Clinical EpidemiologyPub Date : 2026-05-01eCollection Date: 2026-01-01DOI: 10.2147/CLEP.S590446
Gencer Kurt, Rune Erichsen
{"title":"Venous Thromboembolism After Total Colectomy in Inflammatory Bowel Disease: Risk Factors and Mortality - a Danish Population-Based Cohort Study.","authors":"Gencer Kurt, Rune Erichsen","doi":"10.2147/CLEP.S590446","DOIUrl":"https://doi.org/10.2147/CLEP.S590446","url":null,"abstract":"<p><strong>Purpose: </strong>Total colectomy is a key intervention in inflammatory bowel disease (IBD) management and a high-risk procedure for postoperative venous thromboembolism (VTE). We investigated risk factors for postoperative VTE and VTE-associated mortality in patients with IBD undergoing total colectomy.</p><p><strong>Patients and methods: </strong>We conducted a population-based cohort study using Danish registries (1996-2021), including all patients with IBD who underwent total colectomy (n=5303). We calculated the 90-day cumulative risk of VTE and used Cox regression to assess the association between potential risk factors and VTE. We used the Kaplan-Meier method to calculate 1-year mortality after VTE, and we compared mortality between patients with and without VTE using Cox regression as an estimate of the mortality rate ratio.</p><p><strong>Results: </strong>The 30-day VTE risk was 0.6% in patients with Crohn's disease and 1.3% in those with ulcerative colitis. During this period, the strongest risk factors were age (adjusted hazard ratio 3.95 [95% CI 1.87-8.37]) for 41-60 years and 2.96 [1.30-6.75] for ≥60 years vs ≤40 years), calendar year of total colectomy (3.84 [1.10-13.34] for 2014-2020 vs 1996-2001), high comorbidity burden (2.14 [0.94-4.88] vs low comorbidity), IBD duration <1 year (1.84 [0.81-4.16] vs 1-5 years), male sex (1.56 ([0.92-2.64]), and corticosteroid use (1.55 [0.86-2.79]). In secondary analyses, comparing preoperative systemic corticosteroid use to non-use, we found a twofold higher 30-day VTE rate. Most associations persisted for 31-90 days, though with some attenuation. The 1-year mortality risk after VTE was 21.0% (hazard ratio of 7.65 [95% CI, 3.12-18.73]).</p><p><strong>Conclusion: </strong>Several patient and clinical factors were associated with elevated postoperative VTE risk, and VTE after total colectomy carried a substantially increased 1-year mortality. These findings may help identify high-risk subgroups and inform future studies of extended thromboprophylaxis and perioperative management in IBD.</p>","PeriodicalId":10362,"journal":{"name":"Clinical Epidemiology","volume":"18 ","pages":"590446"},"PeriodicalIF":3.2,"publicationDate":"2026-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13142717/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147834508","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Clinical EpidemiologyPub Date : 2026-04-30eCollection Date: 2026-01-01DOI: 10.2147/CLEP.S609824
Avery Shuei-He Yang, Hsin-Yu Fan Chiang, Daniel Hsiang-Te Tsai, Albert Tzu-Ming Chuang, Edward Chia-Cheng Lai
{"title":"Association Between Pneumonia Risk and Anticholinergic Burden Among Patients with Different Frailty Levels [Response to Letter].","authors":"Avery Shuei-He Yang, Hsin-Yu Fan Chiang, Daniel Hsiang-Te Tsai, Albert Tzu-Ming Chuang, Edward Chia-Cheng Lai","doi":"10.2147/CLEP.S609824","DOIUrl":"https://doi.org/10.2147/CLEP.S609824","url":null,"abstract":"","PeriodicalId":10362,"journal":{"name":"Clinical Epidemiology","volume":"18 ","pages":"609824"},"PeriodicalIF":3.2,"publicationDate":"2026-04-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13138278/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147834325","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Clinical EpidemiologyPub Date : 2026-04-29eCollection Date: 2026-01-01DOI: 10.2147/CLEP.S587080
Maria Hee Jung Park Frausing, Morten Schmidt, Ole Dan Jørgensen, Frederikke Nørregaard Jakobsen, Frederik Mikkelsen, Jacob Moesgaard Larsen, Charlotte Ellen Larroudé, Berit Thornvig Philbert, Jens Kristensen, Helle Skovmand Bosselmann, Mayooran Gnanaganesh, Andi Eie Albertsen, Jerzy Malczynski, Lene Svendstrup Christensen, Ulrik Hintze, Janni Broedbaek, Jens Cosedis Nielsen, Jens Brock Johansen
