Investigating the Benefit-Risk Profile of Drugs: From Spontaneous Reporting Systems to Real-World Data for Pharmacovigilance.

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.

Características clínicas de reanimações cardiopulmonares intra-hospitalares registradas em prontuário: estudo transversal / Clinical characteristics of in-hospital cardiopulmonary resuscitations recorded in medical records: a cross-sectional study / Características clínicas de las reanimaciones cardiopulmonares intrahospitalarias registradas en las historias clínicas: estudio transversal

Objetivo: identificar características clínicas das paradas cardiopulmonares e reanimações cardiopulmonares ocorridas em ambiente intra-hospitalar. Método: estudo quantitativo, prospectivo e observacional, a partir de informações de prontuários de pacientes submetidos a manobras de reanimação devido à parada cardiopulmonar entre janeiro e dezembro de 2021. Utilizou-se um instrumento baseado nas variáveis do modelo de registro Utstein. Resultados: em 12 meses foram registradas 37 paradas cardiopulmonares. A maioria ocorreu na unidade de terapia intensiva respiratória, com causa clínica mais prevalente hipóxia. 65% dos pacientes foram intubados no atendimento e 57% apresentaram ritmo atividade elétrica sem pulso. A duração da reanimação variou entre menos de cinco a mais de 20 minutos. Como desfecho imediato, 57% sobreviveram. Conclusão: dentre os registros analisados, a maior ocorrência de paradas cardiopulmonares foi na unidade de terapia intensiva respiratória, relacionada à Covid-19. Foram encontrados registros incompletos e ausência de padronização nas condutas.

Objective: identify the clinical characteristics of cardiopulmonary arrests and cardiopulmonary resuscitations in the in-hospital environment. Method: this is a quantitative, prospective and observational study based on information from the medical records of patients who underwent resuscitation maneuvers due to cardiopulmonary arrest between January and December 2021. An instrument based on the variables of the Utstein registration protocol was used. Results: thirty-seven cardiopulmonary arrests were recorded in 12 months. The majority occurred in a respiratory intensive care unit, with hypoxia being the most prevalent clinical cause. Sixty-five percent of the patients were intubated and 57% had pulseless electrical activity. The duration of resuscitation ranged from less than five to more than 20 min. As for the immediate outcome, 57% survived. Conclusion: among the records analyzed, the highest occurrence of cardiopulmonary arrests was in respiratory intensive care units, and they were related to Covid-19. Moreover, incomplete records and a lack of standardization in cardiopulmonary resuscitation procedures were found.

Objetivo: Identificar las características clínicas de paros cardiopulmonares y reanimaciones cardiopulmonares que ocurren en un ambiente hospitalario. Método: estudio cuantitativo, prospectivo y observacional, realizado a partir de información presente en historias clínicas de pacientes sometidos a maniobras de reanimación por paro cardiorrespiratorio entre enero y diciembre de 2021. Se utilizó un instrumento basado en las variables del modelo de registro Utstein. Resultados: en 12 meses se registraron 37 paros cardiopulmonares. La mayoría ocurrió en la unidad de cuidados intensivos respiratorios, la causa clínica más prevalente fue la hipoxia. El 65% de los pacientes fue intubado durante la atención y el 57% presentaba un ritmo de actividad eléctrica sin pulso. La duración de la reanimación varió entre menos de cinco y más de 20 minutos. Como resultado inmediato, el 57% sobrevivió. Conclusión: entre los registros analizados, la mayor cantidad de paros cardiopulmonares se dio en la unidad de cuidados intensivos respiratorios, relacionada con Covid-19. Se encontraron registros incompletos y falta de estandarización en el procedimiento.

