RESUMEN
AIMS: Atrial fibrillation (AF) is a risk factor for brain infarction, which can lead to epilepsy. We aimed to investigate whether treatment of AF with direct oral anticoagulants (DOACs) affects the risk of epilepsy in comparison to treatment with the vitamin K antagonist phenprocoumon (PPC). METHODS AND RESULTS: We performed an active comparator, nested case-control study based on the German Pharmacoepidemiological Research Database that includes claims data from statutory health insurance providers of about 25 million persons since 2004. In 2011-17, 227 707 AF patients initiated treatment with a DOAC or PPC, of which 1828 cases developed epilepsy on current treatment with an oral anticoagulant. They were matched to 19 084 controls without epilepsy. Patients with DOAC treatment for AF had an overall higher risk of epilepsy with an odds ratio of 1.39, 95% CI (1.24; 1.55) compared to current PPC treatment. Cases had higher baseline CHA2DS2-VASc scores and more frequently a history of stroke than controls. After excluding patients with ischaemic stroke prior to the diagnosis of epilepsy, the risk of epilepsy was still higher on DOACs than on PPC. In contrast, within a cohort of patients with venous thromboembolism, the risk of epilepsy on treatment with DOACs was less elevated [adjusted odds ratio 1.15, 95% CI (0.98; 1.34)]. CONCLUSION: In patients with AF initiating oral anticoagulation, treatment with a DOAC was associated with an increased risk of epilepsy compared to the vitamin K antagonist PPC. Covert brain infarction may explain the observed elevated risk of epilepsy.
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Fibrilación Atrial , Isquemia Encefálica , Accidente Cerebrovascular , Humanos , Fibrilación Atrial/diagnóstico , Fibrilación Atrial/tratamiento farmacológico , Fibrilación Atrial/epidemiología , Accidente Cerebrovascular/diagnóstico , Accidente Cerebrovascular/epidemiología , Accidente Cerebrovascular/etiología , Isquemia Encefálica/diagnóstico , Estudios de Casos y Controles , Anticoagulantes , Fenprocumón/uso terapéutico , Factores de Riesgo , Vitamina K , Administración OralRESUMEN
The impact of genetic variability of pharmacogenes as a possible risk factor for adverse drug reactions is elucidated in the EMPAR (Einfluss metabolischer Profile auf die Arzneimitteltherapiesicherheit in der Routineversorgung/English: influence of metabolic profiles on the safety of drug therapy in routine care) study. EMPAR evaluates possible associations of pharmacogenetically predicted metabolic profiles relevant for the metabolism of frequently prescribed cardiovascular drugs. Based on a German study population of 10,748 participants providing access to healthcare claims data and DNA samples for pharmacogenetic assessment, first analyses were performed and evaluated. The aim of this first evaluation was the characterization of the study population with regard to general parameters such as age, gender, comorbidity, and polypharmacy at baseline (baseline year) as well as important combinations of cardiovascular drugs with relevant genetic variants and predicted metabolic phenotypes. The study was registered in the German Clinical Trials Register (DRKS) on July 6, 2018 (DRKS00013909).
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Efectos Colaterales y Reacciones Adversas Relacionados con Medicamentos , Farmacogenética , Comorbilidad , Humanos , Fenotipo , Factores de RiesgoRESUMEN
BACKGROUND: Population-based data on the prevalence of and real-life treatment for the autoimmune liver diseases (AILD), primary biliary cholangitis (PBC) and autoimmune hepatitis (AIH), are scarce, and such knowledge may help to improve patient care. METHODS: Data of 8.1 million individuals having health insurance with the "Techniker Krankenkasse," the largest German health insurer, were analyzed with regard to the prevalence of and prescribed medication for AILD in Germany from 2011 until 2014. Patients with viral hepatitis B infection (HBV) and alcoholic liver cirrhosis (ALC) served as control groups. Case definition was based on ICD codes. RESULTS: The prevalences of PBC and AIH were 36.9/100â000 inhabitants (95â% CI: 35.6-38.2) and 23.0/100â000 inhabitants (95â% CI: 22.0-24.0) in 2014, respectively. The prevalences of AILD increased from 2011 to 2014 (for PBC by 31â% and for AIH by 29â%), with the largest increase for male patients with PBC. In contrast, the prevalence of HBV declined while that of ALC remained stable. The analysis of prescribed real-life treatment revealed considerable deviations from standard treatment recommendations. Specifically, in older patients with PBC or AIH, undertreatment was common. CONCLUSION: The prevalence of PBC and AIH based on ICD codes is increasing in Germany. The analysis of real-life treatment in this large and population-based cohort points to the unmet need to improve the implementation of treatment guidelines for autoimmune liver diseases in the broader medical community.
