Clinical Epidemiology最新文献

{"title":"Registration of Amyotrophic Lateral Sclerosis: Validity in the Danish National Patient Registry.","authors":"Lotte Sahin Levison, Peter Jepsen, Henning Andersen","doi":"10.2147/CLEP.S458661","DOIUrl":"10.2147/CLEP.S458661","url":null,"abstract":"<p><strong>Purpose: </strong>Health care databases are a valuable source for epidemiological research on amyotrophic lateral sclerosis (ALS) if diagnosis codes are valid. We evaluated the validity of the diagnostic codes for ALS in the Danish National Patient Registry (DNPR).</p><p><strong>Patients and methods: </strong>We obtained data from the DNPR for all adult (>17 years) patients registered with ALS in Denmark between 1987 and 2022 (median population of 4.2 million during the study period). We randomly selected adult patients living in the North Denmark Region and Central Denmark Region (median population 1.4 million), with a primary discharge diagnosis code of ALS, diagnosed at three departments of neurology. We retrieved and reviewed medical records and estimated the positive predictive value (PPV) of the ALS diagnosis.</p><p><strong>Results: </strong>Over 36 years, we identified 5679 patients. From the validation cohort of 300 patients, we were able to retrieve 240 (80%) medical records, and 215 ALS diagnoses were confirmed. The overall positive predictive value was 89.6% (95% confidence interval (CI): 85.1-92.8). The highest PPV was achieved for diagnoses registered for patients aged ≥70 years (93.8; 95% CI: 86.2-97.3) compared to patients <60 years (83.4; 95% CI: 73.3-90.7).</p><p><strong>Conclusion: </strong>We found a high PPV of primary diagnostic codes for ALS from Danish departments of neurology, demonstrating high validity. Thus, the DNPR is a well-suited data source for large-scale epidemiological research on ALS.</p>","PeriodicalId":10362,"journal":{"name":"Clinical Epidemiology","volume":null,"pages":null},"PeriodicalIF":3.9,"publicationDate":"2024-06-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11164206/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141300142","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":"Development and Validation of a META-Algorithm to Identify the Indications of Use of Biological Drugs Approved for the Treatment of Immune-Mediated Inflammatory Diseases from Claims Databases: Insights from the VALORE Project","authors":"Andrea Spini, Luca L'Abbate, Ylenia Ingrasciotta, Giorgia Pellegrini, Massimo Carollo, Valentina Ientile, Olivia Leoni, Martina Zanforlini, Domenica Ancona, Paolo Stella, Anna Cavazzana, Angela Scapin, Sara Lopes, Valeria Belleudi, Gianluca Trifirò","doi":"10.2147/clep.s445120","DOIUrl":"https://doi.org/10.2147/clep.s445120","url":null,"abstract":"<strong>Purpose:</strong> This research aimed to develop and validate a META-algorithm combining individual immune-mediated inflammatory disease (IMID)-specific algorithms to identify the exact IMID indications for incident biological drug users from claims data within the context of the Italian VALORE project.<br/><strong>Methods and Patients:</strong> All subjects with at least one dispensing of TNF-alpha inhibitors, anti-interleukin agents, and selective immunosuppressants approved for IMIDs were identified from claims databases of Latium region in Italy (observation period: 2010– 2020). Validated coding algorithms for identifying individual IMIDs from claims databases were found from published literature and combined into a META-algorithm. Positive predictive value (PPV), sensitivity (Se), negative predictive value (NPV), specificity (Sp), and accuracy (Acc) were estimated for each indication against the electronic therapeutic plans (ETPs) of the Latium region as the reference standard. Lastly, the frequency of the indication of use across individual biologic drugs was compared with that reported in three other Italian regions (Lombardy, Apulia, and the Veneto region).