Purpose: Drug-induced gynecomastia significantly affects patient health and quality of life. This study aimed to perform an exploratory analysis of gynecomastia reports and the most commonly associated medications within the FAERS database. Patients and Methods: A comprehensive analysis of the FAERS from January 2004 to December 2023 was conducted. Disproportionality analysis and subsequent sensitivity analysis were performed to identify drugs potentially associated with gynecomastia, utilizing the reported odds ratio (ROR). Logistic regression analysis was employed to assess potential risk factors. The Weibull shape parameter (WSP) test was used to assess the time-to-onset characteristics of the top drugs associated with gynecomastia. Results: The study identified 30,265 cases of gynecomastia, primarily associated with nervous system drugs, accounting for 85.50% of cases. Notably, risperidone accounted for 80.81% of the total cases. Among the 165 agents with ≥ 5 cases of gynecomastia, the strongest signals were exhibited by risperidone (ROR 602.38, 95% CI 585.07– 620.20), dutasteride (ROR 17.18, 95% CI 15.55– 18.89), spironolactone (ROR 15.8, 95% CI 13.99– 17.83), and paliperidone (ROR 7.16, 95% CI 6.55– 7.84). In the sensitivity analysis of disproportionality, unexpected associations were observed, such as montelukast (n = 21, ROR 1.94, 95% CI 1.26– 2.98). The logistic regression analysis indicated that the risk of risperidone-induced gynecomastia was significantly lower in adults compared to pediatric patients (OR 0.12, 95% CI 0.09– 0.15) and in patients with higher body weight than in those with lower body weight (OR 5.24, 95% CI 3.62– 7.76). The WSP test showed that gynecomastia induced by most of the top 10 common agents tends to occur in an early failure mode. Conclusion: The rankings and signal strengths of drugs associated with gynecomastia were extracted from the FAERS. The age distribution and time-to-onset distribution of the top 10 drugs linked to gynecomastia were investigated, which can facilitate accurate clinical recognition of drug-induced gynecomastia.
目的：药物引起的妇科炎症严重影响患者的健康和生活质量。本研究旨在对 FAERS 数据库中的妇科炎症报告和最常见的相关药物进行探索性分析：对 2004 年 1 月至 2023 年 12 月的 FAERS 进行了全面分析。利用报告的几率比（ROR）进行了比例失调分析和随后的敏感性分析，以确定可能与妇科乳腺增生有关的药物。采用逻辑回归分析评估潜在的风险因素。采用Weibull形状参数（WSP）检验来评估与妇科乳腺增生相关的主要药物的发病时间特征：研究发现了30265例妇科乳腺增生病例，其中85.50%的病例主要与神经系统药物有关。值得注意的是，利培酮占总病例数的 80.81%。在妇科肿瘤病例数≥5 例的 165 种药物中，利培酮（ROR 602.38，95% CI 585.07-620.20）、度他雄胺（ROR 17.18，95% CI 15.55-18.89）、螺内酯（ROR 15.8，95% CI 13.99-17.83）和帕利培酮（ROR 7.16，95% CI 6.55-7.84）的信号最强。在比例失调的敏感性分析中，观察到了意想不到的关联，如孟鲁司特（n = 21，ROR 1.94，95% CI 1.26-2.98）。逻辑回归分析表明，利培酮诱发妇科肿瘤的风险在成人患者中显著低于儿童患者（OR 0.12，95% CI 0.09-0.15），在体重较高的患者中显著低于体重较低的患者（OR 5.24，95% CI 3.62-7.76）。WSP测试表明，在前10种常见药物中，大多数药物诱发的妇科炎症往往发生在早期失效模式：结论：从 FAERS 中提取了与妇科乳腺增生有关的药物的排名和信号强度。结论：从 FAERS 中提取了与妇科肿瘤相关药物的排名和信号强度，研究了与妇科肿瘤相关的前 10 种药物的年龄分布和发病时间分布，有助于临床准确识别药物诱发的妇科肿瘤。
{"title":"Drug-Induced Gynecomastia: Data Mining and Analysis of the FDA Adverse Event Reporting System Database","authors":"Xiuli Yang, Xiaochun Zheng, Miaomiao Zhang, Jinlong Huang, Ping Huang, Jiangfeng Wang","doi":"10.2147/clep.s470959","DOIUrl":"https://doi.org/10.2147/clep.s470959","url":null,"abstract":"<strong>Purpose:</strong> Drug-induced gynecomastia significantly affects patient health and quality of life. This study aimed to perform an exploratory analysis of gynecomastia reports and the most commonly associated medications within the FAERS database.<br/><strong>Patients and Methods:</strong> A comprehensive analysis of the FAERS from January 2004 to December 2023 was conducted. Disproportionality analysis and subsequent sensitivity analysis were performed to identify drugs potentially associated with gynecomastia, utilizing the reported odds ratio (ROR). Logistic regression analysis was employed to assess potential risk factors. The Weibull shape parameter (WSP) test was used to assess the time-to-onset characteristics of the top drugs associated with gynecomastia.