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Incitement to misuse of corticosteroids by Arab YouTubers in a local context. 阿拉伯 YouTubers 在当地煽动滥用皮质类固醇。
IF 0.9 Q4 PUBLIC, ENVIRONMENTAL & OCCUPATIONAL HEALTH Pub Date : 2024-01-01 DOI: 10.3233/JRS-230061
Hind Amghar, Manal El Hani, Yahia Cherrah, Samira Serragui

Background: The ubiquity of social media has ushered in an era where uncontrolled content sharing extends to all subjects, including sensitive topics such as medication consumption.

Objective: To quantify the prevalence of YouTube videos providing information on glucocorticoids and to underscore the risks associated with inaccurate information, which might inadvertently promote inappropriate use of these medications.

Methods: The YouTube videos were selected using predefined keywords from February 20 to March 4, 2023. The videos were categorized into two groups. Category 1 promotes the misuse of corticosteroids, while Category 2 raises awareness about the risks associated with these drugs.

Results: In total, 843 YouTube videos were included. Approximately 76% of the creators were women. Of these, category 1 videos (69.63%) predominated over Category 2 videos (30.37%). Regarding Category 1, dexamethasone was mentioned in 41.53% of cases, followed by hydrocortisone (17.30%). According to these YouTubers, these products/medications are mainly obtained from community pharmacies (58.09%), online shops (20.01%), and through illicit markets and the black market (13.46%). Weight gain was the most common objective, according to 32.62% of the YouTubers.

Conclusion: This study highlights the prevalence of YouTube videos regarding the misuse of corticosteroids. The common focus on weight gain as an objective underscores the importance of educating content creators and viewers about responsible corticosteroid use. Targeted interventions are needed to promote safe and informed medication practices within this online environment.

