Aurélie Mailhac, Lars Pedersen, Anton Pottegård, J. Søndergaard, Torben Æ. Mogensen, H. Sørensen, R. Thomsen
Purpose: A surge in the use of semaglutide injection (Ozempic ® ) approved to treat type 2 diabetes (T2D) has led to a global supply shortage. We investigated contemporary user rates and clinical characteristics of semaglutide (Ozempic ® ) users in Denmark, and the extent of “off-label” prescribing for weight loss. Patients and Methods: Nationwide population-based cross-sectional study based on linked health registries January 2018 through December 2023. All adults who received a first prescription of semaglutide once weekly (Ozempic ® ) were included. We examined quarterly rates of new users and total user prevalences, using other glucagon-like peptide-1 receptor agonists and weight loss medications as comparison. We also investigated user characteristics including T2D, glucose control, comedications, and cardiorenal disease. Results: The new user rate of semaglutide (Ozempic ® ) remained stable at approximately 4 per 1000 adult person-years between 2019 and 2021 and then accelerated, peaking at 10 per 1000 in the first quarter of 2023 after which it declined sharply. User prevalence increased to 91,626 users in Denmark in 2023. The proportion of semaglutide (Ozempic ® ) new users who had a record of T2D declined from 99% in 2018 to only 67% in 2022, increasing again to 87% in 2023. Among people with T2D who initiated semaglutide (Ozempic ® ) in 2023, 52% received antidiabetic polytherapy before initiation, 39% monotherapy, and 8% no antidiabetic therapy. Most T2D initiators had suboptimal glucose control, with 83% having an HbA1c ≥48 mmol/mol and 68% ≥53 mmol/mol despite use of antidiabetic medication, and 29% had established atherosclerotic cardiovascular disease or kidney disease. Conclusion: The use of semaglutide (Ozempic ® ) in Denmark has increased dramatically. Although not approved for weight loss without T2D, one-third of new users in 2022 did not have T2D. Conversely, most initiators with T2D had a clear medical indication for treatment intensification, and “off-label” use can only explain a minor part of the supply shortage.
{"title":"Semaglutide (Ozempic®) Use in Denmark 2018 Through 2023 ‒ User Trends and off-Label Prescribing for Weight Loss","authors":"Aurélie Mailhac, Lars Pedersen, Anton Pottegård, J. Søndergaard, Torben Æ. Mogensen, H. Sørensen, R. Thomsen","doi":"10.2147/clep.s456170","DOIUrl":"https://doi.org/10.2147/clep.s456170","url":null,"abstract":"Purpose: A surge in the use of semaglutide injection (Ozempic ® ) approved to treat type 2 diabetes (T2D) has led to a global supply shortage. We investigated contemporary user rates and clinical characteristics of semaglutide (Ozempic ® ) users in Denmark, and the extent of “off-label” prescribing for weight loss. Patients and Methods: Nationwide population-based cross-sectional study based on linked health registries January 2018 through December 2023. All adults who received a first prescription of semaglutide once weekly (Ozempic ® ) were included. We examined quarterly rates of new users and total user prevalences, using other glucagon-like peptide-1 receptor agonists and weight loss medications as comparison. We also investigated user characteristics including T2D, glucose control, comedications, and cardiorenal disease. Results: The new user rate of semaglutide (Ozempic ® ) remained stable at approximately 4 per 1000 adult person-years between 2019 and 2021 and then accelerated, peaking at 10 per 1000 in the first quarter of 2023 after which it declined sharply. User prevalence increased to 91,626 users in Denmark in 2023. The proportion of semaglutide (Ozempic ® ) new users who had a record of T2D declined from 99% in 2018 to only 67% in 2022, increasing again to 87% in 2023. Among people with T2D who initiated semaglutide (Ozempic ® ) in 2023, 52% received antidiabetic polytherapy before initiation, 39% monotherapy, and 8% no antidiabetic therapy. Most T2D initiators had suboptimal glucose control, with 83% having an HbA1c ≥48 mmol/mol and 68% ≥53 mmol/mol despite use of antidiabetic medication, and 29% had established atherosclerotic cardiovascular disease or kidney disease. Conclusion: The use of semaglutide (Ozempic ® ) in Denmark has increased dramatically. Although not approved for weight loss without T2D, one-third of new users in 2022 did not have T2D. Conversely, most initiators with T2D had a clear medical indication for treatment intensification, and “off-label” use can only explain a minor part of the supply shortage.","PeriodicalId":10362,"journal":{"name":"Clinical Epidemiology","volume":null,"pages":null},"PeriodicalIF":3.9,"publicationDate":"2024-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140768559","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":"Work Disability and Return to Work After Treatment for Acute Lymphoblastic Leukemia: A Danish Nationwide Cohort Study [Letter]","authors":"Huaguo Zhang, Song Wang","doi":"10.2147/clep.s472205","DOIUrl":"https://doi.org/10.2147/clep.s472205","url":null,"abstract":"","PeriodicalId":10362,"journal":{"name":"Clinical Epidemiology","volume":null,"pages":null},"PeriodicalIF":3.9,"publicationDate":"2024-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140788263","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}
David Bergman, Bjorn Roelstraete, Jiangwei Sun, Fahim Ebrahimi, Rickard Lidström, Axel Svedbom, Mona Ståhle, Jonas F Ludvigsson
