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.

Maternal Reports to the Child Protection System: A Longitudinal Analysis of Multiple Children.

Child maltreatment can affect multiple children in a family, yet its occurrence and chronicity has been often assessed by focusing on a single child. Although this approach provides valuable insights, considering the experiences of all children in a family may provide a more complete understanding of maltreatment dynamics. Using linked birth and child protection system (CPS) records from California, we analyzed 20 years of data on 194,514 first-time mothers to document the prevalence, timing, and chronicity of maternal CPS reporting across multiple children. Mothers were categorized by the number of live childbirths: one (25.7%), two (36.2%), three (20.9%), and four or more (17.2%). Overall, 33.0% of mothers were reported to CPS, increasing from 18.5% for mothers with one child to 63.1% for those with four or more children. For mothers with two or more children, more than 70% experienced an initial CPS report only after the second child's birth. Our findings have implications for understanding the dynamics of maternal reports to CPS, emphasizing the need for lasting and family-focused interventions.

Correlation between ultrasonographic and cytologic features of thyroid nodules: a single-center cross-sectional study.

A thyroid nodule is managed according to the clinical context, ultrasound (US) findings, and fine needle aspiration (FNA) results. Most thyroid nodules are benign; however, nodule classification is crucial to avoid unnecessary thyroid surgery. We conducted this study to compare the findings of fine-needle aspiration cytology (FNAC) expressed using the Bethesda system with the features of thyroid US classified using the EU-TIRADS classification to assess the risk of malignancy. A descriptive and analytical study involving 99 patients with thyroid nodules followed up in the Department of Endocrinology-Diabetology and Nutrition. Data were collected from medical records and analyzed using SPSS software V21. FNA was performed on 121 nodules using the BETHESDA system. These nodules were classified as malignant, suspicious for follicular neoplasm, and suspicious for malignancy in 5.8%, 5%, and 1.7% of cases, respectively. As for the EU-TIRADS 2017 classification, 59.5% of benign nodules were classified as EU-TIRADS III, whereas 66.7% of malignant nodules were classified as EU-TIRADS V and significantly related to malignant prediction (P = 0.000). The size of nodules was significantly correlated to the risk of malignancy (P = 0.013). Seventy-five percent of nodules with central vascularity were malignant (P = 0.012). Irregularity of nodule contours was significantly associated with the risk of malignancy, as 30% of nodules with irregular contours were Bethesda VI (P = 0.003). Hypoechogenicity was found in 77.8% of malignant nodules (P = 0.004). Additionally, only 9.2% of the nodules were taller than wide, of which 37.5% were malignant (P = 0.012). For a safe management strategy, US-guided FNAC should be performed on each suspicious thyroid nodule, given the correlation between EU-TIRADS classification features and the risk of malignancy.

Evaluating the Capabilities of Generative AI Tools in Understanding Medical Papers: Qualitative Study.

BACKGROUND: Reading medical papers is a challenging and time-consuming task for doctors, especially when the papers are long and complex. A tool that can help doctors efficiently process and understand medical papers is needed. OBJECTIVE: This study aims to critically assess and compare the comprehension capabilities of large language models (LLMs) in accurately and efficiently understanding medical research papers using the STROBE (Strengthening the Reporting of Observational Studies in Epidemiology) checklist, which provides a standardized framework for evaluating key elements of observational study. METHODS: The study is a methodological type of research. The study aims to evaluate the understanding capabilities of new generative artificial intelligence tools in medical papers. A novel benchmark pipeline processed 50 medical research papers from PubMed, comparing the answers of 6 LLMs (GPT-3.5-Turbo, GPT-4-0613, GPT-4-1106, PaLM 2, Claude v1, and Gemini Pro) to the benchmark established by expert medical professors. Fifteen questions, derived from the STROBE checklist, assessed LLMs' understanding of different sections of a research paper. RESULTS: LLMs exhibited varying performance, with GPT-3.5-Turbo achieving the highest percentage of correct answers (n=3916, 66.9%), followed by GPT-4-1106 (n=3837, 65.6%), PaLM 2 (n=3632, 62.1%), Claude v1 (n=2887, 58.3%), Gemini Pro (n=2878, 49.2%), and GPT-4-0613 (n=2580, 44.1%). Statistical analysis revealed statistically significant differences between LLMs (P<.001), with older models showing inconsistent performance compared to newer versions. LLMs showcased distinct performances for each question across different parts of a scholarly paper-with certain models like PaLM 2 and GPT-3.5 showing remarkable versatility and depth in understanding. CONCLUSIONS: This study is the first to evaluate the performance of different LLMs in understanding medical papers using the retrieval augmented generation method. The findings highlight the potential of LLMs to enhance medical research by improving efficiency and facilitating evidence-based decision-making. Further research is needed to address limitations such as the influence of question formats, potential biases, and the rapid evolution of LLM models.