<br/><strong>Results:</strong> In total, 9755 incident biological drug users with a single IMID indication were identified. Using the newly developed META-algorithm, an indication of use was detected in 95% (n=9255) of the total cohort. The estimated Acc, Se, Sp, PPV, and NPV, against the reference standard were as follows: 0.96, 0.86, 0.97, 0.82, and 0.98 for Crohn’s disease, 0.96, 0.80, 0.98, 0.85, and 0.97 for ulcerative colitis, 0.93, 0.76, 0.99, 0.95, and 0.92 for rheumatoid arthritis, 0.97, 0.75, 0.99, 0.85, and 0.98 for spondylarthritis, and 0.91, 0.92, 0.91, 0.88, and 0.94 for psoriatic arthritis/psoriasis, respectively. Additionally, no substantial difference was observed in the frequency of indication of use by active ingredient among Latium and the other three Italian regions included in the study.<br/><strong>Conclusion:</strong> The newly developed META-algorithm demonstrated high validity estimates in the Italian claims data and was capable of discriminating with good performance among the most frequent IMID indications.<br/><br/><strong>Plain Language Summary:</strong> In the claims database, the lack of information on the indication of use represents a well-known limitation for the conduct of observational studies. This study was conducted to develop and validate a META-algorithm that accurately identifies the exact indication for the use of biological drugs in treating various immune-mediated inflammatory diseases. Using claims databases from the Latium region, we developed and validated a META-algorithm. The META-algorithm combines disease-specific algorithms for different immune-mediated inflammatory diseases (ie, Crohn’s disease, ulcerative colitis, rheumatoid arthritis, spondyloarthritis, psoriasis, and psoriatic arthritis) and was tested against a reference","PeriodicalId":10362,"journal":{"name":"Clinical Epidemiology","volume":null,"pages":null},"PeriodicalIF":3.9,"publicationDate":"2024-06-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141259007","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Risk of Post-Acute Sequelae of SARS-CoV-2 Infection (PASC) Among Patients with Type 2 Diabetes Mellitus on Anti-Hyperglycemic Medications","authors":"Oluwasolape Olawore, Lindsey E Turner, Michael D Evans, Steven G Johnson, Jared D Huling, Carolyn T Bramante, John B Buse, Til Stürmer","doi":"10.2147/clep.s458901","DOIUrl":"https://doi.org/10.2147/clep.s458901","url":null,"abstract":"<strong>Background:</strong> Observed activity of metformin in reducing the risk of severe COVID-19 suggests a potential use of the anti-hyperglycemic in the prevention of post-acute sequelae of SARS-CoV-2 infection (PASC). We assessed the 3-month and 6-month risk of PASC among patients with type 2 diabetes mellitus (T2DM) comparing metformin users to sulfonylureas (SU) or dipeptidyl peptidase-4 inhibitors (DPP4i) users.<br/><strong>Methods:</strong> We used de-identified patient level electronic health record data from the National Covid Cohort Collaborative (N3C) between October 2021 and April 2023. Participants were adults ≥ 18 years with T2DM who had at least one outpatient healthcare encounter in health institutions in the United States prior to COVID-19 diagnosis. The outcome of PASC was defined based on the presence of a diagnosis code for the illness or using a predicted probability based on a machine learning algorithm. We estimated the 3-month and 6-month risk of PASC and calculated crude and weighted risk ratios (RR), risk differences (RD), and differences in mean predicted probability.<br/><strong>Results:</strong> We identified 5596 (mean age: 61.1 years; SD: 12.6) and 1451 (mean age: 64.9 years; SD 12.5) eligible prevalent users of metformin and SU/DPP4i respectively. We did not find a significant difference in risk of PASC at 3 months (RR = 0.86 [0.56; 1.32], RD = − 3.06 per 1000 [− 12.14; 6.01]), or at 6 months (RR = 0.81 [0.55; 1.20], RD = − 4.91 per 1000 [− 14.75, 4.93]) comparing prevalent users of metformin to prevalent users of SU/ DPP4i. Similar observations were made for the outcome definition using the ML algorithm.