Pharmacoepidemiology and Drug Safety最新文献

{"title":"Use of Causal Framework to Evaluate Effect of Abuse Deterrent Properties of Extended-Release Oxycodone on Tampering in a Real-World Settings.","authors":"Karilynn M Rockhill, Hannah Burkett, Richard Dart, Joshua C Black","doi":"10.1002/pds.70085","DOIUrl":"10.1002/pds.70085","url":null,"abstract":"<p><strong>Purpose: </strong>To assess whether exposure to an extended-release (ER) oxycodone with abuse deterrent properties (ADF) reduced tampering of oxycodone in a real-world, postmarket setting to address the thinking behind Category 4 labeling by the FDA.</p><p><strong>Methods: </strong>Data from an observational cross-sectional study of the general adult population (2022) was used under a causal framework to estimate the confounding-adjusted odds of tampering oxycodone after exposure to two types of ADF ER oxycodone. The tampering behaviors of those who used only single entity immediate-release (SE-IR) oxycodone was used as a comparison. The tampering outcome was defined as use by snorting, smoking, or injecting any oxycodone (ER or SE-IR). A directed acyclic graph was used to identify covariates. Average treatment effect among the treated was estimated using inverse propensity score weighting combined with survey weights in a regression.</p><p><strong>Results: </strong>In 2022, 0.14% and 3.0% among the general population reported using the two ER oxycodone groups, while 2.4% used SE-IR oxycodone. Propensity score analyses with both comparators (common support > 98%) balanced demographic, health, and drug use covariates. After adjustment for selection and confounding bias, among those who used ER oxycodone group 1 the odds ratio of tampering with any form of oxycodone was elevated but not statistically significant (2.25; 95% CI: 0.94, 5.39). The odds ratio of tampering by users of ER oxycodone group 2 was significantly elevated (1.90; 95% CI: 1.08, 3.19).</p><p><strong>Conclusions: </strong>Tampering of ER oxycodone products by individuals was rare. We found evidence suggestive of elevated odds of tampering behaviors with use of an ADF ER oxycodone.</p>","PeriodicalId":19782,"journal":{"name":"Pharmacoepidemiology and Drug Safety","volume":"34 1","pages":"e70085"},"PeriodicalIF":2.4,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142952748","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 an ICD-10 Based Proxy for Date of Birth in Electronic Health Record Data.","authors":"Sara Burns, Ariel Mueller, Matthew Smith, Timothy Houle, Michaela K Farber, Tanzeema Hossain, Justin Manjourides","doi":"10.1002/pds.70083","DOIUrl":"https://doi.org/10.1002/pds.70083","url":null,"abstract":"<p><strong>Purpose: </strong>To comply with the Health Insurance Portability and Accountability Act of 1996 (HIPAA) Privacy Rule, many real-world data providers mask a patient's date of birth by supplying only year of birth to data users. The lack of granularity around patient age is a challenge when using RWD, especially for pediatric research studies. In this study, a proxy for patient date of birth is evaluated using electronic health record (EHR) data.</p><p><strong>Methods: </strong>This validation study leverages a retrospective cohort of EHR data from Mass General Brigham (MGB) patients born between January 1, 2018, and December 31, 2022, to assess the use of the date of a patient's first observed International Classification of Diseases 10th Revision Clinical Modification (ICD-10-CM) day-of birth code (Z37* or Z38*) as a proxy for date of birth. Alternative proxy measures such as date of first other infancy-related ICD-10-CM code and date of first clinical activity were also assessed.</p><p><strong>Results: </strong>Of 82 398 patients born during the five-year study period, 58 047 (70.4%) had an ICD-10-CM birth code and were included in the primary analysis. The mean difference between true date of birth and first observed birth code was 0.3 days with a standard deviation of 15.0 days. The first observed birth code occurred within 30 days of the true date of birth in 99.9% of cases.