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Risk of Post-Acute Sequelae of SARS-CoV-2 Infection (PASC) Among Patients with Type 2 Diabetes Mellitus on Anti-Hyperglycemic Medications 服用降糖药物的 2 型糖尿病患者出现 SARS-CoV-2 感染急性后遗症 (PASC) 的风险
IF 3.9 2区 医学 Q1 Medicine Pub Date : 2024-05-31 DOI: 10.2147/clep.s458901
Oluwasolape Olawore, Lindsey E Turner, Michael D Evans, Steven G Johnson, Jared D Huling, Carolyn T Bramante, John B Buse, Til Stürmer
Background: Observed activity of metformin in reducing the risk of severe COVID-19 suggests a potential use of the anti-hyperglycemic in the prevention of post-acute sequelae of SARS-CoV-2 infection (PASC). We assessed the 3-month and 6-month risk of PASC among patients with type 2 diabetes mellitus (T2DM) comparing metformin users to sulfonylureas (SU) or dipeptidyl peptidase-4 inhibitors (DPP4i) users.
Methods: We used de-identified patient level electronic health record data from the National Covid Cohort Collaborative (N3C) between October 2021 and April 2023. Participants were adults ≥ 18 years with T2DM who had at least one outpatient healthcare encounter in health institutions in the United States prior to COVID-19 diagnosis. The outcome of PASC was defined based on the presence of a diagnosis code for the illness or using a predicted probability based on a machine learning algorithm. We estimated the 3-month and 6-month risk of PASC and calculated crude and weighted risk ratios (RR), risk differences (RD), and differences in mean predicted probability.
Results: We identified 5596 (mean age: 61.1 years; SD: 12.6) and 1451 (mean age: 64.9 years; SD 12.5) eligible prevalent users of metformin and SU/DPP4i respectively. We did not find a significant difference in risk of PASC at 3 months (RR = 0.86 [0.56; 1.32], RD = − 3.06 per 1000 [− 12.14; 6.01]), or at 6 months (RR = 0.81 [0.55; 1.20], RD = − 4.91 per 1000 [− 14.75, 4.93]) comparing prevalent users of metformin to prevalent users of SU/ DPP4i. Similar observations were made for the outcome definition using the ML algorithm.
Conclusion: The observed estimates in our study are consistent with a reduced risk of PASC among prevalent users of metformin, however the uncertainty of our confidence intervals warrants cautious interpretations of the results. A standardized clinical definition of PASC is warranted for thorough evaluation of the effectiveness of therapies under assessment for the prevention of PASC.

Plain Language Summary: Previous research suggests that metformin, due to its anti-viral, anti-inflammatory, and anti-thrombotic properties may reduce the risk of severe COVID-19. Given the shared etiology of COVID-19 and the post-acute sequelae of SARS-CoV-2 (PASC), and the proposed inflammatory processes of PASC, metformin may also be a beneficial preventive option. We investigated the benefit of metformin for PASC prevention in a population of type 2 diabetes mellitus patients with a COVID-19 diagnosis who were on metformin or two other anti-hyperglycemic medications prior to infection with SARS-CoV-2. Our results were consistent with a reduction in the risk of PASC with the use of metformin, however, the imprecise confidence intervals obtained warrants further investigation of this association of the potential beneficial effect of metformin for preventing PASC in patients with med
背景:观察到二甲双胍在降低严重 COVID-19 风险方面的活性,这表明这种抗高血糖药有可能用于预防 SARS-CoV-2 感染的急性后遗症(PASC)。我们将二甲双胍使用者与磺脲类药物(SU)或二肽基肽酶-4 抑制剂(DPP4i)使用者进行了比较,评估了 2 型糖尿病(T2DM)患者 3 个月和 6 个月的 PASC 风险:我们使用了 2021 年 10 月至 2023 年 4 月期间来自国家 Covid 队列协作组织 (N3C) 的去标识化患者级电子健康记录数据。参与者为≥18 岁的 T2DM 成人,他们在 COVID-19 诊断前至少在美国的医疗机构就诊过一次。PASC 的结果是根据是否存在疾病诊断代码或使用基于机器学习算法的预测概率来定义的。我们估算了 3 个月和 6 个月的 PASC 风险,并计算了粗略和加权风险比 (RR)、风险差异 (RD) 和平均预测概率差异:我们分别发现了 5596 名(平均年龄:61.1 岁;SD:12.6)和 1451 名(平均年龄:64.9 岁;SD:12.5)符合条件的二甲双胍和 SU/DPP4i 流行用户。我们没有发现二甲双胍的流行用户与 SU/DPP4i 的流行用户在 3 个月时的 PASC 风险(RR = 0.86 [0.56; 1.32],RD = - 3.06 per 1000 [- 12.14; 6.01])或 6 个月时的 PASC 风险(RR = 0.81 [0.55; 1.20],RD = - 4.91 per 1000 [- 14.75, 4.93])有明显差异。使用 ML 算法对结果定义也得出了类似的观察结果:我们研究中观察到的估计值与二甲双胍的普遍使用者发生 PASC 的风险降低相一致,但我们的置信区间存在不确定性,因此对结果的解释需要谨慎。需要对 PASC 进行标准化的临床定义,以便对正在评估的预防 PASC 的疗法的有效性进行全面评估。白话摘要:以往的研究表明,二甲双胍因其抗病毒、抗炎和抗血栓的特性,可降低严重 COVID-19 的风险。鉴于 COVID-19 和 SARS-CoV-2 后遗症(PASC)的病因相同,且 PASC 存在炎症过程,二甲双胍可能也是一种有益的预防选择。我们在确诊为 COVID-19 的 2 型糖尿病患者中调查了二甲双胍对预防 PASC 的益处,这些患者在感染 SARS-CoV-2 之前服用过二甲双胍或其他两种降糖药物。我们的研究结果表明,使用二甲双胍可降低PASC的发病风险,但由于置信区间不精确,因此需要进一步研究二甲双胍对药物治疗糖尿病患者预防PASC的潜在有益作用。
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引用次数: 0
Associations Between Estimated Pulse Wave Velocity and Five-Year All-Cause Mortality in Patients with Atherosclerotic Cardiovascular Disease with and without Standard Modifiable Risk Factors: Evidence From NHANES 1999-2016 有和无标准可改变风险因素的动脉粥样硬化性心血管疾病患者的估计脉搏波速度与五年全因死亡率之间的关系:来自 NHANES 1999-2016 的证据
IF 3.9 2区 医学 Q1 Medicine Pub Date : 2024-05-28 DOI: 10.2147/clep.s457054
Xicong Li, Yubiao Chen, Baiyun Liu, Mingyuan Ye, Bei Liu, Lifei Lu, Ruiwei Guo
Aim: The study aimed to analyze the associations between estimated pulse wave velocity (ePWV) and 5-year mortality in atherosclerotic cardiovascular disease (ASCVD) patients with and without standard modifiable risk factors (SMuRFs), which included smoking status, hypertension, diabetes, and hypercholesterolemia.
