Journal of Evidence‐Based Medicine最新文献

{"title":"Guidance Documents for Off-Label Drug Use Management for Chinese Health Care Institutions: A Scoping Review.","authors":"Changcheng Shi, Yingying Yang, Changling Wu, Limin Wang, Yehua Dong, Yajun Qi, Lingling Hu, Ling Chen, Qingyu Li, Qianqian Jiang, Nengming Lin, Gang Wang","doi":"10.1111/jebm.12669","DOIUrl":"https://doi.org/10.1111/jebm.12669","url":null,"abstract":"<p><strong>Background: </strong>Off-label drug use (OLDU) is a common practice in health care institutions, and numerous guidance documents have been developed to guide the management of OLDU in China. This scoping review aims to compare these documents and identify existing issues.</p><p><strong>Methods: </strong>PubMed, EMbase, three Chinese databases, the National Public Service Platform for Standards Information and the official websites of pharmaceutical-related associations were searched to identify guidance documents relevant to the management of OLDU for Chinese health care institutions. We extracted and compared the recommended practices for various aspects of OLDU management, including management systems, organizational structure, prerequisites for OLDU, approval processes, evidence-based evaluation, informed consent, and other related aspects.</p><p><strong>Results: </strong>A total of 16 guidance documents were included, comprising 12 expert consensuses, 2 practice guidelines, and 2 group standards. Only six documents provide specific requirements for the establishment of management systems. Management of OLDU requires involvement from multiple departments or committees, yet only a few documents explicitly delineate the supervisory authority, and the responsibilities of the parties involved. These documents also show significant disparities in their approval process, evidence-based evaluation, and informed consent recommendations. Furthermore, only a minority of the documents provide specific requirements for training and assessments focused on OLDU and improving adverse reaction monitoring.</p><p><strong>Conclusion: </strong>These guidance documents differ significantly in their specific recommendations for the management of OLDU and lack sufficient emphasis on certain critical aspects. It may be beneficial for health administrative authorities to promote the development of unified national guidelines.</p>","PeriodicalId":16090,"journal":{"name":"Journal of Evidence‐Based Medicine","volume":" ","pages":""},"PeriodicalIF":3.6,"publicationDate":"2024-12-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142882280","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Patient-Reported Outcome Scale for Idiopathic Pulmonary Fibrosis: Development and Validation in China.","authors":"Yang Xie, Peng Zhang, Jiaming Ren, Tao Chen, Jiajia Wang, Jiansheng Li","doi":"10.1111/jebm.12659","DOIUrl":"https://doi.org/10.1111/jebm.12659","url":null,"abstract":"<p><strong>Purpose: </strong>To develop and validate the patient-reported outcome scale for idiopathic pulmonary fibrosis (IPF-PRO) to provide a reliable and scientific measure for clinical trials on idiopathic pulmonary fibrosis (IPF).</p><p><strong>Methods: </strong>We analyzed the relevant literature and medical records and conducted interviews and panel discussions to develop the conceptual framework and generate the item pool. We subjected the collected items to removal, mergence, or modification to form the initial scale through a qualitative review by experts and patients. Subsequently, we conducted two field surveys to select items for the final scale based on the classical test theory and item response theory (IRT). Finally, we conducted a formal survey to assess the measurement properties of the IPF-PRO.</p><p><strong>Results: </strong>The IPF-PRO included 18 items across four domains, namely physiology, psychology, environment, and satisfaction. The Cronbach's α coefficient and generalized coefficient of the IPF-PRO were 0.917 and 0.931, respectively. The content validity, structural validity, criterion validity, and discriminant validity all met relevant standards. The results of the item analysis based on IRT were considered acceptable. The ordinal logistic regression analysis findings showed that all items' p values were greater than 0.01 when the domain scores matched variables. The IPF-PRO response and completion rates were both 100%. The median completion time was 7 min [IRQ = 3.7 min (Q3 = 9.0 min, Q1 = 5.3 min)].</p><p><strong>Conclusion: </strong>The 18-item IPF-PRO developed in this study has demonstrated good reliability and validity, indicating that it is a reliable and scientific measure for IPF clinical trials.