Análise dos registros perioperatórios baseados na sistematização da assistência de enfermagem perioperatória: estudo transversal / Analysis of perioperative records based on the systematization of perioperative nursing care: a cross-sectional study / Análisis de registros perioperatorios a partir de la sistematización de la atención de enfermería perioperatoria: estudio transversal

Objetivo: analisar os registros perioperatórios baseados nas etapas de sistematização da assistência de enfermagem perioperatória em um hospital regional público do agreste de Pernambuco. Método: estudo transversal, descritivo, com abordagem quantitativa, obtido com dados secundários, conduzido em um hospital público. A amostra foi composta por 276 prontuários de indivíduos que se submeteram a procedimentos anestésico-cirúrgicos, durante os meses de janeiro a maio de 2023. Utilizou-se a análise descritiva e inferencial. Resultados: a efetuação dos registros da sistematização da assistência de enfermagem perioperatória foi predominante na maioria do período perioperatório, com respectiva significância principalmente no pré-operatório. Conclusão: as atividades satisfatórias corresponderam à visita pré-operatória de enfermagem, histórico, diagnóstico e prescrição de enfermagem. Já as fragilidades identificadas destacaram-se a ausência de reservas sanguíneas, a verificação de alergia e a colocação de placa de eletrocautério, inserção de sonda vesical, a efetuação do controle de perdas sanguíneas, fisiológicas e secreção gástrica.

Objective: analyzing perioperative records based on the phases of systematization of perioperative nursing care in a public regional hospital in Pernambuco's harsh region. Method: a cross-sectional, descriptive study with a quantitative approach, using secondary data, conducted in a public hospital. The sample consisted of 276 medical records of individuals who underwent anesthetic-surgical procedures between January and May 2023. Descriptive and inferential analysis was used. Results: the recording of the systematization of perioperative nursing care was predominant in the majority of the perioperative period, with significance mainly in the preoperative period. Conclusion: the satisfactory activities corresponded to the preoperative nursing visit, history, diagnosis, and nursing prescription. The weaknesses identified were the lack of blood reserves, checking for allergies and placing the electrocautery plate, inserting a urinary catheter, controlling blood loss, physiological loss, and gastric secretion.

Objetivo: analizar los registros perioperatorios a partir de las etapas de sistematización de la atención de enfermería perioperatoria en un hospital público regional de la zona rural de Pernambuco. Método: estudio descriptivo transversal, con enfoque cuantitativo, a partir de datos secundarios, realizado en un hospital público. La muestra estuvo compuesta por 276 historias clínicas de personas sometidas a procedimientos anestésico-quirúrgicos, de enero a mayo de 2023. Se utilizó análisis descriptivo e inferencial. Resultados: el registro de la sistematización de la atención de enfermería perioperatoria predominó en la mayor parte del periodo perioperatorio, con significación principalmente en el periodo preoperatorio. Conclusión: las actividades satisfactorias correspondieron a la visita de enfermería preoperatoria, registro, diagnóstico y prescripción de enfermería. Las debilidades identificadas incluyeron falta de reservas de sangre, comprobación de alergias y colocación de placa de electrocauterio, inserción de sonda vesical, control de la pérdida de sangre, fisiológica y secreción gástrica.

Hospital-acquired malnutrition: point prevalence, risk identifiers and utility of a digital Dashboard to identify high-risk, long-stay patients in five Australian facilities.

BACKGROUND: There are limited hospital-acquired malnutrition (HAM) studies among the plethora of malnutrition literature, and a few studies utilise electronic medical records to assist with malnutrition care. This study therefore aimed to determine the point prevalence of HAM in long-stay adult patients across five facilities, whether any descriptors could assist in identifying these patients and whether a digital Dashboard accurately reflected 'real-time' patient nutritional status. METHODS: HAM was defined as malnutrition first diagnosed >14 days after hospital admission. Eligible patients were consenting adult (≥18 years) inpatients with a length of stay (LOS) >14 days. Palliative, mental health and intensive care patients were excluded. Descriptive, clinical and nutritional data were collected, including nutritional status, and whether a patient had hospital-acquired malnutrition to determine point prevalence. Descriptive Fisher's exact and analysis of variance (ANOVA) tests were used. RESULTS: Eligible patients (n = 134) were aged 68 ± 16 years, 52% were female and 92% were acute admissions. HAM and malnutrition point prevalence were 4.5% (n = 6/134) and 19% (n = 26/134), respectively. Patients with HAM had 72 days greater LOS than those with malnutrition present on admission (p < 0.001). A high proportion of HAM patients were inpatients at a tertiary facility and longer-stay wards. The Dashboard correctly reflected recent ward dietitian assessments in 94% of patients at one facility (n = 29/31). CONCLUSIONS: HAM point prevalence was 4.5% among adult long-stay patients. Several descriptors may be suitable to screen for at-risk patients in future studies. Digital Dashboards have the potential to explore factors related to HAM.