</p><p><strong>Conclusion: </strong>Results from this study suggest that the date of the first day-of ICD-10-CM birth code can be used as a proxy for true patient date of birth in pediatric RWD studies.</p>","PeriodicalId":19782,"journal":{"name":"Pharmacoepidemiology and Drug Safety","volume":"34 1","pages":"e70083"},"PeriodicalIF":2.4,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142952834","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":"Characterization of SARS-CoV-2 Diagnostic Tests and Liver Function Tests Among Patients With COVID-19 Diagnosed in Outpatient Settings Using Administrative Healthcare Data and Data From Commercial Laboratories.","authors":"Ayad K Ali, Aidan Baglivo, Priya Govil, Liza R Gibbs, Marie C Bradley, Keith E Campbell, Aloka Chakravarty, Tamar Lasky, Victoria Derbyshire, Elizabeth M Garry","doi":"10.1002/pds.70094","DOIUrl":"10.1002/pds.70094","url":null,"abstract":"<p><strong>Purpose: </strong>To characterize select laboratory tests ordered versus reported for patients diagnosed with COVID-19 in administrative healthcare and commercial laboratory data.</p><p><strong>Methods: </strong>Among patients with an outpatient COVID-19 diagnosis claim in HealthVerity data (01/01/2021-12/31/2022), this study described baseline characteristics and descriptively compared SARS-CoV-2 diagnostic tests and liver function tests from administrative healthcare (insurance claims and hospital billing data) and commercial laboratories, overall and by code type (e.g., CPT, LOINC). Select liver function tests were also described by method-specific and methodless LOINC.</p><p><strong>Results: </strong>Among 214 998 patients with COVID-19, 46.1% had a SARS-CoV-2 molecular diagnostic test recorded within 7 days of diagnosis (in either administrative or laboratory data); 44.5% had a corresponding CPT in medical claims, while only 10.0% had a corresponding LOINC in laboratory data. In contrast, the six most common liver function tests (albumin, aspartate aminotransferase, total protein, alkaline phosphatase, alanine aminotransferase, and total bilirubin) were identified in 55.7%-56.6% of patients via LOINC, but only in 3.2%-4.2% via CPT claims. Of the total count of select liver function tests performed in the laboratory data, 99.7% of aspartate aminotransferase, 96.1% of direct bilirubin, and 82.9% of lactate dehydrogenase were reported by methodless LOINC rather than method-specific LOINC.</p><p><strong>Conclusions: </strong>Important differences were identified between orders for SARS-CoV-2 diagnostic tests and liver function tests, as well as missingness of LOINC method, highlighting challenges related to completeness of laboratory data in real-world data sources. These challenges underscore a need to improve data quality when considering the utility of laboratory data for research.</p>","PeriodicalId":19782,"journal":{"name":"Pharmacoepidemiology and Drug Safety","volume":"34 1","pages":"e70094"},"PeriodicalIF":2.4,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142979410","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":"A Descriptive Comparative Analysis of Safety Concerns Outlaid in the Risk Management Plans of the European Union and Japan.","authors":"Teruyuki Honda, Mamoru Narukawa","doi":"10.1002/pds.70097","DOIUrl":"10.1002/pds.70097","url":null,"abstract":"<p><strong>Purpose: </strong>This study aimed to obtain a better understanding of the characteristics of the risk management plans (RMP) and the background regulatory policies governing them, in the European Union (EU) and Japan. This was done by descriptively comparing the safety concerns (SCs) listed in the RMP and examining their relationships with product labeling.</p><p><strong>Methods: </strong>Information regarding SCs was collected from the published RMP of both the EU and Japan for the targeted products-all of which were commonly approved in both regions. The concordance rate of the SCs for each product between the EU- and Japan-RMP was calculated. The warning information for each product was collected from the product labeling, summary of product characteristics for the EU, and package insert for Japan, and compared with the SCs listed in the corresponding RMP.