Pharmacoepidemiology and Drug Safety最新文献

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Prevalence of Polypharmacy in Chinese Community-Dwelling Older Adults and Forecast by 2035: A Systematic Review and Meta-Analysis. 中国社区老年人综合用药的患病率及2035年预测:一项系统回顾和荟萃分析。
IF 2.4 4区 医学
Pharmacoepidemiology and Drug Safety Pub Date : 2025-04-01 DOI: 10.1002/pds.70133
Hui Xie, Ruo Jiang, Li Luo, Heqi Sun
{"title":"Prevalence of Polypharmacy in Chinese Community-Dwelling Older Adults and Forecast by 2035: A Systematic Review and Meta-Analysis.","authors":"Hui Xie, Ruo Jiang, Li Luo, Heqi Sun","doi":"10.1002/pds.70133","DOIUrl":"10.1002/pds.70133","url":null,"abstract":"<p><strong>Purpose: </strong>We aimed to derive a pooled polypharmacy prevalence estimate and forecast the total polypharmacy cases by 2035 in Chinese community-dwelling older adults.</p><p><strong>Methods: </strong>We searched for studies in three databases (CNKI, Scopus and PubMed). We selected studies according to pre-defined inclusion and exclusion criteria. We assessed study quality using a modified Newcastle-Ottawa Scale. Polypharmacy in our study was defined as the concurrent use of at least five different medications. Pooled prevalence was estimated overall and by regions, time periods, and other important factors. We fitted Bayesian random-effects logit models to synthesize single studies and reported a 95% uncertainty interval (95UI).</p><p><strong>Results: </strong>A total of 25 studies were finally included. The pooled polypharmacy prevalence was estimated to be 31.04% (95UI: 18.16 ~ 47.66). The pooled prevalence was highest in the east region (37.98%, 95UI: 21.92 ~ 57.69), followed by the middle region (33.53%, 95UI: 4.89 ~ 84.46) and the west region (25.85%, 95UI: 8.78 ~ 50.74). The pooled prevalence was 31.10% (95UI: 15.54 ~ 52.72) in the latest 5 years (2017-2021) and 30.88% (95UI: 11.53 ~ 60.56) in the beyond latest 5 years (2005-2016). The per cent change annualized in the forecasted total polypharmacy cases from 2022 to 2035 was estimated to be 3.69%, with the highest total cases forecasted to be 131.7 million (95UI: 77.1 ~ 202.2) in 2035.</p><p><strong>Conclusions: </strong>Our study suggests that polypharmacy is notably prevalent in Chinese community-dwelling older adults, highlighting the need for the development and delivery of community-based interventions targeted at this population.</p>","PeriodicalId":19782,"journal":{"name":"Pharmacoepidemiology and Drug Safety","volume":"34 4","pages":"e70133"},"PeriodicalIF":2.4,"publicationDate":"2025-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143731195","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}
引用次数: 0
Characteristics and Medication Use Patterns of Pregnancies With COVID-19 Ending in Live-Birth in the Sentinel System. 哨点系统中以活产结束的COVID-19妊娠的特点和用药模式
IF 2.4 4区 医学
Pharmacoepidemiology and Drug Safety Pub Date : 2025-04-01 DOI: 10.1002/pds.70121
Mayura Shinde, Austin Cosgrove, Jennifer G Lyons, Maria E Kempner, Jolene Mosley, David Cole, Emma Hoffman, Elizabeth Messenger-Jones, José J Hernández-Muñoz, Danijela Stojanovic, Benedict H W Wong, Yueqin Zhao, Leyla Sahin, Susan E Andrade, Sengwee Toh, Wei Hua
{"title":"Characteristics and Medication Use Patterns of Pregnancies With COVID-19 Ending in Live-Birth in the Sentinel System.","authors":"Mayura Shinde, Austin Cosgrove, Jennifer G Lyons, Maria E Kempner, Jolene Mosley, David Cole, Emma Hoffman, Elizabeth Messenger-Jones, José J Hernández-Muñoz, Danijela Stojanovic, Benedict H W Wong, Yueqin Zhao, Leyla Sahin, Susan E Andrade, Sengwee Toh, Wei Hua","doi":"10.1002/pds.70121","DOIUrl":"10.1002/pds.70121","url":null,"abstract":"<p><strong>Background: </strong>Pregnant women are at high risk for developing severe illness related to COVID-19. We adapted the \"COVID-19 infectiOn aNd medicineS In pregnancy\" (CONSIGN) study protocol as part of an international collaboration to examine medication use patterns among pregnancies in the US.</p><p><strong>Methods: </strong>We identified eligible women aged 12-55 years with documented live-birth deliveries in the Sentinel Distributed Database who had at least one qualifying diagnosis for COVID-19 or a positive-confirmed test for SARS-CoV-2, by trimester of COVID-19 infection. We conducted two sets of analyses comparing medication groups and COVID-19 treatment utilization in the 30 days prior to or after COVID-19 among pregnancies with COVID-19 to: (1) pregnancies without COVID-19 during 6 months prior to or during pregnancy; and (2) non-pregnancy episodes with COVID-19.