Methods: The present retrospective cohort study utilized data from the National Health and Nutrition Examination Survey (NHANES) between 1999 and 2016. Patients with ASCVD who completed both the questionnaire survey and serum testing were included. Patients were categorized into the ≥ 1 SMuRF group if they had at least one SMuRF, while those without any SMuRFs were classified into the SMuRF-less group. The ePWV, which was calculated using the age and mean blood pressure, was evenly divided into three categories: low (Q1), medium (Q2), and high (Q3). Multivariable weighted Cox proportional-hazard regression analyses were utilized to explore the risk factors associated with 5-year mortality in patients with and without SMuRFs. And restricted cubic spline curve (RCS) was used to assess their nonlinear correlation.
Results: A total of 1901 patients with ASCVD were included in the study. For the patients in ≥ 1 SMuRF group, the Q3 group included patients who were older, with a higher proportion of males, more comorbidities, and a lower body mass index than the Q1 group (P< 0.05). The Cox proportional-hazard regression model results revealed, the Q3 group had a higher risk of 5-year mortality than the Q1 group [hazard ratio (HR) 4.30, 95% confidence interval (CI) (2.66, 6.95), P< 0.001]. RCS demonstrated a linear trend between high level of ePWV and decreased risks of mortality. Similar results were observed in the SMuRF-less group [HR 10.62, 95% CI (1.22, 92.06), P=0.032].
Conclusion: A high level of ePWV signified a higher risk of 5-year mortality in ASCVD patients with and without SMuRFs.

Keywords: atherosclerotic cardiovascular disease, standard modifiable risk factors, estimated pulse wave velocity, all-cause mortality
目的:该研究旨在分析动脉粥样硬化性心血管疾病(ASCVD)患者的估计脉搏波速度(ePWV)与5年死亡率之间的关系,这些患者有无标准可改变风险因素(SMuRFs),包括吸烟状况、高血压、糖尿病和高胆固醇血症:本回顾性队列研究利用了 1999 年至 2016 年间美国国家健康与营养调查(NHANES)的数据。研究纳入了同时完成问卷调查和血清检测的 ASCVD 患者。如果患者至少有一个SMuRF,则被归入≥1 SMuRF组,而没有任何SMuRF的患者则被归入无SMuRF组。根据年龄和平均血压计算出的 ePWV 平均分为三类:低(Q1)、中(Q2)和高(Q3)。利用多变量加权 Cox 比例危险回归分析来探讨与 SMuRFs 患者和无 SMuRFs 患者 5 年死亡率相关的风险因素。并使用限制性立方样条曲线(RCS)评估其非线性相关性:研究共纳入 1901 名 ASCVD 患者。在 SMuRF ≥ 1 组患者中,Q3 组比 Q1 组年龄大、男性比例高、合并症多、体重指数低(P< 0.05)。Cox 比例危险回归模型结果显示,Q3 组的 5 年死亡风险高于 Q1 组[危险比 (HR) 4.30,95% 置信区间 (CI) (2.66, 6.95),P< 0.001]。RCS 显示,高水平 ePWV 与死亡风险降低之间呈线性趋势。在无 SMuRF 组也观察到类似结果[HR 10.62,95% CI (1.22,92.06),P=0.032]:关键词:动脉粥样硬化性心血管疾病;标准可改变危险因素;估计脉搏波速度;全因死亡率
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引用次数: 0
Evaluation of Left Truncation and Censoring When Changing the Use of the International Classification of Diseases Eighth Revision Codes to Tenth Revision Codes in the Danish National Patient Registry 在丹麦国家患者登记处将国际疾病分类第八修订版代码改为第十修订版代码时对左截断和删减的评估
IF 3.9 2区 医学 Q1 Medicine Pub Date : 2024-05-18 DOI: 10.2147/clep.s456171
Søren Korsgaard, Frederikke Schønfeldt Troelsen, Katalin Veres, Cecilia Hvitfeldt Fuglsang, Henrik Toft Sørensen
Purpose: In the Danish National Patient Registry (DNPR), covering all Danish hospitals and widely used in research, diseases have been recorded using International Classification of Diseases (ICD) codes, transitioning from the Eighth to the Tenth revision in 1994. Uncertainty exists regarding whether including ICD-8 codes alongside ICD-10 is needed for complete disease identification. We assessed the extent of left-truncation and left-censoring in the DNPR arising from omitting ICD-8 codes.
Patients and Methods: We sampled 500,000 Danes ≥ 40 years of age in 1995, 2010, and 2018. From the DNPR, we identified cardiovascular, endocrine, gastrointestinal, neurological, pulmonary, rheumatic, and urogenital diseases as well as fractures. We obtained the number of people with a disease recorded with ICD-8 codes only (ie, the ICD-8 record would be left-truncated by not using ICD-8 codes), ICD-8 plus ICD-10 codes (ie, the ICD-8 record would be left-censored by not using ICD-8 codes), and ICD-10 codes only. For each ICD group, we calculated the proportion of people with the disease relative to the total sample (ie, 500,000 people) and the total number of people with the disease across all ICD groups.
Results: Overall, the left-truncation issue decreased over the years. Relative to all people with a disease, the left-truncated proportion was for example 59% in 1995 and < 2% in 2018 for diabetes mellitus; 93% in 1995, and 54% in 2018 for appendicitis. The left-truncation issue increased with age group for most diseases. The proportion of disease records left-censored by not using ICD-8 codes was generally low but highest for chronic diseases.
Conclusion: The left-truncation issue diminished over sample years, particularly for chronic diseases, yet remained rather high for selected surgical diseases. The left-truncation issue increased with age group for most diseases. Left-censoring was overall a minor issue that primarily concerned chronic diseases.

