This meta-analysis aimed to evaluate the performance of machine learning (ML) models in predicting postoperative delirium (POD) and to provide guidance for clinical application.
Methods
PubMed, Embase, Cochrane Library, and Web of Science databases were searched from inception to April 29, 2024. Studies reported ML models for predicting POD in adult patients were included. Data extraction and risk of bias assessment were performed using the Transparent Reporting of a multivariable prediction model for Individual Prognosis Or Diagnosis - AI (TRIPOD-AI) and Prediction model Risk Of Bias ASsessment Tool (PROBAST) tools. Meta-analysis with the area under the curve (AUC) was performed using MedCalc software.
Findings
A total of 23 studies were included after screening. Age (n = 20, 86.95%) and Random Forest (RF) (n = 24, 17.27%) were the most frequently used feature and ML algorithm, respectively. The meta-analysis showed an overall AUC of 0.792. The ensemble models (AUC = 0.805) showed better predictive performance than single models (AUC = 0.782). Additionally, considerable variations in AUC were found among different ML algorithms, with AdaBoost (AB) demonstrating good performance with AUC of 0.870. Notably, the generalizability of these models was uncertain due to limitations in external validation and bias assessment.
Implications
The performance of ensemble models were higher than single models, and the AB algorithms demonstrated better performance, compared with other algorithms. However, further research was needed to enhance the generalizability and transparency of ML models.
目的:本荟萃分析旨在评估机器学习(ML)模型在预测术后谵妄(POD)方面的性能,并为临床应用提供指导:方法:检索了 PubMed、Embase、Cochrane Library 和 Web of Science 数据库中从开始到 2024 年 4 月 29 日的内容。纳入了报告成人患者 POD 预测 ML 模型的研究。数据提取和偏倚风险评估使用 "个人预后或诊断多变量预测模型透明报告-AI(TRIPOD-AI)"和 "预测模型偏倚风险评估工具(PROBAST)"工具进行。使用 MedCalc 软件对曲线下面积(AUC)进行了元分析:经过筛选,共纳入 23 项研究。年龄(n = 20,86.95%)和随机森林(RF)(n = 24,17.27%)分别是最常用的特征和 ML 算法。荟萃分析显示,总体 AUC 为 0.792。集合模型(AUC = 0.805)比单一模型(AUC = 0.782)显示出更好的预测性能。此外,不同 ML 算法的 AUC 也有很大差异,AdaBoost(AB)的 AUC 为 0.870,表现出色。值得注意的是,由于外部验证和偏差评估的局限性,这些模型的普适性并不确定:启示:集合模型的性能高于单一模型,与其他算法相比,AB 算法的性能更好。然而,要提高 ML 模型的普遍性和透明度,还需要进一步研究。
{"title":"Machine Learning for Prediction of Postoperative Delirium in Adult Patients: A Systematic Review and Meta-analysis","authors":"Hao Chen MSc , Dongdong Yu MSc , Jing Zhang MSc , Jianli Li PhD","doi":"10.1016/j.clinthera.2024.09.013","DOIUrl":"10.1016/j.clinthera.2024.09.013","url":null,"abstract":"<div><h3>Purpose</h3><div>This meta-analysis aimed to evaluate the performance of machine learning (ML) models in predicting postoperative delirium (POD) and to provide guidance for clinical application.</div></div><div><h3>Methods</h3><div>PubMed, Embase, Cochrane Library, and Web of Science databases were searched from inception to April 29, 2024. Studies reported ML models for predicting POD in adult patients were included. Data extraction and risk of bias assessment were performed using the Transparent Reporting of a multivariable prediction model for Individual Prognosis Or Diagnosis - AI (TRIPOD-AI) and Prediction model Risk Of Bias ASsessment Tool (PROBAST) tools. Meta-analysis with the area under the curve (AUC) was performed using MedCalc software.</div></div><div><h3>Findings</h3><div>A total of 23 studies were included after screening. Age (n = 20, 86.95%) and Random Forest (RF) (n = 24, 17.27%) were the most frequently used feature and ML algorithm, respectively. The meta-analysis showed an overall AUC of 0.792. The ensemble models (AUC = 0.805) showed better predictive performance than single models (AUC = 0.782). Additionally, considerable variations in AUC were found among different ML algorithms, with AdaBoost (AB) demonstrating good performance with AUC of 0.870. Notably, the generalizability of these models was uncertain due to limitations in external validation and bias assessment.</div></div><div><h3>Implications</h3><div>The performance of ensemble models were higher than single models, and the AB algorithms demonstrated better performance, compared with other algorithms. However, further research was needed to enhance the generalizability and transparency of ML models.</div></div>","PeriodicalId":10699,"journal":{"name":"Clinical therapeutics","volume":"46 12","pages":"Pages 1069-1081"},"PeriodicalIF":3.2,"publicationDate":"2024-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142459923","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-12-01DOI: 10.1016/j.clinthera.2024.09.025
Mengchen Cao MD, Ava E. Pierce MD, Marquita S. Norman MD, MBA, Bhaskar Thakur PhD, Kiersten Diercks BA, Cooper Hale MD, Yacine Issioui MD, Deborah B. Diercks MD, MSc, MBA
Purpose
High-sensitivity cardiac troponin I (hs-cTnI) and T (hs-cTnT) have been demonstrated to have lower sex-specific 99th percentiles in healthy females. However, these sex-specific thresholds are not widely adopted in clinical practice which could lead to underdiagnosis of acute myocardial infarction in females. We conducted a systematic review to explore sex-specific 99th percentiles for hs-cTnI and hs-cTnT from healthy reference populations.
