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.

Case Report: Radiopharmaceutical extravasation, radiation paranoia, and chilling effect.

The Society of Nuclear Medicine and Molecular Imaging (SNMMI) has publicly commented that they do not support the reporting of large extravasations to patients or regulatory bodies. The comment cites recently published articles suggesting that extravasations are infrequent and not severe. The comment stresses the importance of ensuring patients are not apprehensive or resistant to nuclear medicine procedures because of "radiation paranoia" and a "chilling effect" that can result from misinformation. Radiation paranoia and chilling effect are not defined, and there are no references to specific misinformation. Our experiences and this case suggest the comment may be incongruent with real-world clinical experiences. Our severe case, at a center with a long-standing focus on reducing radiopharmaceutical extravasation, suggests these events can still happen, can be significant, and should be shared with our patients. Our experiences also suggest that being transparent with patients builds trust. We are concerned that a reluctance to recognize the true frequency of extravasations and their severity may create distrust in the relationship between the nuclear medicine community and patients.

Water-soluble AIE photosensitizer in short-wave infrared region for albumin-enhanced and self-reporting phototheranostics.

Organic photosensitizers (PSs) play important roles in phototheranostics, and contribute to the fast development of precision medicine. However, water-soluble and highly emissive organic PSs, especially those emitting in the short-wave infrared region (SWIR), are still challenging. Also, it's difficult to prepare self-reporting PSs for visualizing the treatment via stimulated emission depletion (STED) nanoscopy. Thus, in this work, a water-soluble molecule of DTPAP-TBZ-I with aggregation-induced emission features is designed for the self-reporting photodynamic therapy (PDT) in an ultra-high resolution. In contrast to single molecule, its complex (DTPAP-TBZ-I@BSA) shows much enhanced fluorescence properties and reactive oxygen species (ROS) generation in SWIR window. Their photoluminescence quantum yield is determined to be ∼20.6 % and the enhancement of ROS generation is ∼18-fold. During the PDT, immigration of the complex from cytoplasm to nucleus is also observed via STED nanoscopy with a resolution of 66.11 nm, which allows self-report in the PDT treatment. DTPAP-TBZ-I@BSA is finally utilized for the imaging-guided PDT in vivo with a tumor inhibition rate of 84 %. This is the first work in albumin-enhanced water-soluble organic PSs in SWIR window for self-reporting phototheranostics at ultra-high resolutions, providing an ideal solution for the next generation of photosensitizers for precise medicine.

Pancreatitis Associated With Teduglutide: A Disproportionality Analysis via the Food and Drug Administration Adverse Event Reporting System (FAERS) Database.

Introduction Teduglutide is a glucagon-like peptide-2 analog that is indicated for the treatment of short bowel syndrome (SBS) by reducing patient dependence on parenteral support. Due to the rarity of SBS as well as the recent timeline of the adoption of teduglutide, the safety of teduglutide is relatively poorly understood. Several recent clinical case reports have highlighted elevated pancreatic enzymes and pancreatitis as a concerning complication of teduglutide. This prompts a systematic study of the association between pancreatitis and teduglutide. Methods This study conducts a case-control design disproportionality analysis by using data from the US Food and Drug Administration Adverse Event Reporting System (FAERS). Reports from the first quarter of 2020 through the first quarter of 2024 were retrieved from this database, and a disproportionality analysis was conducted. The analysis consisted of traditional methods of analyzing adverse drug events such as the reporting odds ratio (ROR) and proportional reporting ratio (PRR), as well as Bayesian methods such as the empirical Bayes geometric mean (EBGM) and information component (IC). A confidence interval for ROR and PRR that excludes a ratio of 1 or a confidence interval for IC that excludes a score of 0 was used as the criterion for a statistically significant association between pancreatitis risk and teduglutide use. Results Out of 11,696 reports of teduglutide adverse effects in over four years of adverse effects data drawn from the FAERS database, 79 cases of pancreatitis were identified. The disproportionality analysis revealed an ROR of 3.73 (95% CI (2.99, 4.66)), a PRR of 3.71 (95% CI (2.97, 4.63)), an EBGM of 3.70, and an IC of 1.84 (95% CI (1.51, 2.16)). All of these statistics indicate a statistically significant association between pancreatitis risk and teduglutide use. Conclusion The results reveal a statistically significant association between pancreatitis risk and teduglutide use. Our findings highlight the necessity for the careful monitoring of pancreatitis in patients undergoing teduglutide therapy going forward.