<br/><strong>Conclusion:</strong> The observed estimates in our study are consistent with a reduced risk of PASC among prevalent users of metformin, however the uncertainty of our confidence intervals warrants cautious interpretations of the results. A standardized clinical definition of PASC is warranted for thorough evaluation of the effectiveness of therapies under assessment for the prevention of PASC.<br/><br/><strong>Plain Language Summary:</strong> Previous research suggests that metformin, due to its anti-viral, anti-inflammatory, and anti-thrombotic properties may reduce the risk of severe COVID-19. Given the shared etiology of COVID-19 and the post-acute sequelae of SARS-CoV-2 (PASC), and the proposed inflammatory processes of PASC, metformin may also be a beneficial preventive option. We investigated the benefit of metformin for PASC prevention in a population of type 2 diabetes mellitus patients with a COVID-19 diagnosis who were on metformin or two other anti-hyperglycemic medications prior to infection with SARS-CoV-2. Our results were consistent with a reduction in the risk of PASC with the use of metformin, however, the imprecise confidence intervals obtained warrants further investigation of this association of the potential beneficial effect of metformin for preventing PASC in patients with med","PeriodicalId":10362,"journal":{"name":"Clinical Epidemiology","volume":null,"pages":null},"PeriodicalIF":3.9,"publicationDate":"2024-05-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141189532","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Associations Between Estimated Pulse Wave Velocity and Five-Year All-Cause Mortality in Patients with Atherosclerotic Cardiovascular Disease with and without Standard Modifiable Risk Factors: Evidence From NHANES 1999-2016","authors":"Xicong Li, Yubiao Chen, Baiyun Liu, Mingyuan Ye, Bei Liu, Lifei Lu, Ruiwei Guo","doi":"10.2147/clep.s457054","DOIUrl":"https://doi.org/10.2147/clep.s457054","url":null,"abstract":"<strong>Aim:</strong> The study aimed to analyze the associations between estimated pulse wave velocity (ePWV) and 5-year mortality in atherosclerotic cardiovascular disease (ASCVD) patients with and without standard modifiable risk factors (SMuRFs), which included smoking status, hypertension, diabetes, and hypercholesterolemia.<br/><strong>Methods:</strong> The present retrospective cohort study utilized data from the National Health and Nutrition Examination Survey (NHANES) between 1999 and 2016. Patients with ASCVD who completed both the questionnaire survey and serum testing were included. Patients were categorized into the ≥ 1 SMuRF group if they had at least one SMuRF, while those without any SMuRFs were classified into the SMuRF-less group. The ePWV, which was calculated using the age and mean blood pressure, was evenly divided into three categories: low (Q1), medium (Q2), and high (Q3). Multivariable weighted Cox proportional-hazard regression analyses were utilized to explore the risk factors associated with 5-year mortality in patients with and without SMuRFs. And restricted cubic spline curve (RCS) was used to assess their nonlinear correlation.<br/><strong>Results:</strong> A total of 1901 patients with ASCVD were included in the study. For the patients in ≥ 1 SMuRF group, the Q3 group included patients who were older, with a higher proportion of males, more comorbidities, and a lower body mass index than the Q1 group (P&lt; 0.05). The Cox proportional-hazard regression model results revealed, the Q3 group had a higher risk of 5-year mortality than the Q1 group [hazard ratio (HR) 4.30, 95% confidence interval (CI) (2.66, 6.95), P&lt; 0.001]. RCS demonstrated a linear trend between high level of ePWV and decreased risks of mortality. Similar results were observed in the SMuRF-less group [HR 10.62, 95% CI (1.22, 92.06), P=0.032].<br/><strong>Conclusion:</strong> A high level of ePWV signified a higher risk of 5-year mortality in ASCVD patients with and without SMuRFs.