Need for Transparency and Clinical Interpretability in Hemorrhagic Stroke Artificial Intelligence Research: Promoting Effective Clinical Application.

PURPOSE: This study aimed to evaluate the quality of artificial intelligence (AI)/machine learning (ML) studies on hemorrhagic stroke using the Minimum Information for Medical AI Reporting (MINIMAR) and Minimum Information About Clinical Artificial Intelligence Modeling (MI-CLAIM) frameworks to promote clinical application. MATERIALS AND METHODS: PubMed, MEDLINE, and Embase were searched for AI/ML studies on hemorrhagic stroke. Out of the 531 articles found, 29 relevant original research articles were included. MINIMAR and MI-CLAIM scores were assigned by two experienced radiologists to assess the quality of the studies. RESULTS: We analyzed 29 investigations that utilized AI/ML in the field of hemorrhagic stroke, involving a median of 224.5 patients. The majority of studies focused on diagnostic outcomes using computed tomography scans (89.7%) and were published in computer science journals (48.3%). The overall adherence rates to reporting guidelines, as assessed through the MINIMAR and MI-CLAIM frameworks, were 47.6% and 46.0%, respectively. In MINIMAR, none of the studies reported the socioeconomic status of the patients or how missing values had been addressed. In MI-CLAIM, only two studies applied model-examination techniques to improve model interpretability. Transparency and reproducibility were limited, as only 10.3% of the studies had publicly shared their code. Cohen's kappa between the two radiologists was 0.811 and 0.779 for MINIMAR and MI-CLAIM, respectively. CONCLUSION: The overall reporting quality of published AI/ML studies on hemorrhagic stroke is suboptimal. It is necessary to incorporate model examination techniques for interpretability and promote code openness to enhance transparency and increase the clinical applicability of AI/ML studies.

Improvement in Adverse Drug Reaction (ADR) Knowledge: A Pre- and Post-video Intervention Study Among Doctors.

Background Adverse drug reactions (ADRs) represent a significant public health concern, contributing to mortality, morbidity, and healthcare costs worldwide. Healthcare practitioners especially doctors play a vital role in identifying and reporting ADR. This study investigates the prevalence of knowledge regarding ADR among doctors and enhances it with educational intervention. It also explores the association between demographic factors and baseline ADR awareness. Methods A prospective cross-sectional interventional study was conducted among doctors in Ahmedabad, India, to evaluate their knowledge of ADR reporting and the effectiveness of an educational video intervention. Pre- and post-intervention questionnaires were administered to assess knowledge improvement. Statistical analysis, including paired t-tests and chi-square tests, was performed to evaluate the intervention's impact and explore associations between demographic factors and ADR awareness. Results Analysis of pre- and post-intervention questionnaires revealed a significant increase in correct response rates post-intervention, indicating the effectiveness of the educational video intervention. Demographic factors, particularly age, were associated with ADR awareness. Following the intervention, participants demonstrated an improved understanding of ADR definitions, WHO causality assessment, reporting mechanisms, and challenges faced by pharmacovigilance programs. All participants found the video helpful and expressed intent to share their knowledge post-intervention. Conclusion The results of the study suggest that educational video intervention can serve as an effective tool for understanding ADR concepts and pharmacovigilance practices. Moreover, the association of demographic factors, particularly age, with ADR awareness further emphasizes the importance of educational interventions in addressing specific population needs.

