Zheng Wang, Dahai Yu, Uchechukwu Levi Osuagwu, Karen Pickering, John Baker, Richard Cutfield, Yamei Cai, Brandon J Orr-Walker, Gerhard Sundborn, Zhanzheng Zhao, David Simmons
Purpose: We aimed to examine socioeconomic inequality (SI) in cause-specific outcomes among adults with impaired glucose tolerance (IGT) and/or Impaired fasting glucose (IFG) in New Zealand (NZ) over 25 years. Patients and Methods: A population-based open cohort was derived from Diabetes Care Support Service in NZ with national databases linkage. Patients aged ≥ 18 years with IGT and/or IFG were enrolled between 01/01/1994 and 31/07/2018 and followed up until death or 31/12/2018. Incident outcomes (all-cause, premature, cardiovascular, and cancer death; cardiovascular, myocardial infarction, stroke, heart failure, and end-stage kidney disease hospitalization) by demographic, anthropometric, socioeconomic status, clinical measurements, enrol-time-periods, and IGT/IFG were evaluated. Adjusted incidence rate ratios, absolute risk difference, and SI measurements (slope and relative index of inequality) were estimated using Age-Period-Cohort models. Results: 29,894 patients (58.5 (SD 14.3) years mean age; 52.2% female) were enrolled with 5.6 (IQR: 4.4– 7.4) years of median follow-up. Mortality rates decreased, whereas hospitalization (except myocardial infarction) rates increased. SI was significant for each outcome. Higher mortality and hospitalization rates and worsened SI were common in men, older, the most deprived, and M&amacrori patients, as well as patients with obesity, current smoking, with both IFG and IGT, and greater metabolic derangement (higher systolic blood pressure, lipids, and HbA1c, and lower level of mean arterial pressure). Conclusion: Enhanced management strategies are necessary for people with IGT and/or IFG to address persisting SI, especially for men, older people, current smokers, NZ European and M&amacrori patients, patients with obesity, or with any abnormal metabolic measurements.
{"title":"Health Inequality in Eight Adverse Outcomes Over a 25-Year Period in a Multi-Ethnic Population in New Zealand Population with Impaired Glucose Tolerance and/or Impaired Fasting Glucose: An Age-Period-Cohort Analysis","authors":"Zheng Wang, Dahai Yu, Uchechukwu Levi Osuagwu, Karen Pickering, John Baker, Richard Cutfield, Yamei Cai, Brandon J Orr-Walker, Gerhard Sundborn, Zhanzheng Zhao, David Simmons","doi":"10.2147/clep.s433714","DOIUrl":"https://doi.org/10.2147/clep.s433714","url":null,"abstract":"<strong>Purpose:</strong> We aimed to examine socioeconomic inequality (SI) in cause-specific outcomes among adults with impaired glucose tolerance (IGT) and/or Impaired fasting glucose (IFG) in New Zealand (NZ) over 25 years.<br/><strong>Patients and Methods:</strong> A population-based open cohort was derived from Diabetes Care Support Service in NZ with national databases linkage. Patients aged ≥ 18 years with IGT and/or IFG were enrolled between 01/01/1994 and 31/07/2018 and followed up until death or 31/12/2018. Incident outcomes (all-cause, premature, cardiovascular, and cancer death; cardiovascular, myocardial infarction, stroke, heart failure, and end-stage kidney disease hospitalization) by demographic, anthropometric, socioeconomic status, clinical measurements, enrol-time-periods, and IGT/IFG were evaluated. Adjusted incidence rate ratios, absolute risk difference, and SI measurements (slope and relative index of inequality) were estimated using Age-Period-Cohort models.<br/><strong>Results:</strong> 29,894 patients (58.5 (SD 14.3) years mean age; 52.2% female) were enrolled with 5.6 (IQR: 4.4– 7.4) years of median follow-up. Mortality rates decreased, whereas hospitalization (except myocardial infarction) rates increased. SI was significant for each outcome. Higher mortality and hospitalization rates and worsened SI were common in men, older, the most deprived, and M&amacrori patients, as well as patients with obesity, current smoking, with both IFG and IGT, and greater metabolic derangement (higher systolic blood pressure, lipids, and HbA1c, and lower level of mean arterial pressure).<br/><strong>Conclusion:</strong> Enhanced management strategies are necessary for people with IGT and/or IFG to address persisting SI, especially for men, older people, current smokers, NZ European and M&amacrori patients, patients with obesity, or with any abnormal metabolic measurements.<br/><br/><strong>Keywords:</strong> impaired glucose tolerance, impaired fasting glucose, New Zealand, M&amacrori, ethnic disparity, socioeconomic inequality, mortality, cardiovascular diseases, heart failure, cancer, end-stage renal disease<br/>","PeriodicalId":10362,"journal":{"name":"Clinical Epidemiology","volume":"3 2","pages":""},"PeriodicalIF":3.9,"publicationDate":"2023-12-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"138524603","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}
Yuchen Gao, Chunrong Wang, Wenhao Dong, Bianfang Li, Jianhui Wang, Jun Li, Yu Tian, Jia Liu, Yuefu Wang
Background: To derive and validate a machine learning (ML) prediction model of acute kidney injury (AKI) that could be used for AKI surveillance and management to improve clinical outcomes. Methods: This retrospective cohort study was conducted in Fuwai Hospital, including patients aged 18 years and above undergoing cardiac surgery admitted between January 1, 2017, and December 31, 2018. Seventy percent of the observations were randomly selected for training and the remaining 30% for testing. The demographics, comorbidities, laboratory examination parameters, and operation details were used to construct a prediction model for AKI by logistic regression and eXtreme gradient boosting (Xgboost). The discrimination of each model was assessed on the test cohort by the area under the receiver operator characteristic (AUROC) curve, while calibration was performed by the calibration plot. Results: A total of 15,880 patients were enrolled in this study, and 4845 (30.5%) had developed AKI. Xgboost model had the higher discriminative ability compared with logistic regression (AUROC, 0.849 [95% CI, 0.837– 0.861] vs 0.803[95% CI 0.790– 0.817], P< 0.001) in the test dataset. The estimated glomerular filtration (eGFR) and creatine on intensive care unit (ICU) arrival are the two most important prediction parameters. A SHAP summary plot was used to illustrate the effects of the top 15 features attributed to the Xgboost model. Conclusion: ML models can provide clinical decision support to determine which patients should focus on perioperative preventive treatment to preemptively reduce acute kidney injury by predicting which patients are not at risk.