背景:社交媒体无处不在:无处不在的社交媒体开创了一个不受控制的内容分享时代,其内容涵盖了所有主题,包括用药等敏感话题:量化提供糖皮质激素相关信息的 YouTube 视频的流行程度,并强调与不准确信息相关的风险,因为不准确信息可能会无意中促进这些药物的不当使用:方法:使用预定义的关键词选取了 2023 年 2 月 20 日至 3 月 4 日期间的 YouTube 视频。这些视频被分为两类。第 1 类宣传滥用皮质类固醇,而第 2 类则提高人们对这些药物相关风险的认识:结果:共收录了 843 个 YouTube 视频。约 76% 的创作者为女性。其中,第 1 类视频(69.63%)比第 2 类视频(30.37%)多。在第 1 类视频中,41.53% 的视频提到了地塞米松,其次是氢化可的松(17.30%)。根据这些优酷用户的说法,这些产品/药物主要是从社区药房(58.09%)、网上商店(20.01%)以及非法市场和黑市(13.46%)获得的。32.62%的优酷用户表示,体重增加是最常见的目的:本研究强调了 YouTube 视频中滥用皮质类固醇的普遍性。体重增加是一个普遍关注的目标,这强调了教育内容创作者和观众负责任地使用皮质类固醇的重要性。需要采取有针对性的干预措施,在这种网络环境中推广安全、知情的用药方法。
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引用次数: 0
Gabapentin monotherapy for epilepsy: A review. 加巴喷丁单药治疗癫痫:综述。
IF 1.7 Q4 PUBLIC, ENVIRONMENTAL & OCCUPATIONAL HEALTH Pub Date : 2023-01-01 DOI: 10.3233/JRS-235001
Liliya Eugenevna Ziganshina, Tatyana Abakumova, Charles H V Hoyle
<p><strong>Background: </strong>Epilepsy is one of the most common chronic neurological disorders, affecting more than 50 million people globally. In this review we summarised the evidence from randomised controlled trials of gabapentin used as monotherapy for the treatment of focal epilepsy, both newly diagnosed and drug-resistant, with or without secondary generalisation.</p><p><strong>Objective: </strong>To assess the effects of gabapentin monotherapy for people with epileptic focal seizures with and without secondary generalisation.</p><p><strong>Methods: </strong>We searched the Cochrane Register of Studies (CRS Web) and MEDLINE (Ovid, 1946 to 24 February 2020) on 25 February 2020. CRS Web includes randomised or quasi-randomised controlled trials from PubMed, Embase, ClinicalTrials.gov, the World Health Organization International Clinical Trials Registry Platform, the Cochrane Central Register of Controlled Trials (CENTRA), and the specialised registers of Cochrane Review Groups including the Cochrane Epilepsy Group. We also searched several Russian databases, reference lists of relevant studies, ongoing trials registers, conference proceedings, and we contacted trial authors.</p><p><strong>Results: </strong>We found five randomised controlled trials (3167 participants) comparing gabapentin to other antiepileptic drugs (AEDs) and differing doses of gabapentin as monotherapy for newly diagnosed focal epilepsy and drug- resistant focal epilepsy with or without secondary generalisation. Two review authors independently applied the inclusion criteria, assessed trial quality, risk of bias, and extracted data. We used the GRADE approach to assess the certainty of evidence and present seven patient-important outcomes in the "Summary of findings" tables. The quality of evidence was very low to moderate due to poor reporting quality, poor trial design, and other risks of bias, such as selective presentation of findings and potential heavy industry input. Better quality research may change our certainty in the effect estimates. None of the included trials reported on the number of people with 50% or greater reduction in seizures and time to withdrawal (retention time) in an extractable way. Gabapentin-treated participants were more likely to withdraw from treatment for any cause (285/539) than those treated with lamotrigine, oxcarbazepine, or topiramate pooled together (695/1317) (RR 1.13, 95% CI 1.02 to 1.25; 3 studies, 1856 participants; moderate-certainty evidence), but not carbamazepine. Fewer people treated with gabapentin withdrew from treatment owing to adverse events (190/525) than those treated with carbamazepine, oxcarbazepine, or topiramate (479/1238), (RR 0.79, 95% CI 0.69 to 0.91; 1763 participants, 3 studies; moderate-certainty evidence), but not lamotrigine.</p><p><strong>Conclusion: </strong>Gabapentin as monotherapy probably controlled seizures no better and no worse than comparator AEDs (lamotrigine, carbamazepine, oxcarbazepine, and
背景:癫痫是最常见的慢性神经系统疾病之一,影响着全球5000多万人。在这篇综述中,我们总结了加巴喷丁作为单药治疗局灶性癫痫的随机对照试验的证据,包括新诊断的和耐药的,有或没有继发性癫痫。目的:评价加巴喷丁单药治疗伴有和不伴有继发全身性癫痫局灶性发作的疗效。方法:我们于2020年2月25日检索了Cochrane研究登记册(CRS Web)和MEDLINE(Ovid,1946年至2020年2月份24日)。CRS Web包括来自PubMed、Embase、ClinicalTrials.gov、世界卫生组织国际临床试验注册平台、Cochrane对照试验中央注册中心(CENTRA)和包括Cochrane癫痫组在内的Cochrane审查组专门注册中心的随机或准随机对照试验。我们还搜索了几个俄罗斯数据库、相关研究的参考文献列表、正在进行的试验登记册、会议记录,并联系了试验作者。结果:我们发现了五项随机对照试验(3167名参与者),将加巴喷丁与其他抗癫痫药物(AED)进行了比较,并将不同剂量的加巴喷汀作为新诊断的局灶性癫痫和耐药性局灶性痫性癫痫的单药治疗,无论是否有继发性癫痫。两位综述作者独立应用了纳入标准,评估了试验质量、偏倚风险和提取的数据。我们使用GRADE方法来评估证据的确定性,并在“结果摘要”表中列出了七个患者的重要结果。由于报告质量差、试验设计差以及其他偏见风险,如选择性陈述研究结果和潜在的重工业投入,证据质量非常低至中等。更高质量的研究可能会改变我们对效果估计的确定性。没有一项纳入的试验报告了癫痫发作和戒断时间(保留时间)以可提取的方式减少50%或更多的人数。加巴喷丁治疗的参与者比拉莫三嗪、奥卡西平或托吡酯联合治疗的参与者(695/1317)更有可能因任何原因退出治疗(285/539)(RR 1.13,95%CI 1.02-1.25;3项研究,1856名参与者;中等确定性证据),但卡马西平除外。因不良事件而退出治疗的加巴喷丁患者(190/525)少于卡马西平、奥卡西平或托吡酯患者(479/1238)(RR 0.79,95%CI 0.69至0.91;1763名参与者,3项研究;中等确定性证据),但拉莫三嗪除外。结论:加巴喷丁单药治疗癫痫发作的效果可能不比对照AED(拉莫三嗪、卡马西平、奥卡西平和托吡酯)好也不差。与卡马西平相比,加巴喷丁在保留研究对象和防止因不良事件而停药方面可能更好。加巴喷丁最常见的副作用是共济失调(协调性差和步态不稳)、头晕、疲劳和嗜睡。
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引用次数: 1
Acute renal failure and cardiac arrhythmias associated with remdesivir use in patients with COVID-19 infections: Analysis using the US FDA adverse event reporting system. COVID-19感染患者使用瑞德西韦相关的急性肾功能衰竭和心律失常:使用美国FDA不良事件报告系统进行分析
IF 1.7 Q4 PUBLIC, ENVIRONMENTAL & OCCUPATIONAL HEALTH Pub Date : 2023-01-01 DOI: 10.3233/JRS-220009
Lisajo Orogun, Te-Yuan Chyou, Prasad S Nishtala

Background: Recently, antivirals, including remdesivir, have been repurposed to treat COVID-19 infections. Initial concerns have been raised about the adverse renal and cardiac events associated with remdesivir.

Objective: This study aimed to analyse the adverse renal and cardiac events associated with remdesivir in patients with COVID-19 infections using the US FDA adverse event reporting system.

Method: A case/non-case method was used to determine adverse drug events associated with remdesivir as the primary suspect drug between January 1, 2020, and November 11, 2021, for patients with COVID-19 infections. Cases were reports for remdesivir with ≥1 ADEs as preferred terms included in the Medical Dictionary of Regulatory Activities (MedDRA) system organ classes 'Renal and urinary disorders' or 'cardiac' disorders. To measure disproportionality in reporting of ADEs, frequentist approaches, including the proportional reporting ratio (PRR) and reporting odds ratio (ROR), were used. The empirical Bayesian Geometric Mean (EBGM) score and information component (IC) value were calculated using a Bayesian approach. A signal was defined as the lower limit of 95% confidence intervals of ROR ≥ 2, PRR ≥ 2, IC > 0, and EBGM > 1 for ADEs with ≥4 reports. Sensitivity analyses were undertaken by excluding reports for non-Covid indications and medications strongly associated with AKI and cardiac arrhythmias.