<br/><strong>Results:</strong> The study identified 30,265 cases of gynecomastia, primarily associated with nervous system drugs, accounting for 85.50% of cases. Notably, risperidone accounted for 80.81% of the total cases. Among the 165 agents with ≥ 5 cases of gynecomastia, the strongest signals were exhibited by risperidone (ROR 602.38, 95% CI 585.07– 620.20), dutasteride (ROR 17.18, 95% CI 15.55– 18.89), spironolactone (ROR 15.8, 95% CI 13.99– 17.83), and paliperidone (ROR 7.16, 95% CI 6.55– 7.84). In the sensitivity analysis of disproportionality, unexpected associations were observed, such as montelukast (n = 21, ROR 1.94, 95% CI 1.26– 2.98). The logistic regression analysis indicated that the risk of risperidone-induced gynecomastia was significantly lower in adults compared to pediatric patients (OR 0.12, 95% CI 0.09– 0.15) and in patients with higher body weight than in those with lower body weight (OR 5.24, 95% CI 3.62– 7.76). The WSP test showed that gynecomastia induced by most of the top 10 common agents tends to occur in an early failure mode.<br/><strong>Conclusion:</strong> The rankings and signal strengths of drugs associated with gynecomastia were extracted from the FAERS. The age distribution and time-to-onset distribution of the top 10 drugs linked to gynecomastia were investigated, which can facilitate accurate clinical recognition of drug-induced gynecomastia.<br/><br/><strong>Keywords:</strong> drug-induced, gynecomastia, FAERS, risperidone, time-to-onset<br/>","PeriodicalId":10362,"journal":{"name":"Clinical Epidemiology","volume":null,"pages":null},"PeriodicalIF":3.9,"publicationDate":"2024-09-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142203746","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}
Johann Kuhn, Valérie Olié, Clémence Grave, Yann Le Strat, Christophe Bonaldi, Pierre Joly
Aim: Myocardial infarction (MI) is a cardiovascular disease caused by necrosis of the myocardium, which places a heavy burden on patients. In France, the proportion of daily smokers remains high, reaching at 25.5% in 2020. We evaluated the impact of smoking reduction scenarios on the projection of MI prevalence, mean age of incident cases and number of MI prevented cases until 2035. Methods and Results: The French government has introduced smoking cessation policies that have led to an annual decrease in smoking prevalence. Based on this annual decline, we implemented three scenarios (SC) simulating an annual decrease in the proportion of smokers aged over 35 (SC1: 1%, ie, natural evolution without intervention, SC2: 2%, SC3: 9.87%) and a fourth scenario (SC4) in which there is a complete discontinuation of smoking from 2024 onwards using MI hospitalization and demographic data, estimations for the proportion of daily smokers between 35 and 95 years and multi-state models. Between 2023 and 2035, MI prevalence increased from 3.18% to 4.23% in males and from 1.00% to 1.46% in females under SC1. MI prevalence was equal to 4.21%, 4.06%, and 3.82% in males and 1.45%, 1.40%, and 1.34% in females in 2035 according to SC2, SC3, and SC4, respectively. Compared with SC1, 0.68% MI cases would be prevented with SC2, 4.52% with SC3 and 10.34% with SC4, with almost half of cases being prevented before 65 years of age. The increase in the mean age of MI incident cases ranged from 3 to 4 years among males and from 1 to 2 years among females. Conclusion: While reducing tobacco use could substantially reduce the number of MI cases prevented, its prevalence would continue to increase due to the ageing population. An integrated prevention strategy that includes the leading cardiovascular risk factors should more efficiently reduce the future burden of MI.