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Hepatitis Autoinmune/epidemiología , Cirrosis Hepática Biliar/epidemiología , Anciano , Alemania/epidemiología , Humanos , Clasificación Internacional de Enfermedades , Masculino , Vigilancia de la Población , PrevalenciaRESUMEN
BACKGROUND: Chronic pain is a frequent and disabling health problem in children and adolescents and is associated with high health care utilization and costs. OBJECTIVE: The aim of this study was to analyze the direct and indirect costs of chronic pain in children and adolescents in monetary terms before and after multimodal pain therapy from a societal perspective. MATERIALS AND METHODS: Health care costs 12 months before and after multimodal pain therapy include direct costs from statutory health insurances and parents as well as indirect costs due to working days lost. RESULTS: Direct median costs before multimodal treatment were 5619⯠(min-max: 377-35,509â¯) per year. In the year after pain therapy, costs decreased to a median of 3262⯠(min-max: 142-42,910â¯) (pâ¯= 0.001). In all, 55% of patients showed a significant cost reduction, while 18% had a cost increase. CONCLUSIONS: An effective multimodal pain therapy may reduce health care costs in children and adolescents. Further economic studies are needed to evaluate long-term effects of pain therapy for children and adolescents with chronic pain in a controlled design.
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Dolor Crónico , Manejo del Dolor , Adolescente , Niño , Dolor Crónico/economía , Costo de Enfermedad , Costos de la Atención en Salud , Humanos , Manejo del Dolor/economíaRESUMEN
In survival analyses, inverse-probability-of-treatment (IPT) and inverse-probability-of-censoring (IPC) weighted estimators of parameters in marginal structural Cox models are often used to estimate treatment effects in the presence of time-dependent confounding and censoring. In most applications, a robust variance estimator of the IPT and IPC weighted estimator is calculated leading to conservative confidence intervals. This estimator assumes that the weights are known rather than estimated from the data. Although a consistent estimator of the asymptotic variance of the IPT and IPC weighted estimator is generally available, applications and thus information on the performance of the consistent estimator are lacking. Reasons might be a cumbersome implementation in statistical software, which is further complicated by missing details on the variance formula. In this paper, we therefore provide a detailed derivation of the variance of the asymptotic distribution of the IPT and IPC weighted estimator and explicitly state the necessary terms to calculate a consistent estimator of this variance. We compare the performance of the robust and consistent variance estimators in an application based on routine health care data and in a simulation study. The simulation reveals no substantial differences between the 2 estimators in medium and large data sets with no unmeasured confounding, but the consistent variance estimator performs poorly in small samples or under unmeasured confounding, if the number of confounders is large. We thus conclude that the robust estimator is more appropriate for all practical purposes.
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Modelos de Riesgos Proporcionales , Análisis de Varianza , Bioestadística , Enfermedades Cardiovasculares/epidemiología , Simulación por Computador , Interpretación Estadística de Datos , Diabetes Mellitus Tipo 2/complicaciones , Diabetes Mellitus Tipo 2/tratamiento farmacológico , Humanos , Hipoglucemiantes/uso terapéutico , Funciones de Verosimilitud , Modelos Logísticos , Modelos Estadísticos , Farmacoepidemiología/estadística & datos numéricos , Análisis de SupervivenciaRESUMEN
BACKGROUND: Measures to raise awareness of the teratogenic potential of valproate and restrict its use in girls/women of childbearing age have been intensified. For Germany, the impact of these measures on valproate prescription rates remains unknown. OBJECTIVES: Trends in prescribing valproate, the underlying treatment indication, and the specialty of the prescribing physician are analyzed. MATERIALS AND METHODS: With claims data from several statutory health insurance providers from 2004 to 2016 (approximately 3.5 million insured persons per year) considering treatment indication and medical specialties of prescribing physicians, we assessed the rate of girls/women (12 to 50 years) with at least one valproate dispensation per year. RESULTS: The age-standardized rate of girls/women with at least one valproate dispensation declined by 28% between 2004 and 2016 (2.91/1000 vs. 2.09/1000). For 2015, the indications were epilepsy (66.9%), bipolar disorder (13.6%), migraine/headache (5.6%), schizoaffective disorder (4.3%), and other mental disorders (8.9%). Among epilepsy patients, the proportion treated with valproate declined from 26.2 to 16.8%, but changed little in patients with bipolar disorder (9.3% vs. 8.0%). A total of 46.3% of valproate dispensations were issued by neurologists or psychiatrists and 29.6% by general practitioners, internal medicine specialists, or family doctors. CONCLUSIONS: Based on German claims data, a decline of valproate dispensations was shown for epilepsy patients of childbearing age, while the proportion in other indications has hardly changed since 2004.