Results: In the main analysis for remdesivir use in patients with COVID-19 infections, we identified 315 adverse cardiac events comprising 31 different MeDRA PTs and 844 adverse renal events comprising 13 different MeDRA PTs. Regarding adverse renal events, disproportionality signals were noted for "renal failure" (ROR = 2.8 (2.03-3.86); EBGM = 1.92 (1.58-2.31), "acute kidney injury" (ROR = 16.11 (12.52-20.73); EBGM = 2.81 (2.57-3.07), "renal impairment" (ROR = 3.45 (2.68-4.45); EBGM = 2.02 (1.74-2.33). Regarding adverse cardiac events, strong disproportionality signals were noted for "electrocardiogram QT prolonged" (ROR = 6.45 (2.54-16.36); EBGM = 2.04 (1.65-2.51), "pulseless electrical activity" (ROR = 43.57 (13.64-139.20); EBGM = 2.44 (1.74-3.33), "sinus bradycardia" (ROR = 35.86 (11.16-115.26); EBGM = 2.82 (2.23-3.53), "ventricular tachycardia" (ROR = 8.73 (3.55-21.45); EBGM = 2.52 (1.89-3.31). The risk of AKI and cardiac arrythmias were confirmed by sensitivity analyses.

Conclusion: This hypothesis-generating study identified AKI and cardiac arrhythmias associated with remdesivir use in patients with COVID-19 infections. The relationship between AKI and cardiac arrhythmias should be further investigated using registries or large clinical data to assess the impact of age, genetics, comorbidity, and the severity of Covid infections as potential confounders.

背景:最近,包括瑞德西韦在内的抗病毒药物已被重新用于治疗COVID-19感染。最初的担忧是与瑞德西韦相关的肾脏和心脏不良事件。目的:本研究旨在利用美国FDA不良事件报告系统分析COVID-19感染患者与瑞德西韦相关的肾脏和心脏不良事件。方法:采用病例/非病例法,对2020年1月1日至2021年11月11日期间COVID-19感染患者以瑞德西韦作为主要可疑药物相关的药物不良事件进行分析。报告的病例中,瑞德西韦的不良反应≥1次,首选术语包括在《调节活动医学词典》(MedDRA)系统器官类别“肾脏和泌尿系统疾病”或“心脏”疾病。为了测量不良事件报告的不相称性,使用了频率分析方法,包括比例报告比(PRR)和报告优势比(ROR)。利用贝叶斯方法计算经验贝叶斯几何平均(EBGM)得分和信息分量(IC)值。≥4例ade报告的95%置信区间ROR≥2、PRR≥2、IC > 0、EBGM > 1定义为信号。通过排除非covid适应症和与AKI和心律失常密切相关的药物的报告,进行敏感性分析。结果:在对COVID-19感染患者使用瑞德西韦的主要分析中,我们确定了315例不良心脏事件,包括31种不同的MeDRA PTs, 844例不良肾脏事件,包括13种不同的MeDRA PTs。对于肾脏不良事件,“肾功能衰竭”的歧化信号被注意到(ROR = 2.8 (2.03-3.86);EBGM = 1.92(1.58 ~ 2.31),“急性肾损伤”(ROR = 16.11 (12.52 ~ 20.73);EBGM = 2.81(2.57 ~ 3.07),“肾功能损害”(ROR = 3.45 (2.68 ~ 4.45);Ebgm = 2.02(1.74-2.33)。对于心脏不良事件,“心电图QT间期延长”存在强烈的歧化信号(ROR = 6.45 (2.54-16.36);EBGM = 2.04(1.65-2.51),“无脉电活动”(ROR = 43.57 (13.64-139.20);EBGM = 2.44(1.74 ~ 3.33),“窦性心动过缓”(ROR = 35.86 (11.16 ~ 115.26);EBGM = 2.82(2.23-3.53),“室性心动过速”(ROR = 8.73 (3.55-21.45);Ebgm = 2.52(1.89-3.31)。敏感性分析证实了AKI和心律失常的风险。结论:这项产生假设的研究确定了COVID-19感染患者使用瑞德西韦相关的AKI和心律失常。AKI与心律失常之间的关系应通过注册表或大量临床数据进一步研究,以评估年龄、遗传、合并症和Covid感染严重程度作为潜在混杂因素的影响。
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引用次数: 0
Analysis of the nervous system and gastrointestinal adverse events associated with solifenacin in older adults using the US FDA adverse event reporting system. 使用美国FDA不良事件报告系统分析老年人与索利那新相关的神经系统和胃肠道不良事件。
IF 1.7 Q4 PUBLIC, ENVIRONMENTAL & OCCUPATIONAL HEALTH Pub Date : 2023-01-01 DOI: 10.3233/JRS-210054
Connie Nicholls, Te-Yuan Chyou, Prasad S Nishtala

Background: Antimuscarinics are the backbone of the pharmacological management of overactive bladder. Still, concerns have been raised over the nervous system (NS) adverse drug events (AEs) due to their dissimilarities to muscarinic receptor-subtype affinities.

Objective: This study aimed to identify the nervous system and gastrointestinal adverse drug events (ADEs) associated with solifenacin use in older adults (≥65 years).