Background: Microscopic colitis (MC) has been associated with several immune-mediated diseases including psoriasis, but earlier research has been limited to psoriasis occurring before MC. Data from large-scale cohort studies investigating MC and risk of future psoriasis are lacking. Objective: To examine the association between MC and psoriasis. Methods: In a nationwide, population-based, matched cohort study in Sweden from 2007 to 2021, we identified 8404 patients with biopsy-verified MC (diagnosed in 2007– 2017), 37,033 matched reference individuals, and 8381 siblings without MC. Information on MC was obtained through the ESPRESSO cohort (a Swedish histopathology database with nationwide coverage). Using Cox regression, we calculated hazard ratios (HRs) and 95% confidence intervals (CIs) for psoriasis up until 2021. Results: During a median follow-up of 9.2 years (interquartile range = 6.7– 11.7), 179 MC patients and 440 reference individuals were diagnosed with psoriasis (241.1 vs 131.8 events per 100,000 person-years), corresponding to one extra case of psoriasis in 91 patients with MC over 10 years. After adjustment for the matching variables (birth year, sex, county of residence, and calendar period) and level of education, we computed an adjusted hazard ratio (aHR) of 1.82 (95% CI = 1.53– 2.17). Stratified by sex, estimates were similar and when examining the aHR across different lengths of follow-up, we found significantly elevated estimates up to 10 years after MC diagnosis. Compared to MC-free siblings, the aHR was 1.85 (95% CI = 1.36– 2.51). Conclusion: Patients with MC are at an almost doubled risk of psoriasis compared to the general population. Clinicians need to consider psoriasis in MC patients with skin lesions.
背景：显微镜下结肠炎（MC）与包括银屑病在内的多种免疫介导疾病相关，但早期研究仅限于 MC 之前发生的银屑病。目前还缺乏大规模队列研究的数据，这些研究调查了 MC 与未来患银屑病的风险：目的：研究 MC 与银屑病之间的关系：2007年至2021年，我们在瑞典进行了一项全国性、基于人群的匹配队列研究，确定了8404名经活检证实的MC患者（2007年至2017年确诊）、37033名匹配参照个体和8381名无MC的兄弟姐妹。有关 MC 的信息通过 ESPRESSO 队列（瑞典覆盖全国的组织病理学数据库）获得。我们使用考克斯回归法计算了2021年前银屑病的危险比（HRs）和95%置信区间（CIs）：在中位随访 9.2 年（四分位间范围 = 6.7-11.7）期间，179 名 MC 患者和 440 名参照个体被诊断为银屑病（每 10 万人年 241.1 例 vs 131.8 例），相当于 10 年间 91 名 MC 患者中多了一个银屑病病例。在对匹配变量（出生年份、性别、居住县和日历期）和教育水平进行调整后，我们计算出调整后的危险比（aHR）为 1.82（95% CI = 1.53-2.17）。按性别进行分层后，估计值相似，而在检查不同随访期的 aHR 时，我们发现 MC 诊断后 10 年内的估计值明显升高。与无 MC 的兄弟姐妹相比，aHR 为 1.85（95% CI = 1.36-2.51）：结论：与普通人群相比，MC 患者患银屑病的风险几乎翻倍。临床医生需要考虑有皮损的 MC 患者是否患有银屑病。
{"title":"Microscopic Colitis and Risk of Incident Psoriasis: A Nationwide Population-Based Matched Cohort Study","authors":"David Bergman, Bjorn Roelstraete, Jiangwei Sun, Fahim Ebrahimi, Rickard Lidström, Axel Svedbom, Mona Ståhle, Jonas F Ludvigsson","doi":"10.2147/clep.s454677","DOIUrl":"https://doi.org/10.2147/clep.s454677","url":null,"abstract":"<strong>Background:</strong> Microscopic colitis (MC) has been associated with several immune-mediated diseases including psoriasis, but earlier research has been limited to psoriasis occurring before MC. Data from large-scale cohort studies investigating MC and risk of future psoriasis are lacking.<br/><strong>Objective:</strong> To examine the association between MC and psoriasis.<br/><strong>Methods:</strong> In a nationwide, population-based, matched cohort study in Sweden from 2007 to 2021, we identified 8404 patients with biopsy-verified MC (diagnosed in 2007– 2017), 37,033 matched reference individuals, and 8381 siblings without MC. Information on MC was obtained through the ESPRESSO cohort (a Swedish histopathology database with nationwide coverage). Using Cox regression, we calculated hazard ratios (HRs) and 95% confidence intervals (CIs) for psoriasis up until 2021.<br/><strong>Results:</strong> During a median follow-up of 9.2 years (interquartile range = 6.7– 11.7), 179 MC patients and 440 reference individuals were diagnosed with psoriasis (241.1 vs 131.8 events per 100,000 person-years), corresponding to one extra case of psoriasis in 91 patients with MC over 10 years. After adjustment for the matching variables (birth year, sex, county of residence, and calendar period) and level of education, we computed an adjusted hazard ratio (aHR) of 1.82 (95% CI = 1.53– 2.17). Stratified by sex, estimates were similar and when examining the aHR across different lengths of follow-up, we found significantly elevated estimates up to 10 years after MC diagnosis. Compared to MC-free siblings, the aHR was 1.85 (95% CI = 1.36– 2.51).<br/><strong>Conclusion:</strong> Patients with MC are at an almost doubled risk of psoriasis compared to the general population. Clinicians need to consider psoriasis in MC patients with skin lesions.<br/><br/>","PeriodicalId":10362,"journal":{"name":"Clinical Epidemiology","volume":null,"pages":null},"PeriodicalIF":3.9,"publicationDate":"2024-03-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140324042","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}
Zhiting Wang, Piia Lavikainen, Katja Wikström, Tiina Laatikainen
