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PURPOSE: Anaphylaxis (ANA) is an important adverse drug reaction. We examined positive predictive values (PPV) and other test characteristics of ICD-10-GM code algorithms for detecting ANA as used in a multinational safety study (PASS). METHODS: We performed a cross-sectional study on routine data from a German academic hospital (2004-2019, age ≥ 18). Chart review was used for case verification. Potential cases were identified from the hospital administration system. The main outcome required at least one of the following: any type of specific in-hospital code (T78.2, T88.6, and T80.5) OR specific outpatient code in combination with a symptom code OR in-hospital non-specific code (T78.4, T88.7, and Y57.9) in combination with two symptom codes. PPV were calculated with 95% confidence interval. Sensitivity analyses modified type of codes, unit of analysis, verification criteria and time period. The most specific algorithm used only primary codes for ANA (numbers added in brackets). RESULTS: Four hundred and sixteen eligible cases were evaluated, and 78 (37) potential ANA cases were identified. PPV were 62.8% (95% CI 51.1-73.5) (main) and 77.4% (58.9-90.4) (most specific). PPV from all modifications ranged from 12.9% to 80.6%. The sensitivity of the main algorithm was 66.2%, specificity 91.5%, and negative predictive value 92.6%. Corresponding figures for the most specific algorithm were 32.4%, 98.0%, and 87.0%. CONCLUSIONS: The PPV of the main algorithm seems of acceptable validity for use in comparative safety research but will underestimate absolute risks by about a third. Restriction to primary discharge codes markedly improves PPV to the expense of reducing sensitivity.
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Anafilaxia , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos , Algoritmos , Anafilaxia/diagnóstico , Anafilaxia/epidemiologia , Estudos Transversais , Bases de Dados Factuais , Hospitais , Humanos , Classificação Internacional de DoençasRESUMO
PURPOSE: Acute liver injury (ALI) is an important adverse drug reaction. We estimated the positive predictive values (PPVs) of ICD-10-GM codes of ALI used in an international postauthorisation safety study (PASS). METHODS: Analyses used routine data (2007 to 2016, adults) from a German academic hospital in a cross-sectional design. Two algorithms from the PASS were applied to extract potential cases from the hospital information system: specific end point (A) (discharge diagnosis of liver disease-specific codes) and less specific end point (B) (discharge and outpatient-specific and nonspecific codes suggestive of liver injury). ALI cases were confirmed on the basis of plasma liver enzyme activity elevation. Secondary analysis was performed following exclusion of cases with known cancer, chronic liver, biliary and pancreatic disease, heart failure, and alcohol-related disorders, as applied in the PASS. RESULTS: On the basis of ICD codes: outcome A, 154 cases (143 with case notes and lab data for case verification); outcome B, 485 cases (357 with case notes and lab data). ALI was confirmed in 71 outcome A cases, PPV of 49.7% (95% confidence interval [CI], 41.2%-58.1%), and 100 outcome B cases, PPV of 28.0% (95% CI, 23.4%-33.0%). Applying exclusion criteria increased PPV (95% CI) to 62.7% (50.0%-74.2%) for outcome A and 45.7% (37.2%-54.3%) for outcome B. CONCLUSIONS: In safety studies on hepatotoxicity based on routine data using ICD-10-GM discharge codes and when validation of potential cases is not feasible, only the more specific codes should be used to describe ALI, and competing diagnoses for liver injury should be excluded to avoid substantial misclassification.
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Doença Hepática Induzida por Substâncias e Drogas/epidemiologia , Codificação Clínica/estatística & dados numéricos , Classificação Internacional de Doenças , Farmacoepidemiologia/métodos , Adulto , Doença Hepática Induzida por Substâncias e Drogas/diagnóstico , Doença Hepática Induzida por Substâncias e Drogas/etiologia , Estudos Transversais , Bases de Dados Factuais/estatística & dados numéricos , Feminino , Alemanha/epidemiologia , Hospitais/estatística & dados numéricos , Humanos , Masculino , Prontuários Médicos/estatística & dados numéricosRESUMO
BACKGROUND: The patient perspective is essential for assessing disease severity, but it is not always adequately considered. We describe how a comprehensive clinical disease severity index (DSI) for inflammatory bowel disease (IBD) correlates with patient global self-assessment (PGSA). METHODS: In an individually linked parallel online survey, physicians provided the DSI, and patients provided self-assessed severity using a global question and visual analog scale (0-100) (PGSA). Mean DSI values by PGSA were calculated with 95% confidence intervals. Pearson correlation (r) and the intraclass correlation coefficient were calculated for PGSA vs DSI. Positive predictive values for identifying severe disease with PGSA categories as a reference were based on a threshold >22 points. RESULTS: The primary analysis included 89 pairs (46 Crohn's disease [CD], 43 ulcerative colitis [UC]) with strict criteria and 147 pairs when less stringent. Common reasons for exclusion were missing values for albumin or colonoscopy. Mean DSI values showed no clear trend with increasing PGSA in CD but good discrimination between moderate, severe, and very severe PGSA in UC. For PGSA on the visual analog scale, r was 0.54 for CD and 0.59 for UC (difference in means: CD 27.7, UC 13.8; intraclass correlation coefficient: CD 0.48, UC 0.58). A high DSI predicted severe disease in 76.2% of CD and 65.2% of UC. CONCLUSIONS: The DSI showed good discrimination for patient-reported disease severity in UC but performed unsatisfactorily in CD. Correlations were moderate. Further refinement of the DSI is suggested to better reflect the patient perspective.
