The International journal of risk & safety in medicine最新文献

{"title":"Population-level COVID-19 mortality trends.","authors":"Michael Gdalevich","doi":"10.1177/09246479251362607","DOIUrl":"10.1177/09246479251362607","url":null,"abstract":"","PeriodicalId":520800,"journal":{"name":"The International journal of risk & safety in medicine","volume":" ","pages":"313"},"PeriodicalIF":0.8,"publicationDate":"2025-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144755672","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Innovative approaches to collecting, aggregating, and analyzing adverse drug events in smart hospitals.","authors":"Francesco De Pretis, Mark van Gils, Markus Varheenmaa, Miia Tiihonen, Markus M Forsberg","doi":"10.1177/09246479251365094","DOIUrl":"10.1177/09246479251365094","url":null,"abstract":"<p><p>BackgroundThe increasing integration of electronic health records (EHRs) and their secondary use provide new pathways to advance drug safety. Smart hospitals use advanced data collection to enhance pharmacovigilance and better detect adverse drug events (ADEs). Finland's secondary-use legislation embodies this data-sharing shift.ObjectiveThis work synthesizes current evidence and proposes strategies to strengthen ADE detection and analysis in smart hospitals by integrating multimodal data sources, including EHRs, sensor data, and the Internet of Medical Things (IoMT), to raise overall drug safety standards.MethodsWe review the Global Trigger Tool (GTT), sensor technologies, and IoMT for ADE detection and outline how these techniques can be combined, offering a more comprehensive approach to monitoring.ResultsIntegrating GTT, sensors, and IoMT into a unified system could improve ADE detection and prevention. Combining pharmacovigilance tools with advanced technology can increase the volume and quality of ADE data and supports a preventive focus on patient safety.ConclusionsThe study underscores the importance of the smart-hospital concept and emerging data-collection methods in pharmacovigilance. By adopting a holistic approach to ADE detection and integrating diverse data sources, more robust drug-safety surveillance and patient care can be achieved when coupled with human oversight and regulatory compliance.</p>","PeriodicalId":520800,"journal":{"name":"The International journal of risk & safety in medicine","volume":" ","pages":"289-301"},"PeriodicalIF":0.8,"publicationDate":"2025-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144786455","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Rates of successful conceptions according to COVID-19 vaccination status: Data from the Czech Republic.","authors":"Vibeke Manniche, Tomáš Fürst, Max Schmeling, Jonathan D Gilthorpe, Peter Riis Hansen","doi":"10.1177/09246479251353384","DOIUrl":"10.1177/09246479251353384","url":null,"abstract":"<p><p>BackgroundAdverse effects of COVID-19 vaccination on human menstrual cycle characteristics have been observed, but limited data are available on the relationship between COVID-19 vaccination status and birth rates.ObjectivesTherefore, we used nationwide data from the Czech Republic to examine rates of successful conceptions (SCs), that is, conceptions leading to live births 9 months later, for women who were either vaccinated or unvaccinated against COVID-19 before SC.MethodsSummary monthly COVID-19 vaccination and birth data for women in the Czech Republic aged 18-39 years were retrieved for the period from January 2021 to December 2023. The numbers of SCs per month per 1000 women were calculated for preconception-vaccinated or unvaccinated women, respectively, as well as the number of SCs per month per 1000 women for all women aged 18-39 years.ResultsDuring the study period, there were approximately 1,300,000 women aged 18-39 years in the Czech Republic, and the proportion of COVID-19-vaccinated women increased from January 2021 until reaching a steady state of around 70% by the end of 2021. At least from June 2021, SCs per 1000 women were considerably lower for women who were vaccinated, compared to those that were unvaccinated, before SC. Furthermore, SC rates for the vaccinated group were much lower than expected based on their proportion of the total population.ConclusionsIn the Czech Republic, SC rates were substantially lower for women vaccinated against COVID-19 before SC than for those who were not vaccinated. These hypothesis-generating and preliminary results call for further studies of the potential influence of COVID-19 vaccination on human fecundability and fertility.