</p>","PeriodicalId":16090,"journal":{"name":"Journal of Evidence‐Based Medicine","volume":" ","pages":"e12659"},"PeriodicalIF":3.6,"publicationDate":"2024-12-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142872163","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Comparative Efficacy and Safety of Different Low-Dose Platelet Inhibitors in Patients With Coronary Heart Disease: A Bayesian Network Meta-Analysis.","authors":"Chunxing Li, Zhao Ren, Jia Liu, Shuo Liang, Hua Liu, Dongxiao Wang, Yue Wang, Yumin Wang","doi":"10.1111/jebm.12671","DOIUrl":"https://doi.org/10.1111/jebm.12671","url":null,"abstract":"<p><strong>Objective: </strong>The optimal low-dose antiplatelet agents in patients with coronary heart disease (CHD) had not been determined. The objective of this study was to compare the impact of different low-dose antiplatelet agents on cardiovascular outcomes and bleeding risks in patients with CHD.</p><p><strong>Methods: </strong>We searched PubMed, Embase, the Cochrane Library, China National Knowledge Infrastructure, VIP, WanFang Data, and China Biology Medicine. Randomized controlled trials (RCTs) enrolling patients with CHD treated with different low-dose platelet aggregation inhibitors were included. The revised Cochrane Risk of Bias Tool for Randomized Trials Risk was used to assess risk of bias in RCTs. A Bayesian random network meta-analysis (NMA) was conducted, with odds ratios (OR) and 95% confidence intervals (CI) as effect estimates in R 4.2.2 software and Stata 15.0. The quality of evidence was assessed using the Confidence in NMA framework.</p><p><strong>Results: </strong>Sixteen RCTs involving 6350 patients were included. All participants were treated with a recommended dose of aspirin plus a low or standard dose of P2Y12 receptor antagonist. Low-level evidence indicated the risk of major adverse cardiovascular events (MACE) was similar among low doses of prasugrel, ticagrelor, standard doses of prasugrel, ticagrelor, and clopidogrel. Low- to moderate-level evidence suggested there was no difference in bleeding risk among low dose of prasugrel, ticagrelor, clopidogrel compared to standard dose of prasugrel, ticagrelor, and clopidogrel. NMA showed that low dose of prasugrel had the highest probability of being the best intervention in terms of MACE, myocardial infarction, and bleeding events leading to discontinuation.</p><p><strong>Conclusion: </strong>Based on low-level evidence, low dose of prasugrel combined with standard dose of aspirin can be recommended for patients with CHD, low dose of ticagrelor was similar in terms of MACE and bleeding compared with standard dose of P2Y12 receptor antagonist.  : The systematic review was registered in PROSPERO with the registration number CRD42023438376.</p>","PeriodicalId":16090,"journal":{"name":"Journal of Evidence‐Based Medicine","volume":" ","pages":""},"PeriodicalIF":3.6,"publicationDate":"2024-12-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142872159","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Methodological Challenges for the Responsible Use of AI in Systematic Reviews: Risk of Bias Assessment.","authors":"Farzad Maleki, Manoochehr Karami","doi":"10.1111/jebm.12665","DOIUrl":"https://doi.org/10.1111/jebm.12665","url":null,"abstract":"","PeriodicalId":16090,"journal":{"name":"Journal of Evidence‐Based Medicine","volume":" ","pages":""},"PeriodicalIF":3.6,"publicationDate":"2024-12-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142846692","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Holistic Approach and Systematized Researcher Guidelines for the Homeopathic Treatment of Lac Caninum Migraines.","authors":"Lenka Tenžera, Tatjana Milenković, Srdjan Ljubisavljević","doi":"10.1111/jebm.12668","DOIUrl":"https://doi.org/10.1111/jebm.12668","url":null,"abstract":"","PeriodicalId":16090,"journal":{"name":"Journal of Evidence‐Based Medicine","volume":" ","pages":""},"PeriodicalIF":3.6,"publicationDate":"2024-12-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142846683","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Postmarketing Safety Surveillance of Topiramate: A Signal Detection and Analysis Study Based on the FDA Adverse Event Reporting System Database.","authors":"Kai Lin, Mengjiao He, Zuoqi Ding","doi":"10.1111/jebm.12667","DOIUrl":"https://doi.org/10.1111/jebm.12667","url":null,"abstract":"<p><strong>Objective: </strong>This study aims to investigate the occurrence of adverse events associated with topiramate by analyzing data from the FDA Adverse Event Reporting System. The goal is to provide a basis for the safe clinical use of topiramate.</p><p><strong>Methods: </strong>Adverse event data from the FDA Adverse Event Reporting System, from its inception through the first quarter of 2024, were extracted. Signal detection was conducted using three methods: the reporting odds ratio, the medicines and healthcare products regulatory agency method, and the Bayesian confidence propagation neural network. Adverse events were statistically analyzed according to the preferred term and system organ class classifications from the Medical Dictionary for Regulatory Activities version 27.0. Positive signals were then compared against the drug label and the Important Medical Event list.