Objective: We aimed to assess how longitudinal body mass index (BMI) trajectories are associated with diabetes complications and all-cause mortality in Finnish patients with type 2 diabetes (T2D). Methods: In this cohort study, electronic health records from public primary and specialized healthcare services in all 13 municipalities of North Karelia, Finland, were utilized. This study included a total of 889 adults with newly diagnosed T2D in 2011 or 2012 (mean age at baseline 62.0 years). Individual BMI trajectories from the T2D diagnosis until 2014 were estimated and grouped by growth mixture modeling (GMM). Hazard ratios (HRs) with 95% confidence intervals (CIs) for microvascular complications, macrovascular complications, any diabetes complications, and all-cause mortality from 2015 to 2022 across BMI trajectory groups were estimated using Cox regression models. Results: Three distinct BMI trajectory groups were identified using GMM and labeled as follows: “stable” (n = 774, 87.1%), “decreasing” (n = 87, 9.8%), and “increasing” (n = 28, 3.1%). During a median follow-up of 8 years, there were 119 (13.3%) patients with microvascular complications, 187 (21.0%) with macrovascular complications, 258 (29.0%) with any diabetes complications, and 180 (20.2%) deaths. Compared with the “stable” BMI, the “increasing” BMI was associated with an increased risk of microvascular complications (HR = 2.88, 95% CI: 1.32 to 6.28), macrovascular complications (HR = 2.52, 95% CI: 1.17 to 5.43), and any diabetes complications (HR = 2.21, 95% CI: 1.16 to 4.20). The “decreasing” BMI was associated with an increased risk of all-cause mortality (HR = 1.90, 95% CI: 1.14 to 3.15), compared to the “stable” BMI. Conclusion: Our findings underscore the significance of continuous BMI monitoring and weight management in patients with T2D. Tailored treatments are crucial for efficiently preventing weight gain and reducing the risk of diabetes complications.
Keywords: body mass index trajectory, type 2 diabetes, diabetes complications, all-cause mortality
{"title":"Trajectories of Body Mass Index and Risk for Diabetes Complications and All-Cause Mortality in Finnish Type 2 Diabetes Patients","authors":"Zhiting Wang, Piia Lavikainen, Katja Wikström, Tiina Laatikainen","doi":"10.2147/clep.s450455","DOIUrl":"https://doi.org/10.2147/clep.s450455","url":null,"abstract":"<strong>Objective:</strong> We aimed to assess how longitudinal body mass index (BMI) trajectories are associated with diabetes complications and all-cause mortality in Finnish patients with type 2 diabetes (T2D).<br/><strong>Methods:</strong> In this cohort study, electronic health records from public primary and specialized healthcare services in all 13 municipalities of North Karelia, Finland, were utilized. This study included a total of 889 adults with newly diagnosed T2D in 2011 or 2012 (mean age at baseline 62.0 years). Individual BMI trajectories from the T2D diagnosis until 2014 were estimated and grouped by growth mixture modeling (GMM). Hazard ratios (HRs) with 95% confidence intervals (CIs) for microvascular complications, macrovascular complications, any diabetes complications, and all-cause mortality from 2015 to 2022 across BMI trajectory groups were estimated using Cox regression models.<br/><strong>Results:</strong> Three distinct BMI trajectory groups were identified using GMM and labeled as follows: “stable” (n = 774, 87.1%), “decreasing” (n = 87, 9.8%), and “increasing” (n = 28, 3.1%). During a median follow-up of 8 years, there were 119 (13.3%) patients with microvascular complications, 187 (21.0%) with macrovascular complications, 258 (29.0%) with any diabetes complications, and 180 (20.2%) deaths. Compared with the “stable” BMI, the “increasing” BMI was associated with an increased risk of microvascular complications (HR = 2.88, 95% CI: 1.32 to 6.28), macrovascular complications (HR = 2.52, 95% CI: 1.17 to 5.43), and any diabetes complications (HR = 2.21, 95% CI: 1.16 to 4.20). The “decreasing” BMI was associated with an increased risk of all-cause mortality (HR = 1.90, 95% CI: 1.14 to 3.15), compared to the “stable” BMI.<br/><strong>Conclusion:</strong> Our findings underscore the significance of continuous BMI monitoring and weight management in patients with T2D. Tailored treatments are crucial for efficiently preventing weight gain and reducing the risk of diabetes complications.<br/><br/><strong>Keywords:</strong> body mass index trajectory, type 2 diabetes, diabetes complications, all-cause mortality<br/>","PeriodicalId":10362,"journal":{"name":"Clinical Epidemiology","volume":null,"pages":null},"PeriodicalIF":3.9,"publicationDate":"2024-03-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140324033","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}
Eva Futtrup Maksten, Rasmus Rask Kragh Jørgensen, Mathilde Selmar Pedersen, Kirsten Fonager, Rie Sander Bech, Ingolf Mølle, Andreas Due Ørskov, Claudia Schöllkopf, Ulrik Malthe Overgaard, Gunhild Nynke Thomsen, Tarec C El-Galaly, Marianne Tang Severinsen
Purpose: Most adult patients diagnosed with acute lymphoblastic leukemia (ALL) are below retirement age. The overall survival of patients with ALL has improved with implementation of high intensity pediatric-inspired treatment protocols. However, this treatment comes with a risk of long-term complications, which could affect the ability to work. The aim of this study was to investigate the risk of disability pension (DP) and return to work (RTW) for patients with ALL. Patients and Methods: Patients aged 18– 60 years diagnosed with ALL between 2005 and 2019 were identified in the Danish National Acute Leukemia Registry. Each patient was matched with five comparators from the general population on birth year, sex, and Charlson Comorbidity Index. The Aalen-Johansen estimator was used to calculate the cumulative risk of DP for