背景:推导并验证急性肾损伤(AKI)的机器学习(ML)预测模型，该模型可用于AKI的监测和管理，以改善临床结果。方法:本回顾性队列研究在阜外医院进行，纳入2017年1月1日至2018年12月31日住院的18岁及以上心脏手术患者。70%的观察对象被随机选择用于训练，剩下的30%用于测试。利用人口统计学、合并症、实验室检查参数和手术细节，采用logistic回归和极限梯度增强(Xgboost)方法构建AKI预测模型。通过接收算子特征曲线下面积(AUROC)评估各模型在试验队列中的判别性，并通过校准图进行校准。结果:本研究共纳入15880例患者，其中4845例(30.5%)发生AKI。与logistic回归相比，Xgboost模型具有更高的判别能力(AUROC, 0.849 [95% CI, 0.837 - 0.861] vs 0.803[95% CI 0.790 - 0.817]， P<0.001)。重症监护病房(ICU)到达时估计的肾小球滤过(eGFR)和肌酸是两个最重要的预测参数。使用SHAP总结图来说明归因于Xgboost模型的前15个特性的影响。结论:ML模型可以通过预测哪些患者无危险，为确定哪些患者围手术期应重点进行预防性治疗，先发制人地减少急性肾损伤提供临床决策支持。
{"title":"An Explainable Machine Learning Model to Predict Acute Kidney Injury After Cardiac Surgery: A Retrospective Cohort Study","authors":"Yuchen Gao, Chunrong Wang, Wenhao Dong, Bianfang Li, Jianhui Wang, Jun Li, Yu Tian, Jia Liu, Yuefu Wang","doi":"10.2147/clep.s404580","DOIUrl":"https://doi.org/10.2147/clep.s404580","url":null,"abstract":"<strong>Background:</strong> To derive and validate a machine learning (ML) prediction model of acute kidney injury (AKI) that could be used for AKI surveillance and management to improve clinical outcomes.<br/><strong>Methods:</strong> This retrospective cohort study was conducted in Fuwai Hospital, including patients aged 18 years and above undergoing cardiac surgery admitted between January 1, 2017, and December 31, 2018. Seventy percent of the observations were randomly selected for training and the remaining 30% for testing. The demographics, comorbidities, laboratory examination parameters, and operation details were used to construct a prediction model for AKI by logistic regression and eXtreme gradient boosting (Xgboost). The discrimination of each model was assessed on the test cohort by the area under the receiver operator characteristic (AUROC) curve, while calibration was performed by the calibration plot.<br/><strong>Results:</strong> A total of 15,880 patients were enrolled in this study, and 4845 (30.5%) had developed AKI. Xgboost model had the higher discriminative ability compared with logistic regression (AUROC, 0.849 [95% CI, 0.837– 0.861] vs 0.803[95% CI 0.790– 0.817], <em>P</em>< 0.001) in the test dataset. The estimated glomerular filtration (eGFR) and creatine on intensive care unit (ICU) arrival are the two most important prediction parameters. A SHAP summary plot was used to illustrate the effects of the top 15 features attributed to the Xgboost model.<br/><strong>Conclusion:</strong> ML models can provide clinical decision support to determine which patients should focus on perioperative preventive treatment to preemptively reduce acute kidney injury by predicting which patients are not at risk.<br/><br/>","PeriodicalId":10362,"journal":{"name":"Clinical Epidemiology","volume":"64 1","pages":""},"PeriodicalIF":3.9,"publicationDate":"2023-12-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"138524565","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}
Lars Frost, Albert Joensen, Ulla Dam-Schmidt, I. Qvist, Margit Brinck, Axel Brandes, Ulla Davidsen, Ole Pedersen, Dorte Damgaard, Inge Mølgaard, Robert Bedsted, Anders Damgaard Møller Schlünsen, Miriam Grijota Chousa, Julie Andersen, Asger Pedersen, S. P. Johnsen, N. Vinter
{"title":"The Danish Atrial Fibrillation Registry: A Multidisciplinary National Pragmatic Initiative for Monitoring and Supporting Quality of Care Based on Data Retrieved from Administrative Registries","authors":"Lars Frost, Albert Joensen, Ulla Dam-Schmidt, I. Qvist, Margit Brinck, Axel Brandes, Ulla Davidsen, Ole Pedersen, Dorte Damgaard, Inge Mølgaard, Robert Bedsted, Anders Damgaard Møller Schlünsen, Miriam Grijota Chousa, Julie Andersen, Asger Pedersen, S. P. Johnsen, N. Vinter","doi":"10.2147/clep.s443473","DOIUrl":"https://doi.org/10.2147/clep.s443473","url":null,"abstract":"","PeriodicalId":10362,"journal":{"name":"Clinical Epidemiology","volume":"214 ","pages":""},"PeriodicalIF":3.9,"publicationDate":"2023-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139023429","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 : 2023-11-29eCollection Date: 2023-01-01DOI: 10.2147/CLEP.S433983
Pernille Tilma Tonnesen, Kevin Kris Warnakula Olesen, Pernille Gro Thrane, Christine Gyldenkerne, Christian Daugaard Peters, Niels Henrik Buus, Michael Maeng
Purpose: To investigate the interplay between chronic kidney disease (CKD) and coronary artery disease (CAD) on the incidence of cardiovascular events in patients with suspected chronic coronary syndrome (CCS).
