Pharmacoepidemiology and Drug Safety最新文献

{"title":"Use of Potentially Nephrotoxic Drugs in Type 2 Diabetes Patients on SGLT2i: A Trajectories Analysis.","authors":"Lanting Yang, Jingchuan Guo, Sandra L Kane-Gill, Nico Gabriel, Kerry M Empey, Kangho Suh, Levent Kirisci, Inmaculada Hernandez","doi":"10.1002/pds.70098","DOIUrl":"10.1002/pds.70098","url":null,"abstract":"<p><strong>Purpose: </strong>To characterize trajectories of nephrotoxic potential (NxP) drug use among older adults with Type 2 Diabetes (T2D) treated with SGLT2is and identify associated patient characteristics.</p><p><strong>Methods: </strong>Using 2012-2019 Medicare data, we selected patients with T2D who filled at least one prescription for SGLT2is. Index date was the date of the first SGLT2i prescription filled. We quantified the number of drugs with NxP used every month during the first 12 months following the index date. The monthly counts of drugs with NxP were incorporated into the group-based trajectory model to identify groups with similar drug use patterns. Finally, we performed a multinomial logistic regression model to examine the association between patient characteristics and group membership.</p><p><strong>Results: </strong>The study cohort comprised 8811 Medicare beneficiaries with T2D who initiated SGLT2i during the study period with the mean age 67.5 ± 10.6 years. We identified 3 trajectories NxP drug use: no (n = 2142, 24%), low (n = 4752, 54%) and high (n = 1917, 22%) use of drugs with NxP, with patients falling into these categories based on the number of drugs with NxP they used over the time: no drugs, one drug, or two or more drugs. Age, gender, low-income subsidy eligibility and clinical characteristics were associated with group membership.</p><p><strong>Conclusions: </strong>We successfully identified three trajectory groups, with a substantial proportion of patients showing low use of drugs with NxP. Both social and clinical factors were associated with the use of NxP drugs.</p>","PeriodicalId":19782,"journal":{"name":"Pharmacoepidemiology and Drug Safety","volume":"34 2","pages":"e70098"},"PeriodicalIF":2.4,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143024299","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Evaluating the Accuracy of Responses by Large Language Models for Information on Disease Epidemiology.","authors":"Kexin Zhu, Jiajie Zhang, Anton Klishin, Mario Esser, William A Blumentals, Juhaeri Juhaeri, Corinne Jouquelet-Royer, Sarah-Jo Sinnott","doi":"10.1002/pds.70111","DOIUrl":"10.1002/pds.70111","url":null,"abstract":"<p><strong>Purpose: </strong>Accurate background epidemiology of diseases are required in pharmacoepidemiologic research. We evaluated the performance of large language models (LLMs), including ChatGPT-3.5, ChatGPT-4, and Google Bard, when prompted with questions on disease frequency.</p><p><strong>Methods: </strong>A total of 21 questions on the prevalence and incidence of common and rare diseases were developed and submitted to each LLM twice on different dates. Benchmark data were obtained from literature searches targeting \"gold-standard\" references (e.g., government statistics, peer-reviewed articles). Accuracy was evaluated by comparing LLMs' responses to the benchmark data. Consistency was determined by comparing the responses to the same query submitted on different dates. The relevance and authenticity of references were evaluated.</p><p><strong>Results: </strong>Three LLMs generated 126 responses. In ChatGPT-4, 76.2% of responses were accurate, which was higher compared to 50.0% in Bard and 45.2% in ChatGPT-3.5. ChatGPT-4 exhibited higher consistency (71.4%) than Bard (57.9%) or ChatGPT-3.5 (46.7%). ChatGPT-4 provided 52 references with 27 (51.9%) providing relevant information, and all were authentic. Only 9.2% (10/109) of references from Bard were relevant. Of 65/109 unique references, 67.7% were authentic, 7.7% provided insufficient information for access, 10.8% provided inaccurate citation, and 13.8% were non-existent/fabricated. ChatGPT-3.5 did not provide any references.</p><p><strong>Conclusions: </strong>ChatGPT-4 outperformed in retrieving information on disease epidemiology compared to Bard and ChatGPT-3.5. However, all three LLMs presented inaccurate responses, including irrelevant, incomplete, or fabricated references. Such limitations preclude the utility of the current forms of LLMs in obtaining accurate disease epidemiology by researchers in the pharmaceutical industry, in academia, or in the regulatory setting.</p>","PeriodicalId":19782,"journal":{"name":"Pharmacoepidemiology and Drug Safety","volume":"34 2","pages":"e70111"},"PeriodicalIF":2.4,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11791122/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143123362","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}