Critical Appraisal of Clinical Trials Evaluating Physical Therapy Treatments for Temporomandibular Disorders: A Scoping Review.

BACKGROUND: Physical therapy seems the most promising treatment for temporomandibular disorders (TMD), although their effectiveness is controversial in general, due to high heterogeneity regarding study designs, applied treatments and outcomes measures. OBJECTIVES: The aim of this scoping review is to analyse the methodological characteristics of clinical trials evaluating physical therapy treatments in subjects with TMD. METHODS: A systematic search was conducted in Medline/PubMed, SPORTDiscus, Scopus, Web of Science, SciELO, Cochrane, ScienceDirect and EMBASE databases on 31 October 2023. Clinical trials evaluating physical therapy interventions in patients older than 18 years with TMD, published in English or Spanish languages. Data regarding content reporting of study designs, sample characteristics, interventions and outcome measures was extracted. Descriptive summary statistics were reported. RESULTS: The search retrieved 15 322 records, and 136 were included. There were 107 randomised clinical trials, 5 non-randomised controlled trials and 24 non-controlled trials. Most studies had moderate to high risk of bias, small sample sizes (median, 44 subjects) and short follow-up periods (1-3 months). The most common diagnostic criteria used was the Research Diagnostic Criteria for Temporomandibular Disorders (RDC/TMD) (48.9%). The most reported experimental interventions were manual therapy (40.4%), exercise (30.2%) and electrotherapy modalities (27.2%), and the most common outcome measure domains were pain (83.8%), range of movement (61.8%), disability (45.6%) and mechanosensitivity (29.4%). There was poor content reporting of experimental interventions. CONCLUSIONS: Current literature of clinical trials of physical therapy interventions for TMD has moderate to high risk of bias, poor content reporting, small sample size and short-term follow-ups which limit internal and external validity, as well as applicability into clinical practice.

Enhancing orthopaedic surgery research: developing manuscripts using systematic checklists.

BACKGROUND AND CHALLENGES: Writing and publishing research is important in the fields of orthopaedic surgery, and medicine in general. In recent years, the number of orthopaedic publications has significantly increased, highlighting the value of possessing the ability to write and publish a paper. However, publishing research is not an easy task, especially if English is not a native language. Non-native English speakers have been reported to experience barriers to writing and publishing research in English, the dominant language of scientific publication. This affects not only individual researchers, but also the scientific community in general. To improve reporting in scientific manuscripts, many peer-reviewed guidelines have been published for a variety of study designs and study types. These guidelines are made available through the EQUATOR (Enhancing the QUAlity and Transparency Of health Research) Network and have associated checklists that guide authors in the synthesis of their research manuscript. PURPOSE: Whether you are a non-native English speaker or a novice research writer, these checklists can ameliorate the process of building your manuscript. The purpose of this paper is to empower orthopaedic researchers, and researchers in general, through an easy-to-follow framework for writing a research manuscript using available checklists and general research knowledge.

Methodological and reporting quality of systematic reviews on aesthetics and reconstructive breast surgery: A meta-research.

OBJECTIVE: To evaluate the methodological and reporting quality of systematic reviews (SR) of randomized controlled trials on esthetics and reconstructive breast surgery. METHODS: Meta-research study with a broad search strategy was developed to retrieve all relevant systematic reviews. We evaluated the methodological and reporting guidance adopted by these reviews and assessed their adequacy to items from AMSTAR-2 (methodological quality) and PRISMA 2020 (reporting quality). The protocol of this study was prospectively published in: https://osf.io/preprints/osf/ucpgd. RESULTS: After the selection process, 15 SR were included; eight (60%) referred the use of a methodological guide and five (33.3%) invertedly referred PRISMA as the methodological guide. Reporting guidelines were referred by none of the included systematic review. The median adequacy to PRISMA-2020 items was 42.9% (Q1 - 38.1%/Q3 - 95.2%) and to AMSTAR-2 items was 33.3% (Q1 - 23.3%/Q3 - 93.3%) which reflects overall low reporting and methodological quality of included SR. The overall confidence in the results using AMSTAR-2 framework was critically low in 73.3% of included SR. Although a small number of SR were included, a high correlation between the methodological and reporting quality was observed (Spearmean rho = 0.96, 95% bias-corrected confidence interval = 0.84 to 0.99). CONCLUSION: Methodological and reposting quality of SR of randomized clinical trials on esthetic or reconstructive breast surgery is poor. Half of the authors referred to the use of valid guidance to plan and conduct their reviews and none of them referred the use of a guidance for reporting their results.