<br/><br/><strong>Keywords:</strong> atherosclerotic cardiovascular disease, standard modifiable risk factors, estimated pulse wave velocity, all-cause mortality<br/>","PeriodicalId":10362,"journal":{"name":"Clinical Epidemiology","volume":null,"pages":null},"PeriodicalIF":3.9,"publicationDate":"2024-05-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141172962","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Evaluation of Left Truncation and Censoring When Changing the Use of the International Classification of Diseases Eighth Revision Codes to Tenth Revision Codes in the Danish National Patient Registry","authors":"Søren Korsgaard, Frederikke Schønfeldt Troelsen, Katalin Veres, Cecilia Hvitfeldt Fuglsang, Henrik Toft Sørensen","doi":"10.2147/clep.s456171","DOIUrl":"https://doi.org/10.2147/clep.s456171","url":null,"abstract":"<strong>Purpose:</strong> In the Danish National Patient Registry (DNPR), covering all Danish hospitals and widely used in research, diseases have been recorded using <em>International Classification of Diseases</em> (ICD) codes, transitioning from the <em>Eighth</em> to the <em>Tenth revision</em> in 1994. Uncertainty exists regarding whether including ICD-8 codes alongside ICD-10 is needed for complete disease identification. We assessed the extent of left-truncation and left-censoring in the DNPR arising from omitting ICD-8 codes.<br/><strong>Patients and Methods:</strong> We sampled 500,000 Danes ≥ 40 years of age in 1995, 2010, and 2018. From the DNPR, we identified cardiovascular, endocrine, gastrointestinal, neurological, pulmonary, rheumatic, and urogenital diseases as well as fractures. We obtained the number of people with a disease recorded with ICD-8 codes only (<em>ie</em>, the ICD-8 record would be left-truncated by not using ICD-8 codes), ICD-8 <em>plus</em> ICD-10 codes (<em>ie</em>, the ICD-8 record would be left-censored by not using ICD-8 codes), and ICD-10 codes only. For each ICD group, we calculated the proportion of people with the disease relative to the total sample (<em>ie</em>, 500,000 people) and the total number of people with the disease across all ICD groups.<br/><strong>Results:</strong> Overall, the left-truncation issue decreased over the years. Relative to all people with a disease, the left-truncated proportion was for example 59% in 1995 and &lt; 2% in 2018 for diabetes mellitus; 93% in 1995, and 54% in 2018 for appendicitis. The left-truncation issue increased with age group for most diseases. The proportion of disease records left-censored by not using ICD-8 codes was generally low but highest for chronic diseases.<br/><strong>Conclusion:</strong> The left-truncation issue diminished over sample years, particularly for chronic diseases, yet remained rather high for selected surgical diseases. The left-truncation issue increased with age group for most diseases. Left-censoring was overall a minor issue that primarily concerned chronic diseases.<br/><br/><strong>Keywords:</strong> epidemiology, methodology, bias, left-truncation, left-censoring<br/>","PeriodicalId":10362,"journal":{"name":"Clinical Epidemiology","volume":null,"pages":null},"PeriodicalIF":3.9,"publicationDate":"2024-05-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141060052","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Influence of Low-Density Lipoprotein Cholesterol Levels on NSAID-Associated Cardiovascular Risks After Myocardial Infarction: A Population-Based Cohort Study","authors":"Mohab Basem, Kasper Bonnesen, Lars Pedersen, Henrik Toft Sørensen, Morten Schmidt","doi":"10.2147/clep.s447451","DOIUrl":"https://doi.org/10.2147/clep.s447451","url":null,"abstract":"<strong>Aim:</strong> To examine whether low-density lipoprotein cholesterol (LDL-C) levels influence the cardiovascular risk associated with non-aspirin non-steroidal anti-inflammatory drug (NSAID) use after myocardial infarction (MI).<br/><strong>Methods:</strong> Using Danish health registries, we conducted a population-based cohort study of all adult patients with first-time MI during 2010– 2020 with an LDL-C value before discharge. Based on the latest LDL-C value, we categorized patients into a low and a high LDL-C group (&lt; 3.0 vs ≥ 3.0 mmol/L). We used time varying Cox regression to compute hazard ratios (HRs) with 95% confidence intervals of the association between NSAID use and a major adverse cardiovascular event (MACE: recurrent MI, ischemic stroke, and all-cause death).