RESUMO
Rapid and detailed post-marketing surveillance of drugs and vaccine is required to enable assessment of their real-world safety and effectiveness. Spontaneous reporting from healthcare professionals and citizens is recognized as the basic method in the passive post-marketing surveillance of drugs and vaccines, allowing the identification of rare adverse drug reactions (ADRs) and adverse events following immunization (AEFIs). According to the current law, online platforms for ADRs and AEFI reporting and related databases are available in every country and at the global level. Recently, the use of electronic health records and the establishment of networks of databases as different sources of real-world data is emerging allowing high-quality, large-scale evaluations and providing real-world evidence on questions of clinical and regulatory interests. Here, we summarize the adverse event pharmacovigilance reporting systems in place at the global, European and in some European countries, and provide examples from recent literature of how the analysis of pharmacovigilance reports can provide evidence for unexpected and novel adverse drug reactions. Furthermore, we discuss the role of real-world data to generate real-world evidence in pharmacovigilance and regulatory activities.
Assuntos
Sistemas de Notificação de Reações Adversas a Medicamentos , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos , Farmacovigilância , Humanos , Sistemas de Notificação de Reações Adversas a Medicamentos/estatística & dados numéricos , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/epidemiologia , Bases de Dados Factuais , Medição de Risco/métodos , Registros Eletrônicos de SaúdeRESUMO
INTRODUCTION: Ureteroscopy has become increasingly chosen as a treatment of choice for patients with kidney stone disease and laser as the energy source for stone lithotripsy is a key part of this. Our aim was to analyse a national database to evaluate the burden of adverse events related to laser fibers and laser machines. METHODS: Search was performed of the Manufacturer User and Facility Device Experience (MAUDE) database in the United States for all events related to holmium laser fibers and holmium laser machines during ureteroscopy between 2012-2021. Information collected included the following: problem, timing, prolonged anaesthesia, early termination of procedure, injury and retained parts. RESULTS: 699 holmium laser fiber events were reported and these had been manufactured by 13 different companies. The commonest problems were breakage outside the patient while in use (26.3%) and breakage of the laser fiber tip (21.2%). Manufacturers concluded root cause to be device failure in 8.9%. 29% of issues occurred before the laser had been activated. 5.2% of cases had to be cancelled as a result of an event. Significantly more injuries were sustained intra-operatively by operating staff compared to patients (6% vs. 0.2%, p < 0.001). All these injuries were superficial burns to the skin with the hand being the most affected body part (88.1%). Zero ocular injuries were reported. Only eight events were related to laser machines and all involved sudden hardware failure but no patient injury. CONCLUSIONS: Laser fibers are fragile. Most adverse events are due to operator error. Direct patient injury from laser fiber is scarce but operating staff should be aware of the risk of sustaining minor burns. Laser machines rarely incur problems and, in this study, did not result in any safety issues beyond need to abort the procedure due to lack of spare equipment.
Assuntos
Bases de Dados Factuais , Cálculos Renais , Lasers de Estado Sólido , Litotripsia a Laser , Ureteroscopia , Humanos , Ureteroscopia/efeitos adversos , Ureteroscopia/métodos , Litotripsia a Laser/métodos , Litotripsia a Laser/efeitos adversos , Litotripsia a Laser/instrumentação , Estados Unidos , Lasers de Estado Sólido/uso terapêutico , Lasers de Estado Sólido/efeitos adversos , Cálculos Renais/cirurgia , Cálculos Renais/terapia , Falha de Equipamento/estatística & dados numéricos , Fatores de TempoRESUMO
Type II diabetes mellitus is a global public health challenge, necessitating robust epidemiological investigations. The majority of evidence reports prevalence as estimations of incidence requiring longitudinal cohort studies that are challenging to conduct. However, this has been addressed by the secondary use of existing health insurance claims data. The current study aimed to examine the incidence of type II diabetes mellitus using existing claims and ledger data. The National Health Insurance and medical care system databases were used to extract type II diabetes mellitus (defined as ICD10 codes E11$-14$) claims data over a period of 5 years for individuals over 40 years old living in one city in Japan. Prevalence was calculated, and insured individuals whose data could be tracked over the entire study period were included in the subsequent analyses. Therefore, annual incidence was calculated by estimating differences in prevalence by year. Data analyses were stratified by sex and age group, and a model analysis was conducted to account for these variables. Overall, the prevalence, diabetes medication usage, and insulin usage were 26.3%, 12.1%, and 2.0%, respectively. Annual incidence of type II diabetes mellitus ranged between 1.2% and 4.6%. Both prevalence and incidence tended to be higher in males and peaked around 60-80 years old. The overall annual incidence was estimated at 3.03% (95% CI: 2.21%-3.85%). The annual incidence was not always associated with a low risk, indicating a consistent risk from middle age onward, although the level of risk varied with age. The current study successfully integrated existing claims and ledger data to explore incidence, and this methodology could be applied to a range of injuries and illnesses in the future.