Methods
The principles of the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines were used to complete this systematic review. We used PubMed and OVID EMBASE to search for original studies published between November 2017 and November 2021 that included reference populations used to establish the 99th percentiles of hs-cTnI and hs-cTnT with the following inclusion criteria: adults; English language; samples taken as part of a healthy, reference population; studies using high-sensitivity troponin assay; and sample size > 300. Studies were excluded if the reference population sample size was < 300, if a conventional troponin assay was used, or if they did not include independently derived, sex-specific 99th percentiles. Data was extracted from the studies through Covidence to perform a qualitative data synthesis. Female-specific, male-specific, and overall 99th percentiles for hs-cTn were compared.
Findings
We reviewed 131 articles of which 19 met inclusion criteria. These 19 studies derived sex-specific 99th percentiles for 11 different hs-cTnI assays and 9 different hs-cTnT assays. More than 90% (13 of 14 studies) of hs-cTnI assays found lower female 99th percentiles compared to male and to overall 99th percentiles. One study included nine different hs-cTnI assays, of which only one assay resulted in a higher female 99th percentile compared to male and to overall 99th percentiles. Eight of nine hs-cTnT studies (88.9%) found lower female 99th percentiles compared to male and to overall 99th percentiles.
Implications
The data shows significantly lower 99th percentiles in females compared to 99th percentiles in males and overall. Incorporating these sex-specific 99th percentile cut-offs into clinical practice could lead to increased diagnosis and potentially better outcomes for females presenting with acute myocardial infarction.
{"title":"Systematic Review of Sex-specific High Sensitivity Cardiac Troponin I and T Thresholds","authors":"Mengchen Cao MD, Ava E. Pierce MD, Marquita S. Norman MD, MBA, Bhaskar Thakur PhD, Kiersten Diercks BA, Cooper Hale MD, Yacine Issioui MD, Deborah B. Diercks MD, MSc, MBA","doi":"10.1016/j.clinthera.2024.09.025","DOIUrl":"10.1016/j.clinthera.2024.09.025","url":null,"abstract":"<div><h3>Purpose</h3><div>High-sensitivity cardiac troponin I (hs-cTnI) and T (hs-cTnT) have been demonstrated to have lower sex-specific 99th percentiles in healthy females. However, these sex-specific thresholds are not widely adopted in clinical practice which could lead to underdiagnosis of acute myocardial infarction in females. We conducted a systematic review to explore sex-specific 99th percentiles for hs-cTnI and hs-cTnT from healthy reference populations.</div></div><div><h3>Methods</h3><div>The principles of the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines were used to complete this systematic review. We used PubMed and OVID EMBASE to search for original studies published between November 2017 and November 2021 that included reference populations used to establish the 99th percentiles of hs-cTnI and hs-cTnT with the following inclusion criteria: adults; English language; samples taken as part of a healthy, reference population; studies using high-sensitivity troponin assay; and sample size > 300. Studies were excluded if the reference population sample size was < 300, if a conventional troponin assay was used, or if they did not include independently derived, sex-specific 99th percentiles. Data was extracted from the studies through Covidence to perform a qualitative data synthesis. Female-specific, male-specific, and overall 99th percentiles for hs-cTn were compared.</div></div><div><h3>Findings</h3><div>We reviewed 131 articles of which 19 met inclusion criteria. These 19 studies derived sex-specific 99th percentiles for 11 different hs-cTnI assays and 9 different hs-cTnT assays. More than 90% (13 of 14 studies) of hs-cTnI assays found lower female 99th percentiles compared to male and to overall 99th percentiles. One study included nine different hs-cTnI assays, of which only one assay resulted in a higher female 99th percentile compared to male and to overall 99th percentiles. Eight of nine hs-cTnT studies (88.9%) found lower female 99th percentiles compared to male and to overall 99th percentiles.