<br/><strong>Results:</strong> We followed 50,573 patients for a median of 3.1 years. While exposed, 521 patients experienced a MACE: 312 in the low LDL-C group and 209 in the high LDL-C group. The HRs for MACE comparing NSAID use with non-use were 1.21 (1.11– 1.32) overall, 1.19 (1.06– 1.33) in the low LDL-C group, and 1.23 (1.07– 1.41) in the high LDL-group. The HRs for recurrent MI and ischemic stroke were comparable between the LDL-C subgroups. The HRs for all-cause death were 1.22 (1.07– 1.39) in the low LDL-C group and 1.54 (1.30– 1.83) in the high LDL-C group. Changing the cut-off value for LDL-C to 1.8 and 1.4 mmol/L showed consistent results.<br/><strong>Conclusion:</strong> In patients with MI, LDL-C levels did not influence the increased risk of MACE associated with NSAID use, but might influence the association between NSAID use and all-cause death. <br/><br/><strong>Keywords:</strong> cardiovascular disease, non-steroidal anti-inflammatory drugs, cholesterol, low-density lipoprotein cholesterol, myocardial infarction, effect modification<br/>","PeriodicalId":10362,"journal":{"name":"Clinical Epidemiology","volume":null,"pages":null},"PeriodicalIF":3.9,"publicationDate":"2024-04-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140636923","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"A Study to Evaluate the Effectiveness and Safety of Prephase Steroid Treatment before Remission Induction Chemotherapy in Patients with Pediatric Acute Lymphoblastic Leukemia Using Common Data Model-Based Real-World Data: A Retrospective Observational Study","authors":"Yoona Choi, Bo Kyung Kim, Jung-Hyun Won, Jae Won Yoo, Wona Choi, Surin Jung, Jae Yoon Kim, In Young Choi, Nack-Gyun Chung, Jae Wook Lee, Jung Yoon Choi, Hyoung Jin Kang, Howard Lee","doi":"10.2147/clep.s454263","DOIUrl":"https://doi.org/10.2147/clep.s454263","url":null,"abstract":"<strong>Background:</strong> Rapid reduction of leukemic cells in the bone marrow during remission induction chemotherapy (RIC) can lead to significant complications such as tumor lysis syndrome (TLS). We investigated whether prephase steroid treatment before RIC could decrease TLS incidence and improve overall survival in pediatric patients with acute lymphoblastic leukemia (ALL).<br/><strong>Methods:</strong> Data were extracted from the Common Data Model databases in two tertiary-care hospitals in Seoul, South Korea. Patients were classified into the treated or untreated group if they had received RIC with prephase steroid treatment ≥ 7 days before RIC in 2012– 2021 or not, respectively. Stabilized Inverse Probability of Treatment Weighting (sIPTW) was applied to ensure compatibility between the treated and untreated groups. The incidence of TLS within 14 days of starting RIC, overall survival (OS), and the incidence of adverse events of special interest were the primary endpoints. Multiple sensitivity analyses were performed.<br/><strong>Results:</strong> Baseline characteristics were effectively balanced between the treated (n=308.4) and untreated (n=246.6) groups after sIPTW. Prephase steroid treatment was associated with a significant 88% reduction in the risk of TLS (OR 0.12, 95% CI: 0.03– 0.41). OS was numerically greater in the treated group than in the untreated group although the difference was not statistically significant (HR 0.64, 95% CI 0.25– 1.64). The treated group experienced significantly elevated risks for hyperbilirubinemia and hyperglycemia. The reduction in TLS risk by prephase steroid treatment was maintained in all of the sensitivity analyses.<br/><strong>Conclusion:</strong> Prephase steroid treatment for ≥ 7 days before RIC in pediatric patients with ALL reduces the risk of TLS, while careful monitoring for toxicities is necessary. If adequately analyzed, real-world data can provide crucial effectiveness and safety information for proper management of pediatric patients with ALL, for whom prospective randomized studies may be difficult to perform for ethical and practical reasons.