{"title":"Impact of Smoking Reduction Scenarios on the Burden of Myocardial Infarction in the French Population Until 2035","authors":"Johann Kuhn, Valérie Olié, Clémence Grave, Yann Le Strat, Christophe Bonaldi, Pierre Joly","doi":"10.2147/clep.s440815","DOIUrl":"https://doi.org/10.2147/clep.s440815","url":null,"abstract":"<strong>Aim:</strong> Myocardial infarction (MI) is a cardiovascular disease caused by necrosis of the myocardium, which places a heavy burden on patients. In France, the proportion of daily smokers remains high, reaching at 25.5% in 2020. We evaluated the impact of smoking reduction scenarios on the projection of MI prevalence, mean age of incident cases and number of MI prevented cases until 2035.<br/><strong>Methods and Results:</strong> The French government has introduced smoking cessation policies that have led to an annual decrease in smoking prevalence. Based on this annual decline, we implemented three scenarios (SC) simulating an annual decrease in the proportion of smokers aged over 35 (SC1: 1%, ie, natural evolution without intervention, SC2: 2%, SC3: 9.87%) and a fourth scenario (SC4) in which there is a complete discontinuation of smoking from 2024 onwards using MI hospitalization and demographic data, estimations for the proportion of daily smokers between 35 and 95 years and multi-state models. Between 2023 and 2035, MI prevalence increased from 3.18% to 4.23% in males and from 1.00% to 1.46% in females under SC1. MI prevalence was equal to 4.21%, 4.06%, and 3.82% in males and 1.45%, 1.40%, and 1.34% in females in 2035 according to SC2, SC3, and SC4, respectively. Compared with SC1, 0.68% MI cases would be prevented with SC2, 4.52% with SC3 and 10.34% with SC4, with almost half of cases being prevented before 65 years of age. The increase in the mean age of MI incident cases ranged from 3 to 4 years among males and from 1 to 2 years among females.<br/><strong>Conclusion:</strong> While reducing tobacco use could substantially reduce the number of MI cases prevented, its prevalence would continue to increase due to the ageing population. An integrated prevention strategy that includes the leading cardiovascular risk factors should more efficiently reduce the future burden of MI.<br/><br/><strong>Keywords:</strong> myocardial infarction, prevalence, burden, projection, tobacco control, smoking prevalence<br/>","PeriodicalId":10362,"journal":{"name":"Clinical Epidemiology","volume":null,"pages":null},"PeriodicalIF":3.9,"publicationDate":"2024-09-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142203747","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}
Pub Date : 2024-09-04eCollection Date: 2024-01-01DOI: 10.2147/CLEP.S493274
Avid Wijaya, Endang Sri Dewi Hastuti Suryandari, Dea Allan Karunia Sakti, Tsalits Maulidah Hariez, Harinto Nur Seha
{"title":"Using Routinely Collected Electronic Healthcare Record Data to Investigate Fibrotic Multimorbidity in England [Letter].","authors":"Avid Wijaya, Endang Sri Dewi Hastuti Suryandari, Dea Allan Karunia Sakti, Tsalits Maulidah Hariez, Harinto Nur Seha","doi":"10.2147/CLEP.S493274","DOIUrl":"https://doi.org/10.2147/CLEP.S493274","url":null,"abstract":"","PeriodicalId":10362,"journal":{"name":"Clinical Epidemiology","volume":null,"pages":null},"PeriodicalIF":3.4,"publicationDate":"2024-09-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11380843/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142153286","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Background: Gastrointestinal tumors represent a significant component of the cancer burden in Asia. This study aims to evaluate the burden of gastrointestinal tumors in Asia from 1990 to 2021 using data from the Global Burden of Disease Study 2021 (GBD 2021). Methods: The absolute incidence, mortality, and disability adjusted life years (DALYs) number and rate of six gastrointestinal tumors(colon and rectum cancer (CRC), stomach cancer (SC), pancreatic cancer (PC), esophageal cancer (EC), liver cancer (LC) and gallbladder and biliary tract cancer (GBTC)) in 48 Asian countries were extracted from GBD 2021. Differences were analyzed based on gender, age, year, location and socio-demographic index (SDI). Results: In 2021, SC accounted for the highest disease burden in Asia (DALYs=16.41million [95% UI: 13.70, 19.62]). From 1990 to 2021, the age-standardized incidence rates of EC, LC, and SC in Asia declined, while the incidence rates of CRC and PC increased significantly, with CRC showing the largest rise (AAPC=1.08 [95% CI: 1.02 to 1.12]). Gastrointestinal tumors DALY rates peaked at age 70 and above, with males generally exhibiting higher rates than females. Furthermore, East Asia bears a higher burden compared to other Asian subregions. A higher SDI correlates with increased DALY rates for PC, but no linear relationship was observed for other gastrointestinal tumors. Conclusion: The burden of gastrointestinal tumors in Asia remains high and may continue to increase. Therefore, effective prevention and treatment measures are essential to address the challenge posed by gastrointestinal tumors.