Patients and methods: Patients with suspected CCS who underwent first-time coronary angiography in Western Denmark between 2003 and 2016 were included in this cohort study. Moreover, an age- and sex-matched general population cohort was established. Patients were stratified according to estimated glomerular filtration rate (eGFR). Presence of CAD was defined as ≥1 obstructive stenosis or non-obstructive diffuse disease. Major adverse cardiovascular events (MACE) were defined as a composite of myocardial infarction, ischemic stroke, and cardiac death.
Results: A total of 42,611 patients were included with a median follow-up of 7.3 years. Patients without and with CAD had MACE rates per 100 person-years that were 0.52 and 1.67 for eGFR ≥90 mL/min/1.73 m2, 0.68 and 2.09 for eGFR 60-89 mL/min/1.73 m2, 1.27 and 3.85 for eGFR 30-59 mL/min/1.73 m2, and 2.27 and 6.92 for eGFR <30 mL/min/1.73 m2. Comparing to eGFR ≥90 mL/min/1.73 m2, the adjusted incidence rate ratios for MACE were 1.29 (1.10-1.51) for eGFR 60-89 mL/min/1.73 m2, 1.86 (1.49-2.33) for eGFR 30-59 mL/min/1.73 m2, and 3.57 (1.92-6.67) for eGFR <30 mL/min/1.73 m2 in patients without CAD, and 1.11 (1.03-1.20), 1.71 (1.55-1.90), and 2.46 (1.96-3.09) in patients with CAD. The inverse relationship between kidney function and risk of MACE was confirmed when comparing patients with and without CAD to matched individuals in the general population.
Conclusion: Absence of CAD is a strong negative predictor of major adverse cardiovascular events in patients with CKD.
{"title":"Absence of Coronary Artery Disease is a Strong Negative Predictor of Major Adverse Cardiovascular Events in Patients with Chronic Kidney Disease.","authors":"Pernille Tilma Tonnesen, Kevin Kris Warnakula Olesen, Pernille Gro Thrane, Christine Gyldenkerne, Christian Daugaard Peters, Niels Henrik Buus, Michael Maeng","doi":"10.2147/CLEP.S433983","DOIUrl":"10.2147/CLEP.S433983","url":null,"abstract":"<p><strong>Purpose: </strong>To investigate the interplay between chronic kidney disease (CKD) and coronary artery disease (CAD) on the incidence of cardiovascular events in patients with suspected chronic coronary syndrome (CCS).</p><p><strong>Patients and methods: </strong>Patients with suspected CCS who underwent first-time coronary angiography in Western Denmark between 2003 and 2016 were included in this cohort study. Moreover, an age- and sex-matched general population cohort was established. Patients were stratified according to estimated glomerular filtration rate (eGFR). Presence of CAD was defined as ≥1 obstructive stenosis or non-obstructive diffuse disease. Major adverse cardiovascular events (MACE) were defined as a composite of myocardial infarction, ischemic stroke, and cardiac death.</p><p><strong>Results: </strong>A total of 42,611 patients were included with a median follow-up of 7.3 years. Patients without and with CAD had MACE rates per 100 person-years that were 0.52 and 1.67 for eGFR ≥90 mL/min/1.73 m<sup>2</sup>, 0.68 and 2.09 for eGFR 60-89 mL/min/1.73 m<sup>2</sup>, 1.27 and 3.85 for eGFR 30-59 mL/min/1.73 m<sup>2</sup>, and 2.27 and 6.92 for eGFR <30 mL/min/1.73 m<sup>2</sup>. Comparing to eGFR ≥90 mL/min/1.73 m<sup>2</sup>, the adjusted incidence rate ratios for MACE were 1.29 (1.10-1.51) for eGFR 60-89 mL/min/1.73 m<sup>2</sup>, 1.86 (1.49-2.33) for eGFR 30-59 mL/min/1.73 m<sup>2</sup>, and 3.57 (1.92-6.67) for eGFR <30 mL/min/1.73 m<sup>2</sup> in patients without CAD, and 1.11 (1.03-1.20), 1.71 (1.55-1.90), and 2.46 (1.96-3.09) in patients with CAD. The inverse relationship between kidney function and risk of MACE was confirmed when comparing patients with and without CAD to matched individuals in the general population.</p><p><strong>Conclusion: </strong>Absence of CAD is a strong negative predictor of major adverse cardiovascular events in patients with CKD.</p>","PeriodicalId":10362,"journal":{"name":"Clinical Epidemiology","volume":"15 ","pages":"1109-1121"},"PeriodicalIF":3.9,"publicationDate":"2023-11-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10693773/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"138482094","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 : 2023-11-29eCollection Date: 2023-01-01DOI: 10.2147/CLEP.S427881
Oh Chan Kwon, Kyungdo Han, Min-Chan Park
Background and aims: Lipid metabolism is altered in systemic sclerosis (SSc), mediating activation of immune cells and fibroblasts. However, it is unclear whether altered lipid profile is associated with a risk of developing SSc. We aimed to assess the association between lipid profile and risk of incident SSc.