Keywords: epidemiology, methodology, bias, left-truncation, left-censoring
目的: 丹麦国家患者登记处(Danish National Patient Registry,DNPR)覆盖了丹麦所有医院,并被广泛用于研究,该登记处使用国际疾病分类(International Classification of Diseases,ICD)代码记录疾病,并于 1994 年从第八版过渡到第十版。关于是否需要将 ICD-8 代码与 ICD-10 代码一起纳入完整的疾病识别,目前还存在不确定性。我们评估了因省略 ICD-8 代码而导致的 DNPR 左截断和左删减的程度:我们在 1995 年、2010 年和 2018 年对 50 万年龄≥ 40 岁的丹麦人进行了抽样调查。从 DNPR 中,我们确定了心血管、内分泌、胃肠道、神经、肺、风湿和泌尿生殖系统疾病以及骨折。我们获得了仅使用 ICD-8 编码(即不使用 ICD-8 编码会对 ICD-8 记录进行左截断)、ICD-8 加 ICD-10 编码(即不使用 ICD-8 编码会对 ICD-8 记录进行左截断)和仅使用 ICD-10 编码记录的疾病患者人数。对于每个 ICD 组,我们都计算了患病人数占样本总数(即 500,000 人)的比例,以及所有 ICD 组的患病总人数:总体而言,左截断问题逐年减少。例如,相对于所有患病人数,1995 年和 < 的左截断比例分别为 59%;2018 年糖尿病的左截断比例为 2%;1995 年阑尾炎的左截断比例为 93%,2018 年为 54%。大多数疾病的左截断问题随着年龄组的增加而增加。因未使用 ICD-8 编码而被左截断的疾病记录比例普遍较低,但慢性病的比例最高:结论:左截断问题随着样本年的增加而减少,尤其是慢性病,但部分外科疾病的左截断问题仍然很严重。在大多数疾病中,左截断问题随年龄组而增加。关键词:流行病学、方法学、偏差、左截断、左删减
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引用次数: 0
Influence of Low-Density Lipoprotein Cholesterol Levels on NSAID-Associated Cardiovascular Risks After Myocardial Infarction: A Population-Based Cohort Study 低密度脂蛋白胆固醇水平对心肌梗死后非甾体抗炎药相关心血管风险的影响:基于人群的队列研究
IF 3.9 2区 医学 Q1 Medicine Pub Date : 2024-04-22 DOI: 10.2147/clep.s447451
Mohab Basem, Kasper Bonnesen, Lars Pedersen, Henrik Toft Sørensen, Morten Schmidt
Aim: To examine whether low-density lipoprotein cholesterol (LDL-C) levels influence the cardiovascular risk associated with non-aspirin non-steroidal anti-inflammatory drug (NSAID) use after myocardial infarction (MI).
Methods: Using Danish health registries, we conducted a population-based cohort study of all adult patients with first-time MI during 2010– 2020 with an LDL-C value before discharge. Based on the latest LDL-C value, we categorized patients into a low and a high LDL-C group (< 3.0 vs ≥ 3.0 mmol/L). We used time varying Cox regression to compute hazard ratios (HRs) with 95% confidence intervals of the association between NSAID use and a major adverse cardiovascular event (MACE: recurrent MI, ischemic stroke, and all-cause death).
Results: We followed 50,573 patients for a median of 3.1 years. While exposed, 521 patients experienced a MACE: 312 in the low LDL-C group and 209 in the high LDL-C group. The HRs for MACE comparing NSAID use with non-use were 1.21 (1.11– 1.32) overall, 1.19 (1.06– 1.33) in the low LDL-C group, and 1.23 (1.07– 1.41) in the high LDL-group. The HRs for recurrent MI and ischemic stroke were comparable between the LDL-C subgroups. The HRs for all-cause death were 1.22 (1.07– 1.39) in the low LDL-C group and 1.54 (1.30– 1.83) in the high LDL-C group. Changing the cut-off value for LDL-C to 1.8 and 1.4 mmol/L showed consistent results.
Conclusion: In patients with MI, LDL-C levels did not influence the increased risk of MACE associated with NSAID use, but might influence the association between NSAID use and all-cause death.

Keywords: cardiovascular disease, non-steroidal anti-inflammatory drugs, cholesterol, low-density lipoprotein cholesterol, myocardial infarction, effect modification
目的:研究低密度脂蛋白胆固醇(LDL-C)水平是否会影响心肌梗死(MI)后使用非阿司匹林类非甾体抗炎药(NSAID)相关的心血管风险:我们利用丹麦健康登记处,对 2010-2020 年间首次心肌梗死且出院前有 LDL-C 值的所有成年患者进行了一项基于人群的队列研究。根据最新的 LDL-C 值,我们将患者分为低 LDL-C 组和高 LDL-C 组(< 3.0 vs ≥ 3.0 mmol/L)。我们使用时变 Cox 回归计算了使用非甾体抗炎药与主要不良心血管事件(MACE:复发性心肌梗死、缺血性中风和全因死亡)之间的危险比(HRs)及 95% 的置信区间:我们对 50,573 名患者进行了中位数为 3.1 年的随访。在暴露期间,521 名患者发生了 MACE:低 LDL-C 组 312 人,高 LDL-C 组 209 人。使用非甾体抗炎药与不使用非甾体抗炎药相比,总体MACE的HR为1.21(1.11-1.32),低LDL-C组为1.19(1.06-1.33),高LDL-C组为1.23(1.07-1.41)。各低密度脂蛋白胆固醇亚组的复发性心肌梗死和缺血性中风的 HR 值相当。低 LDL-C 组的全因死亡 HR 值为 1.22(1.07- 1.39),高 LDL-C 组为 1.54(1.30- 1.83)。将低密度脂蛋白胆固醇的临界值改为 1.8 和 1.4 mmol/L,结果显示一致:结论:在心肌梗死患者中,低密度脂蛋白胆固醇水平不会影响使用非甾体抗炎药导致的MACE风险增加,但可能会影响使用非甾体抗炎药与全因死亡之间的关系。关键词:心血管疾病、非甾体类抗炎药、胆固醇、低密度脂蛋白胆固醇、心肌梗死、效应修饰
{"title":"Influence of Low-Density Lipoprotein Cholesterol Levels on NSAID-Associated Cardiovascular Risks After Myocardial Infarction: A Population-Based Cohort Study","authors":"Mohab Basem, Kasper Bonnesen, Lars Pedersen, Henrik Toft Sørensen, Morten Schmidt","doi":"10.2147/clep.s447451","DOIUrl":"https://doi.org/10.2147/clep.s447451","url":null,"abstract":"<strong>Aim:</strong> To examine whether low-density lipoprotein cholesterol (LDL-C) levels influence the cardiovascular risk associated with non-aspirin non-steroidal anti-inflammatory drug (NSAID) use after myocardial infarction (MI).<br/><strong>Methods:</strong> Using Danish health registries, we conducted a population-based cohort study of all adult patients with first-time MI during 2010– 2020 with an LDL-C value before discharge. Based on the latest LDL-C value, we categorized patients into a low and a high LDL-C group (&lt; 3.0 vs ≥ 3.0 mmol/L). We used time varying Cox regression to compute hazard ratios (HRs) with 95% confidence intervals of the association between NSAID use and a major adverse cardiovascular event (MACE: recurrent MI, ischemic stroke, and all-cause death).<br/><strong>Results:</strong> We followed 50,573 patients for a median of 3.1 years. While exposed, 521 patients experienced a MACE: 312 in the low LDL-C group and 209 in the high LDL-C group. The HRs for MACE comparing NSAID use with non-use were 1.21 (1.11– 1.32) overall, 1.19 (1.06– 1.33) in the low LDL-C group, and 1.23 (1.07– 1.41) in the high LDL-group. The HRs for recurrent MI and ischemic stroke were comparable between the LDL-C subgroups. The HRs for all-cause death were 1.22 (1.07– 1.39) in the low LDL-C group and 1.54 (1.30– 1.83) in the high LDL-C group. Changing the cut-off value for LDL-C to 1.8 and 1.4 mmol/L showed consistent results.<br/><strong>Conclusion:</strong> In patients with MI, LDL-C levels did not influence the increased risk of MACE associated with NSAID use, but might influence the association between NSAID use and all-cause death. <br/><br/><strong>Keywords:</strong> cardiovascular disease, non-steroidal anti-inflammatory drugs, cholesterol, low-density lipoprotein cholesterol, myocardial infarction, effect modification<br/>","PeriodicalId":10362,"journal":{"name":"Clinical Epidemiology","volume":null,"pages":null},"PeriodicalIF":3.9,"publicationDate":"2024-04-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140636923","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}