</div></div><div><h3>Implications</h3><div>The data shows significantly lower 99th percentiles in females compared to 99th percentiles in males and overall. Incorporating these sex-specific 99th percentile cut-offs into clinical practice could lead to increased diagnosis and potentially better outcomes for females presenting with acute myocardial infarction.</div></div>","PeriodicalId":10699,"journal":{"name":"Clinical therapeutics","volume":"46 12","pages":"Pages 988-994"},"PeriodicalIF":3.2,"publicationDate":"2024-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142590359","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-12-01DOI: 10.1016/j.clinthera.2024.10.012
Bryn E. Mumma MD, MAS , Joseph M. Kim MD , Jason H. Rogers MD
Chest pain is one of the most common reasons for emergency department visits in the United States. Common etiologies of chest pain include both anxiety and myocardial infarction (MI); furthermore, anxiety and stress may contribute to the development of MI, particularly MI with non-obstructed coronary arteries (MINOCA). We present the cases of two women with acute chest pain in the setting of acute life stressors who were found to have MINOCA. We discuss the relationship between acute stress, chest pain, and MINOCA, as well as the importance of considering a broad differential diagnosis in women with acute chest pain.
{"title":"Chest Pain in the Setting of Acute Stress: A Tale of Two Women","authors":"Bryn E. Mumma MD, MAS , Joseph M. Kim MD , Jason H. Rogers MD","doi":"10.1016/j.clinthera.2024.10.012","DOIUrl":"10.1016/j.clinthera.2024.10.012","url":null,"abstract":"<div><div>Chest pain is one of the most common reasons for emergency department visits in the United States. Common etiologies of chest pain include both anxiety and myocardial infarction (MI); furthermore, anxiety and stress may contribute to the development of MI, particularly MI with non-obstructed coronary arteries (MINOCA). We present the cases of two women with acute chest pain in the setting of acute life stressors who were found to have MINOCA. We discuss the relationship between acute stress, chest pain, and MINOCA, as well as the importance of considering a broad differential diagnosis in women with acute chest pain.</div></div>","PeriodicalId":10699,"journal":{"name":"Clinical therapeutics","volume":"46 12","pages":"Pages 1005-1009"},"PeriodicalIF":3.2,"publicationDate":"2024-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142692369","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Response to Letter Regarding Article, “Pancreatitis and Pancreatic Cancer Risk Among Patients with Type 2 Diabetes Receiving Dipeptidyl Peptidase 4 Inhibitors: An Updated Meta-Analysis of Randomized Controlled Trials”","authors":"Adili Tuersun , Munire Mohetaer , Munire Tuerhong , Guanxin Hou , Gang Cheng","doi":"10.1016/j.clinthera.2024.09.002","DOIUrl":"10.1016/j.clinthera.2024.09.002","url":null,"abstract":"","PeriodicalId":10699,"journal":{"name":"Clinical therapeutics","volume":"46 12","pages":"Pages 1087-1088"},"PeriodicalIF":3.2,"publicationDate":"2024-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142343083","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-12-01DOI: 10.1016/j.clinthera.2024.09.019
Wensheng Liu , Xuan Ye , Han Shan , Mengmeng Wang , Yingbin Wang , Zihan Guo , Jiyong Liu , Qiong Du
Purpose
Ocular adverse events (oAEs) are a class of adverse events associated with oxaliplatin that are realistically observed in real-world settings. Herein, we aim to describe the clinical characteristics of oAEs associated with oxaliplatin through a systematic review of case reports and to assess a potential safety signal.
Methods
PubMed, Embase, and Cochrane Library databases were used to retrieve case reports. The global disproportionality study was performed leveraging the US Food and Drug Administration Adverse Event Reporting System database from January 2004 to September 2023. Bayesian information component (IC) and reporting odds ratio (ROR) were applied to identify and evaluate potential oAEs associated oxaliplatin.