Methods: From a Korean nationwide database, individuals without SSc who underwent national health check-ups in 2009 were selected and followed-up through 2019. Serum levels of total cholesterol (TC), high-density lipoprotein cholesterol (HDL-C), low-density lipoprotein cholesterol (LDL-C), and triglyceride were measured on the health check-up date in 2009. Individuals who developed SSc during follow-up were identified. Multivariable Cox models were performed to estimate the risk of incident SSc according to TC, HDL-C, LDL-C, and triglyceride levels, respectively.
Results: Of the 9,894,996 individuals selected, 1355 individuals developed SSc during a mean follow-up of 9.2 years (incidence rate=1.49 per 100,000 person-years). Levels of TC (adjusted hazard ratio [aHR] 0.959, 95% confidence interval [CI] 0.945-0.974), HDL-C (aHR 0.968, 95% CI 0.950-0.987), LDL-C (aHR 0.968, 95% CI 0.952-0.983) were inversely associated with the risk of incident SSc, whereas no significant association was observed between levels of triglyceride (aHR 1.004, 95% CI 0.998-1.011) and risk of incident SSc.
Conclusion: Serum levels of TC, HDL-C, and LDL-C were inversely associated with the risk of incident SSc. Our findings provide new insights that altered lipid profile could be considered a non-causal biomarker associated with incident SSc, which could help early diagnosis. The underlying mechanism for this association needs further studies.
背景和目的:脂质代谢在系统性硬化症(SSc)中发生改变，介导免疫细胞和成纤维细胞的激活。然而，目前尚不清楚脂质谱的改变是否与发生SSc的风险相关。我们的目的是评估血脂与SSc发生风险之间的关系。方法:从韩国全国数据库中选择2009年接受全国健康检查的无SSc个体，并随访至2019年。2009年体检时测定血清总胆固醇(TC)、高密度脂蛋白胆固醇(HDL-C)、低密度脂蛋白胆固醇(LDL-C)和甘油三酯水平。在随访期间确定了发展为SSc的个体。采用多变量Cox模型，分别根据TC、HDL-C、LDL-C和甘油三酯水平估计SSc发生的风险。结果:在所选择的9,894,996个个体中，1355个个体在平均9.2年的随访期间发生了SSc(发病率=1.49 / 100,000人年)。TC(校正风险比[aHR] 0.959, 95%可信区间[CI] 0.945-0.974)、HDL-C (aHR 0.968, 95% CI 0.950-0.987)、LDL-C (aHR 0.968, 95% CI 0.952-0.983)水平与SSc发生风险呈负相关，而甘油三酯水平(aHR 1.004, 95% CI 0.998-1.011)与SSc发生风险无显著相关性。结论:血清TC、HDL-C和LDL-C水平与SSc发生风险呈负相关。我们的发现提供了新的见解，即脂质谱的改变可以被认为是与SSc事件相关的非因果生物标志物，这可能有助于早期诊断。这种关联的潜在机制需要进一步研究。
{"title":"Association Between Lipid Profile and Risk of Incident Systemic Sclerosis: A Nationwide Population-Based Study.","authors":"Oh Chan Kwon, Kyungdo Han, Min-Chan Park","doi":"10.2147/CLEP.S427881","DOIUrl":"10.2147/CLEP.S427881","url":null,"abstract":"<p><strong>Background and aims: </strong>Lipid metabolism is altered in systemic sclerosis (SSc), mediating activation of immune cells and fibroblasts. However, it is unclear whether altered lipid profile is associated with a risk of developing SSc. We aimed to assess the association between lipid profile and risk of incident SSc.</p><p><strong>Methods: </strong>From a Korean nationwide database, individuals without SSc who underwent national health check-ups in 2009 were selected and followed-up through 2019. Serum levels of total cholesterol (TC), high-density lipoprotein cholesterol (HDL-C), low-density lipoprotein cholesterol (LDL-C), and triglyceride were measured on the health check-up date in 2009. Individuals who developed SSc during follow-up were identified. Multivariable Cox models were performed to estimate the risk of incident SSc according to TC, HDL-C, LDL-C, and triglyceride levels, respectively.</p><p><strong>Results: </strong>Of the 9,894,996 individuals selected, 1355 individuals developed SSc during a mean follow-up of 9.2 years (incidence rate=1.49 per 100,000 person-years). Levels of TC (adjusted hazard ratio [aHR] 0.959, 95% confidence interval [CI] 0.945-0.974), HDL-C (aHR 0.968, 95% CI 0.950-0.987), LDL-C (aHR 0.968, 95% CI 0.952-0.983) were inversely associated with the risk of incident SSc, whereas no significant association was observed between levels of triglyceride (aHR 1.004, 95% CI 0.998-1.011) and risk of incident SSc.</p><p><strong>Conclusion: </strong>Serum levels of TC, HDL-C, and LDL-C were inversely associated with the risk of incident SSc. Our findings provide new insights that altered lipid profile could be considered a non-causal biomarker associated with incident SSc, which could help early diagnosis. The underlying mechanism for this association needs further studies.</p>","PeriodicalId":10362,"journal":{"name":"Clinical Epidemiology","volume":"15 ","pages":"1095-1107"},"PeriodicalIF":3.9,"publicationDate":"2023-11-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10693781/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"138482095","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}
Mikkel Porsborg Andersen, Rikke Wiingreen, Talip E Eroglu, Helle Collatz Christensen, Laura Bech Polcwiartek, Stig Blomberg, Kristian Kragholm, Christian Torp-Pedersen, Kathrine Kold Sørensen