引用次数: 0
A Study to Evaluate the Effectiveness and Safety of Prephase Steroid Treatment before Remission Induction Chemotherapy in Patients with Pediatric Acute Lymphoblastic Leukemia Using Common Data Model-Based Real-World Data: A Retrospective Observational Study 利用基于通用数据模型的真实世界数据,评估小儿急性淋巴细胞白血病患者在缓解诱导化疗前接受前期类固醇治疗的有效性和安全性的研究:回顾性观察研究
IF 3.9 2区 医学 Q1 Medicine Pub Date : 2024-04-22 DOI: 10.2147/clep.s454263
Yoona Choi, Bo Kyung Kim, Jung-Hyun Won, Jae Won Yoo, Wona Choi, Surin Jung, Jae Yoon Kim, In Young Choi, Nack-Gyun Chung, Jae Wook Lee, Jung Yoon Choi, Hyoung Jin Kang, Howard Lee
Background: Rapid reduction of leukemic cells in the bone marrow during remission induction chemotherapy (RIC) can lead to significant complications such as tumor lysis syndrome (TLS). We investigated whether prephase steroid treatment before RIC could decrease TLS incidence and improve overall survival in pediatric patients with acute lymphoblastic leukemia (ALL).
Methods: Data were extracted from the Common Data Model databases in two tertiary-care hospitals in Seoul, South Korea. Patients were classified into the treated or untreated group if they had received RIC with prephase steroid treatment ≥ 7 days before RIC in 2012– 2021 or not, respectively. Stabilized Inverse Probability of Treatment Weighting (sIPTW) was applied to ensure compatibility between the treated and untreated groups. The incidence of TLS within 14 days of starting RIC, overall survival (OS), and the incidence of adverse events of special interest were the primary endpoints. Multiple sensitivity analyses were performed.
Results: Baseline characteristics were effectively balanced between the treated (n=308.4) and untreated (n=246.6) groups after sIPTW. Prephase steroid treatment was associated with a significant 88% reduction in the risk of TLS (OR 0.12, 95% CI: 0.03– 0.41). OS was numerically greater in the treated group than in the untreated group although the difference was not statistically significant (HR 0.64, 95% CI 0.25– 1.64). The treated group experienced significantly elevated risks for hyperbilirubinemia and hyperglycemia. The reduction in TLS risk by prephase steroid treatment was maintained in all of the sensitivity analyses.
Conclusion: Prephase steroid treatment for ≥ 7 days before RIC in pediatric patients with ALL reduces the risk of TLS, while careful monitoring for toxicities is necessary. If adequately analyzed, real-world data can provide crucial effectiveness and safety information for proper management of pediatric patients with ALL, for whom prospective randomized studies may be difficult to perform for ethical and practical reasons.

背景:在缓解诱导化疗(RIC)期间,骨髓中白血病细胞的快速减少可导致肿瘤溶解综合征(TLS)等严重并发症。我们研究了RIC前的前期类固醇治疗是否能降低急性淋巴细胞白血病(ALL)儿童患者的TLS发生率并提高总生存率:数据来自韩国首尔两家三级医院的通用数据模型数据库。如果患者在2012-2021年接受RIC前≥7天接受过期前类固醇治疗或未接受过期前类固醇治疗,则分别被分为治疗组和未治疗组。为确保治疗组和未治疗组之间的兼容性,采用了稳定逆治疗概率加权法(sIPTW)。主要终点是开始 RIC 后 14 天内 TLS 的发生率、总生存率(OS)和特殊不良事件的发生率。研究还进行了多重敏感性分析:sIPTW治疗后,治疗组(308.4人)和未治疗组(246.6人)的基线特征有效平衡。前阶段类固醇治疗可使TLS风险显著降低88%(OR 0.12,95% CI:0.03- 0.41)。治疗组的 OS 数值高于未治疗组,但差异无统计学意义(HR 0.64,95% CI 0.25-1.64)。治疗组出现高胆红素血症和高血糖的风险明显升高。在所有的敏感性分析中,前阶段类固醇治疗降低 TLS 风险的效果均得以保持:结论:儿童 ALL 患者在 RIC 前接受≥ 7 天的前阶段类固醇治疗可降低 TLS 风险,但必须仔细监测毒性反应。如果对真实世界的数据进行充分分析,就能为正确管理儿童 ALL 患者提供重要的有效性和安全性信息,由于伦理和实际原因,前瞻性随机研究可能难以开展。
{"title":"A Study to Evaluate the Effectiveness and Safety of Prephase Steroid Treatment before Remission Induction Chemotherapy in Patients with Pediatric Acute Lymphoblastic Leukemia Using Common Data Model-Based Real-World Data: A Retrospective Observational Study","authors":"Yoona Choi, Bo Kyung Kim, Jung-Hyun Won, Jae Won Yoo, Wona Choi, Surin Jung, Jae Yoon Kim, In Young Choi, Nack-Gyun Chung, Jae Wook Lee, Jung Yoon Choi, Hyoung Jin Kang, Howard Lee","doi":"10.2147/clep.s454263","DOIUrl":"https://doi.org/10.2147/clep.s454263","url":null,"abstract":"<strong>Background:</strong> Rapid reduction of leukemic cells in the bone marrow during remission induction chemotherapy (RIC) can lead to significant complications such as tumor lysis syndrome (TLS). We investigated whether prephase steroid treatment before RIC could decrease TLS incidence and improve overall survival in pediatric patients with acute lymphoblastic leukemia (ALL).<br/><strong>Methods:</strong> Data were extracted from the Common Data Model databases in two tertiary-care hospitals in Seoul, South Korea. Patients were classified into the treated or untreated group if they had received RIC with prephase steroid treatment ≥ 7 days before RIC in 2012– 2021 or not, respectively. Stabilized Inverse Probability of Treatment Weighting (sIPTW) was applied to ensure compatibility between the treated and untreated groups. The incidence of TLS within 14 days of starting RIC, overall survival (OS), and the incidence of adverse events of special interest were the primary endpoints. Multiple sensitivity analyses were performed.<br/><strong>Results:</strong> Baseline characteristics were effectively balanced between the treated (n=308.4) and untreated (n=246.6) groups after sIPTW. Prephase steroid treatment was associated with a significant 88% reduction in the risk of TLS (OR 0.12, 95% CI: 0.03– 0.41). OS was numerically greater in the treated group than in the untreated group although the difference was not statistically significant (HR 0.64, 95% CI 0.25– 1.64). The treated group experienced significantly elevated risks for hyperbilirubinemia and hyperglycemia. The reduction in TLS risk by prephase steroid treatment was maintained in all of the sensitivity analyses.<br/><strong>Conclusion:</strong> Prephase steroid treatment for ≥ 7 days before RIC in pediatric patients with ALL reduces the risk of TLS, while careful monitoring for toxicities is necessary. If adequately analyzed, real-world data can provide crucial effectiveness and safety information for proper management of pediatric patients with ALL, for whom prospective randomized studies may be difficult to perform for ethical and practical reasons.<br/><br/>","PeriodicalId":10362,"journal":{"name":"Clinical Epidemiology","volume":null,"pages":null},"PeriodicalIF":3.9,"publicationDate":"2024-04-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140636920","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}