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Anticonvulsivantes/efectos adversos , Antimaníacos/efectos adversos , Trastorno Bipolar/tratamiento farmacológico , Prescripciones de Medicamentos/estadística & datos numéricos , Utilización de Medicamentos/tendencias , Epilepsia/tratamiento farmacológico , Trastornos Migrañosos/tratamiento farmacológico , Ácido Valproico/efectos adversos , Adulto , Anticonvulsivantes/uso terapéutico , Antimaníacos/uso terapéutico , Trastorno Bipolar/epidemiología , Epilepsia/epidemiología , Femenino , Alemania , Humanos , Pautas de la Práctica en Medicina , Ácido Valproico/uso terapéuticoRESUMEN
Adverse drug reactions are among the leading causes of death. Pharmacovigilance aims to monitor drugs after they have been released to the market in order to detect potential risks. Data sources commonly used to this end are spontaneous reports sent in by doctors or pharmaceutical companies. Reports alone are rather limited when it comes to detecting potential health risks. Routine statutory health insurance data, however, are a richer source since they not only provide a detailed picture of the patients' wellbeing over time, but also contain information on concomitant medication and comorbidities.To take advantage of their potential and to increase drug safety, we will further develop statistical methods that have shown their merit in other fields as a source of inspiration. A plethora of methods have been proposed over the years for spontaneous reporting data: a comprehensive comparison of these methods and their potential use for longitudinal data should be explored. In addition, we show how methods from machine learning could aid in identifying rare risks. We discuss these so-called enrichment analyses and how utilizing pharmaceutical similarities between drugs and similarities between comorbidities could help to construct risk profiles of the patients prone to experience an adverse drug event.Summarizing these methods will further push drug safety research based on healthcare claim data from German health insurances which form, due to their size, longitudinal coverage, and timeliness, an excellent basis for investigating adverse effects of drugs.
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Sistemas de Registro de Reacción Adversa a Medicamentos , Efectos Colaterales y Reacciones Adversas Relacionados con Medicamentos , Seguro de Salud , Farmacovigilancia , Alemania , Humanos , Seguro de Salud/estadística & datos numéricosRESUMEN
Children and adolescents with mental health problems need effective and safe therapies to support their emotional and social development and to avoid functional impairment and progress of social deficits. Though psychotropic drugs seem to be the preferential treatment, psychotherapy and psychosocial interventions are essential in mental health care. For Germany, current data on the utilization of psychotherapy and psychosocial interventions in children with mental health problems is lacking. To analyse why certain children and adolescents with mental or behavioural disorders do and others do not receive non-drug treatment, we assessed predictors associated with specific non-drug psychiatric/psychotherapeutic treatment including psychosocial interventions, psychotherapy and other non-drug treatments. The study is based on data of two large German health insurance funds, AOK and TK, comprising 30 % of the German child and adolescent population. Predictors of non-drug psychiatric/psychotherapeutic treatment were analysed for 23,795 cases and two controls for every case of the same age and sex in children aged 0-17 years following a new diagnosis of mental or behavioural disorder in 2010. Predictors were divided according to Andersen's behavioural model into predisposing, need and enabling factors. The most prominent and significant predictors positively associated with non-drug psychiatric/psychotherapeutic treatment were the residential region as predisposing factor; specific, both ex- and internalizing, mental and behavioural disorders, psychiatric co-morbidity and psychotropic drug use as need factors; and low area deprivation and high accessibility to outpatient physicians and inpatient institutions with non-drug psychiatric/psychotherapeutic department as enabling factors. In conclusion, the present study suggests that the residential region as proxy for supply of therapist and socioeconomic situation is an influencing factor for the use of psychotherapy. The analysis sheds further light on predisposing, need and enabling factors as predictors of non-drug psychotherapeutic/psychiatric treatment in children and adolescents with mental or behavioural health disorders in Germany. More research is needed to further understand the factors promoting the gap between the need and utilization of mental health care.