patients and comparators from index date (defined as 1 year after diagnosis) with competing events (transplantation or relapse, death, retirement pension, or early retirement pension). Differences in cumulative incidences were calculated using Gray’s test. RTW was calculated as proportions one, three, and five years after the index date for patients holding a job before diagnosis. Results: A total of 154 patients with ALL and 770 matched comparators were included. The 5-year cumulative risk of DP was increased fivefold for patients with ALL compared with the general population. RTW was 41.7%, 65.7%, and 60.7% one, three, and five years after the index date, respectively. Conclusion: The risk of DP in patients with ALL increased significantly compared with the general population. Five years after the index date, RTW was 60.7% for patients with ALL.
Keywords: acute lymphoblastic leukemia, disability pension, return to work
{"title":"Work Disability and Return to Work After Treatment for Acute Lymphoblastic Leukemia: A Danish Nationwide Cohort Study","authors":"Eva Futtrup Maksten, Rasmus Rask Kragh Jørgensen, Mathilde Selmar Pedersen, Kirsten Fonager, Rie Sander Bech, Ingolf Mølle, Andreas Due Ørskov, Claudia Schöllkopf, Ulrik Malthe Overgaard, Gunhild Nynke Thomsen, Tarec C El-Galaly, Marianne Tang Severinsen","doi":"10.2147/clep.s444270","DOIUrl":"https://doi.org/10.2147/clep.s444270","url":null,"abstract":"<strong>Purpose:</strong> Most adult patients diagnosed with acute lymphoblastic leukemia (ALL) are below retirement age. The overall survival of patients with ALL has improved with implementation of high intensity pediatric-inspired treatment protocols. However, this treatment comes with a risk of long-term complications, which could affect the ability to work. The aim of this study was to investigate the risk of disability pension (DP) and return to work (RTW) for patients with ALL.<br/><strong>Patients and Methods:</strong> Patients aged 18– 60 years diagnosed with ALL between 2005 and 2019 were identified in the Danish National Acute Leukemia Registry. Each patient was matched with five comparators from the general population on birth year, sex, and Charlson Comorbidity Index. The Aalen-Johansen estimator was used to calculate the cumulative risk of DP for patients and comparators from index date (defined as 1 year after diagnosis) with competing events (transplantation or relapse, death, retirement pension, or early retirement pension). Differences in cumulative incidences were calculated using Gray’s test. RTW was calculated as proportions one, three, and five years after the index date for patients holding a job before diagnosis.<br/><strong>Results:</strong> A total of 154 patients with ALL and 770 matched comparators were included. The 5-year cumulative risk of DP was increased fivefold for patients with ALL compared with the general population. RTW was 41.7%, 65.7%, and 60.7% one, three, and five years after the index date, respectively.<br/><strong>Conclusion:</strong> The risk of DP in patients with ALL increased significantly compared with the general population. Five years after the index date, RTW was 60.7% for patients with ALL.<br/><br/><strong>Keywords:</strong> acute lymphoblastic leukemia, disability pension, return to work<br/>","PeriodicalId":10362,"journal":{"name":"Clinical Epidemiology","volume":null,"pages":null},"PeriodicalIF":3.9,"publicationDate":"2024-03-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140126615","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}
Anders Møller, Nikolaj Eldrup, Jørn Wetterslev, Dorthe Hellemann, Henning Bay Nielsen, Klaus Rostgaard, Henrik Hjalgrim, Ole Birger Pedersen
Background: Significant changes in Western populations’ abdominal aortic aneurysm (AAA) epidemiology have been reported following the introduction of screening, endovascular AAA repair, and reduced tobacco consumption. We report incidence and mortality of AAA repair in Denmark from 1996 to 2018, where AAA screening was not implemented. Methods: Nationwide cohort study of prospective data from population-based Danish registries covering 1996 to 2018. We identified 15,395 patients undergoing first-time AAA repair using the Danish Vascular Registry. Comorbidity was assessed by Charlson’s Comorbidity Index (CCI). Incidence rate (IR) ratios and mortality rate ratios (MRR) were estimated by multivariable Poisson and Cox regression, respectively. Results: Overall AAA repair IR decreased by 24% from 1996 through 2018, mainly reflecting a 53% IR reduction in ruptured AAA repairs in men. Overall, the IR decreased 52– 63% in age groups below 70 years and increased 81% among octogenarians. The proportion of intact AAAs repaired endovascularly increased from 2% in 1996– 1999 to 42% in 2015– 2018. For both ruptured and intact AAAs the CCI score increased by 0.9% annually independently of age and sex. The adjusted five-year MRR in 2016– 2018 vs.1996– 2000 was 0.46 (95% confidence interval (CI): 0.39– 0.54) following ruptured and 0.51 (95% CI: 0.44– 0.59) following intact AAA repair. Conclusion: In Denmark, overall AAA repair incidence decreased between 1996 and 2018, primarily reflecting a reduction among males and a shift to an older population requiring intervention. These trends mirror changes in tobacco consumption in Denmark. Regardless of age and comorbidity, AAA repair mortality decreased markedly during the study period.