引用次数: 0
Development and Validation of an Intracranial Hemorrhage Risk Score in Older Adults with Atrial Fibrillation Treated with Oral Anticoagulant 开发并验证口服抗凝剂的老年房颤患者颅内出血风险评分
IF 3.9 2区 医学 Q1 Medicine Pub Date : 2024-04-17 DOI: 10.2147/clep.s438013
Lily G Bessette, Daniel E Singer, Ajinkya Pawar, Vincent Wong, Dae Hyun Kim, Kueiyu Joshua Lin
Background: High risk of intracranial hemorrhage (ICH) is a leading reason for withholding anticoagulation in patients with atrial fibrillation (AF). We aimed to develop a claims-based ICH risk prediction model in older adults with AF initiating oral anticoagulation (OAC).
Methods: We used US Medicare claims data to identify new users of OAC aged ≥ 65 years with AF in 2010– 2017. We used regularized Cox regression to select predictors of ICH. We compared our AF ICH risk score with the HAS-BLED bleed risk and Homer fall risk scores by area under the receiver operating characteristic curve (AUC) and assessed net reclassification improvement (NRI) when predicting 1-year risk of ICH.
Results: Our study cohort comprised 840,020 patients (mean [SD] age 77.5 [7.4] years and female 52.2%) split geographically into training (3963 ICH events [0.6%] in 629,804 patients) and validation (1397 ICH events [0.7%] in 210,216 patients) sets. Our AF ICH risk score, including 50 predictors, had superior AUCs of 0.653 and 0.650 in the training and validation sets than the HAS-BLED score of 0.580 and 0.567 (p< 0.001) and the Homer score of 0.624 and 0.623 (p< 0.001). In the validation set, our AF ICH risk score reclassified 57.8%, 42.5%, and 43.9% of low, intermediate, and high-risk patients, respectively, by HAS-BLED score (NRI: 15.3%, p< 0.001). Similarly, it reclassified 0.0, 44.1, and 19.4% of low, intermediate, and high-risk patients, respectively, by the Homer score (NRI: 21.9%, p< 0.001).
Conclusion: Our novel claims-based ICH risk prediction model outperformed the standard HAS-BLED score and can inform OAC prescribing decisions.

背景:颅内出血(ICH)的高风险是心房颤动(AF)患者暂停抗凝治疗的主要原因。我们的目标是开发一个基于索赔的 ICH 风险预测模型,用于预测开始口服抗凝药 (OAC) 的老年房颤患者的 ICH 风险:我们使用美国医疗保险理赔数据来识别 2010 年至 2017 年期间年龄≥ 65 岁、患有房颤的 OAC 新用户。我们使用正则化 Cox 回归来选择 ICH 的预测因子。我们通过接收器操作特征曲线下面积(AUC)比较了房颤 ICH 风险评分与 HAS-BLED 出血风险和 Homer 跌倒风险评分,并评估了预测 1 年 ICH 风险时的净再分类改进(NRI):我们的研究队列包括 840,020 名患者(平均 [SD] 年龄 77.5 [7.4]岁,女性占 52.2%),按地域分为训练集(629,804 名患者中发生 3963 例 ICH 事件 [0.6%])和验证集(210,216 名患者中发生 1397 例 ICH 事件 [0.7%])。在训练集和验证集中,我们的房颤 ICH 风险评分(包括 50 个预测因子)的 AUC 分别为 0.653 和 0.650,优于 HAS-BLED 评分的 0.580 和 0.567(p< 0.001)以及 Homer 评分的 0.624 和 0.623(p< 0.001)。在验证组中,我们的房颤 ICH 风险评分按 HAS-BLED 评分分别对 57.8%、42.5% 和 43.9% 的低危、中危和高危患者进行了重新分类(NRI:15.3%,p< 0.001)。同样,根据 Homer 评分,它分别对 0.0、44.1 和 19.4% 的低危、中危和高危患者进行了重新分类(NRI:21.9%,p< 0.001):我们基于索赔的新型 ICH 风险预测模型优于标准 HAS-BLED 评分,可为 OAC 处方决策提供依据。
{"title":"Development and Validation of an Intracranial Hemorrhage Risk Score in Older Adults with Atrial Fibrillation Treated with Oral Anticoagulant","authors":"Lily G Bessette, Daniel E Singer, Ajinkya Pawar, Vincent Wong, Dae Hyun Kim, Kueiyu Joshua Lin","doi":"10.2147/clep.s438013","DOIUrl":"https://doi.org/10.2147/clep.s438013","url":null,"abstract":"<strong>Background:</strong> High risk of intracranial hemorrhage (ICH) is a leading reason for withholding anticoagulation in patients with atrial fibrillation (AF). We aimed to develop a claims-based ICH risk prediction model in older adults with AF initiating oral anticoagulation (OAC).<br/><strong>Methods:</strong> We used US Medicare claims data to identify new users of OAC aged ≥ 65 years with AF in 2010– 2017. We used regularized Cox regression to select predictors of ICH. We compared our AF ICH risk score with the HAS-BLED bleed risk and Homer fall risk scores by area under the receiver operating characteristic curve (AUC) and assessed net reclassification improvement (NRI) when predicting 1-year risk of ICH.<br/><strong>Results:</strong> Our study cohort comprised 840,020 patients (mean [SD] age 77.5 [7.4] years and female 52.2%) split geographically into training (3963 ICH events [0.6%] in 629,804 patients) and validation (1397 ICH events [0.7%] in 210,216 patients) sets. Our AF ICH risk score, including 50 predictors, had superior AUCs of 0.653 and 0.650 in the training and validation sets than the HAS-BLED score of 0.580 and 0.567 (<em>p</em>&lt; 0.001) and the Homer score of 0.624 and 0.623 (p&lt; 0.001). In the validation set, our AF ICH risk score reclassified 57.8%, 42.5%, and 43.9% of low, intermediate, and high-risk patients, respectively, by HAS-BLED score (NRI: 15.3%, <em>p</em>&lt; 0.001). Similarly, it reclassified 0.0, 44.1, and 19.4% of low, intermediate, and high-risk patients, respectively, by the Homer score (NRI: 21.9%, <em>p</em>&lt; 0.001).<br/><strong>Conclusion:</strong> Our novel claims-based ICH risk prediction model outperformed the standard HAS-BLED score and can inform OAC prescribing decisions.<br/><br/>","PeriodicalId":10362,"journal":{"name":"Clinical Epidemiology","volume":null,"pages":null},"PeriodicalIF":3.9,"publicationDate":"2024-04-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140613864","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}