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Trastornos Mentales/terapia , Servicios de Salud Mental/estadística & datos numéricos , Problema de Conducta/psicología , Psicoterapia/métodos , Adolescente , Niño , Preescolar , Comorbilidad , Femenino , Alemania , Accesibilidad a los Servicios de Salud/estadística & datos numéricos , Necesidades y Demandas de Servicios de Salud/estadística & datos numéricos , Humanos , Lactante , Recién Nacido , Masculino , Trastornos Mentales/diagnóstico , Trastornos Mentales/epidemiología , Características de la ResidenciaRESUMEN
In 2004, the Federal Joint Committee (G-BA) published a new directive for examination and treatment methods with respect to sleep-related breathing disorders for SHI-accredited physicians. The examination procedure is classified in four steps: anamnesis, clinical assessment, cardiorespiratory polygraphy (PG) and cardiorespiratory polysomnography (PSG). Starting with the date of the first PSG we analysed 1. whether this examination was preceded by a polygraphy, 2. whether there was a gain of diagnostic information through PSG, and 3. whether a PSG was used for the first adjustment examinations and controls after prescription of a positive airway pressure device. The analysis is based on claims data from the Techniker Krankenkasse (2009-2012). Diagnostic services were identified by fee schedule codes (EBM) for outpatient services and by procedure codes (OPS) for inpatient services. Sleep disorders were operationalised by ICD-10 codes and information was completed by prescriptions of a CPAP equipment.The study is based on data from 6.6 million persons who were permanently insured from 01.01.2009 to 30.06.2012 by TK. A preceding PG 90 (180) days before PSG was found for less than 56% (73%) of the analysed insured persons. By the latter procedure, only about 60% of the cases with no clear diagnostic information (G47.39) in the preceding quarter could be specified. Prescription of a positive airway pressure device within 90 days after PSG was found for about 45% of the insured. Concerning the stepwise diagnostic procedure for sleep disorders for SHI-accredited physicians, the directive was followed only partly. Against the background of an evidence-based, effective, and efficient diagnostic approach, the results show a clear need for action.
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Formulario de Reclamación de Seguro/estadística & datos numéricos , Polisomnografía/estadística & datos numéricos , Respiración con Presión Positiva/estadística & datos numéricos , Pautas de la Práctica en Medicina/estadística & datos numéricos , Síndromes de la Apnea del Sueño/diagnóstico , Adulto , Anciano , Anciano de 80 o más Años , Femenino , Alemania/epidemiología , Humanos , Masculino , Persona de Mediana Edad , Prevalencia , Síndromes de la Apnea del Sueño/epidemiología , Síndromes de la Apnea del Sueño/terapia , Resultado del Tratamiento , Revisión de Utilización de RecursosRESUMEN
OBJECTIVE: Adrenal crises are potentially life-threatening complications in patients with adrenal insufficiency (AI). Our objective was to investigate the frequency of adrenal crises in different forms of AI. DESIGN/PATIENTS: The Statutory Health Insurance (SHI) database of the Techniker Krankenkasse - covering more than 12% of the German population - was analysed for diagnostic codes from 1 January 2010 to 31 December 2013. MEASUREMENTS: By analysis of routine data from a large healthcare provider. Diagnoses of AI were recorded and classified in primary AI, secondary AI and autoimmune polyglandular syndrome (APS). The ICD-code E27·2 (AC) was retrieved in all cohorts. RESULTS: We found a prevalence of 222/million for secondary and 126/million for primary AI. AC was documented with a frequency of 4·8/100 patient years. Crises were significantly more frequent in patients with primary (7·6/100 patient years) compared to those with secondary AI (3·2/100 patient years; P < 0·0001). Prevalence of crises was higher in individuals with APS (10·9/100 patient years) and highest in patients with primary AI and type 1 diabetes (12·5/100 patient years). CONCLUSIONS: Applying a SHI database comprising more than 9 million individuals, we identified robust data about the risk of AC in different groups of patients with AI. Our data confirm and extend the clinical observation that patients with APS are at highest risk for AC. Approximately 1 of 8 patients with primary AI and type 1 diabetes suffers from an AC each year. Specific targeting of efforts aiming at the prevention of AC is necessary.