Diagnostic screening of private well water using gas chromatography with high resolution mass spectrometry to support well water management.

In the US, private well users are responsible for their own water quality testing, but local health officials are often uncertain what tests to recommend, particularly for regulated organic chemical contaminants. This study evaluated the utility of suspect and non-target screening (NTS) high resolution mass spectrometry (HRMS) as a tool to identify a wide range of organic chemicals of emerging concern in private well water and to inform well water management decisions. Qualitative NTS, which detects chemicals without providing concentrations, was used to analyze 25 private well water samples from Wake County, North Carolina. Using the NIST 20 mass spectral database (M1), NTS tentatively identified 106 unique organic chemicals across the 25 samples and an average of 11 organic chemicals per sample. At least one USEPA ToxCast chemical was identified in each private well water sample. Private well water users were interviewed prior to and after their sample's NTS results were reported back; four county groundwater managers were interviewed after aggregated results for all 25 water samples were reported back. All but one well user participant chose to participate in the reporting-back post-interview. The 24 private well users found NTS results useful and valued the contextualization of their results using NTS results for other well users and a local municipal water sample. Most private well users (67%) were surprised by their well water results, especially regarding the number of tentatively identified organic chemicals detected. All the groundwater managers believed the NTS results were useful and could help improve their testing recommendations to private well users. Even with qualitative limitations, NTS results can be an effective and valuable tool to inform the public and governance stakeholders in decisions around groundwater quality management.

Post-marketing drug safety surveillance of enfortumab vedotin: an observational pharmacovigilance study based on a real-world database.

Background: Enfortumab vedotin (EV) is an antibody-drug conjugate (ADC) that has been approved by the FDA for patients with locally advanced or metastatic urothelial carcinoma (UC). This study presents a comprehensive pharmacovigilance analysis of the post-marketing safety profile of EV in the real-world based on the US Food and Drug Administration Adverse Event Reporting System (FAERS). Methods: Adverse event (AE) reports regarding EV between January 2020 and December 2023 were obtained from the FAERS database. The standardized MedDRA query (SMQ) narrow search AEs on the preferred term (PT) level were used. Disproportionality analysis was performed to identify the AE signals for EV with the reporting odds ratio (ROR), proportional reporting ratio (PRR), multi-item gamma Poisson shrinker (MGPS), and Bayesian confidence propagation neural network (BCPNN). Results: A total of 2,216 reports regarding EV were included in the present study. SMQ analysis results indicated that a stronger strength signal was found in severe cutaneous adverse reactions, retroperitoneal fibrosis, and peripheral neuropathy. A total of 116 significant disproportionality PTs referring to 14 system organ classes (SOCs) were retained by disproportionality analysis, with 49 PTs not listed on the EV drug label. Frequently reported EV-related AEs included rash, peripheral neuropathy, decreased appetite, alopecia, and pruritus. The time to onset of the majority of EV-related AEs was within 30 days (66.05%), with only 0.73% events occurring after 1 year. Conclusion: The disproportionality analysis highlights that dermatologic toxicity and peripheral neuropathy were the major AEs induced by EV. The potential AEs not listed on the drug label were mainly related to gastrointestinal, hepatic, and pulmonary events. Further research is needed to confirm and explore the EV-related AEs in clinical practice.

Stratified analysis of the association between anti-obesity medications and digestive adverse events: a real-world study based on the FDA adverse event reporting system database.