</p><p><strong>Results: </strong>A total of 259 products that were approved for sale in both the EU and Japan (1998-2023), for which RMP were available in both regions, were analyzed. While 51.0% of the SCs labeled as important identified risks (IIRs) in the EU-RMP were concordant with those in the Japan-RMP, 20.4% of the SCs listed as IIRs in the Japan-RMP were concordant with those in the EU-RMP. The concordance rate between the SCs identified as IIRs and the warning information was 18.6% for the EU-RMP and 88.4% for the Japan-RMP.</p><p><strong>Conclusions: </strong>The low SC concordance rate between the EU- and Japan-RMP indicates a different approach to selecting RMP SCs by the two regulatory authorities.</p>","PeriodicalId":19782,"journal":{"name":"Pharmacoepidemiology and Drug Safety","volume":"34 1","pages":"e70097"},"PeriodicalIF":2.4,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142979461","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":"Post-Marketing Safety of Ustekinumab Based on 14-Year Follow-Up in Danish National Patient Data.","authors":"Sejun Kim, Andreas Jensen, Alexander Egeberg, Lone Graff Stensballe","doi":"10.1002/pds.70064","DOIUrl":"10.1002/pds.70064","url":null,"abstract":"<p><strong>Purpose: </strong>Psoriasis (PsO), a chronic inflammatory skin disorder affecting a substantial proportion of populations globally, often necessitates systemic treatment including biologics. This 14-year cohort study, based on Danish national register data, aimed to investigate the enduring safety profile of ustekinumab compared to other systemic psoriasis treatments.</p><p><strong>Methods: </strong>Using comprehensive Danish national register data, this study scrutinized patients diagnosed with psoriasis or psoriatic arthritis (PsA) who received ustekinumab. The treatment group comparators were non-biological systemic treatment (non-biologic), tumor necrosis factor α inhibitor medicine groups (TNF-α), interleukin (IL)-17 inhibitors (IL-17), and IL-23 inhibitors (IL-23). The study periods for comparisons were 2009-2022 for non-biologic and TNF-α, 2015-2022 for IL-17, and 2018-2022 for IL-23. Outcomes were malignancies, cardiovascular events, serious infections, and serious hypersensitivity reactions. Cox proportional hazards regression models were employed to analyze two estimands: a standard intention-to-treat (ITT) estimand and a continuous-index-treatment (CIT) estimand, which considered switch and re-initiation of treatments within individuals.</p><p><strong>Results: </strong>Users of ustekinumab were found to be younger on average, with an average age of 45.1 years compared to 51.6, 47.2, 49.0, and 48.4 years in the non-biologic, TNF-α, IL-17, and IL-23 groups, respectively. Also, 57.3% of the ustekinumab users were male, compared to 46.7%, 48.9%, 50.9%, and 58.3% for the non-biologic, TNF-α, IL-17, and IL-23 groups, respectively. Although the hazard ratio estimates varied across comparators, ustekinumab was found to be safe: regardless of PsA status, no discernible safety signals in terms of malignancy, MACE, severe infections, or severe hypersensitivity reactions were observed for ustekinumab when compared to the treatment comparators.</p><p><strong>Conclusions: </strong>The present study corroborated the enduring safety of ustekinumab in the context of PsO treatment.</p>","PeriodicalId":19782,"journal":{"name":"Pharmacoepidemiology and Drug Safety","volume":"33 12","pages":"e70064"},"PeriodicalIF":2.4,"publicationDate":"2024-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11599636/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142731642","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":"Real-World Evidence BRIDGE: A Tool to Connect Protocol With Code Programming.","authors":"Albert Cid Royo, Roel Elbers Jhj, Daniel Weibel, Vjola Hoxhaj, Zeynep Kurkcuoglu, Miriam C J Sturkenboom, Tiago A Vaz, Constanza L Andaur Navarro","doi":"10.1002/pds.70062","DOIUrl":"10.1002/pds.70062","url":null,"abstract":"<p><strong>Objective: </strong>To enhance documentation on programming decisions in Real World Evidence (RWE) studies.