Accuracy of an artificial intelligence-enabled diagnostic assistance device in recognizing normal chest radiographs: a service evaluation.

Objectives: Artificial intelligence (AI) enabled devices may be able to optimize radiologists' productivity by identifying normal and abnormal chest X-rays (CXRs) for triaging. In this service evaluation, we investigated the accuracy of one such AI device (qXR). Methods: A randomly sampled subset of general practice and outpatient-referred frontal CXRs from a National Health Service Trust was collected retrospectively from examinations conducted during November 2022 to January 2023. Ground truth was established by consensus between 2 radiologists. The main objective was to estimate negative predictive value (NPV) of AI. Results: A total of 522 CXRs (458 [87.74%] normal CXRs) from 522 patients (median age, 64 years [IQR, 49-77]; 305 [58.43%] female) were analysed. AI predicted 348 CXRs as normal, of which 346 were truly normal (NPV: 99.43% [95% CI, 97.94-99.93]). The sensitivity, specificity, positive predictive value, and area under the ROC curve of AI were found to be 96.88% (95% CI, 89.16-99.62), 75.55% (95% CI, 71.34-79.42), 35.63% (95% CI, 28.53-43.23), and 91.92% (95% CI, 89.38-94.45), respectively. A sensitivity analysis was conducted to estimate NPV by varying assumptions of the prevalence of normal CXRs. The NPV ranged from 88.96% to 99.54% as prevalence increased. Conclusions: The AI device recognized normal CXRs with high NPV and has the potential to increase radiologists' productivity. Advances in knowledge: There is a need for more evidence on the utility of AI-enabled devices in identifying normal CXRs. This work adds to such limited evidence and enables researchers to plan studies to further evaluate the impact of such devices.

Inclusion, reporting and analysis of demographic variables in chronobiology and sleep research.

Many aspects of sleep and circadian physiology are sensitive to participant-level characteristics. While recent research robustly highlights the importance of considering participant-level demographic information, the extent to which this information is consistently collected, and reported in the literature, remains unclear. This article investigates study sample characteristics within the published sleep and chronobiology research over the past 40 years. 6,777 articles were identified and a random sample of 20% was included. The reporting of sample size, age, sex, gender, ethnicity, level of education, socio-economic status, and profession of the study population was scored, and any reported aggregate summary statistics for these variables were recorded. We observed a significant upward trend in the reporting and analysis of demographic variables in sleep and chronobiology research. However, we found that while > 90% of studies reported age or sex, all other variables were reported in < 25% of cases. Reporting quality was highly variable, indicating an opportunity to standardize reporting guidelines for participant-level characteristics to facilitate Meta analyses.

"Under"-reporting of complications following AF ablation: Comparison of the Manufacturer and User Facility Device Experience FDA database and a voluntary invitation-based registry - the POTTER-AF 3 Study.