{"title":"The Danish Pacemaker and ICD Register: Review of Clinical and Research Potential.","authors":"Maria Hee Jung Park Frausing, Morten Schmidt, Ole Dan Jørgensen, Frederikke Nørregaard Jakobsen, Frederik Mikkelsen, Jacob Moesgaard Larsen, Charlotte Ellen Larroudé, Berit Thornvig Philbert, Jens Kristensen, Helle Skovmand Bosselmann, Mayooran Gnanaganesh, Andi Eie Albertsen, Jerzy Malczynski, Lene Svendstrup Christensen, Ulrik Hintze, Janni Broedbaek, Jens Cosedis Nielsen, Jens Brock Johansen","doi":"10.2147/CLEP.S587080","DOIUrl":"https://doi.org/10.2147/CLEP.S587080","url":null,"abstract":"<p><p>The Danish Pacemaker and ICD Register (DPIR) was established in 1982 as a hardware registry and clinical quality database dedicated to cardiac implantable electronic device (CIED) therapy. It is among the most comprehensive and longest-running CIED registries in the world and has recorded over 200,000 CIED procedures in more than 133,000 individuals. Leveraging the Danish registry infrastructure, individual-level linkage to other national clinical and administrative registries via the unique personal identification number greatly expands its research potential. This review summarizes the development, database structure, variable content and quality, and the clinical and scientific impact of DPIR. Examples of data quality include complete national coverage of all CIED procedures, standardized data-entry fields that minimize variability across centers, mandatory reporting of core variables, and high concordance between registry entries and source documentation. Data from DPIR has informed clinical practice guidelines and supported clinical quality improvement in Denmark and internationally.</p>","PeriodicalId":10362,"journal":{"name":"Clinical Epidemiology","volume":"18 ","pages":"587080"},"PeriodicalIF":3.2,"publicationDate":"2026-04-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13135762/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147834505","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Continued Use of Medications Withdrawn Internationally for Safety Concerns: Insights from an Urban Employed Population in China.","authors":"Luyi Chen, Yuzhi Han, Shaoxi Pan, Shanshan Li, Shujun Wang, Hongyan Wu, Beini Lyu","doi":"10.2147/CLEP.S596457","DOIUrl":"https://doi.org/10.2147/CLEP.S596457","url":null,"abstract":"<p><strong>Purpose: </strong>Some drugs approved for marketing are later withdrawn in other countries due to safety concerns. This study aimed to examine the use of such drugs in China and explore factors associated with continued prescribing.</p><p><strong>Methods: </strong>A 5% random sample of the Urban Employee Basic Medical Insurance (UEBMI) database (2019-2021) from a province in China was used. Withdrawn drugs were identified from two global databases, the Onakpoya dataset and the WITHDRAWN 2.0 database that included withdrawals from 1950 to 2020. Generalized linear mixed models incorporating hospital random effects were applied, adjusting for individual-level covariates (age, sex, ethnicity, occupation, and supplementary public servant medical benefits) and institution-level covariates (medical institution level, hospital ownership and type, and region of treatment).</p><p><strong>Results: </strong>We included 293,859 insured individuals, of whom 16,510 (5.62%) received at least one withdrawn drug. Thirty-eight such drugs were prescribed, 26 of which remained available without restriction in China. Overall use declined from 6.21% in 2019 to 5.46% in 2021. Mean per-person spending on withdrawn drugs declined from 402.88 yuan in 2019 to 258.36 yuan in 2021. The reductions in usage and spending were mainly observed in inpatient prescribing. Nervous system medications were most frequently used (27.3% of outpatient and 52.2% of inpatient uses) and accounted for the largest share of expenditures (40.3%). Greater use was observed among men, retirees, and those with supplementary public servant medical benefits, as well as in tertiary, private, and general hospitals.</p><p><strong>Conclusion: </strong>Drugs withdrawn internationally for safety concerns continued to be prescribed in China, despite overall declines in use. Efforts to strengthen post-marketing surveillance, improve alignment between domestic regulatory actions and global safety evidence, and enhance prescribing oversight-particularly in higher-level hospitals-may help reduce avoidable patient exposure to unsafe medications.</p>","PeriodicalId":10362,"journal":{"name":"Clinical Epidemiology","volume":"18 ","pages":"596457"},"PeriodicalIF":3.2,"publicationDate":"2026-04-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13134553/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147812062","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Clinical EpidemiologyPub Date : 2026-04-24eCollection Date: 2026-01-01DOI: 10.2147/CLEP.S612503