Assuntos
Bases de Dados Factuais , Diabetes Mellitus Tipo 2 , Humanos , Masculino , Diabetes Mellitus Tipo 2/epidemiologia , Feminino , Pessoa de Meia-Idade , Incidência , Idoso , Adulto , Japão/epidemiologia , Idoso de 80 Anos ou mais , Estudos de Coortes , Seguro Saúde/estatística & dados numéricos , PrevalênciaRESUMO
OBJECTIVES: We aimed to investigate the association between the albumin-corrected anion gap (ACAG) and the prognosis of cardiogenic shock (CS). DESIGN: A multicentre retrospective cohort study. SETTING: Data were collected from the Medical Information Mart for Intensive Care (MIMIC-IV) and eICU Collaborative Research Database (eICU-CRD) datasets. PARTICIPANTS: 808 and 700 individuals from the MIMIC-IV and eICU-CRD, respectively, who were diagnosed with CS. PRIMARY AND SECONDARY OUTCOMES: The primary endpoint was short-term all-cause mortality, including intensive care unit (ICU), in-hospital and 28-day mortality. The secondary endpoints were the 28-day free from the ICU duration and the length of ICU stay. RESULTS: CS patients were divided into two groups according to the admission ACAG value: the normal ACAG group (≤20 mmol/L) and the high ACAG group (> 20 mmol/L). CS patients with higher ACAG values exhibited increased short-term all-cause mortality rates, including ICU mortality (MIMIC-IV cohort: adjusted HR: 1.43, 95% CI=1.05-1.93, p=0.022; eICU-CRD cohort: adjusted HR: 1.38, 95% CI=1.02-1.86, p=0.036), in-hospital mortality (MIMIC-IV cohort: adjusted HR: 1.31, 95% CI=1.01-1.71, p=0.03; eICU-CRD cohort: adjusted HR: 1.47, 95% CI=1.12-1.94, p=0.006) and 28-day mortality (adjusted HR: 1.42, 95% CI: 1.11 to 1.83, p=0.007). A positive linear correlation was observed between the ACAG value and short-term mortality rates via restricted cubic splines. Compared with the AG, the ACAG presented a larger area under the curve for short-term mortality prediction. In addition, the duration of intensive care was longer, whereas the 28-day free from the ICU duration was shorter in patients with a higher ACAG value in both cohorts. CONCLUSION: The ACAG value was independently and strongly associated with the prognosis of patients with CS, indicating that the ACAG value is superior to the conventional AG value.
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Equilíbrio Ácido-Base , Mortalidade Hospitalar , Unidades de Terapia Intensiva , Choque Cardiogênico , Humanos , Estudos Retrospectivos , Choque Cardiogênico/mortalidade , Masculino , Feminino , Idoso , Prognóstico , Pessoa de Meia-Idade , Unidades de Terapia Intensiva/estatística & dados numéricos , Tempo de Internação/estatística & dados numéricos , Bases de Dados Factuais , Albumina Sérica/análise , Idoso de 80 Anos ou maisRESUMO
BACKGROUND: Iatrogenic urinary injury (IUI) can lead to significant complications after colorectal surgery, especially when diagnosis is delayed. This study analyzes risk factors associated with IUI and delayed IUI among patients undergoing colorectal procedures. METHODS: Adults undergoing colorectal surgery between 2012 and 2021 were identified in the American College of Surgeons National Surgical Quality Improvement Program (NSQIP®) database. Multivariable regression analysis was used to determine risk factors and outcomes associated with IUI and delayed IUI. RESULTS: Among 566,036 patients, 5836 patients (1.0%) had IUI after colorectal surgery, of whom 236 (4.0%) had delayed IUI. Multiple preoperative risk factors for IUI and delayed IUI were identified, with disseminated cancer [adjusted odds ratio (aOR) 1.4, 95% confidence interval (CI) 1.2-1.5; p < 0.001] and diverticular disease [aOR 1.1, 95% CI 1.0-1.2; p = 0.009] correlated with IUI and increased body mass index [aOR 1.6, 95% CI 1.2-2.1; p = 0.003] and ascites [aOR 5.6, 95% CI 2.1-15.4; p = 0.001] associated with delayed IUI. Laparoscopic approach was associated with decreased risk of IUI [aOR 0.4, 95% CI 0.4-0.5; p < 0.001] and increased risk of delayed IUI [aOR 1.8, 95% CI 1.4-2.5; p < 0.001]. Both IUI and delayed IUI were associated with significant postoperative morbidity, with severe multiorgan complications seen in delayed IUI. CONCLUSIONS: While IUI occurs infrequently in colorectal surgery, unrecognized injuries can complicate repair and cause other negative postoperative outcomes. Patients with complex intra-abdominal pathology are at increased risk of IUI, and patients with large body habitus undergoing laparoscopic procedures are at increased risk of delayed IUI.