Trends in Adolescent Depression Screening Outcomes Over the COVID-19 Pandemic at a Large, Integrated Health Care System in Southern California.

PURPOSE: Little is known about changes in depression screening outcomes among adolescents in primary healthcare across the COVID-19 pandemic. We describe trends in depression screening outcomes within a large integrated health care system in Southern California. METHODS: Retrospective electronic health record data from preventative healthcare visits of 11-12-year-olds and 13-17-year-olds screened for depression from March 1, 2017, to August 31, 2022, were extracted in 6-month blocks. The percentages of screens meeting "threshold depression" were reported overall, and by sex, race or ethnicity, and median household income quintiles. We used Poisson regression to estimate rate ratios of threshold depression in 3 winter blocks (September to February) comparing lockdown (2020), reopening (2021) to a pre-COVID (2019) period, and reopening relative to lockdown. Disparities in trends by sex, race, or ethnicity and household income were tested using interaction terms. RESULTS: Of 735,333 visits with complete screening (183,550 for 11-12-year-olds and 551,783 for 13-17-year-olds), 4.6%, 6.5%, and 7.4% of 11-12-year-olds had "threshold depression" during winter blocks of pre-COVID, lockdown and reopening, respectively. The corresponding rates were 5.8%, 8.5%, and 9.8% for 13-17-year-olds. The rates were higher during lockdown and reopening relative to pre-COVID and higher during reopening relative to lockdown for both age groups (all p-values <.001). Trends differed by sex in both age groups (p-values <.001) and by race or ethnicity (p = .001) in the 13-17-year age group. DISCUSSION: Californian adolescents demonstrated an increase in threshold depression since COVID lockdown starting March 2020 with further increase observed during reopening in September 2021. Future studies are needed to determine the long-term trends.

Effects of COVID-19 on Irish general practice activity from 2019 to 2021: a retrospective analysis of 500,000 consultations using electronic medical record data.

BACKGROUND: General practice (GP) is crucial to primary care delivery in the Republic of Ireland and is almost fully computerised. General practice teams were the first point of contact for much COVID-19-related care and there were concerns routine healthcare activities could be disrupted due to COVID-19 and related restrictions. AIMS: The study aimed to assess effects of the pandemic on GP activity through analysis of electronic medical record data from general practice clinics in the Irish Midwest. METHODS: A retrospective, descriptive study of electronic medical record data relating to patient record updates, appointments and medications prescribed across 10 GP clinics over the period 2019-2021 inclusive. RESULTS: Data relating to 1.18 million record transactions for 32 k patients were analysed. Over 500 k appointments were examined, and demographic trends presented. Overall appointment and prescribing activity increased over the study period, while a dip was observed immediately after the pandemic's arrival in March 2020. Delivery of non-childhood immunisations increased sixfold as a result of COVID-19, childhood immunisation activity was maintained, while cervical smears decreased in 2020 as the screening programme was halted. A quarter of consultations in 2020 and 2021 were teleconsultations, and these were more commonplace for younger patients. CONCLUSIONS: General practice responded robustly to the pandemic by taking on additional activities while maintaining routine services where possible. The shift to teleconsulting was a significant change in workflow. Analysing routinely collected electronic medical record data can provide valuable insights for service planning, and access to these insights would be beneficial for future pandemic responses.

Recording of Alcohol Use Disorder in Electronic Health Records: Developing a Recommended Codelist for Research.