{"title":"Trends in Abdominal Aortic Aneurysm Repair Incidence, Comorbidity, Treatment, and Mortality: A Danish Nationwide Cohort Study, 1996–2018","authors":"Anders Møller, Nikolaj Eldrup, Jørn Wetterslev, Dorthe Hellemann, Henning Bay Nielsen, Klaus Rostgaard, Henrik Hjalgrim, Ole Birger Pedersen","doi":"10.2147/clep.s427348","DOIUrl":"https://doi.org/10.2147/clep.s427348","url":null,"abstract":"<strong>Background:</strong> Significant changes in Western populations’ abdominal aortic aneurysm (AAA) epidemiology have been reported following the introduction of screening, endovascular AAA repair, and reduced tobacco consumption. We report incidence and mortality of AAA repair in Denmark from 1996 to 2018, where AAA screening was not implemented.<br/><strong>Methods:</strong> Nationwide cohort study of prospective data from population-based Danish registries covering 1996 to 2018. We identified 15,395 patients undergoing first-time AAA repair using the Danish Vascular Registry. Comorbidity was assessed by Charlson’s Comorbidity Index (CCI). Incidence rate (IR) ratios and mortality rate ratios (MRR) were estimated by multivariable Poisson and Cox regression, respectively.<br/><strong>Results:</strong> Overall AAA repair IR decreased by 24% from 1996 through 2018, mainly reflecting a 53% IR reduction in ruptured AAA repairs in men. Overall, the IR decreased 52– 63% in age groups below 70 years and increased 81% among octogenarians. The proportion of intact AAAs repaired endovascularly increased from 2% in 1996– 1999 to 42% in 2015– 2018. For both ruptured and intact AAAs the CCI score increased by 0.9% annually independently of age and sex. The adjusted five-year MRR in 2016– 2018 vs.1996– 2000 was 0.46 (95% confidence interval (CI): 0.39– 0.54) following ruptured and 0.51 (95% CI: 0.44– 0.59) following intact AAA repair.<br/><strong>Conclusion:</strong> In Denmark, overall AAA repair incidence decreased between 1996 and 2018, primarily reflecting a reduction among males and a shift to an older population requiring intervention. These trends mirror changes in tobacco consumption in Denmark. Regardless of age and comorbidity, AAA repair mortality decreased markedly during the study period.<br/><br/>","PeriodicalId":10362,"journal":{"name":"Clinical Epidemiology","volume":null,"pages":null},"PeriodicalIF":3.9,"publicationDate":"2024-03-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140114905","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}
Charles Vesteghem, Martin Bøgsted, Deirdre Cronin-Fenton, Laurids Østergaard Poulsen
Background: Reconstructing patient treatment trajectories is important to generate real-world evidence for epidemiological studies. The Danish National Patient Registry (DNPR) contains information about drug prescriptions and could therefore be used to reconstruct treatment trajectories. We aimed to evaluate and enhance two existing methods to reconstruct systemic anticancer treatment trajectories. Methods: This study was based on data from 8738 consecutive patients with solid tumors treated in the North Denmark Region between 2009 and 2019. Two approaches found in the literature as well as two new approaches were applied to the DNPR data. All methods relied on time intervals between two consecutive drug administrations to determine if they belonged to the same treatment line. MedOnc, a local dataset from the Department of Oncology, Aalborg University Hospital was used as a reference. To evaluate the performance of each method, F1-scores were calculated after matching the lines identified in both datasets. We used three different matching strategies: stringent matching, loose matching, and matching based on line numbers, controlling for overfitting. Results: Overall, the two new approaches outperformed the simpler and best performing of the two existing methods, with F1-scores of 0.47 and 0.45 vs 0.44 for stringent matching and 0.84 and 0.83 vs 0.82 for loose matching. Nevertheless, only one of the new methods outperformed the existing simpler method when matching on the number of lines (0.73 vs 0.72). Large differences were seen by cancer site, especially for the stringent and line number matchings. Performances were relatively stable by calendar year. Conclusion: The high F1-scores for the new methods confirm that they should be generally preferred to reconstruct systemic anticancer treatment trajectories using the DNPR.