BACKGROUND: Numerous digestive system adverse events (dsAEs) have been observed during the use of anti-obesity medications (AOMs), leading to concerns about the safety of these medications. However, most current studies are limited to the association of one class of drugs with specific digestive disorders, and there is no cascading analysis of AOMs in the digestive system. This study aims to use data from the United States Food and Drug Administration Adverse Event Reporting System (FAERS) for a stratified analysis of the reported associations between AOMs and dsAEs. METHODS: We analyzed adverse event reports submitted to FAERS between January 2015 and December 2023 related to obesity treatment. It is important to note that FAERS data cannot establish causality or incidence rates. Pharmacovigilance (PV) signals were detected by disproportionate analyses through proportionate reporting ratio (PRR), reporting odds ratios (ROR), and information components (IC) to detect dsAEs associated with AOMs. Reporting rates, severity, and response outcomes of digestive adverse events were compared across AOMs by multivariate logistic regression analysis. RESULTS: Among 34,396 adverse events (AEs) related to obesity treatment, 8844 dsAEs were analyzed. Comparing with semaglutide and liraglutide, tirzepatide exhibited fewer reported dsAEs while semaglutide and liraglutide showed a high correlation with non-lethal pancreatitis reports. Bupropion-naltrexone (31.65%) reported the highest number of dsAEs, and a PV signal was detected in mouth and lips AEs (ROR = 2.97, 95% CI: 2.42-3.6). Orlistat (ROR = 3.30, 95% CI: 3.08-3.55) exhibited the highest association with gastrointestinal AEs compared to other AOMs. PV signal for hepatobiliary AEs (ROR = 6.13, 95% CI: 3.45-10.88) with phentermine-topiramate still needs further clarification. CONCLUSIONS: Tirzepatide may be considered for patients with a history of digestive system disease or an elevated risk of pancreatitis based on the pattern of reported dsAEs. Caution is needed for the orofacial AEs when using bupropion-naltrexone. Orlistat has a higher reporting rate of gastrointestinal AEs, but these events are typically less severe. Phentermine-topiramate's association with liver impairment requires further clinical investigation. This article provides insights into the reported associations between AOMs and dsAEs, which may aid clinicians in making more informed decisions about individualizing medication and managing potential adverse events.

Discrepancies between Coronary Artery Calcium Score and Coronary Artery Disease Severity in Computed Tomography Angiography Studies.

The aim of this paper is to demonstrate the difference in usefulness of the coronary artery calcium score (CACS) and the full assessment of the severity of coronary artery disease in coronary computed tomography angiography (CCTA) studies. The difference between the population risk of coronary artery disease (CAD) assessed by the CACS and the severity of CAD was demonstrated in images from two CCTA studies. The first image is from a patient with a CACS of 0 and significant coronary artery stenosis. In the native phase of CCTA examination, no calcified changes were detected in the topography of the coronary arteries. In the middle section of the left descending artery (LAD), at the level of the second diagonal branch (Dg2), a large non-calcified atherosclerotic plaque was visible. Mid-LAD stenosis was estimated to be approximately 70%. The second image features a patient with a high CACS but no significant coronary artery stenosis. The calcium score of individual coronary arteries calculated using the Agatston method was as follows: left main (LM) 0, LAD 403, left circumflex (LCx) 207.7, right coronary artery (RCA) 12. CACS was 622.7, representing a significant population risk of significant CAD. In the proximal and middle sections of the LAD, numerous calcified and mixed atherosclerotic plaques with positive remodeling were visible, causing stenosis of 25-50%. Similarly, in the proximal and middle sections of the LCx, numerous calcified and mixed atherosclerotic plaques with positive remodeling were visualized, causing stenoses of 25-50%. Calcified atherosclerotic plaques were found in the RCA, causing stenosis <25%. The entire CCTA image met CAD-RADS 2 (coronary artery disease reporting and data system) criteria. In summary, CACS may be applicable in population-based studies to assess the risk of significant CAD. In the evaluation of individual patients, a comprehensive assessment of CAD severity based on the angiographic phase of the CCTA examination should be used.

Impact of Structured Reporting of Lower Extremity CT Angiography on Report Quality and Workflow Efficiency.