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Doença Iatrogênica , Complicações Pós-Operatórias , Humanos , Masculino , Feminino , Fatores de Risco , Pessoa de Meia-Idade , Complicações Pós-Operatórias/etiologia , Complicações Pós-Operatórias/epidemiologia , Idoso , Bases de Dados Factuais , Cirurgia Colorretal/efeitos adversos , Adulto , Laparoscopia/efeitos adversos , Laparoscopia/estatística & dados numéricos , Sistema Urinário/lesões , Estudos Retrospectivos , Estados Unidos/epidemiologia , Estudos de CoortesRESUMO
Purpose: To compare an optical coherence tomography (OCT) real-world reference database (RW-RDB) of "healthy" eyes obtained from optometry practices to a commercial reference database (RDB). Methods: OCT scans from 6804 individuals 18 years and older were sampled from a larger database tested at 10 optometry practices involved in refractive and screening services. Employing a reading center method, OCT scans from both eyes of 4932 (4.9K) individuals were judged to be of acceptable quality with an absence of pathology. The 4.9K RW-RDB was compared to a commercial RDB with 398 eyes (398 RDB). Results: The means and distributions of global circumpapillary retinal nerve fiber layer (G-cpRNFL) and global ganglion cell layer (G-GCL) thickness, as well as five key anatomical parameters affecting cpRNFL thickness, were not significantly different for all but one parameter (fovea-to-disc distance) and one thickness metric (G-cpRNFL). In both cases, the difference amounted to less than 1.5%. By design, the number of 4.9K RW-RDB eyes 70 years and older (724, 14.7%) was greater than for the 398 RDB (40, 10.1%). The error bands on the 5% and 1% quantile regression lines (QRLs) were substantially narrower for the 4.9K RW-RDB. Conclusions: The 398 RDB and 4.9K RW-RDB have similar characteristics and appear to come from a similar population. However, the large size of the 4.9K RW-RDB leads to narrower error bands of the QRLs, which has the potential to increase accuracy. Translational Relevance: The larger RW-RDB offers the opportunity to better characterize healthy eyes for clinical diagnosis and clinical trials by furthering our understanding of the patterns of artifacts, exploring covariates, developing separate RW-RDBs, and/or improving AI models.
Assuntos
Bases de Dados Factuais , Optometria , Tomografia de Coerência Óptica , Humanos , Masculino , Feminino , Tomografia de Coerência Óptica/métodos , Pessoa de Meia-Idade , Adulto , Idoso , Fibras Nervosas , Células Ganglionares da Retina/citologia , Adulto Jovem , Valores de Referência , AdolescenteRESUMO
BACKGROUND: Updated prevalence estimates along the continuum of Alzheimer's disease (AD) can foster a more nuanced and effective approach to managing AD within the current healthcare landscape. OBJECTIVES: This study aims to estimate the prevalence and severity distribution of dementia/AD (including mild, moderate, and severe stages) and all-cause mild cognitive impairment (MCI) in the United States using data from the Health and Retirement Study (HRS). DESIGN: Retrospective study. SETTING: Data from the bi-annual HRS surveys involving in-depth interviews of a representative sample of Americans aged >50 years. PARTICIPANTS: Dementia/AD and all-cause MCI patients from the 4 most recent HRS surveys (2014, 2016, 2018 and 2020). MEASUREMENTS: AD was identified based on diagnosis (self-report). Cognitive performance (modified Telephone Interview of Cognitive Status [TICS-m]) scores in the dementia/AD range were also captured; all-cause MCI was similarly identified using the TICS-m. Dementia/AD and MCI prevalence, as well as the distribution by dementia/AD stage (mild, moderate, or severe), were estimated. Sampling weights developed by HRS were applied to ensure the sample's representativeness of the target population and unbiased estimates for population parameters. RESULTS: Across the four HRS surveys, the total number of HRS respondents ranged from 15,000 to 21,000 (unweighted); 7,000 to 14,000 had TICS-m scores. The estimated prevalence of AD (all severity categories combined) in the 2014, 2016, 2018, and 2020 HRS surveys was 1.2%, 1.2%, 1.3% and 1.0%, respectively using the diagnosis-based approach; using the cognitive performance-based approach, 23-27% patients had scores in the dementia/AD ranges across the 4 surveys. The estimated prevalence of all-cause MCI was consistently 23% in each survey. In the 2020 survey, the distribution of mild, moderate, and severe disease stages was 34%, 45%, and 21%, respectively, in patients self-reporting an AD diagnosis, and 55%, 40%, and 5%, respectively in all patients meeting TICS-m threshold for dementia/AD. CONCLUSION: The prevalence of AD diagnosis based on self-report was approximately 1% across the 4 most recent HRS surveys and may reflect the proportion of patients who have actively sought healthcare for AD. Among HRS survey respondents with cognitive scores available, over 20% were in the dementia/AD range. The distribution of disease by stage differed for self-reported AD diagnosis vs dementia/AD based on cognitive scores. Discordance in estimates of dementia/AD and stage distributions underscores a need for better understanding of clinical practice patterns in AD diagnosis, use of clinical assessment tools, and severity classification in the United States. Accurate patient identification is needed, especially early in the AD disease continuum, to allow for timely and appropriate initiation of new anti-amyloid treatments.