{"title":"Burden of Gastrointestinal Tumors in Asian Countries, 1990–2021: An Analysis for the Global Burden of Disease Study 2021","authors":"Donglin Jiang, Yangxue Wu, Ling Liu, Yajing Shen, Tiandong Li, Yin Lu, Peng Wang, Changqing Sun, Kaijuan Wang, Keyan Wang, Hua Ye","doi":"10.2147/clep.s472553","DOIUrl":"https://doi.org/10.2147/clep.s472553","url":null,"abstract":"<strong>Background:</strong> Gastrointestinal tumors represent a significant component of the cancer burden in Asia. This study aims to evaluate the burden of gastrointestinal tumors in Asia from 1990 to 2021 using data from the Global Burden of Disease Study 2021 (GBD 2021).<br/><strong>Methods:</strong> The absolute incidence, mortality, and disability adjusted life years (DALYs) number and rate of six gastrointestinal tumors(colon and rectum cancer (CRC), stomach cancer (SC), pancreatic cancer (PC), esophageal cancer (EC), liver cancer (LC) and gallbladder and biliary tract cancer (GBTC)) in 48 Asian countries were extracted from GBD 2021. Differences were analyzed based on gender, age, year, location and socio-demographic index (SDI).<br/><strong>Results:</strong> In 2021, SC accounted for the highest disease burden in Asia (DALYs=16.41million [95% <em>UI</em>: 13.70, 19.62]). From 1990 to 2021, the age-standardized incidence rates of EC, LC, and SC in Asia declined, while the incidence rates of CRC and PC increased significantly, with CRC showing the largest rise (AAPC=1.08 [95% <em>CI</em>: 1.02 to 1.12]). Gastrointestinal tumors DALY rates peaked at age 70 and above, with males generally exhibiting higher rates than females. Furthermore, East Asia bears a higher burden compared to other Asian subregions. A higher SDI correlates with increased DALY rates for PC, but no linear relationship was observed for other gastrointestinal tumors.<br/><strong>Conclusion:</strong> The burden of gastrointestinal tumors in Asia remains high and may continue to increase. Therefore, effective prevention and treatment measures are essential to address the challenge posed by gastrointestinal tumors.<br/><br/>","PeriodicalId":10362,"journal":{"name":"Clinical Epidemiology","volume":null,"pages":null},"PeriodicalIF":3.9,"publicationDate":"2024-09-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142203768","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}
Pub Date : 2024-09-03eCollection Date: 2024-01-01DOI: 10.2147/CLEP.S463363
Guilian Birindwa, Michael Maeng, Pernille Gro Thrane, Christine Gyldenkerne, Reimar Wernich Thomsen, Kevin Kris Warnakula Olesen
Background: Diabetes mellitus (DM) patients without coronary artery disease (CAD) have a higher all-cause mortality rate than patients with neither DM nor CAD. We examined cause-specific death of DM patients with and without CAD.
Methods: We conducted a cohort study of all patients who underwent CAG in Western Denmark between 2003 and 2016. Using Danish health registries, patients were followed for a maximum of 10 years and stratified according to their DM and CAD status. Outcomes included all-cause-, cancer-, circulatory-, and endocrinologic death. Ten-year cumulative risks were computed as well as adjusted and unadjusted hazard ratios (aHR and HR).
Results: A total of 132,432 patients (28,524 deaths, median follow-up of 6.2 years) were included. Compared to patients with neither DM nor CAD, DM patients without CAD had a higher 10-year risk of all-cause death (27.9% versus 19.7%, aHR 1.43 [95% CI 1.35-1.52]), cancer death (7.2% versus 5.4%, aHR 1.29 [95% CI 1.15-1.46]), circulatory death (9.1% versus 6.9%, aHR 1.35 [95% CI 1.22-1.49]), and endocrinologic death (3.9% versus 0.3%, aHR 14.02 [95% CI 10.95-17.95]). Among endocrinologic deaths, 87% were due to classical complications of DM, such as diabetic nephropathy and ketoacidosis, in DM patients without CAD.
Conclusion: Diabetes patients without CAD exhibit a higher risk of all-cause mortality, driven primarily by elevated rates of cancer, circulatory, and endocrinologic deaths, particularly related to diabetic microvascular complications.
{"title":"Causes of Excess Mortality in Diabetes Patients Without Coronary Artery Disease: A Cohort Study Revealing Endocrinologic Contributions.","authors":"Guilian Birindwa, Michael Maeng, Pernille Gro Thrane, Christine Gyldenkerne, Reimar Wernich Thomsen, Kevin Kris Warnakula Olesen","doi":"10.2147/CLEP.S463363","DOIUrl":"https://doi.org/10.2147/CLEP.S463363","url":null,"abstract":"<p><strong>Background: </strong>Diabetes mellitus (DM) patients without coronary artery disease (CAD) have a higher all-cause mortality rate than patients with neither DM nor CAD. We examined cause-specific death of DM patients with and without CAD.</p><p><strong>Methods: </strong>We conducted a cohort study of all patients who underwent CAG in Western Denmark between 2003 and 2016. Using Danish health registries, patients were followed for a maximum of 10 years and stratified according to their DM and CAD status. Outcomes included all-cause-, cancer-, circulatory-, and endocrinologic death. Ten-year cumulative risks were computed as well as adjusted and unadjusted hazard ratios (aHR and HR).