Findings
A total of 20 cases from the systematic case review (of 13 screened articles) were reported on oAEs associated with oxaliplatin, with ages between 26 and 76 years. Therein, 16 (84.2%) cases described loss of vision, and the remaining cases presented with bilateral blepharoptosis, papilledema, and optic disc swelling. Insights from the US Food and Drug Administration Adverse Event Reporting System database showed that oAEs accounted for 4.28% (n = 1194) of the overall oxaliplatin-related adverse event reports, of which 1140 (95.48%) had a serious outcome. The median (interquartile range) onset time of oAEs with oxaliplatin was day 1 (0–25; n = 649). Disproportionality analysis revealed that ocular injuries NEC (n = 28, ROR, 22.72; lower limit of the 95% 2-sided CI for IC, 3.12) was the most significant signals detected. Additionally, unexpected significant oAEs, including eyelid ptosis, eyelid edema, eye movement disorder, blepharospasm, periorbital edema, swelling of eyelid, ophthalmoplegia, retinal vein thrombosis, cataract nuclear, blindness cortical, cataract subcapsular, and lacrimation disorder, were also reported disproportionality.
Implications
Our study systematically described the characteristics and outcomes of oxaliplatin-related ocular toxicity and also uncovered potential oAEs that were not disclosed in the package insert. Further prospective epidemiologic studies to validate these findings are warranted.
{"title":"Unraveling the Spectrum of Ocular Toxicity with Oxaliplatin: Clinical Feature Analysis of Cases and Pharmacovigilance Assessment of the US Food and Drug Administration Adverse Event Reporting System Database","authors":"Wensheng Liu , Xuan Ye , Han Shan , Mengmeng Wang , Yingbin Wang , Zihan Guo , Jiyong Liu , Qiong Du","doi":"10.1016/j.clinthera.2024.09.019","DOIUrl":"10.1016/j.clinthera.2024.09.019","url":null,"abstract":"<div><h3>Purpose</h3><div>Ocular adverse events (oAEs) are a class of adverse events associated with oxaliplatin that are realistically observed in real-world settings. Herein, we aim to describe the clinical characteristics of oAEs associated with oxaliplatin through a systematic review of case reports and to assess a potential safety signal.</div></div><div><h3>Methods</h3><div>PubMed, Embase, and Cochrane Library databases were used to retrieve case reports. The global disproportionality study was performed leveraging the US Food and Drug Administration Adverse Event Reporting System database from January 2004 to September 2023. Bayesian information component (IC) and reporting odds ratio (ROR) were applied to identify and evaluate potential oAEs associated oxaliplatin.</div></div><div><h3>Findings</h3><div>A total of 20 cases from the systematic case review (of 13 screened articles) were reported on oAEs associated with oxaliplatin, with ages between 26 and 76 years. Therein, 16 (84.2%) cases described loss of vision, and the remaining cases presented with bilateral blepharoptosis, papilledema, and optic disc swelling. Insights from the US Food and Drug Administration Adverse Event Reporting System database showed that oAEs accounted for 4.28% (n = 1194) of the overall oxaliplatin-related adverse event reports, of which 1140 (95.48%) had a serious outcome. The median (interquartile range) onset time of oAEs with oxaliplatin was day 1 (0–25; n = 649). Disproportionality analysis revealed that ocular injuries NEC (n = 28, ROR, 22.72; lower limit of the 95% 2-sided CI for IC, 3.12) was the most significant signals detected. Additionally, unexpected significant oAEs, including eyelid ptosis, eyelid edema, eye movement disorder, blepharospasm, periorbital edema, swelling of eyelid, ophthalmoplegia, retinal vein thrombosis, cataract nuclear, blindness cortical, cataract subcapsular, and lacrimation disorder, were also reported disproportionality.</div></div><div><h3>Implications</h3><div>Our study systematically described the characteristics and outcomes of oxaliplatin-related ocular toxicity and also uncovered potential oAEs that were not disclosed in the package insert. Further prospective epidemiologic studies to validate these findings are warranted.</div></div>","PeriodicalId":10699,"journal":{"name":"Clinical therapeutics","volume":"46 12","pages":"Pages 1049-1058"},"PeriodicalIF":3.2,"publicationDate":"2024-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142459925","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Inflammation is a response of the immune system to protect the body against various diseases or injuries. Serum trimethylamine N-oxide (TMAO) levels may vary depending on age, gender, habits, comorbidities, and microbiota.