</p>","PeriodicalId":520800,"journal":{"name":"The International journal of risk & safety in medicine","volume":" ","pages":"302-306"},"PeriodicalIF":0.8,"publicationDate":"2025-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12552754/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144328439","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Comparative study of brachytherapy using ring and ovoid applicators in treatment of advanced cervical cancer.","authors":"Reham S Sherif, Hend M Kareem, Reem H El-Gebaly, Mohamed A Shehata, Reham A A Aziz","doi":"10.1177/09246479251353380","DOIUrl":"10.1177/09246479251353380","url":null,"abstract":"<p><p>BackgroundImage-guided brachytherapy became essential to cervical cancer treatment following chemo-radiotherapy. A variety of applicators including Tandem-Ring (TR) and Tandem-Ovoid (TO) applicators are used to apply brachytherapy.ObjectiveThis study aims to dosimetrically compare TR versus TO applicators by using two different optimization techniques.MethodsBoth applicator sets were applied to the 24 patients. The prescribed dose was 7 Gy/fraction, and the treatment plans were normalized to HR-CTV. Two different optimization techniques are applied, along the four treatment fractions. The first optimization technique was a theoretical assumption that aimed to deliver 7 Gy to 90 % of the volume of the HR-CTV. While the second was the clinical situation which aimed to preserve the organs at risk (OARs) according to the ICRU 89 dose-volume constraints, considering that, 90% of HR-CTV is covered by not less than 90% of the prescribed dose. DVHs were generated, and dosimetric parameters including point A, and D2cc of rectum, bladder, and sigmoid, as well as the dose at different volumes of HR-CTV and IR-CTV, were recorded and compared.ResultsThe results demonstrate that using Ovoid-Tandem applicators achieved significantly higher dose at point A, significantly higher coverage to both HR-CTV and IR-CTV, in addition to significantly better protection to the mean D2cc of the rectum in both optimization techniques. On the other hand, using Ring-Tandem applicators give significantly more protection to the mean D2cc of the bladder, but HR-CTV and IR-CTV have significantly lower coverage.ConclusionOvoid-Tandem and Ring-Tandem applicators are the most common interchangeable intracavitary gynecological applicators. In this study, the results demonstrated that Ovoid-Tandem applicators have the advantages of significantly higher coverage for HR-CTV, and IR-CTV, in addition to more protection for D2cc of the rectum. On the contrary, Ring-Tandem applicators can provide higher protection for D2cc of the bladder, and more comfort to the patients.</p>","PeriodicalId":520800,"journal":{"name":"The International journal of risk & safety in medicine","volume":" ","pages":"260-269"},"PeriodicalIF":0.8,"publicationDate":"2025-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144328438","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"SSRI antidepressants and perceived loss of lean muscle in men: A qualitative exploration of some online anecdotal concerns.","authors":"Nicholas Norman Adams","doi":"10.1177/09246479251346445","DOIUrl":"10.1177/09246479251346445","url":null,"abstract":"<p><p>BackgroundThis study examines anecdotal reports from online discussion forums suggesting possible links between SSRI antidepressants and loss of lean muscle mass, particularly in men. Given limited existing scientific research, this study bolsters academic discourse.ObjectiveDo self-reported experiences from internet forums indicate a perceived connection between SSRI use and muscle mass reductions?MethodA Google keyword search identified 202 posts from 14 randomly selected online antidepressant discussion forums. Posts were collected and thematically analysed.ResultsForum users reported difficulties in maintaining or gaining lean muscle after commencing SSRI treatment. Key themes included frustration, confusion, and attempts to rationalise perceived changes.ConclusionFindings suggest an area for further exploration, regarding the physiological impact of SSRIs on muscle composition. While reports remain anecdotal, they highlight concerns immediately relevant to both patients and healthcare professionals. As the study is based on self-reported experiences from anonymous sources, findings lack scientific validation but highlight requirements for further studies to explore prevalence and broader applicability. Research observations spotlight a need for further, structured clinical research to investigate possible effects of SSRIs on muscle mass.Future research should include controlled clinical trials and longitudinal studies to examine a potential association in more detail.</p>","PeriodicalId":520800,"journal":{"name":"The International journal of risk & safety in medicine","volume":" ","pages":"208-217"},"PeriodicalIF":0.8,"publicationDate":"2025-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12552761/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144129747","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Restoring TADS: RIAT reanalysis of the Treatment for Adolescents with Depression Study.","authors":"Natalie Aboustate, Jon Jureidini, Richard Woodman, Joanna Le Noury, Julie Klau, Elia Abi-Jaoude, Melissa Raven","doi":"10.1177/09246479251337879","DOIUrl":"10.1177/09246479251337879","url":null,"abstract":"<p><p>BackgroundThe Treatment for Adolescents with Depression Study (TADS) continues to influence international clinical practice guidelines for adolescent depression.ObjectiveWe assessed TADS' effectiveness and harms through a Restoring Invisible and Abandoned Trials (RIAT)-led reanalysis.MethodsTADS was a phase-three multicentre, parallel four-arm randomised controlled superiority trial that randomised adolescents (<i>n</i> = 439) to fluoxetine alone (FLX), CBT alone (CBT), open-label fluoxetine plus CBT (COMB) or placebo pill alone (PBO) over 12 weeks. COMB and CBT groups were unblinded to their treatment allocation. Primary outcomes were the Children's Depression Rating Scale-Revised (CDRS-R) and Clinical Global Impression-Improvement scale (CGI-I).ResultsOur ITT reanalysis showed a significant decrease in CDRS-R at 12 weeks in COMB compared with PBO (-6.65; <i>p</i> < 0.001) and CBT (-7.63, <i>p</i> < 0.001), but not FLX (-4.07, <i>p</i> = 0.063). There was no difference between FLX, CBT and PBO. There was a higher proportion of CGI-I responders in COMB (73.72% [SE 4.43]) compared with all other arms: FLX (64.16% [SE 4.76]), CBT (51.06% [SE 5.29]) and PBO (38.76% [SE 4.87]; all <i>p</i> < 0.001); FLX had more responders than PBO (<i>p</i> = 0.004). 