</p><p><strong>Results: </strong>From 2020 to 2022, we identified 52 355 pregnancies with COVID-19 matched to 52 355 pregnancies without COVID-19 (assigned same matched COVID-19 date), and 40 518 matched non-pregnancy episodes with COVID-19. Outpatient medication use in the 30 days prior to or after the COVID-19 date (or matched date) was quite low (< 15%) among pregnancies with and without COVID-19. Non-pregnancy episodes with COVID-19 had higher use of all medication groups in 30 days prior to COVID-19. However, in the 30 days post-COVID-19, anti-bacterials, anti-inflammatories such as NSAIDs, and analgesics were more common, and COVID-19-specific medications were less frequently used (< 1%) among pregnancies with COVID-19. Assessing COVID-19 severity, more pregnancies had a non-severe COVID-19 diagnosis than non-pregnancy episodes with COVID-19 (87.2% vs. 79.9%).</p><p><strong>Conclusions: </strong>In this retrospective evaluation, selected medication utilization was higher post-COVID-19 among pregnancies with COVID-19, compared to those without COVID-19 and to non-pregnancy episodes with COVID-19. However, the low use of COVID-19-specific medications underscores the need for a safety evaluation of therapies used for COVID-19 management in the pregnant population.</p>","PeriodicalId":19782,"journal":{"name":"Pharmacoepidemiology and Drug Safety","volume":"34 4","pages":"e70121"},"PeriodicalIF":2.4,"publicationDate":"2025-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143731162","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}
引用次数: 0
Agreement Between Parental Self-Reported Antiseizure Medication Use and Dispensed Prescription Records From a National Prescription Database. 家长自我报告的抗癫痫药物使用和国家处方数据库中分配的处方记录之间的协议。
IF 2.4 4区 医学
Pharmacoepidemiology and Drug Safety Pub Date : 2025-04-01 DOI: 10.1002/pds.70139
Emilie Willoch Olstad, Hedvig Nordeng, Marte-Helene Bjørk, Kaja Kristine Selmer, Kristina Gervin
{"title":"Agreement Between Parental Self-Reported Antiseizure Medication Use and Dispensed Prescription Records From a National Prescription Database.","authors":"Emilie Willoch Olstad, Hedvig Nordeng, Marte-Helene Bjørk, Kaja Kristine Selmer, Kristina Gervin","doi":"10.1002/pds.70139","DOIUrl":"10.1002/pds.70139","url":null,"abstract":"<p><strong>Purpose: </strong>Accurate measurement of medication exposure is crucial for studying the safety of antiseizure medications (ASMs) during pregnancy. Pregnancy safety studies of ASMs frequently rely on secondary data from drug prescription registries to assess potential teratogenic effects and impact on fetal development. This study aimed to evaluate the agreement between dispensed prescriptions registered in a national database and self-reported ASM use by parents.</p><p><strong>Methods: </strong>The Norwegian Prescription Database (NorPD) was linked to the Norwegian Mother, Father, and Child Cohort Study (MoBa) and the Medical Birth Registry of Norway (MBRN). Participants included mothers and fathers in the MoBa-study between 2004 and 2009. Agreement between dispensed ASM prescriptions and self-reported use was assessed by calculating Cohen's kappa (κ), sensitivity, and specificity, with self-reported use as the reference standard.</p><p><strong>Results: </strong>A total of 40 632 pregnant women and 42 247 fathers were included. Maternal dispensed ASM prescriptions during pregnancy showed strong overall agreement (κ = 0.81) with self-reported use, with a sensitivity of 80.6% and specificity of 99.9%. Paternal dispensed ASM prescriptions up to 7 months prior to conception also demonstrated strong agreement (κ = 0.81) with self-reported use. Analysis of individual ASMs revealed varying reliability: levetiracetam and lamotrigine had the highest agreement among maternal (κ = 0.92) and paternal (κ = 0.92) dispensed prescriptions, respectively.</p><p><strong>Conclusion: </strong>There is strong agreement between dispensed ASM prescriptions and self-reported medication use by parents, supporting the use of prescription data for evaluating the risks of ASM use during pregnancy.</p>","PeriodicalId":19782,"journal":{"name":"Pharmacoepidemiology and Drug Safety","volume":"34 4","pages":"e70139"},"PeriodicalIF":2.4,"publicationDate":"2025-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11937424/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143710784","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}