Methods: A case/non-case analysis was performed on the reports submitted to the FDA Adverse Event Reporting System (FAERS) between 01/01/2004 and 30/06/2020. Cases were reports for solifenacin with ≥1 ADEs as preferred terms included in the Medical Dictionary of Regulatory Activities (MedDRA) system organ classes 'nervous system' or 'gastrointestinal' disorders. Non-cases were all other remaining reports for solifenacin. The case/non-cases was compared between solifenacin and other bladder antimuscarinics. Frequentist approaches, including the proportional reporting ratio (PRR) and reporting odds ratio (ROR), were used to measure disproportionality. The empirical Bayesian Geometric Mean (EBGM) score and information component (IC) value were calculated using a Bayesian approach. A signal was defined as the lower limit of 95% confidence intervals of ROR ≥ 2, PRR ≥ 2, IC > 0, EBGM > 1, for ADEs with ≥4 reports.

Results: 107 MedDRA preferred terms (PTs) comprising 970 ADE reports were retrieved for nervous system disorders associated with solifenacin. For gastrointestinal disorders, 129 MedDRA PTs comprising 1817 ADE reports were retrieved. Statistically significant results were found for 'altered state of consciousness': ROR = 9.71 (2.13-44.35), PRR = 9.69 (2.12-44.2) and IC = 1.29 (0.93-1.66).

Conclusions: The disproportionality reporting of 'altered state of consciousness', a previously unidentified ADE, was unexpected. Further monitoring of this ADE is needed to ensure patient safety, as this could be linked to poor balance and falls in older adults.

背景:抗蛇毒素是治疗膀胱过度活跃的主要药物。然而,由于毒蕈碱受体亚型亲和性不同,神经系统(NS)药物不良事件(ae)引起了关注。目的:本研究旨在确定老年人(≥65岁)使用索利那新相关的神经系统和胃肠道药物不良事件(ADEs)。方法:对2004年1月1日至2020年6月30日提交给FDA不良事件报告系统(FAERS)的报告进行病例/非病例分析。报告的病例中,索非那新ade≥1,首选术语包括调节活动医学词典(MedDRA)系统器官分类“神经系统”或“胃肠道”疾病。其余报告均为索利那新无病例。比较索利那新与其他膀胱抗蛇毒素的病例/非病例。频率方法,包括比例报告比(PRR)和报告优势比(ROR),用于测量不比例。利用贝叶斯方法计算经验贝叶斯几何平均(EBGM)得分和信息分量(IC)值。对于≥4例ade报告,信号定义为ROR≥2、PRR≥2、IC > 0、EBGM > 1的95%置信区间下限。结果:检索到与索非那新相关的神经系统疾病的107个MedDRA首选术语(PTs),包括970个ADE报告。对于胃肠道疾病,检索了129份MedDRA PTs,其中包括1817份ADE报告。“意识状态改变”的结果具有统计学意义:ROR = 9.71 (2.13-44.35), PRR = 9.69 (2.12-44.2), IC = 1.29(0.93-1.66)。结论:“意识状态改变”(一种先前未被识别的ADE)的比例失调报告是出乎意料的。需要进一步监测这种不良反应,以确保患者安全,因为这可能与老年人平衡能力差和跌倒有关。
{"title":"Analysis of the nervous system and gastrointestinal adverse events associated with solifenacin in older adults using the US FDA adverse event reporting system.","authors":"Connie Nicholls,&nbsp;Te-Yuan Chyou,&nbsp;Prasad S Nishtala","doi":"10.3233/JRS-210054","DOIUrl":"https://doi.org/10.3233/JRS-210054","url":null,"abstract":"<p><strong>Background: </strong>Antimuscarinics are the backbone of the pharmacological management of overactive bladder. Still, concerns have been raised over the nervous system (NS) adverse drug events (AEs) due to their dissimilarities to muscarinic receptor-subtype affinities.</p><p><strong>Objective: </strong>This study aimed to identify the nervous system and gastrointestinal adverse drug events (ADEs) associated with solifenacin use in older adults (≥65 years).</p><p><strong>Methods: </strong>A case/non-case analysis was performed on the reports submitted to the FDA Adverse Event Reporting System (FAERS) between 01/01/2004 and 30/06/2020. Cases were reports for solifenacin with ≥1 ADEs as preferred terms included in the Medical Dictionary of Regulatory Activities (MedDRA) system organ classes 'nervous system' or 'gastrointestinal' disorders. Non-cases were all other remaining reports for solifenacin. The case/non-cases was compared between solifenacin and other bladder antimuscarinics. Frequentist approaches, including the proportional reporting ratio (PRR) and reporting odds ratio (ROR), were used to measure disproportionality. The empirical Bayesian Geometric Mean (EBGM) score and information component (IC) value were calculated using a Bayesian approach. A signal was defined as the lower limit of 95% confidence intervals of ROR ≥ 2, PRR ≥ 2, IC > 0, EBGM > 1, for ADEs with ≥4 reports.</p><p><strong>Results: </strong>107 MedDRA preferred terms (PTs) comprising 970 ADE reports were retrieved for nervous system disorders associated with solifenacin. For gastrointestinal disorders, 129 MedDRA PTs comprising 1817 ADE reports were retrieved. Statistically significant results were found for 'altered state of consciousness': ROR = 9.71 (2.13-44.35), PRR = 9.69 (2.12-44.2) and IC = 1.29 (0.93-1.66).</p><p><strong>Conclusions: </strong>The disproportionality reporting of 'altered state of consciousness', a previously unidentified ADE, was unexpected. Further monitoring of this ADE is needed to ensure patient safety, as this could be linked to poor balance and falls in older adults.</p>","PeriodicalId":45237,"journal":{"name":"INTERNATIONAL JOURNAL OF RISK & SAFETY IN MEDICINE","volume":"34 1","pages":"63-73"},"PeriodicalIF":1.7,"publicationDate":"2023-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10839516","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}
引用次数: 0
Making the most of a Morbidity and Mortality meeting. 充分利用发病率和死亡率会议。
IF 1.7 Q4 PUBLIC, ENVIRONMENTAL & OCCUPATIONAL HEALTH Pub Date : 2023-01-01 DOI: 10.3233/JRS-210077
Gabriella Quiney, Gianluca Colucci