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Doença de Alzheimer , Disfunção Cognitiva , Humanos , Estados Unidos/epidemiologia , Doença de Alzheimer/epidemiologia , Doença de Alzheimer/diagnóstico , Feminino , Idoso , Masculino , Prevalência , Estudos Retrospectivos , Disfunção Cognitiva/epidemiologia , Disfunção Cognitiva/diagnóstico , Pessoa de Meia-Idade , Demência/epidemiologia , Demência/diagnóstico , Idoso de 80 Anos ou mais , Índice de Gravidade de Doença , Bases de Dados FactuaisRESUMO
Aerosol-transmitted viruses possess strong infectivity and can spread over long distances, earning the difficult-to-control title. They cause various human diseases and pose serious threats to human health. Mutations can increase the transmissibility and virulence of the strains, reducing the protection provided by vaccines and weakening the efficacy of antiviral drugs. In this study, we established a manually curated database (termed AVM) to store information on aerosol-transmitted viral mutations (VMs). The current version of the AVM contains 42,041 VMs (including 2613 immune escape mutations), 45 clinical information datasets, and 407 drugs/antibodies/vaccines. Additionally, we recorded 88 human diseases associated with viruses and found that the same virus can target multiple organs in the body, leading to diverse diseases. Furthermore, the AVM database offers a straightforward user interface for browsing, retrieving, and downloading information. This database is a comprehensive resource that can provide timely and valuable information on the transmission, treatment, and diseases caused by aerosol-transmitted viruses (http://www.bio-bigdata.center/AVM).
Assuntos
Aerossóis , Mutação , Humanos , Antivirais/farmacologia , Bases de Dados Genéticas , Vírus/genética , Vírus/classificação , Vírus/patogenicidade , Viroses/transmissão , Viroses/virologia , Viroses/genética , Bases de Dados Factuais , Curadoria de Dados/métodosRESUMO
BACKGROUND: Severe acute cholecystitis (AC) is a challenging disease because it comprises coexisting systemic infections that lead to vital organ dysfunction. This study evaluated the optimal surgical timing and efficacy of preoperative percutaneous cholecystostomy (PC) for patients with severe AC. METHODS: Data of 142 patients who underwent cholecystectomy for severe AC between 2011 and 2021 were retrospectively collected from the multi-institutional database of the Hiroshima Surgical Study Group of Clinical Oncology. Patients were divided into the early cholecystectomy (EC) group (within 72 h of symptom onset) and delayed cholecystectomy (DC) group. They were also subdivided into the upfront cholecystectomy group and preoperative PC before cholecystectomy group. The diagnosis and severity of AC were graded according to the Tokyo Guidelines 2018. Clinicopathological variables and outcomes were compared. RESULTS: No significant differences in age, body mass index, American Society of Anesthesiologists (ASA) classification, and Charlson comorbidity index between the EC and DC groups were observed. Preoperative drainage was more commonly performed for the DC group than for the EC group. Local severe AC features were more commonly detected in the DC group than in the EC group. The postoperative outcomes of the EC and DC groups were comparable. Compared to the PC before cholecystectomy group, the upfront cholecystectomy group included more patients with ASA physical status ≥ 3 and more patients who used oral warfarin. Warfarin usage and cardiovascular dysfunction rates of the PC after cholecystectomy group were higher than those of the upfront cholecystectomy group. PC was associated with significantly less intraoperative bleeding and shorter hospital stays. CONCLUSIONS: Patients who can tolerate general anesthesia are good candidates for EC. Patients who use warfarin and those with cardiovascular dysfunction are considered to be at high risk for postoperative complications; therefore, to prevent AC recurrence during the waiting period, PC before cholecystectomy during the same admission is more appropriate than upfront cholecystectomy for these patients.