{"title":"Validation of Immune-Related Adverse Event (irAE) Case Definitions in a Real-World Lung Cancer Population.","authors":"James S Heyward, Jodi B Segal, Hemalkumar B Mehta, Joseph C Murray","doi":"10.1002/pds.70100","DOIUrl":"10.1002/pds.70100","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Background: &lt;/strong&gt;The use of real-world data is increasing to examine immune-related adverse event (irAE) incidence and risk factors in immune checkpoint inhibitor (ICI) users. We aimed to validate five case definition algorithms for irAE in a Johns Hopkins lung cancer registry.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Methods: &lt;/strong&gt;We conducted a retrospective cohort study using linked electronic health record (EHR) and cancer registry data from a large academic healthcare system. The Lung Immunotherapy irAE Monitoring Registry assesses irAEs in a group of patients treated for lung cancer at Johns Hopkins Medicine from 2013 to 2020. We used data from inpatient, outpatient, and emergency department encounters, including International Classification of Disease (ICD)-10 codes and medication administration records to classify the presence or absence of irAEs using five distinct algorithms. These algorithms included three that used both diagnosis (Dx) and medication (Rx) codes, one that used Rx codes only, and one that used Dx codes only, ranging from most numerous criteria (most stringent) to least numerous criteria (least stringent). We compared all five algorithms' performances against chart review-ascertained irAE status and reported sensitivity (Se), specificity (Sp), positive predictive value (PPV), negative predictive value (NPV), and C-statistic (C-stat), with 95% confidence intervals (CI). We also explored algorithm performance by specific organ system toxicities and by Common Terminology Criteria for Adverse Events (CTCAE) severity.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Results: &lt;/strong&gt;The study cohort included 354 patients with ICI exposure for whom chart review-ascertained irAE status was available. A total of 89 (25.1%) experienced at least one irAE (38 pneumonitis, 12 arthritis, 12 colitis, 7 thyroiditis, and others). Across algorithm versions, Se ranged from 59.3% to 93.2% in descending order of algorithm stringency; Sp ranged from 21.0% to 77.6% in ascending order of algorithm stringency, and PPV ranged from 19.1% to 34.7%. The C-stat ranged from 0.57 (95% CI, 0.53-0.61) (Dx codes only) to 0.71 (0.64-0.77) (Rx codes only). For severe irAE (CTCAE Grade 3-5), all algorithms performed better than in the primary analysis, and four exceeded the threshold for usefulness as a measurement tool (maximum C-stat: 0.78 [0.71-0.85] [Rx codes only]). For severe tissue-specific toxicities, algorithmic detection of irAE pneumonitis, colitis, and hepatitis performed better than for the overall group of severe toxicities. Generally, the algorithm versions depicted a Se-Sp tradeoff depending on algorithm stringency.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Conclusion: &lt;/strong&gt;In this validation study of five irAE case definition algorithms, a combination of ICD-10 codes and medication administration codes generally perform well to identify more severe irAE (CTCAE Grade 3-5), and severe pneumonitis, hepatitis, and colitis (common irAEs) among all possible irAE severity levels and sites. Medication codes alone ","PeriodicalId":19782,"journal":{"name":"Pharmacoepidemiology and Drug Safety","volume":"34 2","pages":"e70100"},"PeriodicalIF":2.4,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11970256/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143441239","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}

{"title":"Impact of Regulatory Action on Dose Maximalization for Vitamin B6 Dietary Supplements on the Reporting Pattern for Neuropathy.","authors":"Florence van Hunsel, Joep Scholl, Misha Vrolijk, Corine Ekhart","doi":"10.1002/pds.70108","DOIUrl":"10.1002/pds.70108","url":null,"abstract":"<p><strong>Background: </strong>Vitamin B6 deficiency is linked to neurological disorders. However, supplementation with high doses of vitamin B6 has also been linked to neuropathy as an adverse drug reaction. Review of cases from the Dutch Spontaneous Reporting System (SRS) and other data led to a regulatory action to lower the maximum daily dose (DD) of vitamin B6 in supplements to 21 mg/day from October 1, 2018.</p><p><strong>Purpose: </strong>The aim of this study was to investigate if there was an effect of the regulatory action in 2018 on maximum daily dosage for vitamin B6 on the reporting pattern of neuropathy to the SRS in the Netherlands.