Purpose: Electronic health records (EHR) are valuable resources for health research; however, their use is challenging. A validated alcohol use disorder (AUD) codelist for UK primary care is needed to improve population-based research in this patient group. We aimed to develop an AUD codelist for use in the Clinical Practice Research Datalink (CPRD) Aurum database, a UK EHR primary-care database. Methods: The CPRD code browser was searched using keywords related to alcohol use using a previously developed search strategy. The resulting codes were categorised as AUD if they were: a) diagnostic of AUD, b) indicated alcohol withdrawal, or c) indicated chronic alcohol-related harm (physical or mental). Codes related to alcohol use but not used to define AUD were also classified into relevant categories (alcohol status, acute harm, and alcohol screening). All codes were categorised independently by at least two reviewers (one person reviewed all codes and five reviewers (all practising GPs) each reviewed a subset of codes (100-200 codes each). Disagreements in categorisation were discussed by at least three coders and a consensus was reached. The reliability of categorisation was assessed using kappa statistics. Results: In total, 556 potential codes related to alcohol use were identified. The Kappa for reliability between coders was moderate for both AUD (0.72) and across all categories (0.62), with substantial variability between coders (AUD: 0.33-0.97; all categories 0.36-0.74). In the final codelist, 138 codes were included as indicating AUD: 38 codes identified which indicated diagnosis of AUD, 14 indicating withdrawal plus 85 codes indicating chronic alcohol-related harm (41 physical health and 44 mental health). Conclusion: Many codes are used in primary care to record alcohol use and associated harms, and there is substantial variability in how clinicians categorise them. While future work formally validating the codelist against gold standard clinical reviews and qualitative work with General Practitioners is needed for a deeper understanding of coding processes, we have documented here the process used for the development of an AUD codelist within primary care which can be used as a reference for future research.

To read or not to read - A cross-sectional study of Swedish primary care patients' adoption of patient accessible electronic health records.

Objective: Patient-accessible electronic health records (PAEHR) were implemented in the Stockholm region of Sweden seven years ago. This study examines socio-demographic and psychographic factors associated with reading/not reading these records, as well as the common reasons for such behaviours. Methods: Patients or guardians of minors seeking face-to-face or digital primary healthcare in the Stockholm region responded to a questionnaire about whether they were aware that they could read their PAEHR, and if so, if they had read it and reasons for reading or not reading. We conducted a comparative analysis of readers and non-readers and a stepwise multiple logistic regression. Results: The majority of participants were aware that they could read the PAEHR (86%) and among those aware, 77% had read it. The odds of reading decreased with increased age, unfavourable opinion of PAEHR, low information literacy and being single. Access to a smartphone increased the probability of reading. Participants who had read their PAEHR had commonly read it to get an overview of their health and care (65%) and to follow up on a healthcare visit (55%). Participants who had not read their PAEHR stated generally that they did not need to (63%) and/or had received sufficient information from their providers (38%). Conclusions: While most people were aware they could read the PAEHR and many had read it, a digital divide and several barriers to reading the PAEHR were identified. Efforts to increase PAEHR reading may be targeted at older people, people needing more informal support, those who may be excluded due to limited information literacy, and towards improving the patient portals' usability.

Perception towards electronic health records & uptake of digital health IDs among the urban residents in northern India: A mixed methods study.

Background & objectives Ayushman Bharat Digital Mission (ABDM) envisages a unique digital health ID for all citizens of India, to create electronic health records (EHR) of individuals. The present study assessed the uptake of Digital Health IDs by the patient and general population, their attitude toward EHR, and explored the barriers to digital ID and utilizing electronic health records services. Methods A concurrent explanatory mixed methods study was undertaken in Chandigarh, India, with an analytical cross-sectional design as a quantitative part and a qualitative descriptive study. The study participants were 419 individuals aged ≥18 yr who attended the urban primary healthcare centre (n=399) and the community-based screening camps (n=20) between July 2021 and January 2022. Latent Class Analysis (LCA) was undertaken to identify hidden sub-population characteristics. In-depth interviews were done to identify the barriers to health ID uptake. Results The digital health ID uptake rate was 78 per cent (n=327). Among the study participants, those who were aware of EHR, those who wanted a national EHR system, those who were confident with the government on EHR security, and those who were willing to make national EHR accessible for research showed significantly higher digital health ID uptake than their counterparts. The themes identified under barriers of uptake from the qualitative interviews were lack of awareness, technology-related (including digital literacy) and utility-related. Interpretation & conclusions Increasing EHR awareness, digital health literacy, and enacting data protection laws may improve the acceptance of the digital health ecosystem in India.