Background: Morbidity and Mortality meetings (M&Ms) are a fundamental element of surgical practice. However, there has been little investigation into best practices, to maximise education and improvement outcomes.

Objective: Create a new, evidence-based M&M methodology, that facilitates standardised analysis of errors in a non-judgemental fashion, and highlights areas for improvement.

Methods: A Quality Improvement (QI) methodology was used. This project encompassed a literature review and two sequential QI cycles. A literature review and initial survey highlighted best practice and identified areas for improvement. From this information, a new standardised format was created, which centred around a new modified Fishbone framework, incorporating the London Protocol methodology. The project then sequentially tested new formats, with feedback collected for every new format.

Results: The literature review and surveys guided improvement of the M&M. The need for standardisation was highlighted. The new PowerPoint template and modified Fishbone ensured presentations and analysis were consistent and systematic. Participants reported that M&Ms were more engaging, interactive and structured, ensuring improved discussion of errors. The modified Fishbone framework reinforced a blame-free, system-focused analysis.

Conclusion: M&Ms are a critical aspect of patient safety. This project utilised simple QI tools to encourage collaborative reflection, learning and improvement.

背景:发病率和死亡率会议(M&Ms)是外科实践的基本要素。然而,几乎没有对最佳实践进行调查,以最大限度地提高教育和改善成果。目标:创建一种新的、基于证据的M&M方法,以非判断的方式促进错误的标准化分析,并突出需要改进的领域。方法:采用质量改进(QI)方法。该项目包括文献综述和两个连续的QI循环。文献回顾和初步调查突出了最佳实践并确定了需要改进的领域。根据这些信息,创建了一种新的标准化格式,该格式以新的修改鱼骨框架为中心,结合了伦敦议定书的方法。该项目随后测试了新格式,并收集了每个新格式的反馈。结果:通过文献回顾和问卷调查指导了M&M的改进。与会者强调了标准化的必要性。新的PowerPoint模板和修改后的Fishbone确保了演示和分析的一致性和系统性。参与者报告说,m&m更有吸引力,互动性和结构化,确保改进对错误的讨论。修改后的鱼骨框架加强了无责任、以系统为中心的分析。结论:m&m是患者安全的重要方面。这个项目使用简单的质量评价工具来鼓励协作反思、学习和改进。
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引用次数: 1
Analysis of the CONKO-001 trial: Is the validity of the study sufficient to recommend adjuvant chemotherapy for pancreatic cancer? CONKO-001 试验分析:研究的有效性是否足以推荐胰腺癌辅助化疗?
IF 1.7 Q4 PUBLIC, ENVIRONMENTAL & OCCUPATIONAL HEALTH Pub Date : 2023-01-01 DOI: 10.3233/JRS-210015
Katrin Bauer, Doris Henne-Bruns, Giulia Manzini

Background: Since randomized controlled trials have indicated that adjuvant chemotherapy prolongs survival and reduces recurrence rates after surgical resection of pancreatic adenocarcinoma, a gemcitabine based chemotherapy has become part of the interdisciplinary treatment concept for pancreatic cancer in accordance to current guidelines.

Objectives: The aim of this project was to analyse the validity of the CONKO-001 trial as a basis for the recommendation of adjuvant chemotherapy in many international guidelines.

Methods: We analysed the validity of the CONKO-001 trial regarding study design, recruitment period, participating institutions, patient selection, randomisation, stratification, standardization of surgical treatment and histological examination, statistical methods and interpretation of results. We additionally analysed the study regarding the risk of bias using the RoB 2 Tool. Finally we reviewed the influence of the pharmaceutical industry and potential conflicts of interest.

Results: We identified several shortcomings of the study concerning the study protocol, the participating clinics, the patient recruitment, the randomization pattern, the standardization of surgical treatment and histological examination, the statistical methods, the evaluation of the results and the influence of the pharmaceutical industry. According to the Cochrane RoB 2 Tool the study was judged to raise some concerns in three of the five risk domains for the outcome "overall survival".

Conclusions: Based on our review, the results of the CONKO-001-study should be revisited and critically reviewed. The recommendation to include adjuvant chemotherapy with gemcitabine deserves a critical appraisal.