</p><p><strong>Methods: </strong>We investigated trends in the number of reports received until December 31, 2023, DD mentioned in the reports, and the correlation between DD and plasma vitamin B6 levels. A change point analysis was used to get insight into the pattern of reports over time.</p><p><strong>Results: </strong>Two hundred and twenty-four reports were included. After the regulatory action for dose maximization from October 2018, only one report mentions a dosage which is much higher than the recommended 21 mg DD. Only 15% of the variability in plasma levels mentioned in reports can be explained by the DD. Twelve statistical change points were noted, especially around some peaks in the reporting pattern for instance in 2018. However, from the second half of 2019, the number of reports on vitamin B6 and neuropathy per time period is lower and no change points were detected.</p><p><strong>Conclusions: </strong>Although our study has limitations, we clearly see an effect of regulatory action on the doses of vitamin B6 used in neuropathy reports. However, some cases describing neuropathy related to vitamin B6 supplementation with lower doses are still reported after the regulatory action in 2018. Therefore, the association between low-dose vitamin B6 products and neuropathy should be studied further.</p>","PeriodicalId":19782,"journal":{"name":"Pharmacoepidemiology and Drug Safety","volume":"34 2","pages":"e70108"},"PeriodicalIF":2.4,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11779544/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143067097","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}

{"title":"Utilisation Trends of Lisdexamfetamine: Insights From Recent Medicine Shortages in Australia.","authors":"Jack Janetzki, Lisa Kalisch, Kelly Hall, Nicole Pratt","doi":"10.1002/pds.70113","DOIUrl":"10.1002/pds.70113","url":null,"abstract":"<p><strong>Purpose: </strong>Investigate the impact of recent notified medicine shortages on dispensing patterns of 30, 40, 50, and 60 mg strengths of lisdexamfetamine for treatment of Attention Deficit Hyperactivity Disorder (ADHD) in Australia.</p><p><strong>Methods: </strong>Pharmaceutical Benefits Scheme (PBS) aggregate dispensing data for 2022-2024 were analysed. Monthly dispensings and Defined Daily Doses (DDDs) for lisdexamfetamine were calculated overall and by product strength.</p><p><strong>Results: </strong>From January 2022 to August 2023, there was a constant increase in overall dispensing and volume of lisdexamfetamine likely due to expansion of PBS prescribing restrictions allowing subsidy of this medicine for patients 18 years and older in February 2021. Dispensings of the 30 mg strength decreased from August 2023 corresponding with shortages of this product. Dispensings of the 50 mg peaked in October 2023 then decreased. During the shortage of the 30 and 50 mg strengths, dispensings of the 40 and 60 mg strengths increased, however, by December 2023 dispensings of these strengths were also decreasing. Dispensings of 70 mg strengths grew steadily throughout 2024. DDDs changed substantially during the shortage period suggesting that people likely transitioned to different strengths of lisdexamfetamine to maintain their dose.</p><p><strong>Conclusion: </strong>Dispensing patterns of lisdexamfetamine, by strength, changed significantly during the medicines shortages periods revealing potential changes in prescriber and patient behaviours, such as switching to higher strength products or using medicines intermittently, to maintain continuity of care. To facilitate quality use of medicines during shortages, dispensing patterns must be monitored so that inequities of access can be identified and addressed.</p>","PeriodicalId":19782,"journal":{"name":"Pharmacoepidemiology and Drug Safety","volume":"34 2","pages":"e70113"},"PeriodicalIF":2.4,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11811742/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143391334","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}