背景：重建患者的治疗轨迹对于为流行病学研究提供真实世界的证据非常重要。丹麦国家患者登记处（Danish National Patient Registry，DNPR）包含药物处方信息，因此可用于重建治疗轨迹。我们的目的是评估和改进现有的两种重建系统性抗癌治疗轨迹的方法：本研究基于 2009 年至 2019 年期间在北丹麦地区接受治疗的 8738 名连续实体瘤患者的数据。文献中的两种方法和两种新方法被应用于 DNPR 数据。所有方法都依赖于两次连续给药之间的时间间隔来确定它们是否属于同一治疗线。奥尔堡大学医院肿瘤部的本地数据集 MedOnc 被用作参考。为了评估每种方法的性能，我们在对两个数据集中识别出的治疗线进行匹配后计算了 F1 分数。我们使用了三种不同的匹配策略：严格匹配、宽松匹配和基于线号的匹配，并控制了过拟合：总体而言，两种新方法的性能优于现有两种方法中最简单、性能最好的方法，严格匹配的 F1 分数分别为 0.47 和 0.45，而松散匹配的 F1 分数分别为 0.84 和 0.83，而松散匹配的 F1 分数为 0.82。然而，在行数匹配方面，只有一种新方法优于现有的简单方法（0.73 对 0.72）。癌症部位的差异很大，特别是严格匹配和行数匹配。不同日历年的性能相对稳定：结论：新方法的高 F1 分数证实，在使用 DNPR 重建全身抗癌治疗轨迹时，一般应首选新方法。
{"title":"Extracting Systemic Anticancer Treatment Lines from the Danish National Patient Registry for Solid Tumour Patients Treated in the North Denmark Region Between 2009 and 2019","authors":"Charles Vesteghem, Martin Bøgsted, Deirdre Cronin-Fenton, Laurids Østergaard Poulsen","doi":"10.2147/clep.s442591","DOIUrl":"https://doi.org/10.2147/clep.s442591","url":null,"abstract":"<strong>Background:</strong> Reconstructing patient treatment trajectories is important to generate real-world evidence for epidemiological studies. The Danish National Patient Registry (DNPR) contains information about drug prescriptions and could therefore be used to reconstruct treatment trajectories. We aimed to evaluate and enhance two existing methods to reconstruct systemic anticancer treatment trajectories.<br/><strong>Methods:</strong> This study was based on data from 8738 consecutive patients with solid tumors treated in the North Denmark Region between 2009 and 2019. Two approaches found in the literature as well as two new approaches were applied to the DNPR data. All methods relied on time intervals between two consecutive drug administrations to determine if they belonged to the same treatment line. MedOnc, a local dataset from the Department of Oncology, Aalborg University Hospital was used as a reference. To evaluate the performance of each method, F1-scores were calculated after matching the lines identified in both datasets. We used three different matching strategies: stringent matching, loose matching, and matching based on line numbers, controlling for overfitting.<br/><strong>Results:</strong> Overall, the two new approaches outperformed the simpler and best performing of the two existing methods, with F1-scores of 0.47 and 0.45 vs 0.44 for stringent matching and 0.84 and 0.83 vs 0.82 for loose matching. Nevertheless, only one of the new methods outperformed the existing simpler method when matching on the number of lines (0.73 vs 0.72). Large differences were seen by cancer site, especially for the stringent and line number matchings. Performances were relatively stable by calendar year.<br/><strong>Conclusion:</strong> The high F1-scores for the new methods confirm that they should be generally preferred to reconstruct systemic anticancer treatment trajectories using the DNPR.<br/><br/>","PeriodicalId":10362,"journal":{"name":"Clinical Epidemiology","volume":null,"pages":null},"PeriodicalIF":3.9,"publicationDate":"2024-03-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140044183","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}
Margit Kriegbaum, Bent Struer Lind, Mia Klinten Grand, Christen Lykkegaard Andersen
Background: The Copenhagen General Practice Laboratory (CGPL) was founded in 1922 to provide paraclinical analyses to the primary health-care sector in Copenhagen. At the end of 2015, CGPL was closed and the CopLab database was established to make CGPL data available for research. Methods: We isolated tests performed at the CGPL with clinically relevant test results. The database was linked to national registers containing health, social, and demographic information. Results are presented with descriptive statistics showing counts, percentages, medians, and interquartile ranges (IQR). Results: The CopLab database includes 1,373,643 unique individuals from primary care with test results from laboratory analyses of blood/urine/semen as well as cardiac and lung function tests collected by CGPL from greater Copenhagen from 2000 to 2015. The CopLab database holds nearly all test results requested by general practitioners throughout years 2000 to 2015 for residents in the greater Copenhagen area. The median age of the individuals was 51 years and 59.7% were females. Each individual has a median of 4 requisitions. More than 1 million participants are currently alive and living in Denmark and may be followed in national registries such as the Danish National Patient Registry, Laboratory Database, National Prescription Database etc.
