PEGASUS trial reported reduction of composite primary endpoint after conventional 180mg/daily ticagrelor (CT), and lower 120mg/daily dose ticagrelor (LT) at expense of extra bleeding. Following approval of CT and LT for long-term secondary prevention indication, recent FDA review verified some bleeding outcomes in PEGASUS. To compare the risks after CT and LT against placebo by seven TIMI scale variables, and 9 bleeding categories considered as serious adverse events (SAE) in light of PEGASUS drug discontinuation rates (DDR). The DDR in all PEGASUS arms was high reaching astronomical 32% for CT. The distribution of some outcomes (TIMI major, trauma, epistaxis, iron deficiency, hemoptysis, and anemia) was reasonable. However, the TIMI minor events were heavily underreported when compared to similar trials. Other bleedings (intracranial, spontaneous, hematuria, and gastrointestinal) appear sporadic, lacking expected dose-dependent impact of CT and LT. Few SAE outcomes (fatal, ecchymosis, hematoma, bruises, bleeding) paradoxically reported more bleeding after LT than after CT. Many bleeding outcomes were probably missed in PEGASUS potentially due to massive non-compliance, information censoring, or both. The FDA must improve reporting of trial outcomes especially in the sponsor-controlled environment when DDR and incomplete follow-up rates are high.

• MeSH
• adenosin aplikace a dávkování   škodlivé účinky   analogy a deriváty   MeSH
• cenzura ve výzkumu MeSH
• infarkt myokardu farmakoterapie   MeSH
• krvácení chemicky indukované   MeSH
• lidé MeSH
• randomizované kontrolované studie jako téma MeSH
• rozvrh dávkování léků MeSH
• Check Tag
• lidé MeSH
• Publikační typ
• úvodníky MeSH

• MeSH
• analýza dat MeSH
• statistika jako téma MeSH
• zdraví MeSH

• Konspekt
• Statistika
• NLK Obory
• statistika, zdravotnická statistika
• lékařství

Motivated by a longitudinal oral health study, we propose a flexible modeling approach for clustered time-to-event data, when the response of interest can only be determined to lie in an interval obtained from a sequence of examination times (interval-censored data) and on top of that, the determination of the occurrence of the event is subject to misclassification. The clustered time-to-event data are modeled using an accelerated failure time model with random effects and by assuming a penalized Gaussian mixture model for the random effects terms to avoid restrictive distributional assumptions concerning the event times. A general misclassification model is discussed in detail, considering the possibility that different examiners were involved in the assessment of the occurrence of the events for a given subject across time. A Bayesian implementation of the proposed model is described in a detailed manner. We additionally provide empirical evidence showing that the model can be used to estimate the underlying time-to-event distribution and the misclassification parameters without any external information about the latter parameters. We also provide results of a simulation study to evaluate the effect of neglecting the presence of misclassification in the analysis of clustered time-to-event data.

• MeSH
• Bayesova věta MeSH
• časové faktory MeSH
• dítě MeSH
• lidé MeSH
• longitudinální studie * MeSH
• orální zdraví statistika a číselné údaje   MeSH
• počítačová simulace MeSH
• shluková analýza * MeSH
• statistické modely * MeSH
• Check Tag
• dítě MeSH
• lidé MeSH
• mužské pohlaví MeSH
• ženské pohlaví MeSH
• Publikační typ
• časopisecké články MeSH

• Klíčová slova
• Analýza dat, Analýza statistická, Regrese,

• Konspekt
• Statistika
• NLK Obory
• statistika, zdravotnická statistika

The aim of the study is to model concentrations of selected biogenic amines in various fish species (Atlantic salmon, Atlantic cod, striped catfish) bought in retail stores in Central Europe. Since the data contains non-detectable values, statistical methods for left-censored values from the exponential and Weibull distributions are applied and used to evaluate and compare the amount of biogenic amines in fish samples. Moreover, a risk of exceeding certain limits of biogenic amine concentrations to protect human health is determined. There are relatively high concentrations of putrescine, cadaverine and histamine in almost all fish species. Moreover, there was a significant difference in mean concentrations (distributions of concentrations, respectively) of histamine, tyramine and spermidine among the species.