BACKGROUND: The Manufacturer and User Facility Device Experience (MAUDE) database houses medical device reports of adverse events involving medical devices marketed in the United States submitted to the U.S. Food and Drug Administration (FDA) by mandatory and voluntary reporters. The MAUDE database is frequently used in clinical studies to report on device-related complications. Data about its efficacy are scarce. OBJECTIVE: To compare the mandatory MAUDE database (MAUDE group) with the invitation-based POTTER-AF Study (POTTER-AF 1 group) regarding data quality, procedural characteristics, diagnosis, treatment, and survival. METHODS: The reports of esophageal fistula esophageal fistula following atrial fibrillation (AF) ablation in the MAUDE database were compared to those in the POTTER-AF Study between 01/08/2009 and 31/08/2019. RESULTS: Esophageal fistula was reported in 47 patients in the MAUDE group and in 81 in the POTTER-AF 1 group. Procedures were performed with radiofrequency, cryoenergy or laser energy in 66.0%, 31.9% and 2.1% (MAUDE group) and in 96.3%, 2.5% and 1.2% (POTTER-AF 1 group). The median time to symptoms was 21 (14, 32.5) days (MAUDE group) and 18.0 (6.8, 22.3) days (POTTER-AF 1 group; p=0.031). The diagnostic method was reported in 38.3% of patients in the MAUDE group and in 98.8% in the POTTER-AF 1 group, the treatment in 57.4% and 100% and the outcome in all patients. In the MAUDE group, treatment was surgical (51.9%), endoscopic (37.0%), combined (3.7%) or conservative (7.4%), compared to 43.2%, 19.8%, 7.4% and 29.6% in the POTTER-AF 1 group. Overall mortality was 76.6% in the MAUDE group and 61.7% in the POTTER-AF 1 group (p=0.118). CONCLUSION: In the mandatory MAUDE database, less esophageal fistula cases were reported as compared to an invitation-based study. The data quality in the MAUDE database was significantly poorer.

Large Language Models for Simplified Interventional Radiology Reports: A Comparative Analysis.

PURPOSE: To quantitatively and qualitatively evaluate and compare the performance of leading large language models (LLMs), including proprietary models (GPT-4, GPT-3.5 Turbo, Claude-3-Opus, and Gemini Ultra) and open-source models (Mistral-7b and Mistral-8×7b), in simplifying 109 interventional radiology reports. METHODS: Qualitative performance was assessed using a five-point Likert scale for accuracy, completeness, clarity, clinical relevance, naturalness, and error rates, including trust-breaking and post-therapy misconduct errors. Quantitative readability was assessed using Flesch Reading Ease (FRE), Flesch-Kincaid Grade Level (FKGL), SMOG Index, and Dale-Chall Readability Score (DCRS). Paired t-tests and Bonferroni-corrected p-values were used for statistical analysis. RESULTS: Qualitative evaluation showed no significant differences between GPT-4 and Claude-3-Opus for any metrics evaluated (all Bonferroni-corrected p-values: p = 1), while they outperformed other assessed models across five qualitative metrics (p < 0.001). GPT-4 had the fewest content and trust-breaking errors, with Claude-3-Opus second. However, all models exhibited some level of trust-breaking and post-therapy misconduct errors, with GPT-4-Turbo and GPT-3.5-Turbo with few-shot prompting showing the lowest error rates, and Mistral-7B and Mistral-8×7B showing the highest. Quantitatively, GPT-4 surpassed Claude-3-Opus in all readability metrics (all p < 0.001), with a median FRE score of 69.01 (IQR: 64.88-73.14) versus 59.74 (IQR: 55.47-64.01) for Claude-3-Opus. GPT-4 also outperformed GPT-3.5-Turbo and Gemini Ultra (both p < 0.001). Inter-rater reliability was strong (κ = 0.77-0.84). CONCLUSIONS: GPT-4 and Claude-3-Opus demonstrated superior performance in generating simplified IR reports, but the presence of errors across all models, including trust-breaking errors, highlights the need for further refinement and validation before clinical implementation. CLINICAL RELEVANCE/APPLICATIONS: With the increasing complexity of interventional radiology (IR) procedures and the growing availability of electronic health records, simplifying IR reports is critical to improving patient understanding and clinical decision-making. This study provides insights into the performance of various LLMs in rewriting IR reports, which can help in selecting the most suitable model for clinical patient-centered applications.

Enhanced Rock Weathering for Carbon Removal-Monitoring and Mitigating Potential Environmental Impacts on Agricultural Land.

Terrestrial enhanced rock weathering (ERW) is the application of pulverized silicate rock to soils for the purposes of carbon removal and improved soil health. Although a geochemical modeling framework for ERW in soils is emerging, there is a scarcity of experimental and field trial data exploring potential environmental impacts, risks, and monitoring strategies associated with this practice. This paper identifies potential negative consequences and positive cobenefits of ERW scale-up and suggests mitigation and monitoring strategies. To do so, we examined literature on not only ERW but also industry, agriculture, ecosystem science, water chemistry, and human health. From this work, we develop recommendations for future research, infrastructure, and policy needs. We also recommend target metrics, risk mitigation strategies, and best practices for monitoring that will permit early detection and prevention of negative environmental impacts.