We assessed the effects of structured reporting (SR) of lower extremity CT angiography (CTA) on report quality and workflow efficiency compared with conventional reports (CR). Surveys were conducted at an academic radiology department before and after the introduction of an SR template. Participants (n = 39, 21) rated report quality and report creation effort (1: very dissatisfied/low to 10: very satisfied/high) and whether SR represents an improvement over CR (1: completely disagree to 5: completely agree). Four residents and two supervising radiologists created both CR and SR of 40 CTA examinations. Report creation time was measured and the factual accuracy of residents' reports was judged. Report completeness (median 8.0 vs. 7.0, p = 0.016) and clinical usefulness (7.0 vs. 4.0, p = 0.029) were rated higher for SR. Supervising radiologists found report clarity improved by SR (8.0 vs. 4.5, p = 0.029). Report creation effort was unchanged (7.0 vs. 6.0, p > 0.05). SR was considered an improvement over CR (median 4.0, IQR,3.0-5.0). Report supervision was shortened by SR (6.2 ± 2.0 min vs. 10.6 ± 3.5 min, p < 0.001) but total time for report creation remained unchanged (36.6 ± 12.8 min vs. 36.4 ± 11.0 min, p > 0.05). Factual accuracy of residents' SR was deemed higher (8.0/9.5 vs. 7.0/7.0, p = 0.006/ < 0.001). In conclusion, SR has the potential to improve report quality and workflow efficiency for lower extremity CTA.

MRI T2w Radiomics-Based Machine Learning Models in Imaging Simulated Biopsy Add Diagnostic Value to PI-RADS in Predicting Prostate Cancer: A Retrospective Diagnostic Study.

BACKGROUND: Currently, prostate cancer (PCa) prebiopsy medical image diagnosis mainly relies on mpMRI and PI-RADS scores. However, PI-RADS has its limitations, such as inter- and intra-radiologist variability and the potential for imperceptible features. The primary objective of this study is to evaluate the effectiveness of a machine learning model based on radiomics analysis of MRI T2-weighted (T2w) images for predicting PCa in prebiopsy cases. METHOD: A retrospective analysis was conducted using 820 lesions (363 cases, 457 controls) from The Cancer Imaging Archive (TCIA) Database for model development and validation. An additional 83 lesions (30 cases, 53 controls) from Hong Kong Queen Mary Hospital were used for independent external validation. The MRI T2w images were preprocessed, and radiomic features were extracted. Feature selection was performed using Cross Validation Least Angle Regression (CV-LARS). Using three different machine learning algorithms, a total of 18 prediction models and 3 shape control models were developed. The performance of the models, including the area under the curve (AUC) and diagnostic values such as sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV), were compared to the PI-RADS scoring system for both internal and external validation. RESULTS: All the models showed significant differences compared to the shape control model (all p < 0.001, except SVM model PI-RADS+2 Features p = 0.004, SVM model PI-RADS+3 Features p = 0.002). In internal validation, the best model, based on the LR algorithm, incorporated 3 radiomic features (AUC = 0.838, sensitivity = 76.85%, specificity = 77.36%). In external validation, the LR (3 features) model outperformed PI-RADS in predictive value with AUC 0.870 vs. 0.658, sensitivity 56.67% vs. 46.67%, specificity 92.45% vs. 84.91%, PPV 80.95% vs. 63.64%, and NPV 79.03% vs. 73.77%. CONCLUSIONS: The machine learning model based on radiomics analysis of MRI T2w images, along with simulated biopsy, provides additional diagnostic value to the PI-RADS scoring system in predicting PCa.

Evaluating information management system in epidemic infectious diseases in Iran.