引用次数: 0
Validity of Major Osteoporotic Fracture Diagnoses in the Danish National Patient Registry 丹麦全国患者登记处重大骨质疏松性骨折诊断的有效性
IF 3.9 2区 医学 Q1 Medicine Pub Date : 2024-04-13 DOI: 10.2147/clep.s444447
Anne Clausen, Sören Möller, Michael Kriegbaum Skjødt, Rasmus Bank Lynggaard, Pernille Just Vinholt, Martin Lindberg-Larsen, Jens Søndergaard, Bo Abrahamsen, Katrine Hass Rubin
Objective: To evaluate the validity of diagnosis codes for Major Osteoporotic Fracture (MOF) in the Danish National Patient Registry (NPR) and secondly to evaluate whether the fracture was incident/acute using register-based definitions including date criteria and procedural codes.
Methods: We identified a random sample of 2400 records with a diagnosis code for a MOF in the NPR with dates in the year of 2018. Diagnoses were coded with the 10th revision of the International Classification of Diseases (ICD-10). The sample included 2375 unique fracture patients from the Region of Southern Denmark. Medical records were retrieved for the study population and reviewed by an algorithmic search function and medical doctors to verify the MOF diagnoses. Register-based definitions of incident/acute MOF was evaluated in NPR data by applying date criteria and procedural codes.
Results: The PPV for MOF diagnoses overall was 0.99 (95% CI: 0.98;0.99) and PPV=0.99 for the four individual fracture sites, respectively. Further, analyses of incident/acute fractures applying date criteria, procedural codes and using patients’ first contact in the NPR resulted in PPV=0.88 (95% CI: 0.84;0.91) for hip fractures, PPV=0.78 (95% CI: 0.74;0.83) for humerus fractures, PPV=0.78 (95% CI: 0.73;0.83) for clinical vertebral fractures and PPV=0.87 (95% CI: 0.83;0.90) for wrist fractures.
Conclusion: ICD-10 coded MOF diagnoses are valid in the NPR. Furthermore, a set of register-based criteria can be applied to qualify if the MOF fracture was incident/acute. Thus, the NPR is a valuable and reliable data source for epidemiological research on osteoporotic fractures.

Keywords: major osteoporotic fractures, validity, positive predictive value, the Danish National Patient Register, algorithmic search function, epidemiology
目的评估丹麦国家患者登记处(NPR)中重大骨质疏松性骨折(MOF)诊断代码的有效性,其次使用基于登记处的定义(包括日期标准和程序代码)评估骨折是否为偶发/急性骨折:我们随机抽取了 2400 份记录,这些记录在 NPR 中带有 MOF 诊断代码,日期为 2018 年。诊断采用《国际疾病分类》第 10 版(ICD-10)编码。样本包括来自南丹麦大区的 2375 名独特的骨折患者。对研究人群的医疗记录进行了检索,并通过算法搜索功能和医生对医疗记录进行了审查,以核实 MOF 诊断。通过应用日期标准和程序代码,在NPR数据中对基于登记册的事故/急性MOF定义进行了评估:MOF诊断的总体PPV为0.99(95% CI:0.98;0.99),四个骨折部位的PPV分别为0.99。此外,应用日期标准、程序代码和使用患者在 NPR 中的首次接触对事故/急性骨折进行分析,结果显示髋部骨折的 PPV=0.88 (95% CI: 0.84;0.91),髋部骨折的 PPV=0.78(95% CI:0.74;0.83),临床椎体骨折的PPV=0.78(95% CI:0.73;0.83),腕部骨折的PPV=0.87(95% CI:0.83;0.90):结论:ICD-10编码的MOF诊断在全国人口普查中是有效的。结论:ICD-10 编码的 MOF 诊断在 NPR 中是有效的。此外,一套基于登记的标准可用于判定 MOF 骨折是否为偶发/急性骨折。因此,国家患者登记册是骨质疏松性骨折流行病学研究的一个宝贵而可靠的数据来源。
{"title":"Validity of Major Osteoporotic Fracture Diagnoses in the Danish National Patient Registry","authors":"Anne Clausen, Sören Möller, Michael Kriegbaum Skjødt, Rasmus Bank Lynggaard, Pernille Just Vinholt, Martin Lindberg-Larsen, Jens Søndergaard, Bo Abrahamsen, Katrine Hass Rubin","doi":"10.2147/clep.s444447","DOIUrl":"https://doi.org/10.2147/clep.s444447","url":null,"abstract":"<strong>Objective:</strong> To evaluate the validity of diagnosis codes for Major Osteoporotic Fracture (MOF) in the Danish National Patient Registry (NPR) and secondly to evaluate whether the fracture was incident/acute using register-based definitions including date criteria and procedural codes.<br/><strong>Methods:</strong> We identified a random sample of 2400 records with a diagnosis code for a MOF in the NPR with dates in the year of 2018. Diagnoses were coded with the 10th revision of the International Classification of Diseases (ICD-10). The sample included 2375 unique fracture patients from the Region of Southern Denmark. Medical records were retrieved for the study population and reviewed by an algorithmic search function and medical doctors to verify the MOF diagnoses. Register-based definitions of incident/acute MOF was evaluated in NPR data by applying date criteria and procedural codes.<br/><strong>Results:</strong> The PPV for MOF diagnoses overall was 0.99 (95% CI: 0.98;0.99) and PPV=0.99 for the four individual fracture sites, respectively. Further, analyses of incident/acute fractures applying date criteria, procedural codes and using patients’ first contact in the NPR resulted in PPV=0.88 (95% CI: 0.84;0.91) for hip fractures, PPV=0.78 (95% CI: 0.74;0.83) for humerus fractures, PPV=0.78 (95% CI: 0.73;0.83) for clinical vertebral fractures and PPV=0.87 (95% CI: 0.83;0.90) for wrist fractures.<br/><strong>Conclusion:</strong> ICD-10 coded MOF diagnoses are valid in the NPR. Furthermore, a set of register-based criteria can be applied to qualify if the MOF fracture was incident/acute. Thus, the NPR is a valuable and reliable data source for epidemiological research on osteoporotic fractures.<br/><br/><strong>Keywords:</strong> major osteoporotic fractures, validity, positive predictive value, the Danish National Patient Register, algorithmic search function, epidemiology<br/>","PeriodicalId":10362,"journal":{"name":"Clinical Epidemiology","volume":null,"pages":null},"PeriodicalIF":3.9,"publicationDate":"2024-04-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140593720","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}
引用次数: 0
Validity of Prescription-Defined and Hospital-Diagnosed Hypertension Compared with Self-Reported Hypertension in Denmark 丹麦处方定义和医院诊断的高血压与自述高血压的有效性比较
IF 3.9 2区 医学 Q1 Medicine Pub Date : 2024-04-11 DOI: 10.2147/clep.s448347
Kasper Bonnesen, Morten Schmidt
Purpose: Hypertension is an important risk factor in cardio-epidemiological research, but data quality remains a concern. We validated different registry-based definitions of hypertension.