</p><p><strong>Results: </strong>A total of 12,168 adverse event reports involving topiramate as the primary suspect were analyzed, resulting in the extraction of 244 positive signals across 15 system organ classes. Among these, 21 signals were identified as serious adverse reactions not included in the drug label, encompassing 5 system organ classes. Notable signals included hypospadias, spina bifida, abortion spontaneous, renal tubular dysfunction, uveitis, retinal detachment, and choroidal effusion. Additionally, signals such as osmotic demyelination syndrome and Arnold-Chiari malformation were identified as requiring further monitoring.</p><p><strong>Conclusion: </strong>This study identified several unexpected and serious adverse reaction signals that align with previously reported cases. These findings underscore the need for ongoing study, focused attention, and vigilant monitoring during the clinical use of topiramate.</p>","PeriodicalId":16090,"journal":{"name":"Journal of Evidence‐Based Medicine","volume":" ","pages":""},"PeriodicalIF":3.6,"publicationDate":"2024-12-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142846701","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Misuse of Guidelines Could Disadvantage and Harm Patients.","authors":"Ernest W Lau, Hendrik Bonnemeier, Benito Baldauf","doi":"10.1111/jebm.12666","DOIUrl":"https://doi.org/10.1111/jebm.12666","url":null,"abstract":"","PeriodicalId":16090,"journal":{"name":"Journal of Evidence‐Based Medicine","volume":" ","pages":""},"PeriodicalIF":3.6,"publicationDate":"2024-12-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142837167","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Evaluating the Performance of ChatGPT-4o in Risk of Bias Assessments.","authors":"Ilari Kuitunen, Ville T Ponkilainen, Rasmus Liukkonen, Lauri Nyrhi, Oskari Pakarinen, Matias Vaajala, Mikko M Uimonen","doi":"10.1111/jebm.12662","DOIUrl":"https://doi.org/10.1111/jebm.12662","url":null,"abstract":"","PeriodicalId":16090,"journal":{"name":"Journal of Evidence‐Based Medicine","volume":" ","pages":""},"PeriodicalIF":3.6,"publicationDate":"2024-12-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142828877","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Insulin Resistance Predicts Prognosis in Patients With Subarachnoid Hemorrhage.","authors":"Pengfei Ding, Dingding Zhang, Haiping Ling, Tao Tao, Yongyue Gao, Yunfei Wang, Huasheng Zhang, Lingyun Wu, Chunhua Hang, Wei Li","doi":"10.1111/jebm.12660","DOIUrl":"https://doi.org/10.1111/jebm.12660","url":null,"abstract":"<p><strong>Objective: </strong>The objective of this study was to determine whether insulin resistance (IR) could be used as a predictor of poor prognosis at 3 months after subarachnoid hemorrhage (SAH).</p><p><strong>Methods: </strong>The study included patients aged 18 years or older with a confirmed diagnosis of SAH due to ruptured aneurysm from January 2021 to March 2024. Patients with confirmed diabetes mellitus and taking glucose-lowering drugs, or taking lipid-lowering drugs, or SAH not due to ruptured aneurysm, or comorbid systemic diseases were excluded. Patients were classified into good prognosis (modified Rankin scale [MRS] 0-2) and poor prognosis (MRS 3-6). Receiver operating characteristic curve (ROC), least absolute shrinkage and selection operator (LASSO) analysis, and multivariate logistic regression analysis were used to determine the potential of triglyceride-glucose (TyG) index and the triglyceride to high-density lipoprotein cholesterol (TG/HDL) ratio as predictors of poor prognosis. Finally, a prognostic prediction model based on IR was constructed.</p><p><strong>Results: </strong>A total of 358 patients were included in this study. Poor prognosis patients had higher age, BMI, hypertension percentage, glucose, triglycerides, TyG index and TG/HDL ratio, and lower HDL. ROC, LASSO, and multivariate logistic regression analysis revealed that age, glucose, TyG index, and TG/HDL ratio had significant potential to predict the prognosis of SAH patients. The prognostic prediction model constructed by combining age, glucose, TyG index, and TG/HDL ratio had high discriminatory power (area under the curve [AUC] = 0.80), satisfactory calibration curves, and good clinical utility.</p><p><strong>Conclusion: </strong>IR is strongly associated with the prognosis of SAH patients, and the combination of age, glucose, TyG index, and TG/HDL ratio can provide a new direction for future treatment.</p>","PeriodicalId":16090,"journal":{"name":"Journal of Evidence‐Based Medicine","volume":" ","pages":""},"PeriodicalIF":3.6,"publicationDate":"2024-12-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142828878","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Misleading Citations and Publication Bias in COVID-19 in Ophthalmology.","authors":"Giacomo Visioli, Maria Pia Pirraglia, Alessandro Lambiase, Magda Gharbiya","doi":"10.1111/jebm.12664","DOIUrl":"https://doi.org/10.1111/jebm.12664","url":null,"abstract":"","PeriodicalId":16090,"journal":{"name":"Journal of Evidence‐Based Medicine","volume":" ","pages":""},"PeriodicalIF":3.6,"publicationDate":"2024-12-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142828803","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}