Aim of the Database: The aim of the National Child Health Registry is to provide comprehensive insight into children’s health and growth on a national scale by continuously monitoring the health status of Danish children. Through this effort, the registry assists the health authorities in prioritizing preventive efforts to promote better child health outcomes. Study Population: The registry includes all Danish children, however, incomplete coverage persists. Main Variables: The National Child Health Registry contains information on exposure to secondhand smoking, breastfeeding duration, and anthropometric measurements through childhood. The information in the registry is divided into three datasets: Smoking, Breastfeeding, and Measurements. Beside specific information on the three topics, all datasets include information on CPR-number, date of birth, sex, municipality, and region of residence. Database Status: The National Child Health Registry was established in 2009 and contains health information on children from all Danish municipalities, collected through routinely performed health examinations conducted by general practitioners and health nurses. Conclusion: The National Child Health Register is an asset to epidemiological and health research with nationwide information on children’s health and growth in Denmark. Due to the unique Danish Civil Registration System, it is possible to link data from the National Child Health Register to information from several other national health and social registers which enables longitudinal unambiguous follow-up. Keywords: child health, children‘s database, register-based research, Danish register, epidemiology
{"title":"The Danish National Child Health Register","authors":"Mikkel Porsborg Andersen, Rikke Wiingreen, Talip E Eroglu, Helle Collatz Christensen, Laura Bech Polcwiartek, Stig Blomberg, Kristian Kragholm, Christian Torp-Pedersen, Kathrine Kold Sørensen","doi":"10.2147/clep.s423587","DOIUrl":"https://doi.org/10.2147/clep.s423587","url":null,"abstract":"Aim of the Database: The aim of the National Child Health Registry is to provide comprehensive insight into children’s health and growth on a national scale by continuously monitoring the health status of Danish children. Through this effort, the registry assists the health authorities in prioritizing preventive efforts to promote better child health outcomes. Study Population: The registry includes all Danish children, however, incomplete coverage persists. Main Variables: The National Child Health Registry contains information on exposure to secondhand smoking, breastfeeding duration, and anthropometric measurements through childhood. The information in the registry is divided into three datasets: Smoking, Breastfeeding, and Measurements. Beside specific information on the three topics, all datasets include information on CPR-number, date of birth, sex, municipality, and region of residence. Database Status: The National Child Health Registry was established in 2009 and contains health information on children from all Danish municipalities, collected through routinely performed health examinations conducted by general practitioners and health nurses. Conclusion: The National Child Health Register is an asset to epidemiological and health research with nationwide information on children’s health and growth in Denmark. Due to the unique Danish Civil Registration System, it is possible to link data from the National Child Health Register to information from several other national health and social registers which enables longitudinal unambiguous follow-up. Keywords: child health, children‘s database, register-based research, Danish register, epidemiology","PeriodicalId":10362,"journal":{"name":"Clinical Epidemiology","volume":"15 2","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2023-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"135764343","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}
Carolina Requeijo, Javier Bracchiglione, Nicolás Meza, Roberto Acosta-Dighero, Josefina Salazar, Marilina Santero, Adriana-G Meade, María Jesús Quintana, Gerardo Rodríguez-Grijalva, Anna Selva, Ivan Solà, Gerard Urrútia, Xavier Bonfill Cosp
Introduction: Despite being commonly recommended, the impact of anticancer drugs (ACDs) on patient-important outcomes beyond survival for advanced hepatobiliary cancers (HBCs) may not have been sufficiently assessed. We aim to identify and map the evidence regarding ACDs versus best supportive care (BSC) for advanced HBCs, considering patient-centered outcomes. Methods: In this mapping review, we included systematic reviews, randomized controlled trials, quasi-experimental, and observational studies comparing ACDs (chemotherapy, immunotherapy, biological/targeted therapy) versus BSC for advanced HBCs. We searched MEDLINE (PubMed), EMBASE (Ovid), Cochrane Library, Epistemonikos, PROSPERO and clinicaltrials.gov for eligible studies. Two reviewers performed the screening and data extraction processes. We developed evidence maps for each type of cancer. Results: We included 87 studies (60 for advanced liver cancer and 27 for gallbladder or bile duct cancers). Most of the evidence favored ACDs for survival outcomes, and BSC for toxicity. We identified several evidence gaps for non-survival outcomes, including quality of life or quality of end-of-life care. Discussion: Patient-important outcomes beyond survival in advanced HBCs are insufficiently assessed by the available evidence. Future studies need to address these gaps to better inform decision-making processes. Keywords: liver neoplasms, gallbladder neoplasms, bile duct neoplasms, antineoplastic agents, immunotherapy, biological therapy, palliative care