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Enfermedad de Addison/complicaciones , Insuficiencia Suprarrenal/complicaciones , Poliendocrinopatías Autoinmunes/patología , Enfermedad de Addison/inmunología , Insuficiencia Suprarrenal/epidemiología , Autoinmunidad , Bases de Datos Factuales , Diabetes Mellitus Tipo 1 , Alemania , Humanos , Seguro de Salud , Poliendocrinopatías Autoinmunes/etiología , Prevalencia , Medición de RiesgoRESUMEN
BACKGROUND AND OBJECTIVE: Percutaneous coronary interventions (PCIs) are increasingly being performed in the treatment of coronary artery disease. The aim of this study is to describe the frequency of PCIs by age, sex, type, and setting of the intervention in Germany. METHODS: Based on routine data of more than eight million insurants from three statutory health insurance funds, quarterly sex- and age-specific intervention rates were calculated between 2004 and 2012. Moreover, inpatient PCIs were subdivided into PCIs with conventional bare metal stents (BMS) and PCIs with drug-eluting stents (DES). Rates were age- and sex-standardized according to the age and sex distribution of the particular years in Germany. RESULTS: Standardized rates increased from 277.3 to 382.2 per 100,000 person-years between 2004 and 2012. The intervention rate was three times higher in men than in women. The relative increase in the overall rate and in the rate of PCI with DES during the study period were 38 and 548 % respectively, whereas the rate of PCI with BMS declined by 48 %. Of all PCIs, 7-11 % were outpatient PCIs during the study period. CONCLUSIONS: PCIs are increasingly being performed in Germany, particularly PCI with DES. The frequency of PCI with BMS implantation is decreasing. Sex-specific differences in the frequency of PCI go beyond differences that would have been expected because of a differing morbidity profile. Our analyses indicate that comparatively few outpatient PCIs are performed.
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Enfermedad de la Arteria Coronaria/epidemiología , Enfermedad de la Arteria Coronaria/cirugía , Intervención Coronaria Percutánea/estadística & datos numéricos , Intervención Coronaria Percutánea/tendencias , Pautas de la Práctica en Medicina/estadística & datos numéricos , Pautas de la Práctica en Medicina/tendencias , Adolescente , Adulto , Distribución por Edad , Anciano , Anciano de 80 o más Años , Niño , Preescolar , Femenino , Alemania/epidemiología , Humanos , Lactante , Recién Nacido , Estudios Longitudinales , Masculino , Persona de Mediana Edad , Distribución por Sexo , Revisión de Utilización de Recursos , Adulto JovenRESUMEN
BACKGROUND: In 2009 a new system for the objective evaluation of nursing homes was introduced in Germany. The so-called nursing transparency agreement (Pflege-Transparenzvereinbarungen) was introduced to provide a reliable tool for an objective comparison of inpatient (PTVS) and outpatient (PTVA) care; however, the new regulations have been the subject of a broad discussion regarding reliability, efficiency and objectivity. AIMS: To overcome the lack of objective health outcomes, this study used administrative data from Germany's largest health insurance fund, the Techniker Krankenkasse, in order to analyze the association between the quality ratings and objective quality measures on an individual level. This is the first study that provides empirical evidence on this topic using administrative data. MATERIAL AND METHODS: The administrative dataset contained information on several individual characteristics as well as data on injuries, poisoning and other extrinsic effects on care-dependent individuals over the age of 64 years who were living in a nursing home in 2009. Based on these data an objective measure was constructed to test whether higher quality ratings of nursing homes led to a better quality of care of the respective patients using non-linear regression models. RESULTS: The results of the estimated models showed no significant evidence of such a relationship, neither considering the probability nor the number of injuries, poisoning and other extrinsic effects. Significant effects were only observed for gender and specific diseases. CONCLUSION: The results of this study support the argument that the current rating procedure for nursing homes has to be refined. Using quality indicators in combination with the administrative data could possibly contribute to such an enhancement.