背景:随机对照试验表明,辅助化疗可延长胰腺腺癌患者的生存期并降低手术切除后的复发率,因此,根据现行指南,以吉西他滨为基础的化疗已成为胰腺癌跨学科治疗理念的一部分:本项目旨在分析CONKO-001试验作为许多国际指南推荐辅助化疗的依据的有效性:我们分析了 CONKO-001 试验在研究设计、招募时间、参与机构、患者选择、随机化、分层、手术治疗和组织学检查的标准化、统计方法和结果解释等方面的有效性。此外,我们还使用 RoB 2 工具分析了研究的偏倚风险。最后,我们审查了制药行业的影响和潜在的利益冲突:我们发现该研究在研究方案、参与诊所、患者招募、随机化模式、手术治疗和组织学检查的标准化、统计方法、结果评估以及制药行业的影响等方面存在一些不足。根据 Cochrane RoB 2 工具,在 "总生存率 "结果的五个风险领域中,该研究被判定在三个领域存在一些问题:根据我们的综述,CONKO-001 研究的结果应重新审视并严格审查。关于使用吉西他滨进行辅助化疗的建议值得严格评估。
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引用次数: 1
Free access to emergency oral contraceptives (EOCs) in the European Union: A regulatory vacuum to be filled. 在欧洲联盟免费获得紧急口服避孕药:有待填补的监管真空。
IF 1.7 Q4 PUBLIC, ENVIRONMENTAL & OCCUPATIONAL HEALTH Pub Date : 2023-01-01 DOI: 10.3233/JRS-220011
Andrea Cioffi, Camilla Cecannecchia, Fernanda Cioffi, Raffaella Rinaldi, Giorgio Bolino

Background: According to the World Health Organization (WHO), any woman in childbearing age who have decided not to take permanently an oral contraceptive but who are sexually active has the right to access emergency contraception (EC). Despite this, in many European countries there are no specific laws governing the criteria for access to emergency oral contraceptives (EOCs) for girls under 18, especially about the need for third party consent. This normative vacuum is dangerous as it risks creating confusion and entrusting the management of the fundamental right of self-determination to the discretion of others. Moreover, in European Union (EU) countries, there is an inequality in terms of access to contraceptive supplies, reimbursement criteria and the availability of information online.

Objective: Our article compares the criteria for access to EOCs (Ulipristal Acetate-UPA and Levonorgestrel-LNG) in the various EU countries to highlight possible disparities and consequent inequalities.

Methods: Government and ministerial websites, European agencies websites, and Contraceptive Use by Method 2019 (WHO) have been consulted.

Results: There are some differences between the various European countries that could configure inequality in EU countries.

Conclusions: It would be appropriate a definitive levelling of the legislation of the European Union on emergency contraception associated with massive information and awareness campaigns.

背景:根据世界卫生组织(世卫组织)的规定,任何已决定不长期服用口服避孕药但性活跃的育龄妇女都有权获得紧急避孕药(EC)。尽管如此,在许多欧洲国家,没有具体法律规定18岁以下女孩获得紧急口服避孕药的标准,特别是关于需要第三方同意的标准。这种规范真空是危险的,因为它有可能造成混乱,并将管理基本自决权利的工作委托给他人。此外,在欧洲联盟(欧盟)国家,在获得避孕用品、偿还标准和获得网上信息方面存在不平等。目的:我们的文章比较了不同欧盟国家获得EOCs(醋酸乌普利司特- upa和左炔诺孕酮- lng)的标准,以突出可能的差异和随之而来的不平等。方法:咨询了政府和部委网站、欧洲机构网站以及《2019年避孕方法使用》(世卫组织)。结果:欧洲各国之间存在一些差异,这些差异可能会导致欧盟国家的不平等。结论:在开展大规模宣传和提高认识运动的同时,明确调整欧洲联盟关于紧急避孕的立法是适当的。
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引用次数: 1
Patient safety culture in a COVID-19 ICU compared to a clinical-surgical ICU in the Brazilian Eastern Amazon: A cross-sectional study. 巴西东亚马逊地区COVID-19重症监护室与临床外科重症监护室的患者安全文化比较:一项横断面研究
IF 1.7 Q4 PUBLIC, ENVIRONMENTAL & OCCUPATIONAL HEALTH Pub Date : 2023-01-01 DOI: 10.3233/JRS-210071
Maria Luiza Rodrigues Dos Santos, Victória Brioso Tavares, Natália Silva da Costa, Marcos Valério Santos da Silva, João Simão de Melo-Neto

Background: The COVID-19 pandemic highlighted the need for a new dynamic in the organization and practices of health services, as it required rapid restructuring to promote safe and harm-free assistance.

Objective: To assess the dimensions of the patient safety culture (PSC) from the perspective of the health team professionals in clinical-surgical ICU (G1) compared to a COVID-19 ICU (G2).

Methods: Cross-sectional, analytical, descriptive and inferential study, using the "Hospital Survey on Patient Safety Culture" questionnaire.

Results: The domain "Supervisor/Manager Expectations and Actions Promoting Patient Safety (PS)" was a potential weakness for G1 (p = 0.003). G2 was most positive on improving PS, being informed about errors, considering PS as a top priority to management, and that the units work together to provide the best care (p > 0.05). G1 was most negative about the work culture with staff from other units, exchange of information across units, and shift changes (p > 0.05). The highest PS grade was related to greater communication, and a smaller frequency of events was reported only for G2 (p > 0.05).

Conclusion: There must be a balance in terms of attention focused on PS between different ICUs in times of crisis, especially regarding the supervisors/managers actions.