</p><p><strong>Results: </strong>A total of 132,432 patients (28,524 deaths, median follow-up of 6.2 years) were included. Compared to patients with neither DM nor CAD, DM patients without CAD had a higher 10-year risk of all-cause death (27.9% versus 19.7%, aHR 1.43 [95% CI 1.35-1.52]), cancer death (7.2% versus 5.4%, aHR 1.29 [95% CI 1.15-1.46]), circulatory death (9.1% versus 6.9%, aHR 1.35 [95% CI 1.22-1.49]), and endocrinologic death (3.9% versus 0.3%, aHR 14.02 [95% CI 10.95-17.95]). Among endocrinologic deaths, 87% were due to classical complications of DM, such as diabetic nephropathy and ketoacidosis, in DM patients without CAD.</p><p><strong>Conclusion: </strong>Diabetes patients without CAD exhibit a higher risk of all-cause mortality, driven primarily by elevated rates of cancer, circulatory, and endocrinologic deaths, particularly related to diabetic microvascular complications.</p>","PeriodicalId":10362,"journal":{"name":"Clinical Epidemiology","volume":null,"pages":null},"PeriodicalIF":3.4,"publicationDate":"2024-09-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11380490/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142153285","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Jonas F Ludvigsson, Johan Askling, Sven Cnattingius, Per Hall, Lars Klareskog, Olof Nyren, John A Baron, Henrik Toft Sørensen
{"title":"Obituary – Anders Ekbom","authors":"Jonas F Ludvigsson, Johan Askling, Sven Cnattingius, Per Hall, Lars Klareskog, Olof Nyren, John A Baron, Henrik Toft Sørensen","doi":"10.2147/clep.s490837","DOIUrl":"https://doi.org/10.2147/clep.s490837","url":null,"abstract":"<strong>","PeriodicalId":10362,"journal":{"name":"Clinical Epidemiology","volume":null,"pages":null},"PeriodicalIF":3.9,"publicationDate":"2024-08-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142203748","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}
Pub Date : 2024-08-28eCollection Date: 2024-01-01DOI: 10.2147/CLEP.S459600
Derek J Bays, Emily N Jenkins, Meghan Lyman, Tom Chiller, Nora Strong, Luis Ostrosky-Zeichner, Martin Hoenigl, Peter G Pappas, George R Thompson Iii
Invasive candidiasis (IC) is an increasingly prevalent, costly, and potentially fatal infection brought on by the opportunistic yeast, Candida. Previously, IC has predominantly been caused by C. albicans which is often drug susceptible. There has been a global trend towards decreasing rates of infection secondary to C. albicans and a rise in non-albicans species with a corresponding increase in drug resistance creating treatment challenges. With advances in management of malignancies, there has also been an increase in the population at risk from IC along with a corresponding increase in incidence of breakthrough IC infections. Additionally, the emergence of C. auris creates many challenges in management and prevention due to drug resistance and the organism's ability to transmit rapidly in the healthcare setting. While the development of novel antifungals is encouraging for future management, understanding the changing epidemiology of IC is a vital step in future management and prevention.
侵袭性念珠菌病（IC）是由机会性酵母菌白色念珠菌引起的一种日益流行、代价高昂且可能致命的感染。以前，IC 主要由白色念珠菌引起，而白色念珠菌通常对药物敏感。全球趋势是白念珠菌继发感染率下降，非白念珠菌感染率上升，耐药性也相应增加，这给治疗带来了挑战。随着恶性肿瘤治疗的进步，IC 的高危人群也在增加，突破性 IC 感染的发病率也相应增加。此外，由于耐药性和该病菌在医疗环境中的快速传播能力，法氏囊菌的出现给管理和预防带来了许多挑战。新型抗真菌药物的开发为未来的管理带来了鼓舞，而了解不断变化的 IC 流行病学则是未来管理和预防的重要一步。
{"title":"Epidemiology of Invasive Candidiasis.","authors":"Derek J Bays, Emily N Jenkins, Meghan Lyman, Tom Chiller, Nora Strong, Luis Ostrosky-Zeichner, Martin Hoenigl, Peter G Pappas, George R Thompson Iii","doi":"10.2147/CLEP.S459600","DOIUrl":"10.2147/CLEP.S459600","url":null,"abstract":"<p><p>Invasive candidiasis (IC) is an increasingly prevalent, costly, and potentially fatal infection brought on by the opportunistic yeast, <i>Candida</i>. Previously, IC has predominantly been caused by <i>C. albicans</i> which is often drug susceptible. There has been a global trend towards decreasing rates of infection secondary to <i>C. albicans</i> and a rise in non-<i>albicans</i> species with a corresponding increase in drug resistance creating treatment challenges. With advances in management of malignancies, there has also been an increase in the population at risk from IC along with a corresponding increase in incidence of breakthrough IC infections. Additionally, the emergence of <i>C. auris</i> creates many challenges in management and prevention due to drug resistance and the organism's ability to transmit rapidly in the healthcare setting. While the development of novel antifungals is encouraging for future management, understanding the changing epidemiology of IC is a vital step in future management and prevention.</p>","PeriodicalId":10362,"journal":{"name":"Clinical Epidemiology","volume":null,"pages":null},"PeriodicalIF":3.4,"publicationDate":"2024-08-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11366240/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142105018","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-08-27eCollection Date: 2024-01-01DOI: 10.2147/CLEP.S470111
Marie Haase Juhl, Anne Estrup Olesen, Ellen Tveter Deilkås, Niels Henrik Bruun, Kirsten Høgh Obling, Nikoline Rytter, Maya Damgaard Larsen, Solvejg Kristensen
Background: A lack of instruments to assess patient safety climate within primary care exists. The objectives of this study were as follows: 1) To adapt the Danish hospital version of the Safety Attitudes Questionnaire (SAQ-DK) for use in primary care; 2) Test the internal consistency and the construct validity of this version; 3) Present benchmark data; and 4) Analyze variance.