背景：哥本哈根全科实验室（Copenhagen General Practice Laboratory，CGPL）成立于1922年，为哥本哈根的初级医疗保健部门提供准临床分析。2015 年底，CGPL 关闭，CopLab 数据库建立，CGPL 数据可供研究使用：我们分离了在CGPL进行的具有临床相关检验结果的检验。该数据库与包含健康、社会和人口信息的国家登记册相链接。结果显示了描述性统计数字，包括计数、百分比、中位数和四分位数间距（IQR）：CopLab数据库包括1,373,643名来自基层医疗机构的独特个体，他们的检测结果来自CGPL从2000年至2015年在大哥本哈根地区收集的血液/尿液/精液实验室分析以及心脏和肺功能检测。CopLab 数据库收录了 2000 年至 2015 年期间全科医生为大哥本哈根地区居民申请的几乎所有检验结果。这些人的年龄中位数为 51 岁，59.7% 为女性。每个人的申请次数中位数为 4 次。目前有 100 多万名参与者在丹麦生活和居住，并可在丹麦国家患者登记处、实验室数据库、国家处方数据库等国家登记处进行跟踪。
{"title":"The Copenhagen Primary Care Laboratory (CopLab) Database","authors":"Margit Kriegbaum, Bent Struer Lind, Mia Klinten Grand, Christen Lykkegaard Andersen","doi":"10.2147/clep.s437123","DOIUrl":"https://doi.org/10.2147/clep.s437123","url":null,"abstract":"<strong>Background:</strong> The Copenhagen General Practice Laboratory (CGPL) was founded in 1922 to provide paraclinical analyses to the primary health-care sector in Copenhagen. At the end of 2015, CGPL was closed and the CopLab database was established to make CGPL data available for research.<br/><strong>Methods:</strong> We isolated tests performed at the CGPL with clinically relevant test results. The database was linked to national registers containing health, social, and demographic information. Results are presented with descriptive statistics showing counts, percentages, medians, and interquartile ranges (IQR).<br/><strong>Results:</strong> The CopLab database includes 1,373,643 unique individuals from primary care with test results from laboratory analyses of blood/urine/semen as well as cardiac and lung function tests collected by CGPL from greater Copenhagen from 2000 to 2015. The CopLab database holds nearly all test results requested by general practitioners throughout years 2000 to 2015 for residents in the greater Copenhagen area. The median age of the individuals was 51 years and 59.7% were females. Each individual has a median of 4 requisitions. More than 1 million participants are currently alive and living in Denmark and may be followed in national registries such as the Danish National Patient Registry, Laboratory Database, National Prescription Database etc.<br/><br/>","PeriodicalId":10362,"journal":{"name":"Clinical Epidemiology","volume":null,"pages":null},"PeriodicalIF":3.9,"publicationDate":"2024-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140002054","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}
Background and Aims: Cholelithiasis etiology intricately involves lipid metabolism. We sought to investigate the plausible causal link between genetically proxied lipid-lowering medications—specifically HMGCR inhibitors, PCSK9 inhibitors, and NPC1L1 inhibitors—and cholelithiasis risk. Methods: Our study utilized two genetic instruments for exposure to lipid-lowering drugs. These instruments encompassed genetic variants linked to low-density lipoprotein (LDL) cholesterol within or in proximity to drug target genes, along with loci governing gene expression traits of these targets. Effect estimates were derived through Inverse-variance-weighted MR (IVW-MR) and summary-data-based MR (SMR) methods. Results: Higher HMGCR-mediated LDL cholesterol levels (IVW-MR, OR = 2.15, 95% CI = 1.58– 2.94; P = 0.000) and increased HMGCR expression (SMR, OR = 1.19, 95% CI = 1.04– 1.37; P = 0.014) are linked to elevated cholelithiasis risk, suggesting potential benefits of HMGCR inhibition. In contrast, higher PCSK9-mediated LDL cholesterol levels (IVW-MR, OR = 0.72, 95% CI = 0.56– 0.94; P = 0.015) and increased PCSK9 expression (SMR, OR = 0.90, 95% CI = 0.82– 0.99; P = 0.035) both correlate with lower cholelithiasis risk, indicating that PCSK9 inhibition may elevate this risk. Nevertheless, no substantial link emerged between NPC1L1-mediated LDL cholesterol or NPC1L1 expression and cholelithiasis in both IVW-MR and SMR analyses. Conclusion: This MR investigation affirms the causal link between the utilization of HMGCR inhibitors and a diminished risk of cholelithiasis. Additionally, it indicates a causal link between PCSK9 inhibitors use and increased cholelithiasis risk. However, no significant correlation was found between NPC1L1 inhibitors use and cholelithiasis risk.