{"title":"Anticancer Drugs Compared to No Anticancer Drugs in Patients with Advanced Hepatobiliary Cancer: A Mapping Review and Evidence Gap Map","authors":"Carolina Requeijo, Javier Bracchiglione, Nicolás Meza, Roberto Acosta-Dighero, Josefina Salazar, Marilina Santero, Adriana-G Meade, María Jesús Quintana, Gerardo Rodríguez-Grijalva, Anna Selva, Ivan Solà, Gerard Urrútia, Xavier Bonfill Cosp","doi":"10.2147/clep.s431498","DOIUrl":"https://doi.org/10.2147/clep.s431498","url":null,"abstract":"Introduction: Despite being commonly recommended, the impact of anticancer drugs (ACDs) on patient-important outcomes beyond survival for advanced hepatobiliary cancers (HBCs) may not have been sufficiently assessed. We aim to identify and map the evidence regarding ACDs versus best supportive care (BSC) for advanced HBCs, considering patient-centered outcomes. Methods: In this mapping review, we included systematic reviews, randomized controlled trials, quasi-experimental, and observational studies comparing ACDs (chemotherapy, immunotherapy, biological/targeted therapy) versus BSC for advanced HBCs. We searched MEDLINE (PubMed), EMBASE (Ovid), Cochrane Library, Epistemonikos, PROSPERO and clinicaltrials.gov for eligible studies. Two reviewers performed the screening and data extraction processes. We developed evidence maps for each type of cancer. Results: We included 87 studies (60 for advanced liver cancer and 27 for gallbladder or bile duct cancers). Most of the evidence favored ACDs for survival outcomes, and BSC for toxicity. We identified several evidence gaps for non-survival outcomes, including quality of life or quality of end-of-life care. Discussion: Patient-important outcomes beyond survival in advanced HBCs are insufficiently assessed by the available evidence. Future studies need to address these gaps to better inform decision-making processes. Keywords: liver neoplasms, gallbladder neoplasms, bile duct neoplasms, antineoplastic agents, immunotherapy, biological therapy, palliative care","PeriodicalId":10362,"journal":{"name":"Clinical Epidemiology","volume":"174 5-6","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2023-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"135614752","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 : 2023-11-01eCollection Date: 2023-01-01DOI: 10.2147/CLEP.S422386
Haoshuang Liu, Jingfeng Chen, Weihao Shao, Su Yan, Suying Ding
Objective: Numerous pharmacological interventions are now under investigation for the treatment of the 2019 coronavirus pandemic (COVID-19), and the evidence is rapidly evolving. Our aim is to evaluate the comparative efficacy and safety of these drugs.
Methods: We searched for randomized clinical trials (RCTs) on the efficacy and safety of novel oral antivirals for the treatment of hospitalized COVID-19 patients until November 30, 2022, including baricitinib, ivermectin (IVM), favipiravir (FVP), chloroquine (CQ), lopinavir and ritonavir (LPV/RTV), hydroxychloroquine (HCQ), and hydroxychloroquine plus azithromycin (HCQ+AZT). The main outcomes of this network meta-analysis (NMA) were in-hospital mortality, adverse event (AE), recovery time, and improvement in peripheral capillary oxygen saturation (SpO2). For dichotomous results, the odds ratio (OR) was used, and the 95% confidence interval (CI) was determined. We also used meta-regression to explore whether different treatments affected efficacy and safety. STATA 15.0 was used to conduct the NMA. The research protocol was registered with PROSPERO (#CRD 42023415743).
Results: Thirty-six RCTs, with 33,555 hospitalized COVID-19 patients, were included in this analysis. First, we compared the efficacy of different novel oral antivirals. Baricitinib (OR 0.56, 95% CI: 0.35 to 0.90) showed the highest probability of being the optimal probiotic species in reducing in-hospital mortality and suggested that none of the interventions reduced AE better than placebo. In terms of safety outcomes, IVM ranked first in improving the recovery time of hospitalized COVID-19 patients (mean difference (MD) -1.36, 95% CI: -2.32 to -0.39). In addition, patients were most likely to increase SpO2 (OR 1.77, 95% CI: 0.09 to 3.45). The meta-regression revealed no significant differences between participants using different novel oral antivirals in all outcomes in hospitalized COVID-19 patients.
Conclusion: Currently, baricitinib has reduced in-hospital mortality in hospitalized COVID-19 patients, with moderate certainty of evidence. IVM appeared to be a safer option than placebo in improving recovery time, while FVP was associated with increased SpO2 safety outcomes. These preliminary evidence-based observations should guide clinical practice until more data are made public.