<br/><br/>","PeriodicalId":10362,"journal":{"name":"Clinical Epidemiology","volume":null,"pages":null},"PeriodicalIF":3.9,"publicationDate":"2024-04-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140636920","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Development and Validation of an Intracranial Hemorrhage Risk Score in Older Adults with Atrial Fibrillation Treated with Oral Anticoagulant","authors":"Lily G Bessette, Daniel E Singer, Ajinkya Pawar, Vincent Wong, Dae Hyun Kim, Kueiyu Joshua Lin","doi":"10.2147/clep.s438013","DOIUrl":"https://doi.org/10.2147/clep.s438013","url":null,"abstract":"<strong>Background:</strong> High risk of intracranial hemorrhage (ICH) is a leading reason for withholding anticoagulation in patients with atrial fibrillation (AF). We aimed to develop a claims-based ICH risk prediction model in older adults with AF initiating oral anticoagulation (OAC).<br/><strong>Methods:</strong> We used US Medicare claims data to identify new users of OAC aged ≥ 65 years with AF in 2010– 2017. We used regularized Cox regression to select predictors of ICH. We compared our AF ICH risk score with the HAS-BLED bleed risk and Homer fall risk scores by area under the receiver operating characteristic curve (AUC) and assessed net reclassification improvement (NRI) when predicting 1-year risk of ICH.<br/><strong>Results:</strong> Our study cohort comprised 840,020 patients (mean [SD] age 77.5 [7.4] years and female 52.2%) split geographically into training (3963 ICH events [0.6%] in 629,804 patients) and validation (1397 ICH events [0.7%] in 210,216 patients) sets. Our AF ICH risk score, including 50 predictors, had superior AUCs of 0.653 and 0.650 in the training and validation sets than the HAS-BLED score of 0.580 and 0.567 (<em>p</em>&lt; 0.001) and the Homer score of 0.624 and 0.623 (p&lt; 0.001). In the validation set, our AF ICH risk score reclassified 57.8%, 42.5%, and 43.9% of low, intermediate, and high-risk patients, respectively, by HAS-BLED score (NRI: 15.3%, <em>p</em>&lt; 0.001). Similarly, it reclassified 0.0, 44.1, and 19.4% of low, intermediate, and high-risk patients, respectively, by the Homer score (NRI: 21.9%, <em>p</em>&lt; 0.001).<br/><strong>Conclusion:</strong> Our novel claims-based ICH risk prediction model outperformed the standard HAS-BLED score and can inform OAC prescribing decisions.<br/><br/>","PeriodicalId":10362,"journal":{"name":"Clinical Epidemiology","volume":null,"pages":null},"PeriodicalIF":3.9,"publicationDate":"2024-04-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140613864","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Validity of Major Osteoporotic Fracture Diagnoses in the Danish National Patient Registry","authors":"Anne Clausen, Sören Möller, Michael Kriegbaum Skjødt, Rasmus Bank Lynggaard, Pernille Just Vinholt, Martin Lindberg-Larsen, Jens Søndergaard, Bo Abrahamsen, Katrine Hass Rubin","doi":"10.2147/clep.s444447","DOIUrl":"https://doi.org/10.2147/clep.s444447","url":null,"abstract":"<strong>Objective:</strong> To evaluate the validity of diagnosis codes for Major Osteoporotic Fracture (MOF) in the Danish National Patient Registry (NPR) and secondly to evaluate whether the fracture was incident/acute using register-based definitions including date criteria and procedural codes.<br/><strong>Methods:</strong> We identified a random sample of 2400 records with a diagnosis code for a MOF in the NPR with dates in the year of 2018. Diagnoses were coded with the 10th revision of the International Classification of Diseases (ICD-10). The sample included 2375 unique fracture patients from the Region of Southern Denmark. Medical records were retrieved for the study population and reviewed by an algorithmic search function and medical doctors to verify the MOF diagnoses. Register-based definitions of incident/acute MOF was evaluated in NPR data by applying date criteria and procedural codes.