Clinical Data Flow in Botswana Clinics: Protocol for a Mixed-Methods Assessment.

BACKGROUND: Botswana has made significant investments in its health care information infrastructure, including vertical programs for child health and nutrition, HIV care, and tuberculosis. However, effectively integrating the more than 18 systems in place for data collection and reporting has proved to be challenging. The Botswana Health Data Collaborative Roadmap Strategy (2020-24) states that "there exists parallel reporting systems and data is not integrated into the mainstream reports at the national level," seconded by the Botswana National eLearning strategy (2020), which states that "there is inadequate information flow at all levels, proliferation of systems, reporting tools are not synthesized; hence too many systems are not communicating." OBJECTIVE: The objectives of this study are to (1) create a visual representation of how data are processed and the inputs and outputs through each health care system level; (2) understand how frontline workers perceive health care data sharing across existing platforms and the impact of data on health care service delivery. METHODS: The setting included a varied range of 30 health care facilities across Botswana, aiming to capture insights from multiple perspectives into data flow and system integration challenges. The study design combined qualitative and quantitative methodologies, informed by the rapid assessment process and the technology assessment model for resource limited settings. The study used a participatory research approach to ensure comprehensive stakeholder engagement from its inception. Survey instruments were designed to capture the intricacies of data processing, sharing, and integration among health care workers. A purposive sampling strategy was used to ensure a wide representation of participants across different health care roles and settings. Data collection used both digital surveys and in-depth interviews. Preliminary themes for analysis include perceptions of the value of health care data and experiences in data collection and sharing. Ethical approvals were comprehensively obtained, reflecting the commitment to uphold research integrity and participant welfare throughout the study. RESULTS: The study recruited almost 44 health care facilities, spanning a variety of health care facilities. Of the 44 recruited facilities, 27 responded to the surveys and participated in the interviews. A total of 75% (112/150) of health care professionals participating came from clinics, 20% (30/150) from hospitals, and 5% (8/150) from health posts and mobile clinics. As of October 10, 2023, the study had collected over 200 quantitative surveys and conducted 90 semistructured interviews. CONCLUSIONS: This study has so far shown enthusiastic engagement from the health care community, underscoring the relevance and necessity of this study's objectives. We believe the methodology, centered around extensive community engagement, is pivotal in capturing a nuanced understanding of the health care data ecosystem. The focus will now shift to the analysis phase of the study, with the aim of developing comprehensive recommendations for improving data flow within Botswana's health care system. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/52411.

Longitudinal assessment of health-related quality of life after SARS-CoV-2 infection and the associations with clinical and social characteristics in a general practice population.

BACKGROUND: We aimed to investigate the longitudinal impact of COVID-19 and the effects of clinical and psychosocial factors, accounting for post-COVID conditions (PCC), on the mental and physical aspect of health-related quality of life (HRQoL) of patients diagnosed with COVID-19. METHODS: Data from the Nivel Corona Cohort were used, which includes individuals with an established SARS-CoV-2 infection that received four questionnaires over a year's time with questions regarding HRQoL (SF-12), symptoms and social characteristics. PCC was determined based on questionnaire data. Data on medical history and healthcare utilization were obtained from electronic health records from general practice. A repeated measures linear mixed model was used to explore associations between clinical and social characteristics, and the course of mental and physical HRQoL after a SARS-CoV-2 infection, taking PCC into account. RESULTS: One hundred fifty-eight individuals of whom it was possible to determine whether they had PCC or not were included in this study. Seventy-six (48.1%) developed PCC, which was associated with a persistent reduction in both physical and mental HRQoL. Hospitalization during the acute phase of the infection had a negative impact on the physical HRQoL, which decreased over time. Females, people older than 53, and those with increased resilience and mental HRQoL before infection were more likely to report a more positive mental HRQoL over time. CONCLUSION: The negative association PCC has with both mental and physical HRQoL for at least six months, calls for more research to support patients with PCC.

End user experience of a widely used artificial intelligence based sepsis system.