Aims
In this study, we investigated whether TMAO levels have diagnostic significance and their potential as a marker in the early diagnosis of the disease. Another aim of the research was to identify changes in TMAO levels as a reflection of the deterioration in the microflora, and IL-6, IL-10, IL-1β, TNF-alpha, and LPS levels in patient groups. Then, we recognized relationships between these parameters in patients infected with COVID-19 without septic shock and with COVID-19 who were without transmission of COVID-19 in septic shock.
Study Design
A total of 160 patients were investigated, including 40 patients infected with COVID-19 without septic contact, 40 patients with COVID-19 positive septic shock, 40 patients with COVID-19 negative septic shock, and 40 healthy individuals as the control group.
Results
TNF-α and IL-1β levels were significantly lower (P < 0.001) and IL-6 and IL-10 levels were significantly higher (P < 0.001) in patient groups than in control groups. IL-1β showed a significant decrease, especially in the groups infected with COVID-19. Although IL-6, increased even more in the groups infected with COVID-19.
Conclusions
LPS level was remarkably high in the sepsis group infected with COVID-19 compared to the other groups. TMAO level was significantly higher (P < 0.001) in the sepsis group. Therefore, TMAO is a potential biomarker in sepsis and septic shock.
{"title":"Correlation of Triethylamine N-oxide (TMAO), LPS, and TNF-Alpha Levels With Clinical Features of the Disease in Patients With and Without Septic Shock Infected With COVID-19 Virus","authors":"Kübra Polat , Mehtap Gömleksiz , Kübra Oral , Nevzat Gözel , Gaweł Sołowski , Tugҫe Kaymaz , Mehmet Ferit Gürsu","doi":"10.1016/j.clinthera.2024.09.021","DOIUrl":"10.1016/j.clinthera.2024.09.021","url":null,"abstract":"<div><h3>Background</h3><div>Inflammation is a response of the immune system to protect the body against various diseases or injuries. Serum trimethylamine N-oxide (TMAO) levels may vary depending on age, gender, habits, comorbidities, and microbiota.</div></div><div><h3>Aims</h3><div>In this study, we investigated whether TMAO levels have diagnostic significance and their potential as a marker in the early diagnosis of the disease. Another aim of the research was to identify changes in TMAO levels as a reflection of the deterioration in the microflora, and IL-6, IL-10, IL-1β, TNF-alpha, and LPS levels in patient groups. Then, we recognized relationships between these parameters in patients infected with COVID-19 without septic shock and with COVID-19 who were without transmission of COVID-19 in septic shock.</div></div><div><h3>Study Design</h3><div>A total of 160 patients were investigated, including 40 patients infected with COVID-19 without septic contact, 40 patients with COVID-19 positive septic shock, 40 patients with COVID-19 negative septic shock, and 40 healthy individuals as the control group.</div></div><div><h3>Results</h3><div>TNF-α and IL-1β levels were significantly lower (<em>P</em> < 0.001) and IL-6 and IL-10 levels were significantly higher (<em>P</em> < 0.001) in patient groups than in control groups. IL-1β showed a significant decrease, especially in the groups infected with COVID-19. Although IL-6, increased even more in the groups infected with COVID-19.</div></div><div><h3>Conclusions</h3><div>LPS level was remarkably high in the sepsis group infected with COVID-19 compared to the other groups. TMAO level was significantly higher (<em>P</em> < 0.001) in the sepsis group. Therefore, TMAO is a potential biomarker in sepsis and septic shock.</div></div>","PeriodicalId":10699,"journal":{"name":"Clinical therapeutics","volume":"46 12","pages":"Pages e1-e8"},"PeriodicalIF":3.2,"publicationDate":"2024-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142496506","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-12-01DOI: 10.1016/j.clinthera.2024.11.006
Sarah M. Perman MD, MSCE, William Meurer MD, MS, Robert Silbergleit MD, Angela F. Jarman MD, MPH