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Casas de Salud/clasificación , Casas de Salud/estadística & datos numéricos , Intoxicación/epidemiología , Garantía de la Calidad de Atención de Salud/estadística & datos numéricos , Calidad de la Atención de Salud/estadística & datos numéricos , Heridas y Lesiones/epidemiología , Anciano , Anciano de 80 o más Años , Medicina Basada en la Evidencia , Femenino , Alemania/epidemiología , Humanos , Masculino , Evaluación de Resultado en la Atención de Salud/métodos , Evaluación de Resultado en la Atención de Salud/normas , Intoxicación/prevención & control , Prevalencia , Garantía de la Calidad de Atención de Salud/normas , Indicadores de Calidad de la Atención de Salud/normas , Indicadores de Calidad de la Atención de Salud/estadística & datos numéricos , Calidad de la Atención de Salud/normas , Factores de Riesgo , Resultado del Tratamiento , Heridas y Lesiones/prevención & controlRESUMEN
After an introduction to the theme with an overview of the implementation of the Disease Management Programs (DMP), accompanying documentation, present utilization and costs of the programs, the present article is primarily devoted to the issue of the analysis of the benefits of DMP. Following an assessment of the legally specified evaluation requirements, in the absence of a prospective, randomized, controlled trial (RCT), the results of three studies are first summarized, which, with the application of propensity score matching, utilize the routine data of the statutory health insurance schemes to form a control group. The overview concludes with a look at the planned changes in evaluation and the intended expansion of the DMP to programs for other chronic illnesses.
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Enfermedad Crónica/economía , Enfermedad Crónica/terapia , Atención a la Salud/economía , Costos de la Atención en Salud/estadística & datos numéricos , Accesibilidad a los Servicios de Salud/economía , Control de Costos/legislación & jurisprudencia , Análisis Costo-Beneficio/economía , Análisis Costo-Beneficio/legislación & jurisprudencia , Atención a la Salud/legislación & jurisprudencia , Manejo de la Enfermedad , Alemania , Costos de la Atención en Salud/legislación & jurisprudencia , Accesibilidad a los Servicios de Salud/legislación & jurisprudencia , Humanos , Modelos Económicos , Objetivos OrganizacionalesRESUMEN
The present study is one of the few that includes tissue samples in the evaluation of target prediction algorithms designed to detect microRNA (miRNA) sequences that might interact with particular messenger RNA (mRNA) sequences. Twelve different target prediction tools were used to find miRNA sequences that might interact with CCL20 gene expression. Different algorithms predicted controversial miRNA sequences for CCL20 regulation due to a different weighting of parameters. Hsa-miR-21 and hsa-miR-145 suggested by four or more programs were chosen for further investigation. Possible real interaction of these miRNA sequences with CCL20 gene expression was monitored using luciferase assays and expression analyses of tissue samples of colorectal adenocarcinoma by either qRT-PCR or ELISA. Folding status of seed-binding sites in complete mRNA and 3'UTR of CCL20 was predicted. Prediction of miRNA expression was attempted based on CCL20 expression data. Eight of the target prediction tools forecasted a role for hsa-miR-21 and four mentioned hsa-miR-145 in CCL20 gene regulation. Laboratory experimentation showed that CCL20 may serve as a target of hsa-miR-21 but not hsa-miR-145. Expression of the molecules resulted in no clear assertion. Folding of seed-binding sites was predicted to be relatively constant for the complete mRNA and 3'UTR. Predicting miRNA expression based on target gene expression was impossible. This might be attributable to the fact that effects of miRNA activity may oscillate between gene product repression and activation. Additional systematic studies are needed to address this issue.