Exploring transparent reporting and data availability in systematic reviews to identify subgroup evidence: imaging for suspected hepatocellular carcinoma in the non-cirrhotic liver.

We aim to illustrate the role of complete and transparent reporting coupled with access to data sourced from published systematic reviews, especially assisting in the identification of evidence for subgroups within the context of a rare disease. To accomplish this principle, we provide a real-world example encountered during the revision of the Dutch clinical practice guideline for hepatocellular carcinoma. Specifically, we retrieved insights from two Cochrane reviews to identify direct evidence concerning the diagnostic test accuracy of computed tomography and magnetic resonance imaging for detecting hepatocellular carcinomas in suspected patients without liver cirrhosis. Through reusing the Cochrane review authors' efforts already undertaken in their exhaustive literature search and selection, we successfully identified relevant direct evidence for this subgroup of suspected patients without cirrhosis and performed an evidence synthesis within the constraints of limited resources for the guideline revision. This approach holds the potential for replication in other subgroups in the context of rare diseases, contingent on the transparent and complete reporting of systematic reviews, as well as the availability and accessibility of their extracted data. Consequently, we underscore the importance of adhering to established reporting guidelines for systematic reviews, while simultaneously advocating for increased availability and accessibility to data. Such practices would not only increase the transparency and reproducibility of systematic reviews but could also increase reusability of their data. In turn, the increased reusability could result in reduced resource utilization in other sectors such as the guideline developing community as we show in our example.

[Gender-sensitive health indicators for health reporting at the Robert Koch Institute (GBE-GI)-a pilot project as part of the Joint Action PreventNCD project]. / Geschlechtersensible Gesundheitsindikatoren für die Gesundheitsberichterstattung am Robert Koch-Institut (GBE-GI) ­ Ein Pilotprojekt im Rahmen der "Joint Action PreventNCD".

Health reporting (GBE) based on gender-sensitive indicators can provide information on gender inequalities, improve health promotion and healthcare, promote gender mainstreaming, and provide relevant information for gender equality measures. To date, there is no set of gender-sensitive health indicators for Federal Health Reporting at the Robert Koch Institute. As part of the Joint Action Prevent Non-Communicable Diseases, gender-sensitive health indicators are to be identified, evaluated, and integrated into the Robert Koch Institute's health reporting website in a pilot project. This is done in three work packages. In a scoping review, the available evidence on gender-sensitive health indicators and theoretical explanations for gender inequality in EU and OECD member states since 2014 will initially be assessed (work package 1). Building on this, identified indicators and explanatory approaches will be collated for evaluation and selection in a structured consensus process as part of a three-stage Delphi approach consisting of a focus group discussion and an online survey (work package 2). The evaluated indicator set will then be integrated into the Robert Koch Institute's health reporting website (work package 3). The results will be disseminated via scientific publications and conference presentations. An English full-text version of this article is available at SpingerLink as Supplementary Information.

Reimagining the ADR Alert Card: a novel approach to recurrence prevention in low-cost settings for adverse drug reactions.

OBJECTIVES: Adverse drug reactions (ADRs) are among the leading standalone causes of morbidity and hospitalisation and contribute substantially to an increase in healthcare expenditure. Repeat ADR events, although difficult to quantify, are a recognised problem that lead to preventable suffering for the patient. The current approaches for the prevention of ADR recurrence in low/middle-income countries range from inefficient to non-existent. There is very little literature that focuses on the preventability of ADRs in such settings. This study aimed to develop the ADR Alert Card, an economical innovation designed as a stop gap in preventing ADR recurrence, and to evaluate its utility by validating the system through input from medical professionals. METHODS: The ADR Alert Card was validated and registered with the Copyrights Office of the Government of India. To obtain the opinion of healthcare professionals and gauge the status quo in prevention of ADR recurrence, we conducted an online descriptive cross-sectional study over a period of 6 months. RESULTS: The survey received 218 responses. Demographics varied, ranging across different healthcare specialties and years of experience. Our study found that existing practice in ADR recurrence prevention was inadequate, and most healthcare workers were unaware of an alternative approach. Unique solutions were provided by the respondents, with the majority favouring a card format for preventing recurrence. CONCLUSIONS: After being introduced to the ADR Alert Card, there was an overwhelming consensus on the utility and practicality of this card in preventing ADR recurrence.