Objectives: Research on the Epic Sepsis System (ESS) has predominantly focused on technical accuracy, neglecting the user experience of healthcare professionals. Understanding these experiences is crucial for the design of Artificial Intelligence (AI) systems in clinical settings. This study aims to explore the socio-technical dynamics affecting ESS adoption and use, based on user perceptions and experiences. Materials and Methods: Resident doctors and nurses with recent ESS interaction were interviewed using purposive sampling until data saturation. A content analysis was conducted using Dedoose software, with codes generated from Sittig and Singh's and Salwei and Carayon's frameworks, supplemented by inductive coding for emerging themes. Results: Interviews with 10 healthcare providers revealed mixed but generally positive or neutral perceptions of the ESS. Key discussion points included its workflow integration and usability. Findings were organized into 2 main domains: workflow fit, and usability and utility, highlighting the system's seamless electronic health record integration and identifying design gaps. Discussion: This study offers insights into clinicians' experiences with the ESS, emphasizing the socio-technical factors that influence its adoption and effective use. The positive reception was tempered by identified design issues, with clinician perceptions varying by their professional experience and frequency of ESS interaction. Conclusion: The findings highlight the need for ongoing ESS refinement, emphasizing a balance between technological advancement and clinical practicality. This research contributes to the understanding of AI system adoption in healthcare, suggesting improvements for future clinical AI tools.

Attention-based Imputation of Missing Values in Electronic Health Records Tabular Data.

The imputation of missing values (IMV) in electronic health records tabular data is crucial to enable machine learning for patient-specific predictive modeling. While IMV methods are developed in biostatistics and recently in machine learning, deep learning-based solutions have shown limited success in learning tabular data. This paper proposes a novel attention-based missing value imputation framework that learns to reconstruct data with missing values leveraging between-feature (self-attention) or between-sample attentions. We adopt data manipulation methods used in contrastive learning to improve the generalization of the trained imputation model. The proposed self-attention imputation method outperforms state-of-the-art statistical and machine learning-based (decision-tree) imputation methods, reducing the normalized root mean squared error by 18.4% to 74.7% on five tabular data sets and 52.6% to 82.6% on two electronic health records data sets. The proposed attention-based missing value imputation method shows superior performance across a wide range of missingness (10% to 50%) when the values are missing completely at random.

Predictive Factors of Apparent Treatment Resistant Hypertension Among Patients With Hypertension Identified Using Electronic Health Records.

BACKGROUND: Early identification of a patient with resistant hypertension (RH) enables quickly intensified treatment, short-interval follow-up, or perhaps case management to bring his or her blood pressure under control and reduce the risk of complications. OBJECTIVE: To identify predictors of RH among individuals with newly diagnosed hypertension (HTN), while comparing different prediction models and techniques for managing missing covariates using electronic health records data. DESIGN: Risk prediction study in a retrospective cohort. PARTICIPANTS: Adult patients with incident HTN treated in any of the primary care clinics of one health system between April 2013 and December 2016. MAIN MEASURES: Predicted risk of RH at the time of HTN identification and candidate predictors for variable selection in future model development. KEY RESULTS: Among 26,953 individuals with incident HTN, 613 (2.3%) met criteria for RH after 4.7 months (interquartile range, 1.2-11.3). Variables selected by the least absolute shrinkage and selection operator (LASSO), included baseline systolic blood pressure (SBP) and its missing indicator (a dummy variable created if baseline SBP is absent), use of antihypertensive medication at the time of cohort entry, body mass index, and atherosclerosis risk. The random forest technique achieved the highest area under the curve (AUC) of 0.893 (95% CI, 0.881-0.904) and the best calibration with a calibration slope of 1.01. Complete case analysis is not a valuable option (AUC = 0.625). CONCLUSIONS: Machine learning techniques and traditional logistic regression exhibited comparable levels of predictive performance after handling the missingness. We suggest that the variables identified by this study may be good candidates for clinical prediction models to alert clinicians to the need for short-interval follow up and more intensive early therapy for HTN.

Analyzing Comorbidity Patterns in Patients With Thyroid Disease Using Large-Scale Electronic Medical Records: Network-Based Retrospective Observational Study.