{"title":"Adapting the European Concerted Action on Congenital Anomalies and Twins (EUROCAT) Guide 1.5 for Use in Post-Authorisation Safety Studies Using US Data.","authors":"Sarah Ruth Hoffman, Geetika Kalloo, Stephan Lanes, Aziza Jamal-Allial, Todd Sponholtz, Corinne Brooks, Maria Guzman, Maria I Van Rompay, Oluwadamilola Onasanya, Vincent J Willey, Erica Foster, Nadia Messeh, Jill Layton, Dawn Ponist, Maryline L E Noan-Lainé, Krista Schroeder","doi":"10.1002/pds.70109","DOIUrl":"10.1002/pds.70109","url":null,"abstract":"<p><strong>Purpose: </strong>Many post-authorization safety studies focus on congenital malformations and rely on diagnosis codes found in US data sources. However, no authoritative standards exist for identifying and classifying malformations in these data. To address this, we translated an existing public health surveillance guide, the European Concerted Action on Congenital Anomalies and Twins (EUROCAT), into an ICD-10-CM code list for use in studies using US administrative healthcare data. The EUROCAT guide was selected for its decisive major or minor classification of each code. However, translation was required for use in US data sources since EUROCAT utilizes ICD-10-BPA which differs from ICD-10-CM (the coding system commonly encountered in US data sources).</p><p><strong>Methods: </strong>We mapped EUROCAT to ICD-10-CM. For each code, manual review was conducted by two or more researchers, and major/minor classification was based on code descriptions since some codes differed between coding systems.</p><p><strong>Results: </strong>A final code list was created, containing 916 ICD-10-CM codes for 744 major and 172 minor malformations. The code list contains ICD-10-CM codes, their corresponding descriptions, their major or minor classification and disease category according to EUROCAT, and variables indicating anomalies caused by genetic or infectious diseases unlikely attributable to a medication.</p><p><strong>Conclusions: </strong>We adapted the EUROCAT Guide 1.5 into an ICD-10-CM code list for use in pregnancy studies using US data sources. This list includes new ICD-10-CM codes available in 2024. As new ICD-10-CM codes become available, or as the EUROCAT Guide is updated, further updates to this list will be needed.</p>","PeriodicalId":19782,"journal":{"name":"Pharmacoepidemiology and Drug Safety","volume":"34 2","pages":"e70109"},"PeriodicalIF":2.4,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11829207/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143425954","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}

{"title":"Validation of Clinical Practice Research Datalink (CPRD) Aurum Mother-Baby Link.","authors":"Catherine Vasilakis-Scaramozza, Rebecca Persson, George Kafatos, David Neasham, Katrina Wilcox Hagberg, Susan Jick","doi":"10.1002/pds.5860","DOIUrl":"10.1002/pds.5860","url":null,"abstract":"<p><strong>Purpose: </strong>Assess the validity of the Clinical Practice Research Datalink (CPRD) Aurum Mother-Baby Link (MBL).</p><p><strong>Methods: </strong>We assessed the validity of CPRD Aurum MBL pairs using several strategies. Our study population was based on all available MBL pairs in a 100-practice sample of CPRD Aurum. We sent a questionnaire to the general practitioner of a sample of MBL patients asking if linkage was correct and whether delivery date was correct within 14 days. We also compared MBL delivery date to the matched child's birth date in CPRD Aurum. Finally, in the Hospital Episode Statistics (HES) eligible population, we compared MBL delivery date to birthing parent's HES delivery date.</p><p><strong>Results: </strong>The study population included 124 962 MBL pairs: 124 962 livebirths, 91 218 birthing parents, and 123 562 deliveries. Based on 361 questionnaire responses standardized to the MBL population, 85% (95% CI 74%-96%) of pairs were confirmed as correctly matched, <1% (0.04%-1.4%) were incorrectly matched, and 13% (10%-18%) could not be confirmed. For 71% (61%-82%) of the sample, delivery date was correct within 14 days. Among the entire population of 124 962 MBL pairs, 73% of MBL pairs had MBL delivery date within the baby's birth month recorded in CPRD Aurum. Among 79 834 patients with HES linkage, 94% of 107 080 MBL deliveries in CPRD Aurum were confirmed in HES.</p><p><strong>Conclusions: </strong>Our various assessments of CPRD Aurum MBL found the great majority of pairs were correctly matched and most delivery dates were correct within 14 days. Further refinement of delivery dates may be necessary for some studies.</p>","PeriodicalId":19782,"journal":{"name":"Pharmacoepidemiology and Drug Safety","volume":"34 2","pages":"e5860"},"PeriodicalIF":2.4,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143440477","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Advancing Research Transparency and Reproducibility in Pharmacoepidemiology.","authors":"Shirley V Wang, Anton Pottegård","doi":"10.1002/pds.70096","DOIUrl":"https://doi.org/10.1002/pds.70096","url":null,"abstract":"","PeriodicalId":19782,"journal":{"name":"Pharmacoepidemiology and Drug Safety","volume":"34 2","pages":"e70096"},"PeriodicalIF":2.4,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143414778","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Geographic and Temporal Patterns in Biologic Prescriptions for Inflammatory Bowel Diseases in the Public Healthcare System in Brazil: An Ecological Study.","authors":"Caroline Tianeze de Castro, Marcio Dos Santos Natividade, Marcos Pereira, Samilly Silva Miranda, Erika Aragão, Carlos Antonio de Souza Teles Santos, Djanilson Barbosa Dos Santos","doi":"10.1002/pds.70114","DOIUrl":"10.1002/pds.70114","url":null,"abstract":"<p><strong>Purpose: </strong>To analyze the geographic and temporal patterns of biologic prescriptions for inflammatory bowel disease (IBD) in Brazil's public national unified health system (SUS).