<br/><strong>Results:</strong> The PPV for MOF diagnoses overall was 0.99 (95% CI: 0.98;0.99) and PPV=0.99 for the four individual fracture sites, respectively. Further, analyses of incident/acute fractures applying date criteria, procedural codes and using patients’ first contact in the NPR resulted in PPV=0.88 (95% CI: 0.84;0.91) for hip fractures, PPV=0.78 (95% CI: 0.74;0.83) for humerus fractures, PPV=0.78 (95% CI: 0.73;0.83) for clinical vertebral fractures and PPV=0.87 (95% CI: 0.83;0.90) for wrist fractures.<br/><strong>Conclusion:</strong> ICD-10 coded MOF diagnoses are valid in the NPR. Furthermore, a set of register-based criteria can be applied to qualify if the MOF fracture was incident/acute. Thus, the NPR is a valuable and reliable data source for epidemiological research on osteoporotic fractures.<br/><br/><strong>Keywords:</strong> major osteoporotic fractures, validity, positive predictive value, the Danish National Patient Register, algorithmic search function, epidemiology<br/>","PeriodicalId":10362,"journal":{"name":"Clinical Epidemiology","volume":null,"pages":null},"PeriodicalIF":3.9,"publicationDate":"2024-04-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140593720","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Validity of Prescription-Defined and Hospital-Diagnosed Hypertension Compared with Self-Reported Hypertension in Denmark","authors":"Kasper Bonnesen, Morten Schmidt","doi":"10.2147/clep.s448347","DOIUrl":"https://doi.org/10.2147/clep.s448347","url":null,"abstract":"<strong>Purpose:</strong> Hypertension is an important risk factor in cardio-epidemiological research, but data quality remains a concern. We validated different registry-based definitions of hypertension.<br/><strong>Patients and Methods:</strong> The cohort included all first-time responders of the Danish National Health Surveys (2010, 2013, or 2017). Prescription-defined hypertension was defined as ≥ 1 or ≥ 2 filled prescriptions of antihypertensive specific drugs in ≥ 1 or ≥ 2 different antihypertensive drug classes within 90, 180, or 365 days before survey response. Hospital-diagnosed hypertension was defined from hypertension diagnoses within five years before the survey response. Considering self-reported hypertension as the reference, we calculated the positive predictive value (PPV), the negative predictive value (NVP), the sensitivity, and the specificity of prescription-defined and hospital-diagnosed hypertension.<br/><strong>Results:</strong> Among 442,490 survey responders, 127,247 (29%) had self-reported hypertension. For prescription-defined hypertension with 365-day lookback, the PPV was highest for ≥ 2 prescriptions in ≥ 2 drug classes (94%) and lowest for ≥ 1 prescription in ≥ 1 drug class (85%). The NPV was highest for ≥ 1 prescription in ≥ 2 drug classes (94%) and lowest for ≥ 1 prescription in ≥ 2 drug classes (80%). The sensitivity was highest for ≥ 1 prescription in ≥ 1 drug class (79%) and lowest for ≥ 2 prescriptions in ≥ 2 drug classes (30%). The specificity was ≥ 94% for all algorithms. The PPV and specificity did not change noteworthy with length of lookback period, whereas the NPV and the sensitivity generally were higher for longer lookback. The algorithm ≥ 1 prescription in ≥ 2 drug classes with 365-day lookback was among the best balanced across all measures of validity (PPV=88%, NPV=94%, sensitivity=75%, specificity=96%). For hospital-diagnosed hypertension, the PPV was 90%, the NPV was 76%, the sensitivity was 22%, and the specificity was 99%.<br/><strong>Conclusion:</strong> Compared with self-reported hypertension, the algorithms for prescription-defined and hospital-diagnosed hypertension had high predictive values and specificity, but low sensitivity.<br/><br/><strong>Keywords:</strong> epidemiologic studies, epidemiology, hypertension, predictive value of tests, sensitivity and specificity, validation study<br/>","PeriodicalId":10362,"journal":{"name":"Clinical Epidemiology","volume":null,"pages":null},"PeriodicalIF":3.9,"publicationDate":"2024-04-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140593727","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}