The performance of an inflammatory bowel disease severity score was compared with self-perceived severity based on an individually linked online survey of patients and their physicians. Agreement and prediction of severe disease were moderate and should be improved by integrating the patients' perspective.
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INTRODUCTION: Patients with inflammatory bowel diseases (IBD) often report psychological problems, unemployment, disability, sick leave and compromised quality of life. The effect of psychological interventions on health-related outcomes in IBD is controversial as previous reviews faced the obstacle of high heterogeneity among provided multimodular interventions. The heterogeneity can be addressed with network meta-analysis (NMA) and (multi)component NMA (CNMA). We aim to investigate whether psychological interventions can improve quality of life, clinical and social outcomes in IBD using NMA and CNMA. This is the study protocol. METHODS AND ANALYSIS: We will consider randomised, quasi-randomised and non-randomised controlled trials, including cluster randomised and cross-over trials with 2 months of minimum follow-up. The conditions to be studied comprise Crohn's disease and ulcerative colitis in children, adolescents and adults. We will include any psychological intervention aiming to change the health status of the study participant.We will search Medline, Embase, Web of Science, CENTRAL, LILACS, Psyndex, PsycINFO, Google Scholar and trial registries from inception (the search will be updated before the review completion). Two authors will independently screen all references based on titles and abstracts. For data extraction, standard forms are developed and tested before extraction. All information will be assessed independently by at least two reviewers, and disagreements solved by consensus discussion or a third rater if necessary.The data synthesis will include a pairwise meta-analysis supported by meta-regression. We will conduct NMA (all treatments will constitute single nodes of the network) and CNMA (we will define all treatments as sums of core components, eg, cognitive +behaviour, or cognitive +behaviour + relaxation, and additionally consider interactions) using the R Package netmeta. ETHICS AND DISSEMINATION: No ethical approval is required. Reports will include the final report to the funder, conference presentation, peer-reviewed publication and a patient report. PROSPERO REGISTRATION NUMBER: CRD42021250446.
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Doenças Inflamatórias Intestinais , Intervenção Psicossocial , Adolescente , Adulto , Criança , Doença Crônica , Humanos , Doenças Inflamatórias Intestinais/terapia , Metanálise como Assunto , Metanálise em Rede , Qualidade de Vida , Revisões Sistemáticas como AssuntoRESUMO
In 2019 the Gemeindenotfallsanitäter was introduced in the area of Oldenburg, and scientific monitoring starting 2021 with Inanspruchnahme, Leistungen und Effekte des Gemeindenotfallsanitäters. Since then, it is possible to track patient journeys, starting from the emergency call to the subsequent treatment. This short communication provides an overview of the necessary data-acquisition and dataflow from all participating institutions and its possibilities.
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Toxoplasma gondii (T. gondii) has a high worldwide prevalence and an underestimated impact on neuropsychiatric disorders. Previous studies related T. gondii to disorders associated with the dysfunctional dopaminergic system. However, an association between T. gondii infection and adult attention-deficit/hyperactivity disorder (ADHD) has not yet been studied. In a sex- and age-matched case-control study, we investigated the seropositivity, serointensity, and avidity of latent T. gondii infection in adult ADHD patients and examined the influence of those variables on the symptomatology of ADHD. Of 140 participants, 20.0% were seropositive for anti-T. gondii IgG and 0% for anti-T. gondii IgM. T. gondii seropositivity was associated with 2.8-fold increase in the odds of ADHD in a confounder-adjusted multivariable analysis. Age and consumption of raw/undercooked meat were confirmed as significant predictors of T. gondii seropositivity. Multiple linear regression analysis of self-rated ADHD-related symptom severity in all participants revealed a significant association with T. gondii seropositivity, elevated IgG titers (serointensity), and stronger anti-T. gondii IgG avidity. Overall symptom severity was increased in seropositive ADHD patients compared to seronegative subjects with ADHD. In particular, hyperactivity was significantly associated with serointensity. We conclude that there is a high rate of T. gondii seropositivity in adults with ADHD. Additionally, our results suggest a clinical impact of latent T. gondii infection on ADHD-related symptoms in a serointensity- and avidity-dependent manner.