{"title":"Erratum: SEPLINE: Socioeconomic Position in Epidemiological Research-A National Guideline on Danish Registry Data [Corrigendum].","authors":"","doi":"10.2147/CLEP.S612503","DOIUrl":"https://doi.org/10.2147/CLEP.S612503","url":null,"abstract":"<p><p>[This corrects the article DOI: 10.2147/CLEP.S520772.].</p>","PeriodicalId":10362,"journal":{"name":"Clinical Epidemiology","volume":"18 ","pages":"612503"},"PeriodicalIF":3.2,"publicationDate":"2026-04-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13123562/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147764214","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Clinical EpidemiologyPub Date : 2026-04-24eCollection Date: 2026-01-01DOI: 10.2147/CLEP.S581524
Sruthi Adimadhyam, Rebecca Hawrusik, Hye Seung Lee, Caroline J Jjingo, Jane A Gwira, Maria E Kempner, Megan Wiley, Andrew B Petrone, Yueqin Zhao, Danijela Stojanovic, Efe Eworuke, Adebola Ajao
{"title":"Association Between Race and COVID-19 Outcomes During the Pre-Vaccination Period in the United States (2020-2021).","authors":"Sruthi Adimadhyam, Rebecca Hawrusik, Hye Seung Lee, Caroline J Jjingo, Jane A Gwira, Maria E Kempner, Megan Wiley, Andrew B Petrone, Yueqin Zhao, Danijela Stojanovic, Efe Eworuke, Adebola Ajao","doi":"10.2147/CLEP.S581524","DOIUrl":"https://doi.org/10.2147/CLEP.S581524","url":null,"abstract":"<p><strong>Objective: </strong>To determine the association between race, a proxy for social determinants of health, and COVID-19 outcomes adjusted for demographic, clinical, and socioeconomic differences.</p><p><strong>Methods: </strong>We conducted a retrospective cohort study using administrative claims data in the Sentinel Distributed Database. We identified 841,628 individuals diagnosed with COVID-19; and separately, 133,773 individuals hospitalized with COVID-19 between April 1, 2020, and March 31, 2021, in the US. Eligible individuals required at least 6 months of enrollment in a health plan prior to cohort entry. Crude and adjusted associations between self-reported race (Asian, Black or African American, American Indian or Alaska Native [AIAN], Native Hawaiian or Other Pacific Islander [NHOPI], White, or Unknown) and COVID-19 outcomes (hospitalization with COVID-19; critical COVID; 30-day all-cause inpatient mortality) were determined using multivariable logistic regression.</p><p><strong>Results: </strong>Of the 841,628 individuals with COVID-19, 45.5% were White, 42.1% were of Unknown race, 9.5% Black or African American, 2% Asian, 0.5% NHOPI, and 0.3% AIAN. All subpopulations had increased odds of hospitalization compared to White population (AIAN, adjusted Odds Ratio 1.45 [95% confidence interval 1.11-1.90]; Asian population 1.58 [1.38-1.80]; Black or African American population 1.58 [1.40-1.78]; NHOPI 1.32 [1.22-1.42]). There were 133,773 individuals hospitalized with COVID-19, 56.2% of whom were White, 23.4% of Unknown race, 17.6% Black or African American, 1.5% Asian, 0.9% NHOPI, and 0.4% AIAN. Over half of all hospitalized individuals progressed to critical COVID (58%) and 14.2% died within 30 days. Progression to critical COVID was significantly higher in NHOPI population compared to White population (1.17 [1.03-1.32]). AIAN population (1.52 [1.20-1.91]), Asian population (1.30 [1.13-1.49]), and NHOPI population (1.24 [1.06-1.45]) had significantly higher odds of 30-day inpatient mortality compared to White population.</p><p><strong>Conclusion: </strong>We identified significant differences in COVID-19 outcomes in different subgroups within a diverse US population.</p>","PeriodicalId":10362,"journal":{"name":"Clinical Epidemiology","volume":"18 ","pages":"581524"},"PeriodicalIF":3.2,"publicationDate":"2026-04-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13123566/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147764168","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Clinical EpidemiologyPub Date : 2026-04-23eCollection Date: 2026-01-01DOI: 10.2147/CLEP.S611590
Henrik Toft Sørensen, Erzsébet Horváth-Puhó, Janet L Peacock
{"title":"An Introduction to Competing Risks in Epidemiology [Response to Letter].","authors":"Henrik Toft Sørensen, Erzsébet Horváth-Puhó, Janet L Peacock","doi":"10.2147/CLEP.S611590","DOIUrl":"https://doi.org/10.2147/CLEP.S611590","url":null,"abstract":"","PeriodicalId":10362,"journal":{"name":"Clinical Epidemiology","volume":"18 ","pages":"611590"},"PeriodicalIF":3.2,"publicationDate":"2026-04-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13118635/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147764036","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Clinical EpidemiologyPub Date : 2026-04-20eCollection Date: 2026-01-01DOI: 10.2147/CLEP.S596174