Patients and Methods: The cohort included all first-time responders of the Danish National Health Surveys (2010, 2013, or 2017). Prescription-defined hypertension was defined as ≥ 1 or ≥ 2 filled prescriptions of antihypertensive specific drugs in ≥ 1 or ≥ 2 different antihypertensive drug classes within 90, 180, or 365 days before survey response. Hospital-diagnosed hypertension was defined from hypertension diagnoses within five years before the survey response. Considering self-reported hypertension as the reference, we calculated the positive predictive value (PPV), the negative predictive value (NVP), the sensitivity, and the specificity of prescription-defined and hospital-diagnosed hypertension.
Results: Among 442,490 survey responders, 127,247 (29%) had self-reported hypertension. For prescription-defined hypertension with 365-day lookback, the PPV was highest for ≥ 2 prescriptions in ≥ 2 drug classes (94%) and lowest for ≥ 1 prescription in ≥ 1 drug class (85%). The NPV was highest for ≥ 1 prescription in ≥ 2 drug classes (94%) and lowest for ≥ 1 prescription in ≥ 2 drug classes (80%). The sensitivity was highest for ≥ 1 prescription in ≥ 1 drug class (79%) and lowest for ≥ 2 prescriptions in ≥ 2 drug classes (30%). The specificity was ≥ 94% for all algorithms. The PPV and specificity did not change noteworthy with length of lookback period, whereas the NPV and the sensitivity generally were higher for longer lookback. The algorithm ≥ 1 prescription in ≥ 2 drug classes with 365-day lookback was among the best balanced across all measures of validity (PPV=88%, NPV=94%, sensitivity=75%, specificity=96%). For hospital-diagnosed hypertension, the PPV was 90%, the NPV was 76%, the sensitivity was 22%, and the specificity was 99%.
Conclusion: Compared with self-reported hypertension, the algorithms for prescription-defined and hospital-diagnosed hypertension had high predictive values and specificity, but low sensitivity.

Keywords: epidemiologic studies, epidemiology, hypertension, predictive value of tests, sensitivity and specificity, validation study
目的:高血压是心脏流行病学研究中的一个重要风险因素,但数据质量仍是一个令人担忧的问题。我们验证了基于登记册的不同高血压定义:研究对象包括丹麦国家健康调查(2010 年、2013 年或 2017 年)的所有首次应答者。处方定义的高血压是指在调查回答前 90 天、180 天或 365 天内,≥ 1 或≥ 2 个已开具的≥ 1 或≥ 2 个不同降压药物类别的降压药物处方。医院诊断的高血压是指调查回答前五年内诊断出的高血压。以自我报告的高血压为参考,我们计算了处方定义的高血压和医院诊断的高血压的阳性预测值(PPV)、阴性预测值(NVP)、灵敏度和特异性:在 442 490 名调查对象中,127 247 人(29%)自述患有高血压。对于处方定义的高血压(365 天回溯),≥ 2 种药物类别中≥ 2 个处方的 PPV 最高(94%),≥ 1 种药物类别中≥ 1 个处方的 PPV 最低(85%)。≥2类药物中≥1张处方的NPV最高(94%),≥2类药物中≥1张处方的NPV最低(80%)。≥1类药物中≥1张处方的灵敏度最高(79%),≥2类药物中≥2张处方的灵敏度最低(30%)。所有算法的特异性均≥94%。PPV 和特异性没有随回溯期的长短发生显著变化,而 NPV 和灵敏度通常在回溯期较长时较高。回溯期为 365 天、≥ 1 个处方≥ 2 个药物类别的算法在所有有效性衡量标准中都是最均衡的(PPV=88%,NPV=94%,灵敏度=75%,特异性=96%)。对于医院诊断的高血压,PPV 为 90%,NPV 为 76%,灵敏度为 22%,特异性为 99%:与自我报告的高血压相比,处方定义的高血压和医院诊断的高血压的算法具有较高的预测值和特异性,但灵敏度较低。 关键词:流行病学研究;流行病学;高血压;检测的预测值;灵敏度和特异性;验证研究
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引用次数: 0
A Harmonised Approach to Curating Research-Ready Datasets for Asthma, Chronic Obstructive Pulmonary Disease (COPD) and Interstitial Lung Disease (ILD) in England, Wales and Scotland Using Clinical Practice Research Datalink (CPRD), Secure Anonymised Information Linkage (SAIL) Databank and DataLoch 英格兰、威尔士和苏格兰利用临床实践研究数据链 (CPRD)、安全匿名信息链接 (SAIL) 数据库和数据洛赫 (DataLoch) 收集哮喘、慢性阻塞性肺病 (COPD) 和间质性肺病 (ILD) 研究用数据集的统一方法
IF 3.9 2区 医学 Q1 Medicine Pub Date : 2024-04-04 DOI: 10.2147/clep.s437937
Sara Hatam, Sean Timothy Scully, Sarah Cook, Hywel T Evans, Alastair Hume, Constantinos Kallis, Ian Farr, Chris Orton, Aziz Sheikh, Jennifer K Quint
Background: Electronic healthcare records (EHRs) are an important resource for health research that can be used to improve patient outcomes in chronic respiratory diseases. However, consistent approaches in the analysis of these datasets are needed for coherent messaging, and when undertaking comparative studies across different populations.