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.

Contrast-enhanced magnetic resonance neurography for diagnosing brachial plexopathy: improved visualization and additional imaging features.

Contrast-enhanced magnetic resonance neurography (CE-MRN) holds promise for diagnosing brachial plexopathy by enhancing nerve visualization and revealing additional imaging features in various lesions. This study aims to validate CE-MRN's efficacy in improving brachial plexus (BP) imaging across different patient cohorts. Seventy-one subjects, including 19 volunteers and 52 patients with BP compression/entrapment, injury, and neoplasms, underwent both CE-MRN and plain MRN. Two radiologists assessed nerve visibility, with inter-reader agreement evaluated. Quantitative parameters such as signal intensity (SI), contrast-to-noise ratio (CNR), and contrast ratio (CR) of the C7 nerve were measured. Both qualitative scoring and quantitative metrics were compared between CE-MRN and plain MRN within each patient group. Patient classification followed the Neuropathy Score Reporting and Data System (NS-RADS), summarizing additional imaging features for each brachial plexopathy type. Inter-reader agreement for qualitative assessment was strong. CE-MRN significantly enhanced BP visualization and nerve-tissue contrast across all cohorts, particularly in volunteers and patients with injuries. It also uncovered additional imaging features such as hypointense signals in ganglia, compressed nerve sites, and neoplastic enhancements. CE-MRN effectively mitigated muscle edema and vascular contamination, enabling precise classification of BP injuries. Overall, CE-MRN consistently enhances BP visualization and provides valuable imaging features for accurate diagnosis.

Evaluating guideline and registration policies among neurology journals: a cross-sectional analysis.

BACKGROUND: Neurological disorders have had a substantial rise the last three decades, imposing substantial burdens on both patients and healthcare costs. Consequently, the demand for high-quality research has become crucial for exploring effective treatment options. However, current neurology research has some limitations in terms of transparency, reproducibility, and reporting bias. The adoption of reporting guidelines (RGs) and trial registration policies has been proven to address these issues and improve research quality in other medical disciplines. It is unclear the extent to which these policies are being endorsed by neurology journals. Therefore, our study aims to evaluate the publishing policies of top neurology journals regarding RGs and trial registration. METHODS: For this cross-sectional study, neurology journals were identified using the 2021 Scopus CiteScore Tool. The top 100 journals were listed and screened for eligibility for our study. In a masked, duplicate fashion, investigators extracted data on journal characteristics, policies on RGs, and policies on trial registration using information from each journal's Instruction for Authors webpage. Additionally, investigators contacted journal editors to ensure information was current and accurate. No human participants were involved in this study. Our data collection and analyses were performed from December 14, 2022, to January 9, 2023. RESULTS: Of the 356 neurology journals identified, the top 100 were included into our sample. The five-year impact of these journals ranged from 50.844 to 2.226 (mean [SD], 7.82 [7.01]). Twenty-five (25.0%) journals did not require or recommend a single RG within their Instructions for Authors webpage, and a third (33.0%) did not require or recommend clinical trial registration. The most frequently mentioned RGs were CONSORT (64.6%), PRISMA (52.5%), and ARRIVE (53.1%). The least mentioned RG was QUOROM (1.0%), followed by MOOSE (9.0%), and SQUIRE (17.9%). CONCLUSIONS: While many top neurology journals endorse the use of RGs and trial registries, there are still areas where their adoption can be improved. Addressing these shortcomings leads to further advancements in the field of neurology, resulting in higher-quality research and better outcomes for patients.

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.

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.

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.