BACKGROUND: Thyroid disease (TD) is a prominent endocrine disorder that raises global health concerns; however, its comorbidity patterns remain unclear. OBJECTIVE: This study aims to apply a network-based method to comprehensively analyze the comorbidity patterns of TD using large-scale real-world health data. METHODS: In this retrospective observational study, we extracted the comorbidities of adult patients with TD from both private and public data sets. All comorbidities were identified using ICD-10 (International Classification of Diseases, 10th Revision) codes at the 3-digit level, and those with a prevalence greater than 2% were analyzed. Patients were categorized into several subgroups based on sex, age, and disease type. A phenotypic comorbidity network (PCN) was constructed, where comorbidities served as nodes and their significant correlations were represented as edges, encompassing all patients with TD and various subgroups. The associations and differences in comorbidities within the PCN of each subgroup were analyzed and compared. The PageRank algorithm was used to identify key comorbidities. RESULTS: The final cohorts included 18,311 and 50,242 patients with TD in the private and public data sets, respectively. Patients with TD demonstrated complex comorbidity patterns, with coexistence relationships differing by sex, age, and type of TD. The number of comorbidities increased with age. The most prevalent TDs were nontoxic goiter, hypothyroidism, hyperthyroidism, and thyroid cancer, while hypertension, diabetes, and lipoprotein metabolism disorders had the highest prevalence and PageRank values among comorbidities. Males and patients with benign TD exhibited a greater number of comorbidities, increased disease diversity, and stronger comorbidity associations compared with females and patients with thyroid cancer. CONCLUSIONS: Patients with TD exhibited complex comorbidity patterns, particularly with cardiocerebrovascular diseases and diabetes. The associations among comorbidities varied across different TD subgroups. This study aims to enhance the understanding of comorbidity patterns in patients with TD and improve the integrated management of these individuals.

Epidemiology of self-limited epilepsy with centrotemporal spikes (SeLECTS): A population study using primary care records.

BACKGROUND AND OBJECTIVE: Information on self-limited epilepsy with centrotemporal spikes (SeLECTS) epidemiology is limited. We aimed to determine the incidence of SeLECTS in children, its association with socioeconomic deprivation and the prevalence of neurodevelopmental comorbidities. METHOD: We performed a retrospective cohort study (2004-2017) using anonymised, linked, routinely collected, primary care and demographic data for children in Wales. We used primary care diagnosis codes to identify children (aged 0-16 years) with SeLECTS and other epilepsies and to record antiseizure medication (ASM) prescriptions and neurodevelopmental comorbidities. We used a mixed effects Poisson regression model to determine temporal trends of SeLECTS incidence and its association with socioeconomic deprivation. RESULTS: We identified 6,732 children with epilepsy, 186 (3%) with SeLECTS. In 2017, epilepsy and SeLECTS prevalence was 0.55% and 0.02% respectively with corresponding crude incidence of 51.2/100,000/year and 1.1/100,000/year. The incidence of epilepsy in children decreased with decreasing deprivation with an adjusted incidence rate ratio (AIRR) of 0.72 (95% CI 0.64-0.82) in the least deprived compared with the most deprived quintile. The corresponding AIRR for children with SeLECTS was 1.35 (95% CI 0.46-1.99). 34% of children with epilepsy, 18% of children with SeLECTS and 3% of all children in Wales had a neurodevelopmental disorder and or school problems. Half of children with SeLECTS were treated with ASM. CONCLUSIONS: We identified a lower than previously reported incidence of SeLECTS, which may be due to under-recording of SeLECTS. There was no change in the incidence of SeLECTS over time, whilst the incidence of childhood epilepsy overall was decreasing. There was no significant association between incidence of SeLECTS and deprivation but the modest sample size needs to be considered. Children with SeLECTS should be screened for neurodevelopmental and or learning comorbidities. Treatment for SeLECTS remains debatable.

Real-world treatment patterns, survival outcomes, and health care resource utilization for locally advanced or metastatic urothelial carcinoma in Spain.