背景:2019冠状病毒病大流行突出表明,卫生服务的组织和做法需要一种新的动态,因为它需要快速重组,以促进安全和无害的援助。目的:从临床外科ICU (G1)与COVID-19 ICU (G2)的卫生团队专业人员的角度评估患者安全培养(PSC)的维度。方法:采用“医院患者安全文化调查”问卷进行横断面、分析、描述和推理研究。结果:“主管/经理期望和行动促进患者安全(PS)”领域是G1的潜在弱点(p = 0.003)。G2最积极的是改善PS,被告知错误,将PS视为管理的首要任务,各单位共同努力提供最佳护理(p > 0.05)。G1对与其他单位员工的工作文化、跨单位信息交流和轮班变化最为负面(p > 0.05)。最高的PS分级与更大的沟通有关,只有G2的事件发生频率较小(p > 0.05)。结论:在危机时刻,不同icu之间对PS的关注程度必须达到平衡,特别是在主管/管理人员的行动方面。
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引用次数: 1
A systematic review and meta-analysis for risk factor profiles in patients with resistant Acinetobacter baumannii infection relative to control patients. 耐药鲍曼不动杆菌感染患者与对照组患者风险因素的系统回顾和荟萃分析。
IF 1.7 Q4 PUBLIC, ENVIRONMENTAL & OCCUPATIONAL HEALTH Pub Date : 2023-01-01 DOI: 10.3233/JRS-220037
Prity Rani Deshwal, Raisa Fathima, Muskan Aggarwal, Nalla Surender Reddy, Pramil Tiwari

Background: Acinetobacter baumannii is a major cause of nosocomial infections and high mortality rates. Evaluation of risk factors for such resistant infections may aid surveillance and diagnostic initiatives, as well as, can be crucial in early and appropriate antibiotic therapy.

Objective: To identify the risk factors in patients with resistant A. baumannii infection with respect to controls.

Methods: Prospective or retrospective cohort and case-control studies reporting the risk factors for resistant A. baumannii infection were collected through two data sources, MEDLINE/PubMed and OVID/Embase. Studies published in the English language were included while animal studies were excluded. The Newcastle-Ottawa Scale was used to assess the quality of studies. The odds ratio of developing antibiotic resistance in patients with A. baumannii infection was pooled using a random-effect model.

Results: The results are based on 38 studies with 60878 participants (6394 cases and 54484 controls). A total of 28, 14, 25, and 11 risk factors were identified for multi-drug resistant (MDRAB), extensive-drug resistant (XDRAB), carbapenem-resistant (CRAB) and imipenem resistant A. baumannii infection (IRAB), respectively. In the MDRAB infection group, exposure to carbapenem (OR 5.51; 95% CI: 3.88-7.81) and tracheostomy (OR 5.01; 95% CI: 2.12-11.84) were identified with maximal pool odd's ratio. While previous use of amikacin (OR 4.94; 95% CI: 1.89-12.90) and exposure to carbapenem (OR 4.91; 95% CI: 2.65-9.10) were the foremost factors associated with developing CRAB infection. Further analysis revealed, mechanical ventilation (OR 7.21; 95% CI: 3.79-13.71) and ICU stay (OR 5.88; 95% CI: 3.27-10.57) as the most significant factors for XDRAB infection.

Conclusion: The exposure of carbapenem, amikacin (previous) and mechanical ventilation were the most significant risk factors for multidrug, extensive-drug, and carbapenem resistance in patients with A. baumannii infection respectively. These findings may guide to control and prevent resistant infections by identifying the patients at higher risk of developing resistance.

背景:鲍曼不动杆菌是造成医院内感染和高死亡率的主要原因。对此类耐药性感染的风险因素进行评估有助于监测和诊断工作,对早期和适当的抗生素治疗也至关重要:方法:前瞻性或回顾性病例研究:方法:通过 MEDLINE/PubMed 和 OVID/Embase 两个数据源收集报告耐药鲍曼不动杆菌感染风险因素的前瞻性或回顾性队列研究和病例对照研究。纳入了以英语发表的研究,但排除了动物研究。采用纽卡斯尔-渥太华量表评估研究质量。采用随机效应模型对鲍曼不动杆菌感染患者产生抗生素耐药性的几率进行了汇总:结果:38 项研究共 60878 名参与者(6394 例病例和 54484 例对照)。耐多药(MDRAB)、广泛耐药(XDRAB)、耐碳青霉烯类(CRAB)和耐亚胺培南鲍曼尼菌感染(IRAB)的风险因素分别为 28、14、25 和 11 个。在 MDRAB 感染组中,暴露于碳青霉烯类(OR 5.51;95% CI:3.88-7.81)和气管切开术(OR 5.01;95% CI:2.12-11.84)被认为具有最大的池奇比。之前使用过阿米卡星(OR 4.94;95% CI:1.89-12.90)和接触过碳青霉烯类(OR 4.91;95% CI:2.65-9.10)是与 CRAB 感染相关的首要因素。进一步分析表明,机械通气(OR 7.21;95% CI:3.79-13.71)和重症监护室住院(OR 5.88;95% CI:3.27-10.57)是导致 XDRAB 感染的最重要因素:结论:暴露于碳青霉烯类、阿米卡星(既往)和机械通气分别是鲍曼不动杆菌感染患者对多药、广药和碳青霉烯类耐药的最重要风险因素。这些发现可通过识别耐药风险较高的患者,为控制和预防耐药感染提供指导。
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引用次数: 0
Can Twitter posts serve as early indicators for potential safety signals? A retrospective analysis. 推特帖子能作为潜在安全信号的早期指示器吗?回顾性分析。
IF 1.7 Q4 PUBLIC, ENVIRONMENTAL & OCCUPATIONAL HEALTH Pub Date : 2023-01-01 DOI: 10.3233/JRS-210024
Revati Pathak, Daniel Catalan-Matamoros

Background: As Twitter has gained significant popularity, tweets can serve as large pool of readily available data to estimate the adverse events (AEs) of medications.