{"title":"Advances in Enrolling Pregnant Persons Into Acute Care Clinical Trials, A Discussion With the Influence of Cooling Duration on Efficacy in Cardiac Arrest Patients (ICECAP) Trial Principal Investigators","authors":"Sarah M. Perman MD, MSCE, William Meurer MD, MS, Robert Silbergleit MD, Angela F. Jarman MD, MPH","doi":"10.1016/j.clinthera.2024.11.006","DOIUrl":"10.1016/j.clinthera.2024.11.006","url":null,"abstract":"","PeriodicalId":10699,"journal":{"name":"Clinical therapeutics","volume":"46 12","pages":"Pages 945-948"},"PeriodicalIF":3.2,"publicationDate":"2024-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142754835","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-11-30DOI: 10.1016/j.clinthera.2024.11.008
Senta Frol, René Chapot
{"title":"Letter to the Editor, Regarding \"Optimizing Acute Ischemic Stroke Outcomes: The Role of Tenecteplase Before Mechanical Thrombectomy\" Recently Published by Ketabforoush and Colleagues.","authors":"Senta Frol, René Chapot","doi":"10.1016/j.clinthera.2024.11.008","DOIUrl":"https://doi.org/10.1016/j.clinthera.2024.11.008","url":null,"abstract":"","PeriodicalId":10699,"journal":{"name":"Clinical therapeutics","volume":" ","pages":""},"PeriodicalIF":3.2,"publicationDate":"2024-11-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142767052","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-11-01DOI: 10.1016/j.clinthera.2024.08.010
Hanxu Zhang PhD , Xiaoran Hou MS , Yidan Gou MS , Yanyan Chen MS , Shuo An MD , Yingsheng Wei MD , Rongcai Jiang MD , Ye Tian MD , Hengjie Yuan PhD
Purpose
Approximately 20% to 30% of intracerebral hemorrhage (ICH) patients were reported to be on antiplatelet therapy (APT), and association between prior APT and prognosis was unclear. We aimed to clarify the impact of APT on the prognosis of ICH through an updated systematic review and meta-analysis, and to further compare the risk of single APT (SAPT) or dual APT (DAPT) prior to ICH as well as the risk associated with various antiplatelet drugs.
Methods
EMBASE, MEDLINE via Ovid SP and Web of Science were searched from inception of each database to November 4, 2023. Included studies reported prognosis in both patients with prior APT and those without.
Findings
A total of 433,103 patients from 43 studies were included in the meta-analysis. Both univariate and multivariate analyses demonstrated a significant association between prior-APT and an increased mortality risk (odd ratio [OR] 1.43, 95% confidence interval [CI] 1.28–1.59; OR 1.20, 95%CI 1.10–1.30, respectively). The risk was higher in short term follow-up (Univariate OR 1.73, 95%CI 1.22–2.46; Multivariate OR 1.94, 95%CI 1.48–2.55). A notably increased risk of hematoma expansion was also observed in patients previously treated with APT (Univariate OR 1.47, 95%CI 1.12–1.94; Multivariate OR 1.88, 95%CI 1.30–2.71), which were mainly attributed to events within 24 hours. The impact of prior-APT on poor functional outcome was inconsistent between univariate and multivariate analyses. Both direct and indirect comparisons showed that SAPT significantly reduced the risk of mortality (OR 0.67, 95%CI 0.64–0.70; OR 0.84, 95%CI 0.71–0.99) and poor functional outcome (OR 0.84, 95%CI 0.72–0.98; OR 0.81, 95%CI 0.72–0.91) compared to DAPT.
Implications
Prior-APT increased the risk of mortality and hematoma expansion in patients with ICH. The increased risk of mortality and hematoma expansion was more obvious in the short term follow-up and within 24 hours, respectively. The effect of APT on poor functional outcome exhibited inconsistency between univariate and multivariate analyses, suggesting that further investigation is warranted to clarify this relationship. In comparison with DAPT, SAPT could decrease the risk of mortality and poor functional outcome. Further studies focusing on antiplatelet drug response, racial differences, and specific APT regimens may help verify the influence.