Health information management is a vital and constructive component of the health system, refers to the process of producing and collecting, organising and storing, analysing, disseminating and using information. The aim of this study was to evaluate the strengths and weaknesses of the information management system in epidemic infectious diseases in Iran, specifically focusing on the registration, reporting, quality, confidentiality, and security of infectious disease data. This assessment was conducted from the perspective of policymakers and experts responsible for data registration and reporting. After examining the processes of registering and reporting infectious disease data and interviewing experts, a researcher-designed questionnaire was prepared to evaluate the infectious disease information management system. To assess the content validity of the Content Validity Index and Content Validity Ratio Index, a questionnaire was utilized. The reliability of the questionnaire was confirmed using Cronbach's alpha. By employing purposeful sampling and adhering to the inclusion criteria, 150 participants were included in the study. Questionnaires were distributed via email, WhatsApp, or Telegram to employees at various levels of Iran's health and treatment systems who were responsible for registering and reporting infectious disease data. The study encompassed 100 participants who successfully concluded the research. The results highlight that the key strength of healthcare data registration lies in its ability to "depict the epidemic curve during outbreaks of infectious diseases." Conversely, a notable weakness was the "insufficient collaboration from non-academic sectors (e.g., clinics, private laboratories) in registering and reporting infectious diseases. The present study's findings suggest that the issue lies not in the framework itself, but rather in the execution and functionality of the strategies. We can cultivate a repository of reliable and beneficial data by incorporating initiatives like training programs, enforcing regulations with consequences for inadequate data documentation, offering both material and motivational rewards, and streamlining all data collection and reporting systems.

Use of Web-Based Surveys to Collect Long-Term Pediatric Outcomes in Patients With Twin-Twin Transfusion Syndrome Treated With Fetoscopic Laser Photocoagulation: Observational Study.

Background: In the United States, patients with monochorionic diamniotic twins who undergo in utero fetoscopic laser photocoagulation (FLP) for twin-twin transfusion syndrome (TTTS) may travel great distances for care. After delivery, many parents cannot return to study sites for formal pediatric evaluation due to geographic location and cost. Objective: The aim of this study was to collect long-term pediatric outcomes in patients who underwent FLP for TTTS. Methods: We assessed the feasibility of using a web-based survey designed in REDCap (Research Electronic Data Capture; Vanderbilt University) to collect parent-reported outcomes in children treated for TTTS at a single center during 2011-2019. Patients with ≥1 neonatal survivor were invited via email to complete 5 possible questionnaires: the child status questionnaire (CSQ); fetal center questionnaire (FCQ); Ages & Stages Questionnaires, Third Edition (ASQ-3); Modified Checklist for Autism in Toddlers, Revised With Follow-Up (M-CHAT-R/F); and thank you questionnaire (TYQ). The R programming language (R Foundation for Statistical Computing) was used to automate survey distribution, scoring, and creation of customized reports. The survey was performed in 2019 and repeated after 12 months in the same study population in 2020. Results: A total of 389 patients in 26 different states and 2 international locations had an email address on file and received an invitation in 2019 to complete the survey (median pediatric age 48.9, IQR 1.0-93.6 months). Among surveyed mothers in 2019, the overall response rate was 37.3% (145/389), and the questionnaire completion rate was 98% (145/148), 87.8% (130/148), 71.1% (81/100), 86.4% (19/22), and 74.3% (110/148) for the CSQ, FCQ, ASQ-3, M-CHAT-R/F, and TYQ, respectively. In 2020, the overall response rate was 57.8% (56/97), and the questionnaire completion rate was 96.4% (54/56), 91.1% (51/56), 86.1% (31/36), 91.7% (11/12), and 80.4% (45/56) for the CSQ, FCQ, ASQ-3, M-CHAT-R/F, and TYQ, respectively. Conclusions: This is the first study to use both REDCap and computer automation to aid in the dissemination, collection, and reporting of surveys to collect long-term pediatric outcomes in the field of fetal medicine.

A national analysis of systemic adverse events of beta-blockers used for glaucoma therapy.