Assuntos
Colecistectomia , Colecistite Aguda , Colecistostomia , Cuidados Pré-Operatórios , Humanos , Colecistite Aguda/cirurgia , Estudos Retrospectivos , Masculino , Feminino , Colecistostomia/métodos , Idoso , Colecistectomia/métodos , Pessoa de Meia-Idade , Cuidados Pré-Operatórios/métodos , Resultado do Tratamento , Tempo para o Tratamento/estatística & dados numéricos , Índice de Gravidade de Doença , Complicações Pós-Operatórias/epidemiologia , Complicações Pós-Operatórias/etiologia , Japão , Bases de Dados Factuais , Idoso de 80 Anos ou mais , Tempo de Internação/estatística & dados numéricosRESUMO
BACKGROUND: Real-world evidence (RWE) plays a key role in regulatory and healthcare decision-making, but the potentially fragmentated nature of generated evidence may limit its utility for clinical decision-making. Heterogeneity and a lack of reproducibility in RWE resulting from inconsistent application of methodologies across data sources should be minimized through harmonization. METHODS: This paper's aim is to describe and reflect upon a multidisciplinary research platform (FOUNTAIN; FinerenOne mUlti-database NeTwork for evidence generAtIoN) with coordinated studies using diverse RWE generation approaches and explore the platform's strengths and limitations. With guidance from an executive advisory committee of multidisciplinary experts and patient representatives, the goal of the FOUNTAIN platform is to harmonize RWE generation across a portfolio of research projects, including research partner collaborations and a common data model (CDM)-based program. FOUNTAIN's overarching objectives as a research platform are to establish long-term collaborations among pharmacoepidemiology research partners and experts and to integrate diverse approaches for RWE generation, including global protocol execution by research partners in local data sources and common protocol execution in multiple data sources through federated data networks, while ensuring harmonization of medical definitions, methodology, and reproducible artifacts across all studies. Specifically, the aim of the multiple studies run within the frame of FOUNTAIN is to provide insight into the real-world utilization, effectiveness, and safety of finerenone across its life-cycle. RESULTS: Currently, the FOUNTAIN platform includes 9 research partner collaborations and 8 CDM-mapped data sources from 7 countries (United States, United Kingdom, China, Japan, The Netherlands, Spain, and Denmark). These databases and research partners were selected after a feasibility fit-for-purpose evaluation. Six multicountry, multidatabase, cohort studies are ongoing to describe patient populations, current standard of care, comorbidity profiles, healthcare resource use, and treatment effectiveness and safety in different patient populations with chronic kidney disease and type 2 diabetes. Strengths and potential limitations of FOUNTAIN are described in the context of valid RWE generation. CONCLUSION: The establishment of the FOUNTAIN platform has allowed harmonized execution of multiple studies, promoting consistency both within individual studies that employ multiple data sources and across all studies run within the platform's framework. FOUNTAIN presents a proposal to efficiently improve the consistency and generalizability of RWE on finerenone.
Assuntos
Medicina Baseada em Evidências , Humanos , Medicina Baseada em Evidências/métodos , Medicina Baseada em Evidências/normas , Bases de Dados Factuais/estatística & dados numéricos , Projetos de Pesquisa , Reprodutibilidade dos Testes , Antagonistas de Receptores de Mineralocorticoides/uso terapêuticoRESUMO
BACKGROUND: Skin cancer is one of the highly occurring diseases in human life. Early detection and treatment are the prime and necessary points to reduce the malignancy of infections. Deep learning techniques are supplementary tools to assist clinical experts in detecting and localizing skin lesions. Vision transformers (ViT) based on image segmentation classification using multiple classes provide fairly accurate detection and are gaining more popularity due to legitimate multiclass prediction capabilities. MATERIALS AND METHODS: In this research, we propose a new ViT Gradient-Weighted Class Activation Mapping (GradCAM) based architecture named ViT-GradCAM for detecting and classifying skin lesions by spreading ratio on the lesion's surface area. The proposed system is trained and validated using a HAM 10000 dataset by studying seven skin lesions. The database comprises 10 015 dermatoscopic images of varied sizes. The data preprocessing and data augmentation techniques are applied to overcome the class imbalance issues and improve the model's performance. RESULT: The proposed algorithm is based on ViT models that classify the dermatoscopic images into seven classes with an accuracy of 97.28%, precision of 98.51, recall of 95.2%, and an F1 score of 94.6, respectively. The proposed ViT-GradCAM obtains better and more accurate detection and classification than other state-of-the-art deep learning-based skin lesion detection models. The architecture of ViT-GradCAM is extensively visualized to highlight the actual pixels in essential regions associated with skin-specific pathologies. CONCLUSION: This research proposes an alternate solution to overcome the challenges of detecting and classifying skin lesions using ViTs and GradCAM, which play a significant role in detecting and classifying skin lesions accurately rather than relying solely on deep learning models.