{"title":"Association Between Prior Antiplatelet Therapy and Prognosis in Patients With Intracerebral Hemorrhage: A Systematic Review and Meta-Analysis","authors":"Hanxu Zhang PhD , Xiaoran Hou MS , Yidan Gou MS , Yanyan Chen MS , Shuo An MD , Yingsheng Wei MD , Rongcai Jiang MD , Ye Tian MD , Hengjie Yuan PhD","doi":"10.1016/j.clinthera.2024.08.010","DOIUrl":"10.1016/j.clinthera.2024.08.010","url":null,"abstract":"<div><h3>Purpose</h3><div>Approximately 20% to 30% of intracerebral hemorrhage (ICH) patients were reported to be on antiplatelet therapy (APT), and association between prior APT and prognosis was unclear. We aimed to clarify the impact of APT on the prognosis of ICH through an updated systematic review and meta-analysis, and to further compare the risk of single APT (SAPT) or dual APT (DAPT) prior to ICH as well as the risk associated with various antiplatelet drugs.</div></div><div><h3>Methods</h3><div>EMBASE, MEDLINE via Ovid SP and Web of Science were searched from inception of each database to November 4, 2023. Included studies reported prognosis in both patients with prior APT and those without.</div></div><div><h3>Findings</h3><div>A total of 433,103 patients from 43 studies were included in the meta-analysis. Both univariate and multivariate analyses demonstrated a significant association between prior-APT and an increased mortality risk (odd ratio [OR] 1.43, 95% confidence interval [CI] 1.28–1.59; OR 1.20, 95%CI 1.10–1.30, respectively). The risk was higher in short term follow-up (Univariate OR 1.73, 95%CI 1.22–2.46; Multivariate OR 1.94, 95%CI 1.48–2.55). A notably increased risk of hematoma expansion was also observed in patients previously treated with APT (Univariate OR 1.47, 95%CI 1.12–1.94; Multivariate OR 1.88, 95%CI 1.30–2.71), which were mainly attributed to events within 24 hours. The impact of prior-APT on poor functional outcome was inconsistent between univariate and multivariate analyses. Both direct and indirect comparisons showed that SAPT significantly reduced the risk of mortality (OR 0.67, 95%CI 0.64–0.70; OR 0.84, 95%CI 0.71–0.99) and poor functional outcome (OR 0.84, 95%CI 0.72–0.98; OR 0.81, 95%CI 0.72–0.91) compared to DAPT.</div></div><div><h3>Implications</h3><div>Prior-APT increased the risk of mortality and hematoma expansion in patients with ICH. The increased risk of mortality and hematoma expansion was more obvious in the short term follow-up and within 24 hours, respectively. The effect of APT on poor functional outcome exhibited inconsistency between univariate and multivariate analyses, suggesting that further investigation is warranted to clarify this relationship. In comparison with DAPT, SAPT could decrease the risk of mortality and poor functional outcome. Further studies focusing on antiplatelet drug response, racial differences, and specific APT regimens may help verify the influence.</div></div>","PeriodicalId":10699,"journal":{"name":"Clinical therapeutics","volume":"46 11","pages":"Pages 905-915"},"PeriodicalIF":3.2,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142281578","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-11-01DOI: 10.1016/j.clinthera.2024.08.003
Larry Culpepper MD, MPH , Ashley Martin PhD, MS , Amanda Harrington PhD , Sally W. Wade MPH , Mousam Parikh MSc, BSc
<div><h3>Purpose</h3><div>This study quantified the burdens of bipolar I disorder (BP-I) by examining patient characteristics, health-related quality of life (HRQoL), health care resource utilization (HCRU), and costs of patients with versus without BP-I. Additionally, these outcomes were assessed across BP-I severity levels.</div></div><div><h3>Methods</h3><div>A retrospective, cross-sectional analysis of the 2020 National Health and Wellness Survey was conducted. Adults who self-reported a physician diagnosis of BP-I were assigned to the BP-I cohort, with severity-specific subgroups (mild, moderate, severe) created for analysis. A separate cohort of participants without BP-I or MDD was used for comparison. Exclusion criteria included a schizophrenia diagnosis. Bivariate analyses compared demographic and socioeconomic characteristics between cohorts. HRQoL (Short Form-36v2 Health Survey [SF36v2] mental and physical component scores, EuroQol Five-Dimension Visual Analogue Scale [EQ-5D VAS]), HCRU (health care provider visits, emergency department visits, hospitalizations), and annualized costs (direct and indirect) were evaluated for participants with versus without BP-I as well as across BP-I severity subgroups using multivariate analyses adjusted for key baseline differences. Because BP-I is often misdiagnosed as MDD, outcomes were evaluated in a subgroup of participants with MDD who according to the Mood Disorder Questionnaire screened as having probable BP-I (ie, potentially misdiagnosed BP-I) and were compared with the BP-I severity subgroups.