Methods and Results: We developed a harmonised curation approach to generate comparable patient cohorts for asthma, chronic obstructive pulmonary disease (COPD) and interstitial lung disease (ILD) using datasets from within Clinical Practice Research Datalink (CPRD; for England), Secure Anonymised Information Linkage (SAIL; for Wales) and DataLoch (for Scotland) by defining commonly derived variables consistently between the datasets. By working in parallel on the curation methodology used for CPRD, SAIL and DataLoch for asthma, COPD and ILD, we were able to highlight key differences in coding and recording between the databases and identify solutions to enable valid comparisons.
Conclusion: Codelists and metadata generated have been made available to help re-create the asthma, COPD and ILD cohorts in CPRD, SAIL and DataLoch for different time periods, and provide a starting point for the curation of respiratory datasets in other EHR databases, expediting further comparable respiratory research.

背景:电子医疗记录(EHR)是健康研究的重要资源,可用于改善慢性呼吸系统疾病患者的治疗效果。然而,在进行不同人群的比较研究时,需要采用一致的方法来分析这些数据集,以获得一致的信息:我们开发了一种统一的整理方法,通过在数据集之间统一定义常见的衍生变量,利用临床实践研究数据链(CPRD,英格兰)、安全匿名信息链接(SAIL,威尔士)和数据洛赫(DataLoch,苏格兰)中的数据集生成哮喘、慢性阻塞性肺疾病(COPD)和间质性肺疾病(ILD)的可比患者队列。通过同时研究 CPRD、SAIL 和 DataLoch 用于哮喘、慢性阻塞性肺病和 ILD 的整理方法,我们能够突出数据库之间在编码和记录方面的主要差异,并确定解决方案,以便进行有效比较:已生成的代码表和元数据可用于帮助在 CPRD、SAIL 和 DataLoch 中重新创建不同时期的哮喘、慢性阻塞性肺病和 ILD 队列,并为其他电子病历数据库中呼吸系统数据集的整理提供了一个起点,从而加快了进一步的可比呼吸系统研究。
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引用次数: 0
Validation of Diagnostic Codes to Identify Glaucoma in Taiwan’s Claims Data: A Multi-Institutional Study 台湾索赔数据中识别青光眼的诊断代码验证:多机构研究
IF 3.9 2区 医学 Q1 Medicine Pub Date : 2024-04-03 DOI: 10.2147/clep.s443872
Pei-Ting Lu, Tsung-Hsien Tsai, Chi-Chun Lai, Lan-Hsin Chuang, Shih-Chieh Shao
Background: Healthcare databases play a crucial role in improving our understanding of glaucoma epidemiology, which is the leading cause of irreversible blindness globally. However, the accuracy of diagnostic codes used in these databases to detect glaucoma is still uncertain.
Aim: To assess the accuracy of ICD-9-CM and ICD-10-CM codes in identifying patients with glaucoma, including two distinct subtypes, primary open-angle glaucoma (POAG) and primary angle-closure glaucoma (PACG).
Methods: We analyzed electronic medical records data from a 2% random sample of patients who newly underwent visual field examination in Taiwan’s largest multi-institutional healthcare system from 2011 to 2020. The diagnosis of glaucoma was confirmed by two ophthalmologists, based on the glaucoma diagnostic criteria. The positive predictive value (PPV), negative predictive value (NPV), sensitivity and specificity for ICD-9-CM codes 365.1X and 365.2X, and ICD-10-CM codes H4010X, H4011X, H4012X, H4020X, H4021X, H4022X, H4023X and H4024X for glaucoma were calculated.
Results: We randomly selected 821 patients (mean age: 56.9 years old; female: 50.5%) from the original cohort of 41,050 newly receiving visual field examination in the study. Among 464 cases with an ICD-9-CM glaucoma code, the sensitivity, specificity, PPV and NPV for glaucoma were 86.5, 96.5, 91.9, and 90.9%, respectively. Among 357 cases with an ICD-10-CM glaucoma code, the sensitivity, specificity, PPV and NPV for glaucoma were 87.0, 92.8, 92.2 and 87.9%, respectively. The accuracy of diagnostic codes to identify POAG and PACG remained consistent.
Conclusion: The diagnostic codes were highly reliable for identifying cases of glaucoma in Taiwan’s routine healthcare practice. These results provide confidence when using ICD-9-CM and ICD-10-CM codes to define glaucoma cases in healthcare database research in Taiwan.

背景:青光眼是导致全球不可逆失明的主要原因,而医疗数据库在提高我们对青光眼流行病学的认识方面发挥着至关重要的作用。目的:评估 ICD-9-CM 和 ICD-10-CM 编码在识别青光眼患者(包括原发性开角型青光眼(POAG)和原发性闭角型青光眼(PACG)这两种不同亚型)方面的准确性:我们分析了 2011 年至 2020 年期间在台湾最大的多机构医疗系统中新接受视野检查的 2% 随机抽样患者的电子病历数据。青光眼的诊断由两名眼科医生根据青光眼诊断标准进行确认。计算了青光眼的 ICD-9-CM 编码 365.1X 和 365.2X,以及 ICD-10-CM 编码 H4010X、H4011X、H4012X、H4020X、H4021X、H4022X、H4023X 和 H4024X 的阳性预测值(PPV)、阴性预测值(NPV)、敏感性和特异性:我们从新接受视野检查的 41,050 名患者中随机抽取了 821 名患者(平均年龄:56.9 岁;女性:50.5%)。在 464 例带有 ICD-9-CM 青光眼代码的病例中,青光眼的敏感性、特异性、PPV 和 NPV 分别为 86.5%、96.5%、91.9% 和 90.9%。在 357 个有 ICD-10-CM 青光眼代码的病例中,青光眼的敏感性、特异性、PPV 和 NPV 分别为 87.0%、92.8%、92.2% 和 87.9%。诊断代码识别 POAG 和 PACG 的准确性保持一致:结论:在台湾的常规医疗实践中,诊断代码在识别青光眼病例方面具有很高的可靠性。这些结果为在台湾医疗数据库研究中使用ICD-9-CM和ICD-10-CM代码定义青光眼病例提供了信心。
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引用次数: 0
期刊
Clinical Epidemiology
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