Jianping Chen, Yuanqiao Sun, Jia Zhou, Meng Meng, Fenhe Zhou, Jia He, Gang Zou
{"title":"Interaction Between Maternal Smoking Cessation Timing and Preexisting Hypertension on Fetal Growth Restriction: A Nationwide Population-Based Cohort Study.","authors":"Jianping Chen, Yuanqiao Sun, Jia Zhou, Meng Meng, Fenhe Zhou, Jia He, Gang Zou","doi":"10.2147/CLEP.S596174","DOIUrl":"https://doi.org/10.2147/CLEP.S596174","url":null,"abstract":"<p><strong>Background: </strong>Maternal smoking is a major preventable cause of fetal growth restriction (FGR). Although cessation reduces risk, the benefit depends on its timing, and the role of preexisting hypertension-sharing vascular-placental mechanisms-remains underexplored.</p><p><strong>Patients and methods: </strong>We conducted a population-based retrospective cohort study using US birth data (2020-2024). Maternal smoking was divided as nonsmokers, quit before pregnancy, quit in the first trimester, quit in the second trimester, or persistent smokers. FGR was defined using birth-weight-based percentiles derived from the NICHD fetal growth standards (<3rd, <5th, and <10th). Poisson regression with inverse probability of treatment weighting (IPTW) was used to estimate adjusted risk ratios (aRRs). Effect modification by preexisting hypertension was examined on multiplicative and additive scales.</p><p><strong>Results: </strong>Among 17,381,709 singleton live births, FGR-3rd incidence increased across groups (3.3%, 4.5%, 6.1%, 7.5%, and 10.0%, respectively), showing a dose-response gradient. Compared with nonsmokers, the IPTW-aRRs for FGR-3rd were 1.20 (95% CI:1.17-1.23), 1.61 (1.57-1.66), 2.03 (1.95-2.11) and 2.01 (1.99-2.04) for women who quit before pregnancy, in the first trimester, in the second trimester, and persistent smokers. Preexisting hypertension increased absolute FGR risk but modified associations on the multiplicative scale, with attenuated relative risks among hypertensive women. No meaningful interaction was observed on additive scale. Notably, hypertensive women who quit before pregnancy achieved FGR risks comparable to hypertensive nonsmokers (aRR=0.98, 0.88-1.08). Similar patterns were observed for <5th and <10th percentiles.</p><p><strong>Conclusion: </strong>Earlier smoking cessation is associated with lower risk of FGR. Preexisting hypertension modifies associations on the multiplicative scale, where relative risks were attenuated among hypertensive women, but not on the additive scale, suggesting the independence on the additive scale (a lack of departure from risk additivity). These findings support integrating smoking cessation into preconception and antenatal care, especially for high-risk women.</p>","PeriodicalId":10362,"journal":{"name":"Clinical Epidemiology","volume":"18 ","pages":"596174"},"PeriodicalIF":3.2,"publicationDate":"2026-04-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13109068/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147764158","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Clinical EpidemiologyPub Date : 2026-04-15eCollection Date: 2026-01-01DOI: 10.2147/CLEP.S584318
Dustin Andersen Patel, Karina Kannik, Iman Chanchiri, Peter de Nully Brown, Anne Stidsholt Roug, Kirsten Grønbæk, Marie Bak, Tarec Christoffer El-Galaly, Christen Lykkegaard Andersen
{"title":"Validity of The Danish National Chronic Myeloid Neoplasia Registry.","authors":"Dustin Andersen Patel, Karina Kannik, Iman Chanchiri, Peter de Nully Brown, Anne Stidsholt Roug, Kirsten Grønbæk, Marie Bak, Tarec Christoffer El-Galaly, Christen Lykkegaard Andersen","doi":"10.2147/CLEP.S584318","DOIUrl":"https://doi.org/10.2147/CLEP.S584318","url":null,"abstract":"<p><strong>Purpose: </strong>Myeloproliferative neoplasms (MPN) are rare hematological malignancies with long survival, making real-world evidence essential to complement clinical trial data. The Danish National Chronic Myeloid Neoplasia Registry (DMR) captures nearly all MPN patients nationwide, but its validity has not been systematically evaluated. We aimed to validate key clinical variables in the DMR through a nationwide audit.