{"title":"Efficacy and Safety of Novel Oral Antivirals in Hospitalized COVID-19 Patients: A Network Meta-Analysis of Randomized Clinical Trials.","authors":"Haoshuang Liu, Jingfeng Chen, Weihao Shao, Su Yan, Suying Ding","doi":"10.2147/CLEP.S422386","DOIUrl":"https://doi.org/10.2147/CLEP.S422386","url":null,"abstract":"<p><strong>Objective: </strong>Numerous pharmacological interventions are now under investigation for the treatment of the 2019 coronavirus pandemic (COVID-19), and the evidence is rapidly evolving. Our aim is to evaluate the comparative efficacy and safety of these drugs.</p><p><strong>Methods: </strong>We searched for randomized clinical trials (RCTs) on the efficacy and safety of novel oral antivirals for the treatment of hospitalized COVID-19 patients until November 30, 2022, including baricitinib, ivermectin (IVM), favipiravir (FVP), chloroquine (CQ), lopinavir and ritonavir (LPV/RTV), hydroxychloroquine (HCQ), and hydroxychloroquine plus azithromycin (HCQ+AZT). The main outcomes of this network meta-analysis (NMA) were in-hospital mortality, adverse event (AE), recovery time, and improvement in peripheral capillary oxygen saturation (SpO2). For dichotomous results, the odds ratio (OR) was used, and the 95% confidence interval (CI) was determined. We also used meta-regression to explore whether different treatments affected efficacy and safety. STATA 15.0 was used to conduct the NMA. The research protocol was registered with PROSPERO (#CRD 42023415743).</p><p><strong>Results: </strong>Thirty-six RCTs, with 33,555 hospitalized COVID-19 patients, were included in this analysis. First, we compared the efficacy of different novel oral antivirals. Baricitinib (OR 0.56, 95% CI: 0.35 to 0.90) showed the highest probability of being the optimal probiotic species in reducing in-hospital mortality and suggested that none of the interventions reduced AE better than placebo. In terms of safety outcomes, IVM ranked first in improving the recovery time of hospitalized COVID-19 patients (mean difference (MD) -1.36, 95% CI: -2.32 to -0.39). In addition, patients were most likely to increase SpO2 (OR 1.77, 95% CI: 0.09 to 3.45). The meta-regression revealed no significant differences between participants using different novel oral antivirals in all outcomes in hospitalized COVID-19 patients.</p><p><strong>Conclusion: </strong>Currently, baricitinib has reduced in-hospital mortality in hospitalized COVID-19 patients, with moderate certainty of evidence. IVM appeared to be a safer option than placebo in improving recovery time, while FVP was associated with increased SpO2 safety outcomes. These preliminary evidence-based observations should guide clinical practice until more data are made public.</p>","PeriodicalId":10362,"journal":{"name":"Clinical Epidemiology","volume":"15 ","pages":"1041-1053"},"PeriodicalIF":3.9,"publicationDate":"2023-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10625770/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"71478775","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}
Purpose: To demonstrate that using an instrumental variable (IV) with monotonicity reduces the accuracy of propensity score (PS) weighted estimators for the average treatment effect (ATE). Methods: Monotonicity in the relationship between a binary IV and a binary treatment variable is an important assumption to identify the ATE for compliers who would only take treatment when encouraged by the IV. We perform theoretical and numerical investigations to study the impact of using the IV that satisfies monotonicity on the PS of treatment in terms of the positivity assumption, which requires that the PS be strictly between 0 and 1, and the accuracy of PS weighted estimators. Two versions of monotonicity that result in one-sided or two-sided noncompliance are considered. Results: The PS adjusting for the IV always violates the positivity assumption when noncompliance occurs in one direction (one-sided noncompliance) and is more extreme than without the IV under two-sided noncompliance. These results are valid if the probability of being encouraged to get treatment and the compliance score, the probability of being a complier, are strictly between 0 and 1. Conclusion: Using a binary IV with monotonicity as a covariate for the PS model makes the estimated PSs unnecessarily extreme, reducing the accuracy of the PS weighted estimators. Keywords: average treatment effect, compliance score, instrumental variable, monotonicity, noncompliance, positivity, propensity score
{"title":"Effects of Adjusting for Instrumental Variables on the Bias and Precision of Propensity Score Weighted Estimators: Analysis Under Complete, Near, and No Positivity Violations","authors":"Byeong Yeob Choi, M Alan Brookhart","doi":"10.2147/clep.s427933","DOIUrl":"https://doi.org/10.2147/clep.s427933","url":null,"abstract":"Purpose: To demonstrate that using an instrumental variable (IV) with monotonicity reduces the accuracy of propensity score (PS) weighted estimators for the average treatment effect (ATE). Methods: Monotonicity in the relationship between a binary IV and a binary treatment variable is an important assumption to identify the ATE for compliers who would only take treatment when encouraged by the IV. We perform theoretical and numerical investigations to study the impact of using the IV that satisfies monotonicity on the PS of treatment in terms of the positivity assumption, which requires that the PS be strictly between 0 and 1, and the accuracy of PS weighted estimators. Two versions of monotonicity that result in one-sided or two-sided noncompliance are considered. Results: The PS adjusting for the IV always violates the positivity assumption when noncompliance occurs in one direction (one-sided noncompliance) and is more extreme than without the IV under two-sided noncompliance. These results are valid if the probability of being encouraged to get treatment and the compliance score, the probability of being a complier, are strictly between 0 and 1. Conclusion: Using a binary IV with monotonicity as a covariate for the PS model makes the estimated PSs unnecessarily extreme, reducing the accuracy of the PS weighted estimators. Keywords: average treatment effect, compliance score, instrumental variable, monotonicity, noncompliance, positivity, propensity score","PeriodicalId":10362,"journal":{"name":"Clinical Epidemiology","volume":"135 1-2","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2023-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"135566307","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}
Purpose: Distinguishing ST-elevation myocardial infarction (STEMI) and non-ST-elevation myocardial infarction (NSTEMI) is crucial in acute myocardial infarction (AMI) research due to their distinct characteristics. However, the accuracy of International Classification of Diseases, Tenth Revision, Clinical Modification (ICD-10-CM) codes for STEMI and NSTEMI in Taiwan's National Health Insurance (NHI) database remains unvalidated. Therefore, we developed and validated case definition algorithms for STEMI and NSTEMI using ICD-10-CM and NHI billing codes.