</p><p><strong>Materials and methods: </strong>We analyzed several statistical analysis plans (SAP) within the Vaccine Monitoring Collaboration for Europe (VAC4EU) to identify study design sections and specifications for programming RWE studies. We designed a machine-readable metadata schema containing study sections, codelists, and time anchoring definitions specified in the SAPs with adaptability and user-friendliness.</p><p><strong>Results: </strong>We developed the RWE-BRIDGE, a metadata schema in form of relational database divided into four study design sections with 12 tables: Study Variable Definition (two tables), Cohort Definition (two tables), Post-Exposure Outcome Analysis (one table), and Data Retrieval (seven tables). We provide a guide to populate this metadata schema and a Shiny app that checks the tables. RWE-BRIDGE is available on GitHub (github.com/UMC-Utrecht-RWE/RWE-BRIDGE).</p><p><strong>Discussion: </strong>The RWE-BRIDGE has been designed to support the translation of study design sections from statistical analysis plans into analytical pipelines and to adhere to the FAIR principles, facilitating collaboration and transparency between researcher and programmers. This metadata schema strategy is flexible as it can support different common data models and programming languages, and it is adaptable to the specific needs of each SAP by adding further tables or fields, if necessary. Modified versions of the RWE-BRIGE have been applied in several RWE studies within VAC4EU.</p><p><strong>Conclusion: </strong>RWE-BRIDGE offers a systematic approach to detailing variables, time anchoring, and algorithms for RWE studies. This metadata schema facilitates communication between researcher and programmers.</p>","PeriodicalId":19782,"journal":{"name":"Pharmacoepidemiology and Drug Safety","volume":"33 12","pages":"e70062"},"PeriodicalIF":2.4,"publicationDate":"2024-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11602246/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142739580","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":"Generating Real-World Evidence From the Excellence Network in Rheumatology.","authors":"Timothy Beukelman, Amy Mudano, Patrick Stewart, Shilpa Venkatachalam, Fenglong Xie, Michael George, Howard Busch, Priya Reddy, Kenneth G Saag, Yujie Su, Jeffrey R Curtis","doi":"10.1002/pds.70067","DOIUrl":"10.1002/pds.70067","url":null,"abstract":"<p><strong>Purpose: </strong>The Excellence Network in RheumatoloGY (ENRGY) was founded in 2021 and encompasses data from more than 700 private practice rheumatology providers throughout the United States, forming a practice-based research network (PBRN).</p><p><strong>Methods: </strong>Electronic health record (EHR) data from participating practices are aggregated, including structured data (e.g., clinical assessments) and unstructured data from two different EHR platforms. Targeted data quality efforts ensure capture of high-quality clinical data and reduce missingness. ENRGY network membership also provides participating sites access to technology services that enhance patient care. Centralized ethics approval and pre-existing legal agreements along with electronic tools to curate data and contact eligible study participants improves efficiency of multi-center prospective studies.</p><p><strong>Results: </strong>The ENRGY data warehouse includes linked administrative claims data for commercial and government-provided insurance (31% of patients linked to commercial claims) and patient-generated health data from both in-office and out-of-office settings via a smartphone app as well as biosensor data. ENRGY data and infrastructure can be employed to identify the highest yield sites for prospective studies; identify patients meeting study eligibility criteria; pre-screen individual patient's willingness to participate in specific studies; centralize study data monitoring; and assist in the conduct of prospective studies.</p><p><strong>Conclusion: </strong>ENRGY data have been used to generate a growing number of scientific publications and may serve as a model for PBRNs in other specialties seeking to harness the potential of data linkages, patient-generated data capture, and centralized study infrastructure for observational and interventional research.