</p><p><strong>Methods: </strong>This ecological study used data from patients with IBD in the SUS Outpatient Information System between 2008 and 2022. Prais-Winsten regression was used to estimate the trends in prescription rate of biologics. For geographic analysis, average prescription rate of biologics was calculated by state for three periods: 2008-2012, 2013-2017, and 2018-2022. Global Moran's index (GMI) and local indicators of spatial autocorrelation (LISA) were used to assess spatial autocorrelation and identify spatial clusters of biologic prescriptions, respectively.</p><p><strong>Results: </strong>The prescription rate of biologics increased from 3.0% to 16.7%. Infliximab was the most prescribed drug from 2008 to 2012 (3.0%-4.2%), and adalimumab was the most widely prescribed drug from 2013 to 2022 (4.3%-9.1%). Higher prescription rates of biologics were observed in patients with Crohn's disease than in those with ulcerative colitis (40.5% vs. 3.2%). Biologics were primarily prescribed in the Southeast and South; however, the central-western and northern regions showed greater changes in prescription rates over time. There were increased clusters of high biologic prescriptions across the three evaluated periods.</p><p><strong>Conclusions: </strong>The increase in biologic prescriptions over time may be attributed to their enhanced efficacy in inducing and maintaining IBD remission. Biologic prescriptions in Brazil are experiencing temporal and geographical changes, indicating that disparities in drug prescriptions may decrease with universal, equitable healthcare access, despite administrative challenges in obtaining these medications through SUS.</p>","PeriodicalId":19782,"journal":{"name":"Pharmacoepidemiology and Drug Safety","volume":"34 2","pages":"e70114"},"PeriodicalIF":2.4,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143414785","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"The Healthcare Integrated Research Database (HIRD) as a Real-World Data Source for Pharmacoepidemiologic Research.","authors":"John J Barron, Vincent J Willey, Brett T Doherty, Ozgur Tunceli, Craig R Waltz, Michael Grabner, Daniel C Beachler, Stephan Lanes, Mark J Cziraky","doi":"10.1002/pds.70110","DOIUrl":"10.1002/pds.70110","url":null,"abstract":"<p><strong>Background and methods: </strong>The Healthcare Integrated Research Database (HIRD) is a large, comprehensive real-world data (RWD) source for health-related research. Demographic and healthcare-related characteristics of individuals are sourced from routinely updated RWD. The HIRD includes health insurance claims and other health-related information for individuals enrolled in health insurance plans offered or managed by Elevance Health and has been utilized for research for almost two decades. Individuals in the HIRD reside throughout the United States. Data in the HIRD have been available since January 2006, and are updated monthly.</p><p><strong>Results: </strong>As of July 2024, the researchable population of the HIRD included over 91 million individuals with medical benefits, and over 24 million individuals were actively enrolled. The median age of individuals in the HIRD is 36 years (interquartile range [IQR]: 22, 54), and 50% of individuals in the HIRD are female. The median duration of continuous enrollment in the HIRD is 2.0 years (IQR: 0.8, 4.7). For those actively enrolled, the median duration of continuous enrollment is 3.8 years (IQR: 1.7, 8.3). Other important characteristics of the HIRD include the ability to trace data back to their source, support both deterministic and probabilistic linkage with external data sources, and link family members within health plans.</p><p><strong>Conclusions: </strong>The HIRD has been a trusted resource to generate real-world evidence for a variety of health-related research, including regulatory-required safety studies, comparative effectiveness studies, and health economics and outcomes research.</p>","PeriodicalId":19782,"journal":{"name":"Pharmacoepidemiology and Drug Safety","volume":"34 2","pages":"e70110"},"PeriodicalIF":2.4,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11798679/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143256021","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}