Assuntos
Algoritmos , Aprendizado Profundo , Dermoscopia , Neoplasias Cutâneas , Humanos , Dermoscopia/métodos , Neoplasias Cutâneas/diagnóstico por imagem , Neoplasias Cutâneas/classificação , Neoplasias Cutâneas/patologia , Interpretação de Imagem Assistida por Computador/métodos , Bases de Dados Factuais , Pele/diagnóstico por imagem , Pele/patologiaRESUMO
The human gut microbiota produces diverse, extensive metabolites that have the potential to affect host physiology. Despite significant efforts to identify metabolic pathways for producing these microbial metabolites, a comprehensive metabolic pathway database for the human gut microbiota is still lacking. Here, we present Enteropathway, a metabolic pathway database that integrates 3269 compounds, 3677 reactions, and 876 modules that were obtained from 1012 manually curated scientific literature. Notably, 698 modules of these modules are new entries and cannot be found in any other databases. The database is accessible from a web application (https://enteropathway.org) that offers a metabolic diagram for graphical visualization of metabolic pathways, a customization interface, and an enrichment analysis feature for highlighting enriched modules on the metabolic diagram. Overall, Enteropathway is a comprehensive reference database that can complement widely used databases, and a tool for visual and statistical analysis in human gut microbiota studies and was designed to help researchers pinpoint new insights into the complex interplay between microbiota and host metabolism.
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Bases de Dados Factuais , Microbioma Gastrointestinal , Redes e Vias Metabólicas , Humanos , Software , Biologia Computacional/métodosRESUMO
In order to facilitate technical personnel related to occupational health and safety production to search, obtain, and master information on the hazard classification and health effects of chemical hazards, this article surveyed 14 commonly used foreign databases and 9 commonly used domestic databases, analyzed the characteristics, main content, scope of application, and network resources of each database, and considered the development of database for occupational health hazard of chemical hazards.
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Bases de Dados Factuais , Substâncias Perigosas , Saúde Ocupacional , Humanos , Exposição OcupacionalRESUMO
In recent decades, several databases of critically ill patients have become available in both low-, middle-, and high-income countries from all continents. These databases are also rich sources of data for the surveillance of emerging diseases, intensive care unit performance evaluation and benchmarking, quality improvement projects and clinical research. The Epimed Monitor database is turning 15 years old in 2024 and has become one of the largest of these databases. In recent years, there has been rapid geographical expansion, an increase in the number of participating intensive care units and hospitals, and the addition of several new variables and scores, allowing a more complete characterization of patients to facilitate multicenter clinical studies. As of December 2023, the database was being used regularly for 23,852 beds in 1,723 intensive care units and 763 hospitals from ten countries, totaling more than 5.6 million admissions. In addition, critical care societies have adopted the system and its database to establish national registries and international collaborations. In the present review, we provide an updated description of the database; report experiences of its use in critical care for quality improvement initiatives, national registries and clinical research; and explore other potential future perspectives and developments.
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Bases de Dados Factuais , Unidades de Terapia Intensiva , Melhoria de Qualidade , Sistema de Registros , Humanos , Unidades de Terapia Intensiva/normas , Pesquisa Biomédica , Cuidados Críticos/normas , Cuidados Críticos/tendências , Cuidados Críticos/estatística & dados numéricos , Estado Terminal/terapia , Estado Terminal/epidemiologia , AdultoRESUMO
INTRODUCTION: The diffuse large B-cell lymphoma (Dlbcl) is the most common non-Hodgkin lymphoma and at highest incidence among the elderly. Despite the improved outcomes of patients treated with the first-line (1L) standard of care until the end of 2022, composed by rituximab and polychemotherapy (R-Chop), during the last 20 years, the rate of relapsed and refractory Dlbcl (rrDlbcl) remains elevated. This study has identified and analyzed patients newly diagnosed with Dlbcl and treated with 1L, from the perspective of the Italian National Health Service (Ssn). METHODS: From the administrative database of Fondazione Ricerca e Salute (ReS) including ~5.5 million inhabitants/year in Italy, adults with a new in-hospital Dlbcl diagnosis (index date) and treated with 1L in 2018, 2019, 2020 and 2021 were identified and characterized in terms of demographics and comorbidities during a period (from 4 to 8 years) preceding index date. From 1 to 4 years following index date (follow-up), overall survival (Kaplan-Meier curves), percentage distribution of patients by line of therapy including dispensation/administration of chemo-immunotherapy, hemopoietic stem cell transplantation (Hsct), and direct healthcare costs charge to the Ssn, were evaluated. RESULTS: Overall, from the ReS database, 206 patients newly diagnosed with Dlbcl and treated with 1L from 2018 to 2021 in Italy (incidence from 0.9 to 1.7 x100,000 adult inhabitants) were identified. They were mainly older (median age 68 [56; 75] years), males (56%) and affected by ≥2 comorbidities (52%), mostly cardiometabolic. During 4 years of follow-up, 56% of cases in 2018 survived. During the first follow-up year: 73%, 80%, 100% and 35% of cases in 2018, 2019, 2020 and 2021, respectively, received a 2L; 42% and 64% of cases in 2018 and 2020, respectively, received a 3L. At least one Hsct was found as a 2L among cases in 2018, 2020 and 2021. On average, each patient newly diagnosed with Dlbcl and treated with 1L from 2018 to 2021 caused a total expenditure directly charged to the Ssn ranging from 20,000 to 30,000 during the first follow-up year (chemo-immunotherapy accounted for 40-53%), which reduced with time in favor of other drugs and Hsct. CONCLUSIONS: This analysis confirms the high rate of rrDlbcl and the high economic impact charged to the SSN to support first the chemo-immunotherapy, then the chronic care and the absence of standardized further lines of therapy for patients with rrDlbcl.