引用次数: 0
Tramadol During Pregnancy: Risk of Adverse Pregnancy Outcome and Major Congenital Anomalies. A Comparative Study in the EFEMERIS Database. 妊娠期间曲马多:不良妊娠结局和主要先天性异常的风险。EFEMERIS数据库的比较研究。
IF 2.4 4区 医学
Pharmacoepidemiology and Drug Safety Pub Date : 2025-04-01 DOI: 10.1002/pds.70143
Eva Ferrer, Laurane Delteil, Anthony Caillet, Fatiha Karam, Isabelle Lacroix
{"title":"Tramadol During Pregnancy: Risk of Adverse Pregnancy Outcome and Major Congenital Anomalies. A Comparative Study in the EFEMERIS Database.","authors":"Eva Ferrer, Laurane Delteil, Anthony Caillet, Fatiha Karam, Isabelle Lacroix","doi":"10.1002/pds.70143","DOIUrl":"10.1002/pds.70143","url":null,"abstract":"<p><strong>Purpose: </strong>The aim of the study was to assess the risk of pregnancy termination and major congenital anomalies with tramadol by comparing women exposed to tramadol during pregnancy with women exposed to codeine and unexposed women, using the French EFEMERIS database.</p><p><strong>Methods: </strong>The study was based on the EFEMERIS (Évaluation chez la Femme Enceinte des MÉdicaments et de leurs RISques) database, which contains reimbursed medications prescribed and dispensed to pregnant women, dates of conception and pregnancy outcome, and data on the children (congenital anomalies, neonatal diseases, etc.). Women were considered to be exposed if they were prescribed and dispensed tramadol or codeine at least once during pregnancy. Women who had a pregnancy outcome between July 1, 2004 and December 31, 2020 and living in Haute-Garonne (south-west France) were included in this study.</p><p><strong>Results: </strong>We compared 1602 (1.0%) pregnancies exposed to tramadol (including 1628 fetuses/newborns due to multiple pregnancies) with 6311 (3.8%) exposed to codeine (including 6406 fetuses/newborns) and 158 426 (95.2%) unexposed to tramadol and codeine (including 160 784 fetuses/newborns). The rate of pregnancies exposed to tramadol increased sevenfold between 2004 and 2020. The study showed an increase in the rate of spontaneous pregnancy termination in women exposed to tramadol compared with women exposed to codeine (aHR [95% CI] = 2.23[1.64-3.03]) and unexposed women (aHR [95% CI] = 1.86[1.46-2.37]), after adjustment for maternal age, dispensation of folic acid, teratogenic drugs, NSAIDs, presence of hypertension, diabetes, and long-term Illness. Multivariate analysis did not show an increased rate of major congenital anomalies in fetuses/newborns exposed in utero to tramadol during the first trimester of pregnancy compared with fetuses/newborns exposed to codeine (ORa [95% CI] = 1.03 [0.67-1.57]) and those not exposed to these medications (ORa [95% CI] = 1.24 [0.86-1.79]).</p><p><strong>Conclusion: </strong>This study found an association between tramadol use and the risk of spontaneous pregnancy termination. We cannot conclude that there is a causal link because of a possible indication bias. No association between prescription and dispensation of tramadol during the first trimester of pregnancy and an increased risk of major congenital anomalies has been found.</p>","PeriodicalId":19782,"journal":{"name":"Pharmacoepidemiology and Drug Safety","volume":"34 4","pages":"e70143"},"PeriodicalIF":2.4,"publicationDate":"2025-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11937425/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143710786","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}
引用次数: 0
Development of a Pregnancy Cohort in Commercial Insurance Claims Data: Evaluation of Deliveries Identified From Inpatient Versus Outpatient Claims. 商业保险索赔数据中妊娠队列的发展:对住院与门诊索赔中确定的分娩的评估。
IF 2.4 4区 医学
Pharmacoepidemiology and Drug Safety Pub Date : 2025-03-01 DOI: 10.1002/pds.70115
Jacob C Kahrs, Katelin B Nickel, Mollie E Wood, Sascha Dublin, Michael J Durkin, Sarah S Osmundson, Dustin Stwalley, Elizabeth A Suarez, Anne M Butler