• MeSH
• biogenní aminy chemie   metabolismus   MeSH
• histamin metabolismus   MeSH
• kadaverin metabolismus   MeSH
• lidé MeSH
• maso analýza   MeSH
• monitorování životního prostředí MeSH
• putrescin metabolismus   MeSH
• ryby metabolismus   MeSH
• spermidin MeSH
• zvířata MeSH
• Check Tag
• lidé MeSH
• zvířata MeSH
• Publikační typ
• časopisecké články MeSH
• Geografické názvy
• Evropa MeSH

• MeSH
• biometrie MeSH
• statistika jako téma MeSH

• Konspekt
• Statistika
• NLK Obory
• statistika, zdravotnická statistika
• management, organizace a řízení zdravotnictví

Analýza přežití je soubor statistických metod, ve kterých je zkoumána doba do výskytu sledované události. V biomedicínských aplikacích takovou událostí může být např. výskyt primárního onemocnění nebo úmrtí pacienta. Charakteristickým jevem v analýze přežití je tzv. cenzorování a krácení dat, kdy pracujeme pouze s částečnou informací o přežití pacientů (např. sledování pacientů typicky skončí dřív, než všichni zemřou). Metody analýzy přežití slouží k odhadu rozdělení doby do výskytu sledované události resp. přežití pacienta, k určení rizikových faktorů, které ovlivňují délku přežití, a také k predikci času přežití v závislosti na přítomnosti rizikových faktorů. K rozvoji metod analýzy přežití přispívá také využití teorie čítacích procesů a martingalů. Jednorozměrné metody analýzy přežití nelze použít, jestliže není splněn předpoklad nezávislosti jednotlivých dob přežití. V takovém případě je nutné využít vícerozměrné metody, jako jsou např. vícestavové modely nebo modely náchylnosti.

The survival analysis is a set of statistical methods dealing with time-to-event data. In biomedical applications the event of interest is usually relapse of the disease or death. A special feature of the survival analysis is censoring and truncation of data. When censoring or truncation occurs some information about the patients' survival is lost, e.g. some patients are lost to follow-up or the study ends before all the patients die. The survival analysis methods are used for estimation of the survival time distribution, for identification of risk factors that affect the survival time, and also for predicting the survival time when risk factors are present. Survival analysis methods have been further developed by the means of counting processes and martingale theory. Univariate survival analysis methods have been extended to multivariate setting. The multivariate survival analysis covers the field where independence between survival times cannot be assumed. Multi-state models and frailty models represent the two main approaches of multivariate methods.

• Klíčová slova
• funkce přežití, riziková funkce, kumulativní riziková funkce, cenzorování, krácení, Kaplanova-Meierova funkce přežití, Nelsonova-Aalenova funkce rizika, Coxův model proporcionálních rizik, metoda parciální věrohodnosti, čítací proces, historie, martingal, konkurující rizika, vícestavové modely, modely náchylnosti,
• MeSH
• analýza přežití MeSH
• filtrace MeSH
• financování organizované MeSH
• interpretace statistických dat MeSH
• Kaplanův-Meierův odhad MeSH
• lidé MeSH
• proporcionální rizikové modely MeSH
• Check Tag
• lidé MeSH

Background: Randomized trials have shown increased risk of suicidality associated with efavirenz (EFV). The START (Strategic Timing of Antiretroviral Treatment) trial randomized treatment-naive human immunodeficiency virus (HIV)-positive adults with high CD4 cell counts to immediate vs deferred antiretroviral therapy (ART). Methods: The initial ART regimen was selected prior to randomization (prespecified). We compared the incidence of suicidal and self-injurious behaviours (suicidal behavior) between the immediate vs deferred ART groups using proportional hazards models, separately for those with EFV and other prespecified regimens, by intention to treat, and after censoring participants in the deferred arm at ART initiation. Results: Of 4684 participants, 271 (5.8%) had a prior psychiatric diagnosis. EFV was prespecified for 3515 participants (75%), less often in those with psychiatric diagnoses (40%) than without (77%). While the overall intention-to-treat comparison showed no difference in suicidal behavior between arms (hazard ratio [HR], 1.07, P = .81), subgroup analyses suggest that initiation of EFV, but not other ART, is associated with increased risk of suicidal behavior. When censoring follow-up at ART initiation in the deferred group, the immediate vs deferred HR among those who were prespecified EFV was 3.31 (P = .03) and 1.04 (P = .93) among those with other prespecified ART; (P = .07 for interaction). In the immediate group, the risk was higher among those with prior psychiatric diagnoses, regardless of prespecified treatment group. Conclusions: Participants who used EFV in the immediate ART group had increased risk of suicidal behavior compared with ART-naive controls. Those with prior psychiatric diagnoses were at higher risk.