Assuntos
Protocolos de Quimioterapia Combinada Antineoplásica , Bases de Dados Factuais , Linfoma Difuso de Grandes Células B , Humanos , Linfoma Difuso de Grandes Células B/tratamento farmacológico , Linfoma Difuso de Grandes Células B/terapia , Linfoma Difuso de Grandes Células B/epidemiologia , Itália , Masculino , Idoso , Feminino , Pessoa de Meia-Idade , Protocolos de Quimioterapia Combinada Antineoplásica/uso terapêutico , Protocolos de Quimioterapia Combinada Antineoplásica/economia , Idoso de 80 Anos ou mais , Adulto , Rituximab/administração & dosagem , Estimativa de Kaplan-Meier , Transplante de Células-Tronco Hematopoéticas , Custos de Cuidados de Saúde/estatística & dados numéricos , Vincristina/administração & dosagem , Seguimentos , Ciclofosfamida/administração & dosagem , Ciclofosfamida/uso terapêutico , Doxorrubicina/administração & dosagem , Prednisona/administração & dosagem , Prednisona/uso terapêuticoRESUMO
BACKGROUND: Wilson disease (WD) is a rare disorder of copper metabolism, causing copper accumulation mainly in the liver and the brain. The prevalence of WD was previously estimated around 20 to 33.3 patients per million for the United States, Europe, and Asia, but data on the prevalence of WD in Germany are limited. OBJECTIVES: To describe patient characteristics and to assess prevalence of WD in Germany using a representative claims database. METHODS: WD patients were identified in the WIG2 (Wissenschaftliches Institut für Gesundheitsökonomie und Gesundheitssystemforschung; Scientific Institute for Health Economics and Health Systems Research) benchmark database of 4.5 million insured Germans by combining ICD-10-coding with WD-specific lab tests and treatments. The study period ranged from 2013 to 2016 for assessing patient characteristics, and to 2018 for prevalence, respectively. RESULTS: Seventy unique patients were identified. Most patients (86%) were between 18 and 64 years of age and more often male (60%) than female. Two patients (3%) younger than 18 years were included, as well as 8 patients (11%) older than 64 years. Most common WD subtypes were hepatic (57%), psychiatric (49%), and neurologic (44%). Average prevalence was 20.3 patients per million (range: 17.8-24.4), with similar results for two-year prevalence. Generally, prevalence increased steadily over the study period. Observed mortality was low, with only one death during the study period. CONCLUSIONS: This study adds valuable real-world data on the prevalence and patient characteristics of WD in Germany. Generally, our findings align with other reports and contribute to the global understanding of WD epidemiology. Still, regional and temporal trends remain to be investigated more thoroughly to further the understanding of the natural history and epidemiology of this rare disease.