Patients and methods: We obtained claims data and medical records of inpatient visits from 2016 to 2021 from the hospital's research-based database. Potential STEMI and NSTEMI cases were identified using diagnostic codes, keywords, and procedure codes associated with AMI. Chart reviews were then conducted to confirm the cases. The performance of the developed algorithms for STEMI and NSTEMI was assessed and subsequently externally validated.
Results: The algorithm that defined STEMI as any STEMI ICD code in the first three diagnosis fields had the highest performance, with a sensitivity of 93.6% (95% confidence interval [CI], 91.7-95.2%), a positive predictive value (PPV) of 89.4% (95% CI, 87.1-91.4%), and a kappa of 0.914 (95% CI, 0.900-0.928). The algorithm that used the NSTEMI ICD code listed in any diagnosis field performed best in identifying NSTEMI, with a sensitivity of 82.6% (95% CI, 80.7-84.4%), a PPV of 96.5% (95% CI, 95.4-97.4), and a kappa of 0.889 (95% CI, 0.878-0.901). The algorithm that included either STEMI or NSTEMI ICD codes listed in any diagnosis field showed excellent performance in defining AMI, with a sensitivity of 89.4% (95% CI, 88.2-90.6%), a PPV of 95.6% (95% CI, 94.7-96.4%), and a kappa of 0.923 (95% CI, 0.915-0.931). External validation confirmed these algorithms' efficacy.
Conclusion: Our results provide valuable reference algorithms for identifying STEMI and NSTEMI cases in Taiwan's NHI database.
{"title":"Validation of ICD-10-CM Diagnostic Codes for Identifying Patients with ST-Elevation and Non-ST-Elevation Myocardial Infarction in a National Health Insurance Claims Database.","authors":"Tou-Yuan Tsai, Jen-Feng Lin, Yu-Kang Tu, Jian-Heng Lee, Yu-Ting Hsiao, Sheng-Feng Sung, Ming-Jen Tsai","doi":"10.2147/CLEP.S431231","DOIUrl":"10.2147/CLEP.S431231","url":null,"abstract":"<p><strong>Purpose: </strong>Distinguishing ST-elevation myocardial infarction (STEMI) and non-ST-elevation myocardial infarction (NSTEMI) is crucial in acute myocardial infarction (AMI) research due to their distinct characteristics. However, the accuracy of International Classification of Diseases, Tenth Revision, Clinical Modification (ICD-10-CM) codes for STEMI and NSTEMI in Taiwan's National Health Insurance (NHI) database remains unvalidated. Therefore, we developed and validated case definition algorithms for STEMI and NSTEMI using ICD-10-CM and NHI billing codes.</p><p><strong>Patients and methods: </strong>We obtained claims data and medical records of inpatient visits from 2016 to 2021 from the hospital's research-based database. Potential STEMI and NSTEMI cases were identified using diagnostic codes, keywords, and procedure codes associated with AMI. Chart reviews were then conducted to confirm the cases. The performance of the developed algorithms for STEMI and NSTEMI was assessed and subsequently externally validated.</p><p><strong>Results: </strong>The algorithm that defined STEMI as any STEMI ICD code in the first three diagnosis fields had the highest performance, with a sensitivity of 93.6% (95% confidence interval [CI], 91.7-95.2%), a positive predictive value (PPV) of 89.4% (95% CI, 87.1-91.4%), and a kappa of 0.914 (95% CI, 0.900-0.928). The algorithm that used the NSTEMI ICD code listed in any diagnosis field performed best in identifying NSTEMI, with a sensitivity of 82.6% (95% CI, 80.7-84.4%), a PPV of 96.5% (95% CI, 95.4-97.4), and a kappa of 0.889 (95% CI, 0.878-0.901). The algorithm that included either STEMI or NSTEMI ICD codes listed in any diagnosis field showed excellent performance in defining AMI, with a sensitivity of 89.4% (95% CI, 88.2-90.6%), a PPV of 95.6% (95% CI, 94.7-96.4%), and a kappa of 0.923 (95% CI, 0.915-0.931). External validation confirmed these algorithms' efficacy.</p><p><strong>Conclusion: </strong>Our results provide valuable reference algorithms for identifying STEMI and NSTEMI cases in Taiwan's NHI database.</p>","PeriodicalId":10362,"journal":{"name":"Clinical Epidemiology","volume":"15 ","pages":"1027-1039"},"PeriodicalIF":3.9,"publicationDate":"2023-10-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/eb/80/clep-15-1027.PMC10590151.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"49688997","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}
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