Algorithmic Identification of Treatment-Emergent Adverse Events From Clinical Notes Using Large Language Models: A Pilot Study in Inflammatory Bowel Disease.

Outpatient clinical notes are a rich source of information regarding drug safety. However, data in these notes are currently underutilized for pharmacovigilance due to methodological limitations in text mining. Large language models (LLMs) like Bidirectional Encoder Representations from Transformers (BERT) have shown progress in a range of natural language processing tasks but have not yet been evaluated on adverse event (AE) detection.

A descriptive analysis of postmarketing requirement studies and clinical trials.

Purpose: Under the Food and Drug Administration Amendments Act of 2007 (FDAAA), the FDA has the authority to require applicants to conduct postmarketing studies or clinical trials. These postmarketing requirements (PMRs) provide additional data on the safety of the drug product. The purpose of the study was to conduct a descriptive analysis of FDAAA PMRs and the resulting regulatory actions.

Algorithmic identification of treatment-emergent adverse events from clinical notes using large language models: a pilot study in inflammatory bowel disease.

Background And Aims: Outpatient clinical notes are a rich source of information regarding drug safety. However, data in these notes are currently underutilized for pharmacovigilance due to methodological limitations in text mining. Large language models (LLM) like BERT have shown progress in a range of natural language processing tasks but have not yet been evaluated on adverse event detection.

Validation of diagnosis codes to identify hospitalized COVID-19 patients in health care claims data.

Purpose: Health plan claims may provide complete longitudinal data for timely, real-world population-level COVID-19 assessment. However, these data often lack laboratory results, the standard for COVID-19 diagnosis.

Methods: We assessed the validity of ICD-10-CM diagnosis codes for identifying patients hospitalized with COVID-19 in U.

Data visualization of the relationship between smoking and periodontal site-specific effects across the lifespan in the US adult population.

Background: Data visualization techniques were used to ascertain (1) site-specific effects of cigarette smoking on the periodontium compared to never-smokers; (2) patterns of site-specific effects by age among current and never-smokers using contour maps.

Methods: Data from 10,713 dentate participants aged ≥30 years in NHANES 2009-2014 were used. Pocket depth (PD) and clinical attachment level (CAL) for six sites/tooth were ascertained by smoking status and plotted using contour maps to identify new patterns.

Neutralizing and Neuraminidase Antibodies Correlate With Protection Against Influenza During a Late Season A/H3N2 Outbreak Among Unvaccinated Military Recruits.

Background: Antibodies that inhibit hemagglutination have long been considered a correlate of protection against influenza, but these antibodies are only a subset of potentially protective antibodies. Neutralizing and neuraminidase antibodies may also contribute to protection, but data on their associations with protection are limited.

Methods: We measured preoutbreak hemagglutinin pseudovirus neutralization (PVN) and neuraminidase inhibition (NAI) antibody titers in unvaccinated military recruits who experienced an H3N2 influenza outbreak during training.

Age-dependent distribution of periodontitis in two countries: Findings from NHANES 2009 to 2014 and SHIP-TREND 2008 to 2012.

Objective: We used epidemiologic data of clinical periodontal status from two population-based samples in two countries, United States and Germany, to examine 1) the impact of age on the relative contribution of recession and pocketing on the distribution of clinical attachment loss, and 2) whether it is feasible to define age-dependent thresholds for severe periodontitis.

Methods: The analytical sample was based on persons aged ≥30 and included 10,713 individuals in the United States, participants in NHANES 2009 to 2014, and 3,071 individuals in Pomerania, Germany, participants in the SHIP-Trend 2008 to 2012. NHANES used a full-mouth examination protocol to collect data on recession (R), pocket depth (PD) and clinical attachment loss (CAL) for six sites/tooth on a maximum of 28 teeth; SHIP-Trend used a half-mouth examination at four sites/tooth.

Age-dependent distribution of periodontitis in two countries: Findings from NHANES 2009 to 2014 and SHIP-TREND 2008 to 2012.

Objective: We used epidemiologic data of clinical periodontal status from two population-based samples in two countries, United States and Germany, to examine 1) the impact of age on the relative contribution of recession and pocketing on the distribution of clinical attachment loss, and 2) whether it is feasible to define age-dependent thresholds for severe periodontitis.

Methods: The analytical sample was based on persons aged ≥30 and included 10,713 individuals in the United States, participants in NHANES 2009 to 2014, and 3,071 individuals in Pomerania, Germany, participants in the SHIP-Trend 2008 to 2012. NHANES used a full-mouth examination protocol to collect data on recession (R), pocket depth (PD) and clinical attachment loss (CAL) for six sites/tooth on a maximum of 28 teeth; SHIP-Trend used a half-mouth examination at four sites/tooth.

Significance and Implications of Patient-reported Xerostomia in Sjögren's Syndrome: Findings From the National Institutes of Health Cohort.

Background: Xerostomia is a chief complaint of patients with Sjögren's syndrome (SS). However, newer proposals for SS classification remove xerostomia and hyposalivation from the criteria list. Given these developments and the importance of patient-centered research outcomes, we sought to evaluate the utility of patient-reported xerostomia with implications for classification criteria, and clinical trials targeting SS treatment modalities.

Global Burden of Neonatal Invasive Pneumococcal Disease: A Systematic Review and Meta-analysis.

Background: This study aimed to estimate the global burden of invasive pneumococcal disease (IPD) incidence among neonates during the pre-pneumococcal conjugate vaccine era.

Methods: A systematic search of published and unpublished data was undertaken. Bias assessment and qualitative synthesis of the included studies were carried out.