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Transtorno do Deficit de Atenção com Hiperatividade/complicações , Infecção Latente/complicações , Índice de Gravidade de Doença , Toxoplasma/imunologia , Toxoplasmose/complicações , Adolescente , Adulto , Anticorpos Antiprotozoários/sangue , Anticorpos Antiprotozoários/imunologia , Estudos de Casos e Controles , Feminino , Alemanha/epidemiologia , Humanos , Imunoglobulina G/sangue , Imunoglobulina G/imunologia , Imunoglobulina M/sangue , Imunoglobulina M/imunologia , Infecção Latente/sangue , Masculino , Pessoa de Meia-Idade , Prevalência , Fatores de Risco , Estudos Soroepidemiológicos , Toxoplasmose/sangue , Toxoplasmose/epidemiologia , Toxoplasmose/parasitologia , Adulto JovemRESUMO
Indicators for a decrement in vigilance are a slowdown in reaction times and an increase in alpha power in the electroencephalogram in posterior regions of the brain. Transcranial alternating current stimulation (tACS) is a neuropsychological technique that has been found to interact with intrinsic brain oscillations and is able to enhance cognitive and behavioral performance. Recent studies show that tACS in the gamma frequency range (30-80 Hz) is able to downregulate amplitudes in the alpha frequency range (8-12 Hz), in accordance to the effect referred to as cross-frequency coupling, where intrinsic alpha and gamma waves modulate each other. We applied 40 Hz gamma-tACS to the visual cortex during a vigilance experiment and investigated if stimulation improves reaction times and error rates with time-on-task. In our sham controlled experiment, participants completed two blocks of 30 minutes duration while performing the same visual two-choice task. The first block was used as BASELINE. A statistical analysis with a linear mixed model revealed a significantly lower increase of modeled reaction times over time in the INTERVENTION-block of the tACS-group as compared with their BASELINE-block whereas there was no significant change between the BASELINE- and INTERVENTION-block for the SHAM-group. Error rates did not differ between groups. This paper indicates that gamma-tACS can enhance performance in vigilance tasks as it significantly decreased the slowdown of reaction times in our study.
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Nível de Alerta , Tempo de Reação , Estimulação Transcraniana por Corrente Contínua , Adulto , Ritmo alfa , Comportamento de Escolha/fisiologia , Eletroencefalografia , Feminino , Ritmo Gama , Voluntários Saudáveis , Humanos , Modelos Lineares , Masculino , Córtex Visual/fisiologia , Adulto JovemRESUMO
PURPOSE: Patient satisfaction is frequently used as a health care quality measure despite methodological challenges. By the example of pediatric inflammatory bowel disease (IBD), we assessed factors associated with low satisfaction and examined differences by type of provider. PATIENTS AND METHODS: In a cross-sectional design, a 32-item questionnaire and global questioning were used to assess satisfaction in patients aged 15-25 years. Determinants of low satisfaction were identified by logistic regression (OR with 95% CI). Separate models were calculated for patient-related variables such as age, socioeconomic status (SES), health status (emotional, somatic, quality of life) or region of residence (step 1), and impact of provider (pediatric specialist, adult specialist, no specialist) (step 2). As secondary analysis, we studied the effect of additional indicators such as waiting time, consultation time, and an IBD Management Quality Index (IMQI) on effect estimates (step 3). RESULTS: A total of 567 cases were available for analysis (response 48.2%). The strongest predictors of low satisfaction were anxiety symptoms (OR 2.49, CI 1.14 to 5.45). In step 2, not being seen by a specialist (1.89, 1.16 to 3.10) and having been with the new provider for less than 12 months (1.71, 1.03 to 2.83) were associated with low satisfaction. Satisfaction with adult care provider was similar to pediatric care if adjusted for anxiety, health status, and time with provider (0.95, 0.59 to 1.51). Presence of other quality indicators (step 3), waiting time >30 minutes, consultation time <15 minutes, and low IMQI were all associated with low satisfaction. Age, SES, and region of residence were not found to affect satisfaction in any of the models. CONCLUSION: Anxiety symptoms were most strongly associated with low patient satisfaction. The relevance of recent provider change and not being seen by a specialist underlines the importance of well-planned transition in this age group.