Methods: The SAQ-DK was adapted for use in Danish primary care settings (SAQ-DK-PRIM) and distributed to healthcare staff members from nursing homes (N = 11), homecare units (N = 4) and healthcare units (N = 2), within the municipality of Aarhus, Central Denmark Region, Denmark. Face- and content validity were assessed. The construct validity was evaluated by a set of goodness-of-fit indices. The internal reliability was evaluated using the item-rest correlations, the inter-item correlations, and Cronbach's alpha (α).
Results: The adaptation process resulted in a questionnaire of 10 items. Eight hundred and thirty healthcare staffs participated (78% of the eligible respondents). In total 586 (70.6%) responses were complete and were included in the analysis. Goodness-of-fit indices from the confirmatory factor analysis showed: Chi2=46.90CFI=0.97, RMSEA = 0.063 (90% CI: 0.044-0.084), Probability RMSEA (p close)=0.12. Internal reliability was high (Cronbach's α=0.76). Proportions of participants with a positive attitude was 41.1% and did not differ between the healthcare services. Scale mean score was 70.19 (SD: 18.05) and differed between healthcare services. The safety climate scale scores did not vary according to healthcare service type. ICC was 0.68% indicating no clustering of scores by healthcare service type.
Conclusion: Considering the questionnaire's applicability, short length, strengthened focus on one area of interest and validity, the SAQ-DK-PRIM can serve as a valuable tool for measuring patient safety climate within primary care settings in Denmark.
{"title":"Patient Safety Climate in Danish Primary Care: Adaption and Validation of the Danish Safety Attitudes Questionnaire (SAQ-DK-PRIM).","authors":"Marie Haase Juhl, Anne Estrup Olesen, Ellen Tveter Deilkås, Niels Henrik Bruun, Kirsten Høgh Obling, Nikoline Rytter, Maya Damgaard Larsen, Solvejg Kristensen","doi":"10.2147/CLEP.S470111","DOIUrl":"10.2147/CLEP.S470111","url":null,"abstract":"<p><strong>Background: </strong>A lack of instruments to assess patient safety climate within primary care exists. The objectives of this study were as follows: 1) To adapt the Danish hospital version of the Safety Attitudes Questionnaire (SAQ-DK) for use in primary care; 2) Test the internal consistency and the construct validity of this version; 3) Present benchmark data; and 4) Analyze variance.</p><p><strong>Methods: </strong>The SAQ-DK was adapted for use in Danish primary care settings (SAQ-DK-PRIM) and distributed to healthcare staff members from nursing homes (N = 11), homecare units (N = 4) and healthcare units (N = 2), within the municipality of Aarhus, Central Denmark Region, Denmark. Face- and content validity were assessed. The construct validity was evaluated by a set of goodness-of-fit indices. The internal reliability was evaluated using the item-rest correlations, the inter-item correlations, and Cronbach's alpha (α).</p><p><strong>Results: </strong>The adaptation process resulted in a questionnaire of 10 items. Eight hundred and thirty healthcare staffs participated (78% of the eligible respondents). In total 586 (70.6%) responses were complete and were included in the analysis. Goodness-of-fit indices from the confirmatory factor analysis showed: Chi<sup>2</sup>=46.90CFI=0.97, RMSEA = 0.063 (90% CI: 0.044-0.084), Probability RMSEA (p close)=0.12. Internal reliability was high (Cronbach's α=0.76). Proportions of participants with a positive attitude was 41.1% and did not differ between the healthcare services. Scale mean score was 70.19 (SD: 18.05) and differed between healthcare services. The safety climate scale scores did not vary according to healthcare service type. ICC was 0.68% indicating no clustering of scores by healthcare service type.</p><p><strong>Conclusion: </strong>Considering the questionnaire's applicability, short length, strengthened focus on one area of interest and validity, the SAQ-DK-PRIM can serve as a valuable tool for measuring patient safety climate within primary care settings in Denmark.</p>","PeriodicalId":10362,"journal":{"name":"Clinical Epidemiology","volume":null,"pages":null},"PeriodicalIF":3.4,"publicationDate":"2024-08-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11365490/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142105019","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Örvar Arnarson, Peter Moberger, Filip Sköldberg, Kenneth Smedh, Helgi Birgisson, Ingvar Syk