{"title":"Development of a Pregnancy Cohort in Commercial Insurance Claims Data: Evaluation of Deliveries Identified From Inpatient Versus Outpatient Claims.","authors":"Jacob C Kahrs, Katelin B Nickel, Mollie E Wood, Sascha Dublin, Michael J Durkin, Sarah S Osmundson, Dustin Stwalley, Elizabeth A Suarez, Anne M Butler","doi":"10.1002/pds.70115","DOIUrl":"10.1002/pds.70115","url":null,"abstract":"<p><strong>Purpose: </strong>Studies using insurance claims data to identify pregnancies are rarely able to directly assess the validity of the pregnancy/delivery. Inpatient versus outpatient delivery claims may provide different levels of evidence, but more stringent requirements could result in exclusion of true pregnancies. We identified delivery codes from the inpatient and outpatient settings and examined possible confirmatory evidence suggesting that a delivery truly occurred.</p><p><strong>Methods: </strong>Using a US commercial insurance database (2006-2021), we identified potential pregnancies by presence of delivery claims from a provider and/or facility. We classified deliveries as inpatient (claim date during inpatient admission) or outpatient (claim date not during inpatient admission). We identified possible confirmatory evidence for each delivery including: (1) Presence of both provider and facility delivery codes; (2) presence of both diagnosis and procedure delivery codes; (3) labor and delivery revenue codes; (4) gestational age diagnosis codes; (5) pregnancy-related care codes; (6) linkage to an infant claim; and (7) infant insurance enrollment and linkage to a birthing parent. We quantified the proportion of deliveries with confirmatory evidence by delivery setting. Among deliveries with ≥ 1 piece of confirmatory evidence, we compared patient characteristics by apparent delivery setting.</p><p><strong>Results: </strong>Among 4 084 474 delivery episodes, 96.4% were classified as inpatient and 3.6% outpatient. 99.9% of inpatient and 94.0% of outpatient deliveries had ≥ 1 piece of confirmatory evidence. Pregnancy-related care codes were the most common type of confirmatory evidence (99.0% inpatient, 85.7% outpatient). Deliveries classified as inpatient occurred among patients who were older and more clinically complex (i.e., more pregnancy complications, chronic diseases, and prescription medications).</p><p><strong>Conclusions: </strong>The vast majority of deliveries had confirmatory evidence regardless of apparent setting. Patient characteristics differed by delivery setting. Inclusion of apparent outpatient deliveries may increase the sample size of the study population and improve the generalizability of study results.</p>","PeriodicalId":19782,"journal":{"name":"Pharmacoepidemiology and Drug Safety","volume":"34 3","pages":"e70115"},"PeriodicalIF":2.4,"publicationDate":"2025-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11844750/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143468762","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}
引用次数: 0
A Comparative Real-World Study Evaluating the Safety of Immune Globulin Infusion (Human) 10% Solution and Other Intravenous Immunoglobulin Therapies for the Treatment of Chronic Inflammatory Demyelinating Polyradiculoneuropathy. 一项评估免疫球蛋白输注(人)10%溶液和其他静脉注射免疫球蛋白治疗慢性炎症性脱髓鞘性多根神经病变安全性的比较现实世界研究。
IF 2.4 4区 医学
Pharmacoepidemiology and Drug Safety Pub Date : 2025-03-01 DOI: 10.1002/pds.70124
J Bradley Layton, Colin Anderson-Smits, Zhongwen Huang, Hakan Ay, William Spalding, Bilal Khokhar, Jie Zhou, Lee Bennett, Mary S Anthony
{"title":"A Comparative Real-World Study Evaluating the Safety of Immune Globulin Infusion (Human) 10% Solution and Other Intravenous Immunoglobulin Therapies for the Treatment of Chronic Inflammatory Demyelinating Polyradiculoneuropathy.","authors":"J Bradley Layton, Colin Anderson-Smits, Zhongwen Huang, Hakan Ay, William Spalding, Bilal Khokhar, Jie Zhou, Lee Bennett, Mary S Anthony","doi":"10.1002/pds.70124","DOIUrl":"10.1002/pds.70124","url":null,"abstract":"<p><strong>Purpose: </strong>Immune globulin infusion (human) 10% solution (GAMMAGARD LIQUID; GGL), an intravenous immunoglobulin (IVIG), has recently received U.S. approval for chronic inflammatory demyelinating polyradiculoneuropathy (CIDP). We evaluated thrombotic events, acute kidney injury (AKI), and hemolytic events among patients with CIDP initiating IVIG treatment with GGL, versus a U.S.