• MeSH
• benzoxaziny škodlivé účinky   MeSH
• chování sebezraňující epidemiologie   MeSH
• dospělí MeSH
• HIV infekce komplikace   farmakoterapie   MeSH
• HIV séropozitivita farmakoterapie   MeSH
• látky proti HIV škodlivé účinky   MeSH
• lidé středního věku MeSH
• lidé MeSH
• počet CD4 lymfocytů MeSH
• sebevražda * MeSH
• virová nálož MeSH
• vysoce aktivní antiretrovirová terapie MeSH
• Check Tag
• dospělí MeSH
• lidé středního věku MeSH
• lidé MeSH
• mužské pohlaví MeSH
• ženské pohlaví MeSH
• Publikační typ
• časopisecké články MeSH
• multicentrická studie MeSH
• práce podpořená grantem MeSH
• randomizované kontrolované studie MeSH
• Research Support, N.I.H., Extramural MeSH

• MeSH
• lékařství MeSH
• statistika jako téma MeSH

• Konspekt
• Statistika
• NLK Obory
• statistika, zdravotnická statistika

BACKGROUND: Nonadherence to antiplatelet therapy after percutaneous coronary intervention (PCI) is common, even in clinical trials. OBJECTIVES: The purpose of this study was to investigate the impact of nonadherence to study protocol regimens in the MASTER DAPT (Management of High Bleeding Risk Patients Post Bioresorbable Polymer Coated Stent Implantation With an Abbreviated Versus Prolonged DAPT Regimen) trial. METHODS: At 1-month after PCI, 4,579 high bleeding risk patients were randomized to single antiplatelet therapy (SAPT) for 11 months (or 5 months in patients on oral anticoagulation [OAC]) or dual antiplatelet therapy (DAPT) for ≥2 months followed by SAPT. Coprimary outcomes included net adverse clinical events (NACE), major adverse cardiac and cerebral events (MACE), and major or clinically relevant nonmajor bleeding (MCB) at 335 days. Inverse probability-of-censoring weights were used to correct for nonadherence Academic Research Consortium type 2 or 3. RESULTS: In total, 464 (20.2%) patients in the abbreviated-treatment and 214 (9.4%) in the standard-treatment groups incurred nonadherence Academic Research Consortium type 2 or 3. At inverse probability-of-censoring weights analyses, NACE (HR: 1.01; 95% CI: 0.88-1.27) or MACE (HR: 1.07; 95% CI: 0.83-1.40) did not differ, and MCB was lower with abbreviated compared with standard treatment (HR: 0.51; 95% CI: 0.60-0.73) consistently across OAC subgroups; among OAC patients, SAPT discontinuation 6 months after PCI was associated with similar MACE and lower MCB (HR: 0.47; 95% CI: 0.22-0.99) compared with SAPT continuation. CONCLUSIONS: In the MASTER DAPT adherent population, 1-month compared with ≥3-month DAPT was associated with similar NACE or MACE and lower MCB. Among OAC patients, SAPT discontinuation after 6 months was associated with similar MACE and lower MCB than SAPT continuation (Management of High Bleeding Risk Patients Post Bioresorbable Polymer Coated Stent Implantation With an Abbreviated Versus Prolonged DAPT Regimen [MASTER DAPT]; NCT03023020).

• MeSH
• adherence k farmakoterapii MeSH
• inhibitory agregace trombocytů terapeutické užití   MeSH
• kombinovaná farmakoterapie MeSH
• koronární angioplastika * metody   MeSH
• krvácení chemicky indukované   farmakoterapie   epidemiologie   MeSH
• lidé MeSH
• polymery MeSH
• stenty uvolňující léky * škodlivé účinky   MeSH
• výsledek terapie MeSH
• Check Tag
• lidé MeSH
• Publikační typ
• časopisecké články MeSH
• práce podpořená grantem MeSH
• randomizované kontrolované studie MeSH