</p>","PeriodicalId":19782,"journal":{"name":"Pharmacoepidemiology and Drug Safety","volume":"33 12","pages":"e70067"},"PeriodicalIF":2.4,"publicationDate":"2024-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12007395/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142813906","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":"Hepatotoxicity Score: A New Method to Adjust for Use of Potentially Hepatotoxic Medications by Chronic Liver Disease Status.","authors":"Vincent Lo Re, Craig W Newcomb, Dean M Carbonari, Alyssa K Mezochow, Sean Hennessy, Christopher T Rentsch, Lesley S Park, Janet P Tate, Norbert Bräu, Debika Bhattacharya, Joseph K Lim, Catherine Mezzacappa, Basile Njei, Jason A Roy, Tamar H Taddei, Amy C Justice, Jessie Torgersen","doi":"10.1002/pds.70069","DOIUrl":"10.1002/pds.70069","url":null,"abstract":"<p><strong>Background: </strong>Studies evaluating the hepatic safety of medications have been limited by the inability to control for confounding from receipt of other hepatotoxic drugs.</p><p><strong>Objective: </strong>The objective of this study was to develop an index (Hepatotoxicity Score) to adjust for concomitant hepatotoxic medication exposure within pharmacoepidemiology studies.</p><p><strong>Methods: </strong>We identified 193 medications with ≥ 4 reports of hepatotoxicity and created cohorts of outpatient initiators in the Veterans Health Administration (2000-2021). Exposure occurred from initiation through 30 days after discontinuation or up to 1 year. We measured age-/sex-adjusted rates of hospitalization for severe acute liver injury (ALI) by chronic liver disease (CLD), identified drugs with high rates, and used these rates as weights in the score. To demonstrate real-world use, we calculated the score for proton pump inhibitor (PPI) initiators. We summed the weights of the drugs dispensed within 90 days prior to PPI initiation. Hazard ratios (HRs) of severe ALI (95% confidence intervals) were measured with and without adjustment for Hepatotoxicity Score.</p><p><strong>Results: </strong>Among 89 512 PPI initiators with CLD, HRs of severe ALI were higher for lansoprazole (HR = 2.17 [95% CI, 1.24-3.82]), but not pantoprazole (HR = 0.83 [95% CI, 0.61-1.13]), versus omeprazole. Adjustment for Hepatotoxicity Score attenuated HRs of lansoprazole (HR = 1.99 [95% CI, 1.13-3.50]). Among 2 462 414 PPI initiators without CLD, HRs were not significantly higher for lansoprazole (HR = 1.66 [95% CI, 0.99-2.77]) but were significantly lower for pantoprazole (HR = 0.59 [95% CI, 0.37-0.95]), versus omeprazole. Adjustment for Hepatotoxicity Score attenuated HRs of lansoprazole (HR = 1.52 [95% CI, 0.91-2.54]).</p><p><strong>Conclusions: </strong>The Hepatotoxicity Score provides a tool to adjust for confounding due to concomitant hepatotoxic drug exposure within hepatic safety studies.</p>","PeriodicalId":19782,"journal":{"name":"Pharmacoepidemiology and Drug Safety","volume":"33 12","pages":"e70069"},"PeriodicalIF":2.4,"publicationDate":"2024-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11634562/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142813911","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":"Does Physicians' Clinical Competence, Communication Ability, or Cultural Background Influence Potentially Inappropriate Prescribing of Benzodiazepines and Z-Drugs Among Older Adults With Insomnia?","authors":"Fiona K I Chan, Maria-Teresa Moraga, Bettina Habib, Nadyne Girard, John R Boulet, Robyn Tamblyn","doi":"10.1002/pds.70068","DOIUrl":"10.1002/pds.70068","url":null,"abstract":"<p><strong>Objective: </strong>The objective of this study is to estimate the association between physician's age, sex, clinical and communication competencies, and cultural background on benzodiazepines and Z-drugs (BDZ) prescribing to older adults with insomnia.