369 adverse events were reported for 171 participants, with 66% occurring in those taking fluoxetine. We found 32 serious adverse events (22 in those taking fluoxetine), which varied from original authors' reporting.ConclusionsOur reanalysis replicated the original investigators' reporting that COMB demonstrated the most robust outcomes and that FLX was not superior to PBO. In contrast to the original TADS Team's reporting, there was a higher level of harm uncovered in allocation groups taking fluoxetine, including 11 unreported suicide-related adverse events. Overall, the marked increase in harms among participants taking fluoxetine warrants further circumspection when prescribing it to adolescents.</p>","PeriodicalId":520800,"journal":{"name":"The International journal of risk & safety in medicine","volume":" ","pages":"218-237"},"PeriodicalIF":0.8,"publicationDate":"2025-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12552760/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144153211","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"From reaction to reporting: Impact of pharmacovigilance in a tertiary care hospital setting at Belagavi.","authors":"Pratiksha Kini, Mandati Santhosh Reddy, M S Ganachari","doi":"10.1177/09246479251364713","DOIUrl":"10.1177/09246479251364713","url":null,"abstract":"<p><p>BackgroundAdverse drug reactions (ADRs) pose significant risks to patient safety, particularly in tertiary care settings characterized by polypharmacy and multiple comorbidities. Monitoring and evaluating ADRs is vital to improving therapeutic outcomes and minimizing harm.ObjectiveThis study aimed to assess the pattern, severity, predictability, seriousness, and causality of ADRs reported in a tertiary care teaching hospital in Belagavi, India.MethodsA prospective observational study was conducted on 2035 spontaneously reported ADRs collected between January and December 2024 at the Adverse Drug Reaction Monitoring Centre under the Pharmacovigilance Programme of India (PvPI). Data were analyzed using the WHO-UMC causality assessment, Hartwig and Siegel severity scale, and standard classifications for seriousness and predictability.ResultsAdults (60.54%) and elderly (24.67%) were most frequently affected. Gastrointestinal disorders (23.91%) were the most commonly reported System Organ Class (SOC). Most ADRs were predictable (87.81%) and probable in causality (67.91%). Severe ADRs accounted for 15.97%. Vomiting and headache were the most reported adverse events. Antiretroviral were the most commonly implicated drug class.ConclusionThe majority of ADRs were predictable and involved widely used drug classes. Strengthening pharmacovigilance practices and implementing targeted clinical interventions are essential to prevent avoidable ADRs and improve patient safety.</p>","PeriodicalId":520800,"journal":{"name":"The International journal of risk & safety in medicine","volume":" ","pages":"281-288"},"PeriodicalIF":0.8,"publicationDate":"2025-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144736686","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Perceptions of occupational exposure and adherence to safety measures of handling systemic anti-cancer therapy (SACT) among oncology nurses at the national cancer institute, Sri Lanka.","authors":"Nsasn Senarath, D De Silva, Rwmwk Rathnayake, Ssp Warnakulasuriya, Mkdl Meegoda, S S Jayasinghe","doi":"10.1177/09246479251346172","DOIUrl":"10.1177/09246479251346172","url":null,"abstract":"<p><p>BackgroundChemotherapy is a well-known treatment modality against cancer. Occupational exposure to chemotherapy and related adverse effects are widely reported. Safe handling is vital in the reduction of possible risks.ObjectiveTo assess perceptions of occupational exposure and adherence to safety measures of handling Systemic Anti-Cancer Therapy (SACT) among nurses.MethodsA phenomenological study was carried out using a semi-structured, in-depth interviewer guide following the Health Belief Model (HBM) components. The study adopted a purposive sampling method, and data was collected until it reached the saturation point. A thematic analysis was carried out, preserving the study's trustworthiness.ResultsThe nurse's main role was to administer chemotherapy. The primary learning sources were clinical experience and follow-up with seniors. Nurses accept that they are occupationally exposed to chemotherapy and believe that safety measures are protective against exposure. Surgical gloves and masks were common PPE, and chemotherapy-specific masks and gowns were mainly used in mixing drugs. Staffing, safe work practices, separate waste disposal, and seniors' guidance are identified as protective measures. Headache, vomiting, hair loss, skin irritation, and miscarriages were commonly perceived as adverse effects of handling SACT.ConclusionsAn increased patient count, frequent complex doses, a lack of PPE and facilities, and discomfort with PPE might increase exposure.