Assuntos
Degeneração Hepatolenticular , Humanos , Degeneração Hepatolenticular/epidemiologia , Alemanha/epidemiologia , Feminino , Masculino , Adolescente , Adulto , Adulto Jovem , Pessoa de Meia-Idade , Prevalência , Idoso , Bases de Dados Factuais , CriançaRESUMO
This study analyzed adverse drug events (ADEs) associated with basiliximab, sourced from the Food and Drug Administration Adverse Event Reporting System (FAERS) database, spanning the first quarter of 2004 to the fourth quarter of 2023. We collected ADE data for basiliximab from 2004 Q1 to 2023 Q4. After standardization, we employed several signal quantification methods for analysis, such as the Reporting Odds Ratio (ROR), Proportional Reporting Ratio (PRR), Bayesian Confidence Propensity for Neural Networks (BCPNN), and empirical bayes geometric mean (EBGM). In this analysis of 1520 ADEs reports citing basiliximab as the primary suspect, we identified 295 preferred terms across 24 system organ classifications (SOCs). The 3 most prevalent SOCs were investigated (nâ =â 1403, ROR 2.84, PRR 2.54, IC 1.34, EBGM 2.54), infections and infestations (nâ =â 1198, ROR 2.85, PRR 2.59, IC 1.37, EBGM 2.59), and renal and urinary disorders (nâ =â 903, ROR 6.01, PRR 5.48, IC 2.45, EBGM 5.47). Increased blood creatinine and pyrexia were the most frequently reported adverse events (AEs) associated with basiliximab, and cytomegalovirus infection also demonstrated significant signal intensity. Notably, this study revealed some adverse reactions beyond basiliximab drug instructions, such as mitral valve calcification, diastolic dysfunction, pelvic fluid collection, testicular swelling, soft tissue necrosis, and muscle necrosis. Although basiliximab offers therapeutic benefits, it carries the risk of several adverse reactions. Clinicians should monitor patients for signs of increased serum creatinine level, fever, cytomegalovirus infection, anaphylactic shock, mitral valve calcification, diastolic dysfunction, pelvic fluid collection, testicular swelling, soft tissue necrosis, muscle necrosis, and other events during clinical use.
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Sistemas de Notificação de Reações Adversas a Medicamentos , Basiliximab , Imunossupressores , United States Food and Drug Administration , Humanos , Basiliximab/efeitos adversos , Sistemas de Notificação de Reações Adversas a Medicamentos/estatística & dados numéricos , Estudos Retrospectivos , Estados Unidos , Masculino , Imunossupressores/efeitos adversos , Feminino , Proteínas Recombinantes de Fusão/efeitos adversos , Bases de Dados Factuais , Pessoa de Meia-Idade , AdultoRESUMO
MOTIVATION: Dictionary-based named entity recognition (NER) allows terms to be detected in a corpus and normalized to biomedical databases and ontologies. However, adaptation to different entity types requires new high-quality dictionaries and associated lists of blocked names for each type. The latter are so far created by identifying cases that cause many false positives through manual inspection of individual names, a process that scales poorly. RESULTS: In this work, we aim to improve block list s by automatically identifying names to block, based on the context in which they appear. By comparing results of three well-established biomedical NER methods, we generated a dataset of over 12.5 million text spans where the methods agree on the boundaries and type of entity tagged. These were used to generate positive and negative examples of contexts for four entity types (genes, diseases, species, and chemicals), which were used to train a Transformer-based model (BioBERT) to perform entity type classification. Application of the best model (F1-score = 96.7%) allowed us to generate a list of problematic names that should be blocked. Introducing this into our system doubled the size of the previous list of corpus-wide blocked names. In addition, we generated a document-specific list that allows ambiguous names to be blocked in specific documents. These changes boosted text mining precision by â¼5.5% on average, and over 8.5% for chemical and 7.5% for gene names, positively affecting several biological databases utilizing this NER system, like the STRING database, with only a minor drop in recall (0.6%). AVAILABILITY AND IMPLEMENTATION: All resources are available through Zenodo https://doi.org/10.5281/zenodo.11243139 and GitHub https://doi.org/10.5281/zenodo.10289360.
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Aprendizado Profundo , Bases de Dados Factuais , Dicionários como Assunto , Biologia Computacional/métodos , Processamento de Linguagem Natural , Mineração de Dados/métodosRESUMO
Parkinson's is the second most common neurodegenerative disease, affecting nearly 8.5M people and steadily increasing. In this research, Multimodal Deep Learning is investigated for the Prodromal stage detection of Parkinson's Disease (PD), combining different 3D architectures with the novel Excitation Network (EN) and supported by Explainable Artificial Intelligence (XAI) techniques. Utilizing data from the Parkinson's Progression Markers Initiative, this study introduces a joint co-learning approach for multimodal fusion, enabling end-to-end training of deep neural networks and facilitating the learning of complementary information from both imaging and clinical modalities. DenseNet with EN outperformed other models, showing a substantial increase in accuracy when supplemented with clinical data. XAI methods, such as Integrated Gradients for ResNet and DenseNet, and Attention Heatmaps for Vision Transformer (ViT), revealed that DenseNet focused on brain regions believed to be critical to prodromal pathophysiology, including the right temporal and left pre-frontal areas. Similarly, ViT highlighted the lateral ventricles associated with cognitive decline, indicating their potential in the Prodromal stage. These findings underscore the potential of these regions as early-stage PD biomarkers and showcase the proposed framework's efficacy in predicting subtypes of PD and aiding in early diagnosis, paving the way for innovative diagnostic tools and precision medicine.