</p><p><strong>Methods: </strong>A cohort of international medical graduates (IMGs) who completed their pre-residency licensure exam in 1998-2004 were linked to all U.S. Medicare patients they provided care to in 2014-2015. Their care records in Parts A, B, and D from all physicians were extracted. The first outpatient visit for insomnia to a study IMG was identified for each patient in that period. The outcome was incident BDZ prescribing by the study physician following the visit. Main exposures were physician age, sex, citizenship at birth, and clinical and communication competency as measured on the licensure exam. The association between physician characteristics and BDZ prescribing, adjusting for physician and patient covariates, was estimated using generalized estimating equations multivariable logistic regression.</p><p><strong>Results: </strong>We analyzed 28 018 patients seen by 4069 unique physicians. IMGs born in all other regions of the world were less likely to prescribe BDZs compared to U.S.-born IMGs, with physicians from the United Kingdom being least likely (OR 0.54 [95%CI 0.34-0.85]). Neither physician's clinical competency nor communication ability were associated with BDZ prescribing (OR per 10% increase, respectively: 0.95 [95%CI 0.88-1.02] and 0.98 [95%CI 0.93-1.04]). Older physicians remain more likely to prescribe BDZ (OR per 5-year increase 1.04 [95%CI 1.00-1.08]).</p><p><strong>Conclusions: </strong>The associations between cultural background and physician's age on BDZ prescribing highlight the potential targets for remedial solutions to reduce the use of potentially inappropriate medications.</p>","PeriodicalId":19782,"journal":{"name":"Pharmacoepidemiology and Drug Safety","volume":"33 12","pages":"e70068"},"PeriodicalIF":2.4,"publicationDate":"2024-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11615419/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142771189","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 Early Resumption of Oral Anticoagulation on Recurrence After Surgery for Chronic Subdural Hematoma in Patients With Atrial Fibrillation: A Target Trial Emulation.","authors":"Takayuki Anno, Toshiki Fukasawa, Tomohiro Shinozaki, Masato Takeuchi, Satomi Yoshida, Koji Kawakami","doi":"10.1002/pds.70063","DOIUrl":"10.1002/pds.70063","url":null,"abstract":"<p><strong>Purpose: </strong>Clinicians treating patients with atrial fibrillation (AF) on oral anticoagulants who undergo surgery for chronic subdural hematoma (CSDH) face a dilemma: while early postoperative resumption of anticoagulation is necessary to prevent embolism, it may increase the risk of CSDH recurrence. To date, however, no study has evaluated this question while adequately addressing common biases in observational studies. Here, we assessed this issue using target trial emulation framework.</p><p><strong>Methods: </strong>We identified patients undergoing initial CSDH surgery who had received anticoagulation for AF preoperatively from two hospital-based administrative databases (2014-2022). We compared two treatment strategies: resumption of anticoagulation within 14 days postoperatively versus no resumption during this period. Using a three-step method of cloning, censoring, and weighting, we estimated the risk of CSDH recurrence, along with the risk ratio and risk difference at postoperative day 90.</p><p><strong>Results: </strong>291 CSDH patients with AF were eligible, of whom 29 (10.0%) underwent CSDH reoperation. The weighted estimated 90-day reoperation risk was 11.7% (95% confidence interval [CI], 6.0 to 14.3) for resuming anticoagulation within 14 days postoperatively and 9.4% (95% CI, 4.1 to 12.8) for not resuming within 14 days, corresponding to a risk ratio of 1.20 (95% CI, 0.67 to 2.36) and risk difference of 1.9% (95% CI, -4.0 to 6.6).</p><p><strong>Conclusions: </strong>90-day risk of CSDH recurrence may not differ between early and non-early resumption of anticoagulation, although early resumption could modestly accelerate recurrence. Allowing for the imprecision of the estimates, these findings provide important insights for clinical decision-making regarding anticoagulation resumption.</p>","PeriodicalId":19782,"journal":{"name":"Pharmacoepidemiology and Drug Safety","volume":"33 12","pages":"e70063"},"PeriodicalIF":2.4,"publicationDate":"2024-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142739656","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}