-approved IVIG comparator for CIDP, in individual and combined cohorts of immunoglobulin (Ig)-naive and Ig-experienced participants.</p><p><strong>Methods: </strong>This active-comparator, new-user, cohort study of patients with CIDP used the Merative MarketScan Research and Optum Clinformatics Data Mart databases (2008-2019). Outcomes were compared between adults receiving GGL and comparator IVIGs within propensity score-weighted samples using hazard ratios (HRs) and time period-specific risk ratios (RRs) and risk differences (RDs) with 95% confidence intervals (CI). Database-specific results were meta-analyzed and appropriate.</p><p><strong>Results: </strong>Data from eligible patients in MarketScan (GGL, n = 1441; comparators, n = 2708) and Optum (GGL, n = 644; comparators, n = 1293) were analyzed. Across both databases, HRs, 1-year RRs, and 1-year RDs for thrombotic events did not suggest consistent differences in risk across treatment groups (e.g., MarketScan combined cohort: RR 1.14 [95% CI, 0.50 to 2.55]; Optum combined cohort: 0.60 [0.25 to 1.54]). Similarly, there was no difference in AKI risk between groups (e.g., MarketScan combined cohort: RR 1.25 [95% CI, 0.65 to 2.54]; Optum combined cohort: 0.65 [0.22 to 1.94]). Hemolytic events were rare.</p><p><strong>Conclusions: </strong>Thrombotic events, AKI, and hemolytic events were rare among patients with CIDP receiving IVIG. There were no consistently different outcome risks between patients receiving GGL versus other IVIGs with US approval for CIDP.</p>","PeriodicalId":19782,"journal":{"name":"Pharmacoepidemiology and Drug Safety","volume":"34 3","pages":"e70124"},"PeriodicalIF":2.4,"publicationDate":"2025-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11912303/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143649894","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}
引用次数: 0
Validation of Chronic Inflammatory Demyelinating Polyradiculoneuropathy Coding in US Claims Data. 美国索赔数据中慢性炎性脱髓鞘性多根神经病变编码的验证。
IF 2.4 4区 医学
Pharmacoepidemiology and Drug Safety Pub Date : 2025-03-01 DOI: 10.1002/pds.70123
Joshua U Okonkwo, Erika K Williams, Reza Sadjadi, Sebastian Schneeweiss, Colin Anderson-Smits, Hakan Ay, William Spalding, Priyanka Anand, Zhigang Lu, Kueiyu Joshua Lin
{"title":"Validation of Chronic Inflammatory Demyelinating Polyradiculoneuropathy Coding in US Claims Data.","authors":"Joshua U Okonkwo, Erika K Williams, Reza Sadjadi, Sebastian Schneeweiss, Colin Anderson-Smits, Hakan Ay, William Spalding, Priyanka Anand, Zhigang Lu, Kueiyu Joshua Lin","doi":"10.1002/pds.70123","DOIUrl":"10.1002/pds.70123","url":null,"abstract":"<p><strong>Purpose: </strong>Chronic inflammatory demyelinating polyradiculoneuropathy (CIDP) is a rare autoimmune condition of the peripheral nervous system. The validity of the CIDP diagnosis code in claims data is unclear.</p><p><strong>Methods: </strong>We conducted a validation study testing the performance of claims-based algorithms in identifying CIDP cases, using electronic health record data from the Mass General Brigham Integrated Health Care System linked with Medicare claims data from 01/01/2008 to 12/31/2020. The algorithms require a record of intravenous immunoglobulin (IVIG) use and International Classification of Diseases 9th/10th Revision (ICD9/10) CIDP codes before (including) the date of IVIG use. The positive predictive values (PPVs) of each claims-based algorithm were calculated against the reference standard for CIDP and chronic immune-mediated acquired neuropathy established through chart review by two board-certified neurologists using a standardized abstraction tool.</p><p><strong>Results: </strong>The study cohort consisted of 140 patients (59 in the ICD9 and 81 in the ICD10 era). The PPV of the algorithm requiring at least one CIDP diagnosis code before IVIG use was 66.2% (95% confidence interval [CI], 58.0-74.3). The PPV improved to 71.2% (62.7-79.6) when requiring at least two CIDP codes before IVIG use. The PPV for patients with at least one CIDP code who met the European Academy of Neurology/Peripheral Nerve Society 2021 diagnostic criteria was 30.0% (22.1-37.9).</p><p><strong>Conclusion: </strong>We found that a patient cohort identified using claims-based CIDP diagnoses included a substantial number of patients with other chronic inflammatory acquired neuropathies not formally recognized as CIDP by clinical consensus criteria. Requiring two CIDP codes can improve PPVs.</p>","PeriodicalId":19782,"journal":{"name":"Pharmacoepidemiology and Drug Safety","volume":"34 3","pages":"e70123"},"PeriodicalIF":2.4,"publicationDate":"2025-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143537741","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}