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Algoritmos , Quimiocina CCL20/genética , MicroARNs/metabolismo , ARN Mensajero/química , Regiones no Traducidas 3' , Adulto , Anciano , Anciano de 80 o más Años , Sitios de Unión , Neoplasias Colorrectales/genética , Neoplasias Colorrectales/mortalidad , Femenino , Humanos , Masculino , MicroARNs/química , Persona de Mediana Edad , Pliegue del ARN , ARN Mensajero/metabolismo , Secuencias Reguladoras de Ácido Ribonucleico , Programas InformáticosRESUMEN
OBJECTIVES: Caring for a person often imposes a significant burden on informal caregivers, which is a possible threat to their own health and well-being. The aim of this study is twofold: (i) We analyze whether the risk of the mental burden due to informal caregiving increases when the dependent person suffers from mental disorders. (ii) We investigate if the utilization of formal care assistance reduces this burden. METHOD: Routine data from a sickness fund regarding informal caregivers of frail elderly persons aged more than 65 years is analyzed by estimating pooled logit models. RESULTS: We find evidence for a significant difference of the risk of mental disturbance in informal caregivers when caring for impaired elderly with and without certain mental disorders. However, claiming formal care services in addition to the informal care provision decreases the disturbance. DISCUSSION: There are political implications that arise from our results: First, the already existing system of formal in-home services should be enlarged. Second, special attention should be paid to the health status of the person in need of care when deciding which form of care is appropriate and the least burdensome for the informal caregiver.
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Cuidadores/psicología , Servicios de Atención de Salud a Domicilio/organización & administración , Trastornos Mentales/epidemiología , Salud Mental , Estrés Psicológico/epidemiología , Factores de Edad , Anciano , Anciano de 80 o más Años , Femenino , Alemania , Estado de Salud , Humanos , Masculino , Índice de Severidad de la Enfermedad , Factores Sexuales , Factores SocioeconómicosRESUMEN
Introduction: Pharmacovigilance is vital for drug safety. The process typically involves two key steps: initial signal generation from spontaneous reporting systems (SRSs) and subsequent expert review to assess the signals' (potential) causality and decide on the appropriate action. Methods: We propose a novel discovery and verification approach to pharmacovigilance based on electronic healthcare data. We enhance the signal detection phase by introducing an ensemble of methods which generated signals are combined using Borda count ranking; a method designed to emphasize consensus. Ensemble methods tend to perform better when data is noisy and leverage the strengths of individual classifiers, while trying to mitigate some of their limitations. Additionally, we offer the committee of medical experts with the option to perform an in-depth investigation of selected signals through tailored pharmacoepidemiological studies to evaluate their plausibility or spuriousness. To illustrate our approach, we utilize data from the German Pharmacoepidemiological Research Database, focusing on drug reactions to the direct oral anticoagulant rivaroxaban. Results: In this example, the ensemble method is built upon the Bayesian confidence propagation neural network, longitudinal Gamma Poisson shrinker, penalized regression and random forests. We also conduct a pharmacoepidemiological verification study in the form of a nested active comparator case-control study, involving patients diagnosed with atrial fibrillation who initiated anticoagulant treatment between 2011 and 2017. Discussion: The case study reveals our ability to detect known adverse drug reactions and discover new signals. Importantly, the ensemble method is computationally efficient. Hasty false conclusions can be avoided by a verification study, which is, however, time-consuming to carry out. We provide an online tool for easy application: https://borda.bips.eu.
RESUMEN
ABSTRACT: In this study, we describe the development and validation of a revised Pediatric Chronic Pain Grading (P-CPG) for children aged 8 to 17 years that adds emotional impairment to previously used measures of pain intensity and functional impairment. Such a measure enables the assessment of chronic pain severity in different epidemiological and clinical populations, the stratification of treatment according to pain severity, and the monitoring of treatment outcome. The P-CPG was developed using a representative sample of school children with chronic pain (n = 454; M age = 12.95, SD = 2.22). Construct validity and sensitivity to change were examined within a sample of N = 2448 children and adolescents (M age = 12.71, SD = 2.47) comprising 3 subsamples (school n = 1562, primary care n = 129, and tertiary care n = 757) affected by chronic pain to varying extents. Results showed that P-CPG grades differed significantly among the 3 subsamples, with school children being least affected by chronic pain and tertiary care patients being most affected. As P-CPG grade increased, so did pain intensity, functional impairment, pain-related school absence, and emotional impairment. Convergent validity was demonstrated by significant positive correlations between the P-CPG and global ratings of pain severity as well as objective claims data; the latter reflects greater health care costs with increasing P-CPG scores. Sensitivity to change was supported by a significant reduction in baseline P-CPG grades 3 and 6 months after intensive interdisciplinary pain treatment in tertiary care sample. In conclusion, the P-CPG is an appropriate measure of pain severity in children and adolescents with chronic pain in clinical as well as epidemiological settings.