</p><p><strong>Methods: </strong>We sampled DMR entries from 372 persons registered with essential thrombocythemia (ET), polycythemia vera (PV), primary myelofibrosis (PMF), prefibrotic myelofibrosis (preMF), or unclassifiable MPN (MPN-U) between 2017 and 2021 across all regions of Denmark. We validated eight main variables, including 27 subordinate variables of clinical importance from the DMR, against electronic health records using standardized audit procedures. Positive predictive value (PPV), negative predictive value (NPV), sensitivity, specificity, and accuracy were calculated.</p><p><strong>Results: </strong>Overall, the DMR showed mostly high PPV and intermediate/high NPV values. PPV was high for core diagnostic, treatment and comorbidity variables: ET (0.91), PV (0.95) and PMF (0.97), date of diagnosis (0.97), splenomegaly (0.98), <i>JAK2</i>V617F (0.97), <i>CALR</i> (0.92), hypertension (0.93), hyperlipidemia (0.90), diabetes (0.97), and common treatments (phlebotomy, hydroxyurea, interferon, ruxolitinib ≥.93). Intermediate PPV was observed for diagnoses of preMF (0.78) and MPN-U (0.77), and for the remaining comorbidity variables (0.75-0.85). Most misclassifications arose from false negatives, reflecting the automatic imputation of negative (no) for missing values for selected variables in the DMR which resulted in lower sensitivity and high PPV/specificity.</p><p><strong>Conclusion: </strong>The DMR demonstrates high validity for several clinically relevant variables and constitutes a reliable source of real-world data in MPN research and therefore, crosslinking registry variables with other data sources may enable robust epidemiological studies and unprecedented precision in real-world evidence for MPN patients. Nevertheless, variable documentation and data quality must be critically assessed to account for changes in data entry practices across time periods.</p>","PeriodicalId":10362,"journal":{"name":"Clinical Epidemiology","volume":"18 ","pages":"584318"},"PeriodicalIF":3.2,"publicationDate":"2026-04-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13092446/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147764285","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Clinical EpidemiologyPub Date : 2026-04-13eCollection Date: 2026-01-01DOI: 10.2147/CLEP.S573511
Georg Hahn, Sebastian Schneeweiss, Shirley V Wang
{"title":"Adaptive Multi-Wave Sampling for Efficient Chart Validation.","authors":"Georg Hahn, Sebastian Schneeweiss, Shirley V Wang","doi":"10.2147/CLEP.S573511","DOIUrl":"10.2147/CLEP.S573511","url":null,"abstract":"<p><strong>Purpose: </strong>To use computable phenotypes for characterization of patients and identification of outcomes in studies conducted using healthcare claims and electronic health record data. Chart review studies establish reference labels against which computable phenotypes are compared to understand their measurement characteristics (the quantity of interest), for instance, the positive predictive value.</p><p><strong>Methods: </strong>We describe a method to adaptively evaluate a quantity of interest over sequential samples of charts, with the goal to minimize the number of charts reviewed. With the help of a simultaneous confidence band, we stop the reviewing once the confidence band meets a pre-specified stopping threshold. The contribution of this work is threefold. First, we test the use of an adaptive approach called Neyman's sampling versus random or stratified random sampling. Second, we propose frequentist confidence bands and Bayesian credible intervals to sequentially evaluate the quantity of interest. Third, we propose a tool to predict the stopping time (defined as the number of charts reviewed) at which the chart review would be complete.</p><p><strong>Results: </strong>We observe that Bayesian credible intervals prove to be tighter than its frequentist confidence band counterparts. Moreover, we observe that simple random sampling often performs similarly to Neyman's sampling.</p><p><strong>Conclusion: </strong>We conclude that random sampling in connection with Bayesian credible intervals allows for an efficient validation of a response of interest for both binary and continuous outcomes.</p>","PeriodicalId":10362,"journal":{"name":"Clinical Epidemiology","volume":"18 ","pages":"573511"},"PeriodicalIF":3.2,"publicationDate":"2026-04-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13090130/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147721678","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}