</p>","PeriodicalId":520800,"journal":{"name":"The International journal of risk & safety in medicine","volume":" ","pages":"248-259"},"PeriodicalIF":0.8,"publicationDate":"2025-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144201365","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Rapid review of drug induced Stevens Johnson Syndrome case reports from 2003 to 2023: Trends among monoclonal antibodies and systemic immunosuppressant therapy.","authors":"Maxine Gossell-Williams, Gabrielle McLaren, Rojay Clarke, Shenae Douglas, Devonne Gayle, Kerrian Guthrie","doi":"10.1177/09246479251368022","DOIUrl":"10.1177/09246479251368022","url":null,"abstract":"<p><p>BackgroundDrug-induced Steven-Johnson Syndrome (SJS) is a life-threatening hypersensitivity reaction and systemic steroid immunosuppressant therapy is not universally recommended. With the changing landscape of new drugs, it is important to determine emerging trends in this severe drug induced adverse event.ObjectiveThe objectives were to examine drug induced SJS case reports published from January 1 2003 to December 31 2023 for emerging trends of drugs implicated and systemic immunosuppressant therapy administered.MethodsLiterature search was done using PubMed (MEDLINE) database with keywords and Boolean terms, \"Stevens Johnson Syndrome\" AND \"Case Report,\" filtered for the time period of interest, articles available free and in English. Included case reports were only studies in which a single drug was implicated.ResultsForty-nine case reports met inclusion criteria and critical analysis of quality rated studies from moderate to strong; however, causality assessment instrument was only reported for 10 (20%) case reports. There was equal distribution by sex; patient ages ranged from 2 to 95 years and 34 (69.4%) case reports originated from countries of the Asian continent. Most common drug implicated was carbamazepine, 5 (10.2%); pembrolizumab was implicated in 4 of 9 case reports involving monoclonal antibody drugs. Thirty-seven patients (75.5%) received systemic steroid immunosuppressant therapy. Two patients (4.1%) died during the clinical course.ConclusionThe published case reports are predominately from countries known to be at higher risk of drug induced SJS and the emerging greater number of case reports implicating pembrolizumab may be an important safety concern, needing further investigation. Systemic steroid use was the preferred immunosuppressant therapy.</p>","PeriodicalId":520800,"journal":{"name":"The International journal of risk & safety in medicine","volume":" ","pages":"156-167"},"PeriodicalIF":0.8,"publicationDate":"2025-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144802488","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Pharmacovigilance: Overview of Italian and European regulations, tools, and perspectives.","authors":"Eleonora Castellana, Patricia Madalina Budau, Maria Rachele Chiappetta","doi":"10.1177/09246479251366836","DOIUrl":"10.1177/09246479251366836","url":null,"abstract":"<p><p>BackgroundThis study provides a concise overview of the Italian and European pharmacovigilance (PV) systems.ObjectiveTo evaluate the regulatory frameworks of above mentioned systems, operational tools, and recent trends in adverse drug reaction (ADR) reporting. The primary objective is to highlight the strengths and critical issues of the current system in improving drug safety and protecting public health.MethodsOur analysis confirms a progressive increase in ADR reporting in Italy over the past decade, with a peak in 2021 during the COVID-19 vaccination campaign, followed by a subsequent decline.ResultsHospital physicians and pharmacists remain the primary reporters, while patient reports account for around 10%. The causality assessment process continues to rely heavily on tools such as the Naranjo algorithm and the WHO-UMC criteria, although no single gold standard exists. Despite regulatory improvements and digital infrastructure development, key limitations persist, notably underreporting, inconsistent report quality, and lack of population exposure data.ConclusionWhile Italy's PV system has evolved considerably, a more integrated, proactive, and technology-enhanced approach is required to improve the sensitivity and timeliness of signal detection. Future directions should include the use of artificial intelligence, electronic health records, and real-world evidence to enhance pharmacovigilance performance.</p>","PeriodicalId":520800,"journal":{"name":"The International journal of risk & safety in medicine","volume":" ","pages":"147-155"},"PeriodicalIF":0.8,"publicationDate":"2025-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144796636","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}