenecké úmrtnosti.Závěr: Identifikován byl podíl jednotlivých těhotenských komplikací na perinatální úmrtnosti,který se výrazně liší jednak podle jejich incidence v populaci, jednak podle jejich nepříznivéhovlivu na plod a podle týdne těhotenství, kdy se tento vliv na plod uplatnil.

Objective: To evaluate incidence of selected pregnancy complications and their importance towardsclinical status of fetus and newborn.Design: Retrospective comparative epidemiological study.Setting: Institute for the Care of Mother and Child, Praha4-Podolí; Office of Health Informationand Statistics, Praha.Methods: Comparison of incidence of selected pregnancy complications according to the WHOrecommendations and related perinatal mortality using the data from innovated „Report onmother“ of the Office of Health Information and Statistics database in 2000.Results: Pregnancy complications were observed among 17.6% of all pregnant women in 2000 andparticipated on 47.1% of total perinatal mortality, which was 4.4‰. Incidence of pregnancy complicationsvaried from 0.2% of placenta praevia up to 5.6% of threatening preterm labor. Theirseverity, according to complication-specific perinatal mortality, varied from 2.6‰ for gestationalhypertension up to 103.5‰ for premature separation of placenta. Every sixth mother had morethan one complication; the most frequent combination was threatening preterm labor with anothercomplication. The incidence of pregnancy complications increases with age of mother and isalso associated with lower gestational age of newborn. Complications related to placental dysfunctiontend to lead to stillbirths while complications related to preterm labor result more inearly neonatal mortality.Conclusions: We identified the contribution of particular pregnancy complication to perinatalmortality which varies substantially according to its incidence in population and the negativeeffect on fetus at particular gestational age.

• MeSH
• finanční podpora výzkumu jako téma MeSH
• komplikace těhotenství MeSH
• lidé MeSH
• matky MeSH
• populace MeSH
• těhotenství MeSH
• Check Tag
• lidé MeSH
• těhotenství MeSH
• ženské pohlaví MeSH
• Geografické názvy
• Česká republika MeSH

PURPOSE: to compare observed overall survival vs age-adjusted lifetable (LT) derived life expectancy (LE) in metastatic urothelial bladder cancer (MBCa) patients according to race/ethnicity. METHODS: We identified Caucasian, African American, Hispanic/Latino and Asian metastatic urothelial bladder cancer patients from 2004 to 2011 within the Surveillance, Epidemiology and End Results database. Social Security Administration tables were used to compute 5 year LE. LT-derived LE was compared to observed overall survival OS. Additionally, we relied on Poisson regression plots to display cancer-specific mortality (CSM) relative to other-cause mortality (OCM) for each race/ethnicity. RESULTS: Overall, 2286 MBCa patients were identified. Of those, 1800 (79%) were Caucasian vs 212 (9.3%) African American vs 189 (8.3%) Hispanic/Latino vs 85 (3.7%) Asians. The median age at diagnosis was 71 years for Asians vs 70 for Caucasians vs 67 for Hispanic/Latinos vs 67 for African Americans. African Americans showed the biggest difference between observed OS and LT-predicted LE at five years (- 83.8%), followed by Hispanic/Latinos (- 81%), Caucasians (- 77%) and Asian patients (- 69%). In Poisson regression plots, Hispanic/Latinos displayed the highest cancer-specific mortality rate (88%), while African/Americans showed the highest other cause mortality rate (12%). Conversely, Asian patients displayed the lowest CSM rate (83%) and second lowest OCM rate (7%). CONCLUSIONS: African Americans showed the least favorable survival profile in MBCa, despite being youngest at diagnosis. Contrarily, Asians displayed the best survival profile in MBCa, despite being oldest at diagnosis.

• MeSH
• běloši MeSH
• černoši nebo Afroameričané MeSH
• etnicita MeSH
• karcinom z přechodných buněk * MeSH
• lidé MeSH
• naděje dožití MeSH
• nádory močového měchýře * MeSH
• program SEER MeSH
• Check Tag
• lidé MeSH
• Publikační typ
• časopisecké články MeSH