引用次数: 0
A Brief Report on Proposed Areas of International Harmonization of Real-World Evidence Relevance, Reliability and Quality Standards Among Medical Product Regulators. 关于医疗产品监管机构之间真实世界证据相关性、可靠性和质量标准国际协调建议领域的简要报告。
IF 2.4 4区 医学
Pharmacoepidemiology and Drug Safety Pub Date : 2025-03-01 DOI: 10.1002/pds.70127
Maryam Nafie, Valerie J Parker, Mark McClellan, Rachele M Hendricks-Sturrup
{"title":"A Brief Report on Proposed Areas of International Harmonization of Real-World Evidence Relevance, Reliability and Quality Standards Among Medical Product Regulators.","authors":"Maryam Nafie, Valerie J Parker, Mark McClellan, Rachele M Hendricks-Sturrup","doi":"10.1002/pds.70127","DOIUrl":"10.1002/pds.70127","url":null,"abstract":"<p><strong>Background: </strong>International harmonization of real-world data and evidence (RWD/E) standards is a goal among real-world data/real-world evidence (RWD/E) policy stakeholders. The Duke-Robert J. Margolis Institute for Health Policy developed an online 'International Harmonization of RWE Standards Dashboard' to provide timely updates around these goals.</p><p><strong>Methods: </strong>Guidance for industry (draft and final) and related literature available online by medical product regulators globally was sought and, where needed, translated into English language using a certified translator. Consultations were then held with practicing experts to identify, collate, and interpret documents. An online Tableau tool was assembled to collate guidance documents and regulatory definitions of the following key terms used among the community to describe fit-for-use RWE in regulatory submissions: relevance, reliability, and quality.</p><p><strong>Results: </strong>As of February 2025, the United States Food and Drug Administration (FDA) has released the most RWE guidance documents to date (n = 13; 4 draft, 9 final). Four (4) regulators globally (US FDA, EMA, Taiwan FDA, Brazil ANVISA) have directly defined at least two (2) out of the three key terms (reliability, relevance, quality), indicating alignment around the importance of these terms used in the context of RWD/E. Across these terms, we propose areas of definitional alignment: data representativeness and research and regulatory concern (relevance), accuracy in data interpretation and quality and integrity during data accrual (reliability), and data quality assurance across sites and time (quality). We propose areas of definitional misalignment regarding clinical context, data availability and representativeness, and ensuring study sample sizes and/or datasets are adequate to address a given study question.</p><p><strong>Conclusions: </strong>Our assessment of definitions provided among these four regulators lends us to propose distinct areas for harmonization based on our assessment of where regulators appear to align and highlight opportunities to address misalignment.</p>","PeriodicalId":19782,"journal":{"name":"Pharmacoepidemiology and Drug Safety","volume":"34 3","pages":"e70127"},"PeriodicalIF":2.4,"publicationDate":"2025-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11907323/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143625902","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}
引用次数: 0
Comment on: "Evaluating the Accuracy of Responses by Large Language Models for Information on Disease Epidemiology". 评论:“用大语言模型评估疾病流行病学信息反应的准确性”。
IF 2.4 4区 医学
Pharmacoepidemiology and Drug Safety Pub Date : 2025-03-01 DOI: 10.1002/pds.70137
Divà Beltramin, Cédric Bousquet
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引用次数: 0
Regulatory Risk Communication on Thrombosis With Thrombocytopenia Syndrome for COVID-19 Adenovirus Vector Vaccines: Comment. COVID-19腺病毒载体疫苗致血小板减少综合征血栓形成的监管风险沟通:评论
IF 2.4 4区 医学
Pharmacoepidemiology and Drug Safety Pub Date : 2025-03-01 DOI: 10.1002/pds.70122
Hinpetch Daungsupawong, Viroj Wiwanitkit
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引用次数: 0
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