Background: There is an urgent need to evaluate the quality of healthcare systems to improve and deliver high-quality care. Clinical registries have become important platforms for performance measurements, improvements, and clinical research. Hence, the quality of data in registries is crucial. This study aimed to assess the validity of data in the Swedish Colorectal Cancer Register (SCRCR). Methods: Seven hundred patients from 12 hospitals were randomly selected and proportionally distributed among three different hospital categories in Sweden using two-stage cluster sampling. Validity was assessed by re-abstracting data from the medical files of patients reported to the SCRCR in 2015. Data on histopathology, postoperative complications, and a 3-year follow-up were selected for validation. Re-abstracted data were defined as source data, and validity was defined as the proportion of cases in the SRCRC dataset that agreed with the source data. Validity was expressed as the percentage of exact agreement of non-missing data in both data sets, and Cohen´s kappa coefficient (κ) was used to measure the strength of the agreement. Results: The median agreement of the categorical histopathology variables was 93.4% (κ = 0.83). The general postoperative complication variable showed substantial agreement (84.3%, κ = 0.61). Likewise, the variable for overall cancer recurrence showed an almost perfect agreement (95.7%, κ = 0.86), whereas specific variables for local recurrence and distant recurrence displayed only moderate and fair agreement (85.9% and 89.1%, κ = 0.58 and 0.34, respectively). Conclusion: Validation of the SCRCR data showed high validity of pathology data and recurrence rates, whereas detailed data on recurrence were not as good. Data on postoperative complications were less reliable, although the incidence and Clavien–Dindo grading of severe complications (grade 3b or higher) were reliable.
{"title":"A Validation of the Swedish Colorectal Cancer Register – With Focus on Histopathology, Complications and Recurrences","authors":"Örvar Arnarson, Peter Moberger, Filip Sköldberg, Kenneth Smedh, Helgi Birgisson, Ingvar Syk","doi":"10.2147/clep.s466029","DOIUrl":"https://doi.org/10.2147/clep.s466029","url":null,"abstract":"<strong>Background:</strong> There is an urgent need to evaluate the quality of healthcare systems to improve and deliver high-quality care. Clinical registries have become important platforms for performance measurements, improvements, and clinical research. Hence, the quality of data in registries is crucial. This study aimed to assess the validity of data in the Swedish Colorectal Cancer Register (SCRCR).<br/><strong>Methods:</strong> Seven hundred patients from 12 hospitals were randomly selected and proportionally distributed among three different hospital categories in Sweden using two-stage cluster sampling. Validity was assessed by re-abstracting data from the medical files of patients reported to the SCRCR in 2015. Data on histopathology, postoperative complications, and a 3-year follow-up were selected for validation. Re-abstracted data were defined as source data, and validity was defined as the proportion of cases in the SRCRC dataset that agreed with the source data. Validity was expressed as the percentage of exact agreement of non-missing data in both data sets, and Cohen´s kappa coefficient (κ) was used to measure the strength of the agreement.<br/><strong>Results:</strong> The median agreement of the categorical histopathology variables was 93.4% (κ = 0.83). The general postoperative complication variable showed substantial agreement (84.3%, κ = 0.61). Likewise, the variable for overall cancer recurrence showed an almost perfect agreement (95.7%, κ = 0.86), whereas specific variables for local recurrence and distant recurrence displayed only moderate and fair agreement (85.9% and 89.1%, κ = 0.58 and 0.34, respectively).<br/><strong>Conclusion:</strong> Validation of the SCRCR data showed high validity of pathology data and recurrence rates, whereas detailed data on recurrence were not as good. Data on postoperative complications were less reliable, although the incidence and Clavien–Dindo grading of severe complications (grade 3b or higher) were reliable.<br/><br/>","PeriodicalId":10362,"journal":{"name":"Clinical Epidemiology","volume":null,"pages":null},"PeriodicalIF":3.9,"publicationDate":"2024-08-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141936949","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}
Morten Breinholt Søvsø, Rasmine Birch Haurum, Trine Hagelskær Ebbesen, Ann Øster Rasmussen, Logan Morgan Ward, Mads Lause Mogensen, Erika Frischknecht Christensen, Tim Alex Lindskou