PURPOSE: To evaluate systemic complications for timolol, carteolol, levobunolol, and/or betaxalol by using an FDA Federal Adverse Event Reporting System (FAERS). METHODS: We evaluated FAERS for adverse events associated with ß-blocker use for glaucoma. All reported symptoms were reviewed to identify systemic adverse events and to detect safety signals, defined as information on a new or known side effect that may be caused by a medicine. We used the proportional reporting ratio (PRR), reporting odds ratio (ROR), empirical Bayes geometric mean (EBGM), and information component (IC) as a part of a disproportionality analysis comparing the frequency of ß-blocker symptoms with all other adverse event reports. We considered a signal to be detected when all four disproportionality analysis metrics were positive. RESULTS: We found 10,500,309 total adverse event reports from the FAERS database 2004-2022Q3, which included 8,793 case reports with a primary suspect of a ß-blocker use for glaucoma. 1,838 unique adverse symptoms were reported were associated with ß-blocker. Regarding outcomes, there were 165 (1.88%) reports of disability, 671 (7.63%) reports of hospitalisation, and 1,934 (21.99%) reports of some other unspecified complication. Regarding adverse events, the most reported general, cardiac, and respiratory symptoms were respectively dizziness (n = 281), bradycardia (n = 145), and dyspnoea (n = 195). 256 (2.91%) cases of death were reported. We found significant signals on bradycardia (n = 145), complete atrioventricular block (n = 38), and bronchospasm (n = 23). No allergic, endocrine, constitutional, or gastrointestinal symptoms generated positive signals. CONCLUSION: ß-blocker use in glaucoma therapy can be rarely associated with serious systemic and life-threatening complications.

Perceptions on Medication Administration Errors (MAEs) among nurses at a tertiary government hospital.

AIM: To identify the nurses' perceptions on the occurrence of Medication Administration Errors (MAEs) and barriers to reporting using the MAE Reporting Survey. BACKGROUND: MAEs is a serious public health threat that causes patient injury, death, and results to expensive health care. METHODS: Descriptive statistical analysis. RESULTS: The most frequent reasons for MAEs according to the nurses were physicians' medication orders are not legible (4.67 ± 1.21) and unit staffing levels are inadequate (4.63 ± 1.45). The most frequent reason for unreported MAEs were when med errors occur, nursing administration focuses on the individual rather than looking at the systems as a potential cause of the error (4.95 ± 4.33) and nurses could be blamed if something happens to the patient as a result of the medication error (4.29 ± 1.48). The highest prevalent non-IV related MAEs included wrong time of administration (M = 3.02 ± 2.37) and medication administered after the order to discontinue has been written (M = 2.60 ± 2.11), both with 0-20 % of reported non-IV MAEs. The highest prevalent IV related MAEs included wrong time of administration (M = 2.76 ± 2.29) and medication administered after the order to discontinue has been written (M = 2.45 ± 2.01). More than half (n = 95, % = 54.29) of the respondents stated that 0-20 % of all types of medication errors, including IV and non-IV medication errors are reported. CONCLUSIONS: The findings supported the notion that nurses perceive low percentages of MAEs reporting.

Association of Clopidogrel with Interstitial Lung Disease: Gaining Insight Through the Japanese Pharmacovigilance Database.

Background: The P2Y12 receptor inhibitors clopidogrel and prasugrel are widely used. Clopidogrel and prasugrel have different metabolic pathways, but whether their adverse event (AE) profiles differ significantly is unclear. Objective: This study aimed to compare the possible AEs induced by clopidogrel and prasugrel and to assess the rank-order of their AEs submitted to a spontaneous reporting database. Materials and Methods: Data were extracted from the Japanese Adverse Drug Event Report database (JADER). Reports of AEs associated with clopidogrel and prasugrel were analyzed to calculate the reporting odds ratios (RORs) and 95% confidence intervals (CIs). Results: Based on 5869 reports for clopidogrel (69.6%, men) and 513 reports for prasugrel (74.1%, men), 703 and 135 different AEs were identified, respectively. Bleeding complications including hemorrhage were commonly reported for both clopidogrel and prasugrel. As for AEs related to clopidogrel, unexpected AEs such as interstitial lung disease (227 reports; ROR, 1.77; 95% CI, 1.49-2.10), abnormal hepatic function (137 reports; ROR, 1.27; 95% CI, 1.07-1.51), and hepatocellular injury (96 reports; ROR, 120.0; 95% CI, 94.9-151.8) ranked at relatively high positions based on the number of occurrences, unlike prasugrel. Conclusion: This analysis of the national pharmacovigilance database highlights distinct AE profiles for clopidogrel and prasugrel. Unexpected AEs associated with clopidogrel were identified, providing valuable insights for clinical monitoring and patient safety.