PURPOSE: Real-world evidence on locally advanced or metastatic urothelial carcinoma (la/mUC) management in Spain is limited. This study describes patient characteristics, treatment patterns, survival, and health care resource utilization (HCRU) in this population. METHODS/PATIENTS: This retrospective observational study included all adults with a first diagnosis/record of la/mUC (index date) from January 2015 to June 2020 at nine university hospitals in Spain. Data were collected up to December 31, 2020 (end of study), death, or loss to follow-up. Patient characteristics, treatment patterns, median overall survival (OS) and progression-free survival (PFS) from index date (Kaplan-Meier estimates), and disease-specific HCRU were described. RESULTS: Among 829 patients, median age at diagnosis was 71 years; 70.2% had ≥ 1 comorbidity, and 52.5% were eligible for cisplatin. Median follow-up was 12.7 months. Most (84.7%) patients received first-line systemic treatment; of these, 46.9% (n = 329) received second-line and 16.6% (n = 116) received third-line therapy. Chemotherapy was the most common treatment in all lines of therapy, followed by programmed cell death protein 1/ligand 1 inhibitors. Median (95% confidence interval) OS and PFS were 18.8 (17.5-21.5) and 9.9 (8.9-10.5) months, respectively. Most patients required ≥ 1 outpatient visit (71.8%), inpatient admission (56.6%), or emergency department visit (56.5%). CONCLUSIONS: Therapeutic patterns were consistent with Spanish guideline recommendations. Chemotherapy had a role in first-line treatment of la/mUC in Spain during the study period. However, the disease burden remains high, and new first-line treatments recommended in the latest European guidelines should be made available to patients in Spain.

Impact of scanning strategies on the accuracy of virtual interocclusal records in partially edentulous arch using intraoral scanner: an in vitro study.

PURPOSE: To evaluate the scanning strategies affecting the accuracy of virtual interocclusal records (VIR) in partially edentulous arches using an intraoral scanner in vitro. METHODS: A reference model of a partially edentulous arch with implant analogs in positions 45,46 and 47 was constructed. Six pairs of 1-mm diameter metal beads were placed on the gingival tissue as markers for measurement. Four scanning strategies were tested: Quadrant-arch Scan (group 1), Quadrant-arch Scan with Auxiliary occlusal devices (AOD) (group 2), Full-arch Scan (group 3), Full-arch Scan with AOD (group 4). The model was digitalized with a lab scanner as a reference and 15 scans were obtained for each group. The accuracy of VIR was assessed by comparing the experiment data to the reference digital model. RESULTS: The mean surface deviations of VIR for Groups 1-4 were 89.4 ± 105.2 µm,95.6 ± 132.8 µm,152.3 ± 159.7 µm and 107.6 ± 138.2 µm respectively. Quadrant-arch scans resulted in lower errors of VIR than full-arch scan (P < 0.001). There was a significant interaction between the AOD and scanning span (P = 0.017). The Quadrant-arch scan with AOD　(group 2) produced the least error in the distally extended edentulous area. CONCLUSIONS: Quadrant-arch scans showed better accuracy of VIR than full-arch scans across all tooth positions. The combination of AOD and quadrant-arch scan further enhances VIR accuracy in distally extended edentulous areas.

Use of an ambient artificial intelligence tool to improve quality of clinical documentation.

Background: Electronic health records (EHRs) have contributed to increased workloads for clinicians. Ambient artificial intelligence (AI) tools offer potential solutions, aiming to streamline clinical documentation and alleviate cognitive strain on healthcare providers. Objective: To assess the clinical utility of an ambient AI tool in enhancing consultation experience and the completion of clinical documentation. Methods: Outpatient consultations were simulated with actors and clinicians, comparing the AI tool against standard EHR practices. Documentation was assessed by the Sheffield Assessment Instrument for Letters (SAIL). Clinician experience was measured through questionnaires and the NASA Task Load Index. Results: AI-produced documentation achieved higher SAIL scores, with consultations 26.3% shorter on average, without impacting patient interaction time. Clinicians reported an enhanced experience and reduced task load. Conclusions: The AI tool significantly improved documentation quality and operational efficiency in simulated consultations. Clinicians recognised its potential to improve note-taking processes, indicating promise for integration into healthcare practices.