Introduction: Ambulance requests by general practitioners for primary care patients (GP-requested) are often omitted in studies on increased demand within emergency care but may comprise a substantial patient group. We aimed to assess acute severity, intensive care unit (ICU) admission, and diagnostic pattern, including comorbidity, and mortality among GP-requested ambulance patients, compared to emergency call ambulance patients. Our hypothesis was that emergency call patients had more severe health issues than GP-requested ambulance patients. Methods: Historic population-based cohort study of ambulance patients in the North Denmark Region, 2016– 2020. Hospital contact data including diagnoses, ambulance data, vital signs and vital status was linked using each patient’s unique identification number. Primary outcome measure was mortality within 1, 7, and 30 days. Secondary outcomes were disease severity expressed as modified National Early Warning Score (NEWS2), and ICU admission. Admission status and hospital diagnostic pattern, including comorbidity were described and compared. Results: We included 255,487 patients. GP-requested patients (N = 119,361, 46.7%) were older (median years [IQR] 73 [58– 83] versus 61 [37– 76]) and more had moderate/severe comorbidity (11.9%, N = 13,806 versus 4.9%, N = 6145) than the emergency call patients. Prehospital mNEWS2 median scores were lower for GP-requested patients. For both groups, mNEWS2 was highest among patients aged 66+. GP-requested patients had higher 30-day mortality (9.0% (95% CI: 8.8– 9.2), N = 8996) than emergency call patients (5.2% (95% CI: 5.1– 5.4), N = 6727). Circulatory (12.0%, 11,695/97,112) and respiratory diseases (11.6%, 11,219/97,112) were more frequent among GP-requested patients than emergency call patients ((10.7%, 12,640/118,102) and (5.8%, 6858/118,102)). The highest number of deaths was found for health issues ‘circulatory diseases’ in the emergency call group and ‘other factors’ followed by “respiratory diseases” in the GP-requested group. Conclusion: GP-requested patients constituted nearly half of the EMS volume, they were older, with more comorbidity, had serious conditions with substantial acute severity, and a higher 30-day mortality than emergency call patients.
Keywords: emergency medical services, mortality, diagnoses, early warning scores, after-hours care, primary healthcare, general practitioners
{"title":"Emergency Call versus General Practitioner Requested Ambulances – Patient Mortality, Disease Severity and Pattern","authors":"Morten Breinholt Søvsø, Rasmine Birch Haurum, Trine Hagelskær Ebbesen, Ann Øster Rasmussen, Logan Morgan Ward, Mads Lause Mogensen, Erika Frischknecht Christensen, Tim Alex Lindskou","doi":"10.2147/clep.s469430","DOIUrl":"https://doi.org/10.2147/clep.s469430","url":null,"abstract":"<strong>Introduction:</strong> Ambulance requests by general practitioners for primary care patients (GP-requested) are often omitted in studies on increased demand within emergency care but may comprise a substantial patient group. We aimed to assess acute severity, intensive care unit (ICU) admission, and diagnostic pattern, including comorbidity, and mortality among GP-requested ambulance patients, compared to emergency call ambulance patients. Our hypothesis was that emergency call patients had more severe health issues than GP-requested ambulance patients.<br/><strong>Methods:</strong> Historic population-based cohort study of ambulance patients in the North Denmark Region, 2016– 2020. Hospital contact data including diagnoses, ambulance data, vital signs and vital status was linked using each patient’s unique identification number. Primary outcome measure was mortality within 1, 7, and 30 days. Secondary outcomes were disease severity expressed as modified National Early Warning Score (NEWS2), and ICU admission. Admission status and hospital diagnostic pattern, including comorbidity were described and compared.<br/><strong>Results:</strong> We included 255,487 patients. GP-requested patients (N = 119,361, 46.7%) were older (median years [IQR] 73 [58– 83] versus 61 [37– 76]) and more had moderate/severe comorbidity (11.9%, N = 13,806 versus 4.9%, N = 6145) than the emergency call patients. Prehospital mNEWS2 median scores were lower for GP-requested patients. For both groups, mNEWS2 was highest among patients aged 66+. GP-requested patients had higher 30-day mortality (9.0% (95% CI: 8.8– 9.2), N = 8996) than emergency call patients (5.2% (95% CI: 5.1– 5.4), N = 6727). Circulatory (12.0%, 11,695/97,112) and respiratory diseases (11.6%, 11,219/97,112) were more frequent among GP-requested patients than emergency call patients ((10.7%, 12,640/118,102) and (5.8%, 6858/118,102)). The highest number of deaths was found for health issues ‘circulatory diseases’ in the emergency call group and ‘other factors’ followed by “respiratory diseases” in the GP-requested group.<br/><strong>Conclusion:</strong> GP-requested patients constituted nearly half of the EMS volume, they were older, with more comorbidity, had serious conditions with substantial acute severity, and a higher 30-day mortality than emergency call patients.<br/><br/><strong>Keywords:</strong> emergency medical services, mortality, diagnoses, early warning scores, after-hours care, primary healthcare, general practitioners<br/>","PeriodicalId":10362,"journal":{"name":"Clinical Epidemiology","volume":null,"pages":null},"PeriodicalIF":3.9,"publicationDate":"2024-07-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141869191","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}
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