</div></div><div><h3>Findings</h3><div>Cohorts included 818 participants with BP-I (mild = 336, moderate = 285, severe = 197) and 53,021 participants without BP-I. Participants with BP-I reported significantly lower HRQoL scores on the SF-36v2 and EQ-5D VAS (all measures, <em>P</em> < 0.001), and increasing BP-I severity was predictive of declining HRQoL. Participants with BP-I had significantly greater HCRU (all measures, <em>P</em> < 0.05) than participants without BP-I and increasing BP-I severity was associated with greater HCRU versus the mild BP-I cohort (all measures, <em>P</em> < 0.05). Participants with BP-I incurred significantly greater total direct (<em>P</em> < 0.01) and indirect (<em>P</em> < 0.001) costs versus participants without BP-I. Direct costs were incrementally higher across BP-I severity, while indirect costs were high across all groups but did not differ significantly. Participants with potentially misdiagnosed BP-I (n = 302) had similar HRQoL to those with mild-to-moderate BP-I and similar HCRU and direct costs to those with mild BP-I.</div></div><div><h3>Implications</h3><div>These results demonstrate the substantial clinical and economic burdens associated with BP-I, and these negative impacts generally increase with BP-I severity. The study also suggests that despite not having the diagnosis of BP-I, burdens of potentially misdiagnosed patients are similar to
{"title":"A Retrospective Cross-Sectional Analysis of the Humanistic and Economic Burden of Bipolar I Disorder","authors":"Larry Culpepper MD, MPH , Ashley Martin PhD, MS , Amanda Harrington PhD , Sally W. Wade MPH , Mousam Parikh MSc, BSc","doi":"10.1016/j.clinthera.2024.08.003","DOIUrl":"10.1016/j.clinthera.2024.08.003","url":null,"abstract":"<div><h3>Purpose</h3><div>This study quantified the burdens of bipolar I disorder (BP-I) by examining patient characteristics, health-related quality of life (HRQoL), health care resource utilization (HCRU), and costs of patients with versus without BP-I. Additionally, these outcomes were assessed across BP-I severity levels.</div></div><div><h3>Methods</h3><div>A retrospective, cross-sectional analysis of the 2020 National Health and Wellness Survey was conducted. Adults who self-reported a physician diagnosis of BP-I were assigned to the BP-I cohort, with severity-specific subgroups (mild, moderate, severe) created for analysis. A separate cohort of participants without BP-I or MDD was used for comparison. Exclusion criteria included a schizophrenia diagnosis. Bivariate analyses compared demographic and socioeconomic characteristics between cohorts. HRQoL (Short Form-36v2 Health Survey [SF36v2] mental and physical component scores, EuroQol Five-Dimension Visual Analogue Scale [EQ-5D VAS]), HCRU (health care provider visits, emergency department visits, hospitalizations), and annualized costs (direct and indirect) were evaluated for participants with versus without BP-I as well as across BP-I severity subgroups using multivariate analyses adjusted for key baseline differences. Because BP-I is often misdiagnosed as MDD, outcomes were evaluated in a subgroup of participants with MDD who according to the Mood Disorder Questionnaire screened as having probable BP-I (ie, potentially misdiagnosed BP-I) and were compared with the BP-I severity subgroups.</div></div><div><h3>Findings</h3><div>Cohorts included 818 participants with BP-I (mild = 336, moderate = 285, severe = 197) and 53,021 participants without BP-I. Participants with BP-I reported significantly lower HRQoL scores on the SF-36v2 and EQ-5D VAS (all measures, <em>P</em> < 0.001), and increasing BP-I severity was predictive of declining HRQoL. Participants with BP-I had significantly greater HCRU (all measures, <em>P</em> < 0.05) than participants without BP-I and increasing BP-I severity was associated with greater HCRU versus the mild BP-I cohort (all measures, <em>P</em> < 0.05). Participants with BP-I incurred significantly greater total direct (<em>P</em> < 0.01) and indirect (<em>P</em> < 0.001) costs versus participants without BP-I. Direct costs were incrementally higher across BP-I severity, while indirect costs were high across all groups but did not differ significantly. Participants with potentially misdiagnosed BP-I (n = 302) had similar HRQoL to those with mild-to-moderate BP-I and similar HCRU and direct costs to those with mild BP-I.</div></div><div><h3>Implications</h3><div>These results demonstrate the substantial clinical and economic burdens associated with BP-I, and these negative impacts generally increase with BP-I severity. The study also suggests that despite not having the diagnosis of BP-I, burdens of potentially misdiagnosed patients are similar to ","PeriodicalId":10699,"journal":{"name":"Clinical therapeutics","volume":"46 11","pages":"Pages 855-864"},"PeriodicalIF":3.2,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142343081","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}