Objective: This study evaluated whether tweets were an early indicator for potential safety warnings. Additionally, the trend of AEs posted on Twitter was compared with AEs from the Yellow Card system in the United Kingdom.

Methods: English Tweets for 35 drug-event pairs for the period 2017-2019, two years prior to the date of EMA Pharmacovigilance Risk Assessment Committee (PRAC) meeting, were collected. Both signal and non-signal AEs were manually identified and encoded using the MedDRA dictionary. AEs from Yellow Card were also gathered for the same period. Descriptive and inferential statistical analysis was conducted using Fisher's exact test to assess the distribution and proportion of AEs from the two data sources.

Results: Of the total 61,661 English tweets, 1,411 had negative or neutral sentiment and mention of at least one AE. Tweets for 15 out of the 35 drugs (42.9%) contained AEs associated with the signals. On pooling data from Twitter and Yellow Card, 24 out of 35 drug-event pairs (68.6%) were identified prior to the respective PRAC meetings. Both data sources showed similar distribution of AEs based on seriousness, however, the distribution based on labelling was divergent.

Conclusion: Twitter cannot be used in isolation for signal detection in current pharmacovigilance (PV) systems. However, it can be used in combination with traditional PV systems for early signal detection, as it can provide a holistic drug safety profile.

背景:随着Twitter的普及,Twitter可以作为估计药物不良事件(ae)的大量可用数据池。目的:本研究评估推特是否是潜在安全预警的早期指标。此外,还将Twitter上发布的ae趋势与英国黄牌系统的ae趋势进行了比较。方法:收集2017-2019年(EMA药物警戒风险评估委员会(PRAC)会议召开前两年)期间35对药物事件对的英文推文。使用MedDRA字典手动识别和编码信号和非信号ae。黄牌的ae也在同一时期被收集。使用Fisher精确检验进行描述性和推断性统计分析,以评估来自两个数据源的ae的分布和比例。结果:在总共61661条英文推文中,1411条有负面或中立的情绪,并且提到了至少一个AE。35种药物中有15种(42.9%)的推文包含与信号相关的ae。通过汇总Twitter和黄卡的数据,在各自的PRAC会议之前确定了35对药物事件中的24对(68.6%)。两个数据来源显示基于严重程度的ae分布相似,然而,基于标签的分布是不同的。结论:Twitter不能单独用于当前药物警戒(PV)系统的信号检测。然而,它可以与传统的PV系统结合使用,用于早期信号检测,因为它可以提供整体的药物安全性概况。
{"title":"Can Twitter posts serve as early indicators for potential safety signals? A retrospective analysis.","authors":"Revati Pathak,&nbsp;Daniel Catalan-Matamoros","doi":"10.3233/JRS-210024","DOIUrl":"https://doi.org/10.3233/JRS-210024","url":null,"abstract":"<p><strong>Background: </strong>As Twitter has gained significant popularity, tweets can serve as large pool of readily available data to estimate the adverse events (AEs) of medications.</p><p><strong>Objective: </strong>This study evaluated whether tweets were an early indicator for potential safety warnings. Additionally, the trend of AEs posted on Twitter was compared with AEs from the Yellow Card system in the United Kingdom.</p><p><strong>Methods: </strong>English Tweets for 35 drug-event pairs for the period 2017-2019, two years prior to the date of EMA Pharmacovigilance Risk Assessment Committee (PRAC) meeting, were collected. Both signal and non-signal AEs were manually identified and encoded using the MedDRA dictionary. AEs from Yellow Card were also gathered for the same period. Descriptive and inferential statistical analysis was conducted using Fisher's exact test to assess the distribution and proportion of AEs from the two data sources.</p><p><strong>Results: </strong>Of the total 61,661 English tweets, 1,411 had negative or neutral sentiment and mention of at least one AE. Tweets for 15 out of the 35 drugs (42.9%) contained AEs associated with the signals. On pooling data from Twitter and Yellow Card, 24 out of 35 drug-event pairs (68.6%) were identified prior to the respective PRAC meetings. Both data sources showed similar distribution of AEs based on seriousness, however, the distribution based on labelling was divergent.</p><p><strong>Conclusion: </strong>Twitter cannot be used in isolation for signal detection in current pharmacovigilance (PV) systems. However, it can be used in combination with traditional PV systems for early signal detection, as it can provide a holistic drug safety profile.</p>","PeriodicalId":45237,"journal":{"name":"INTERNATIONAL JOURNAL OF RISK & SAFETY IN MEDICINE","volume":"34 1","pages":"41-61"},"PeriodicalIF":1.7,"publicationDate":"2023-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10839060","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}
引用次数: 1
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INTERNATIONAL JOURNAL OF RISK & SAFETY IN MEDICINE
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