{"title":"Can Lipid-Lowering Drugs Reduce the Risk of Cholelithiasis? A Mendelian Randomization Study","authors":"Hao Dong, Rong Chen, Fang Xu, Fang Cheng","doi":"10.2147/clep.s439642","DOIUrl":"https://doi.org/10.2147/clep.s439642","url":null,"abstract":"<strong>Background and Aims:</strong> Cholelithiasis etiology intricately involves lipid metabolism. We sought to investigate the plausible causal link between genetically proxied lipid-lowering medications—specifically HMGCR inhibitors, PCSK9 inhibitors, and NPC1L1 inhibitors—and cholelithiasis risk.<br/><strong>Methods:</strong> Our study utilized two genetic instruments for exposure to lipid-lowering drugs. These instruments encompassed genetic variants linked to low-density lipoprotein (LDL) cholesterol within or in proximity to drug target genes, along with loci governing gene expression traits of these targets. Effect estimates were derived through Inverse-variance-weighted MR (IVW-MR) and summary-data-based MR (SMR) methods.<br/><strong>Results:</strong> Higher HMGCR-mediated LDL cholesterol levels (IVW-MR, OR = 2.15, 95% CI = 1.58– 2.94; <em>P</em> = 0.000) and increased HMGCR expression (SMR, OR = 1.19, 95% CI = 1.04– 1.37; <em>P</em> = 0.014) are linked to elevated cholelithiasis risk, suggesting potential benefits of HMGCR inhibition. In contrast, higher PCSK9-mediated LDL cholesterol levels (IVW-MR, OR = 0.72, 95% CI = 0.56– 0.94; <em>P</em> = 0.015) and increased PCSK9 expression (SMR, OR = 0.90, 95% CI = 0.82– 0.99; <em>P</em> = 0.035) both correlate with lower cholelithiasis risk, indicating that PCSK9 inhibition may elevate this risk. Nevertheless, no substantial link emerged between NPC1L1-mediated LDL cholesterol or NPC1L1 expression and cholelithiasis in both IVW-MR and SMR analyses.<br/><strong>Conclusion:</strong> This MR investigation affirms the causal link between the utilization of HMGCR inhibitors and a diminished risk of cholelithiasis. Additionally, it indicates a causal link between PCSK9 inhibitors use and increased cholelithiasis risk. However, no significant correlation was found between NPC1L1 inhibitors use and cholelithiasis risk.<br/><br/><strong>Keywords:</strong> cholelithiasis, lipid-lowering drugs, Mendelian randomization analysis, HMGCR inhibitors, PCSK9 inhibitors, NPC1L1 inhibitors<br/>","PeriodicalId":10362,"journal":{"name":"Clinical Epidemiology","volume":null,"pages":null},"PeriodicalIF":3.9,"publicationDate":"2024-02-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139923753","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}
Tim Bothe, Anne-Katrin Fietz, Elke Schaeffner, Antonios Douros, Anna Pöhlmann, Nina Mielke, Cédric Villain, Muhammad Helmi Barghouth, Volker Wenning, Natalie Ebert
Purpose: The validity of ICD-10 diagnostic codes for chronic kidney disease (CKD) in health claims data has not been sufficiently studied in the general population and over time. Patients and Methods: We used data from the Berlin Initiative Study (BIS), a prospective longitudinal cohort of community-dwelling individuals aged ≥ 70 years in Berlin, Germany. With estimated glomerular filtration rate (eGFR) as reference, we assessed the diagnostic validity (sensitivity, specificity, positive [PPV], and negative predictive values [NPV]) of different claims-based ICD-10 codes for CKD stages G3-5 (eGFR < 60mL/min/1.73m²: ICD-10 N18.x-N19), G3 (eGFR 30–< 60mL/min/1.73m²: N18.3), and G4-5 (eGFR < 30mL/min/1.73m²: N18.4– 5). We analysed trends over five study visits (2009– 2019). Results: We included data of 2068 participants at baseline (2009– 2011) and 870 at follow-up 4 (2018– 2019), of whom 784 (38.9%) and 440 (50.6%) had CKD G3-5, respectively. At baseline, sensitivity for CKD in claims data ranged from 0.25 (95%-confidence interval [CI] 0.22– 0.28) to 0.51 (95%-CI 0.48– 0.55) for G3-5, depending on the included ICD-10 codes, 0.20 (95%-CI 0.18– 0.24) for G3, and 0.36 (95%-CI 0.25– 0.49) for G4-5. Over the course of 10 years, sensitivity increased by 0.17 to 0.29 in all groups. Specificity, PPVs, and NPVs remained mostly stable over time and ranged from 0.82– 0.99, 0.47– 0.89, and 0.66– 0.98 across all study visits, respectively. Conclusion: German claims data showed overall agreeable performance in identifying older adults with CKD, while differentiation between stages was limited. Our results suggest increasing sensitivity over time possibly attributable to improved CKD diagnosis and awareness.
Keywords: CKD, diagnostic validity, health claims data, sensitivity, specificity
{"title":"Diagnostic Validity of Chronic Kidney Disease in Health Claims Data Over Time: Results from a Cohort of Community-Dwelling Older Adults in Germany","authors":"Tim Bothe, Anne-Katrin Fietz, Elke Schaeffner, Antonios Douros, Anna Pöhlmann, Nina Mielke, Cédric Villain, Muhammad Helmi Barghouth, Volker Wenning, Natalie Ebert","doi":"10.2147/clep.s438096","DOIUrl":"https://doi.org/10.2147/clep.s438096","url":null,"abstract":"<strong>Purpose:</strong> The validity of ICD-10 diagnostic codes for chronic kidney disease (CKD) in health claims data has not been sufficiently studied in the general population and over time.<br/><strong>Patients and Methods:</strong> We used data from the Berlin Initiative Study (BIS), a prospective longitudinal cohort of community-dwelling individuals aged ≥ 70 years in Berlin, Germany. With estimated glomerular filtration rate (eGFR) as reference, we assessed the diagnostic validity (sensitivity, specificity, positive [PPV], and negative predictive values [NPV]) of different claims-based ICD-10 codes for CKD stages G3-5 (eGFR < 60mL/min/1.73m²: ICD-10 N18.x-N19), G3 (eGFR 30–< 60mL/min/1.73m²: N18.3), and G4-5 (eGFR < 30mL/min/1.73m²: N18.4– 5). We analysed trends over five study visits (2009– 2019).<br/><strong>Results:</strong> We included data of 2068 participants at baseline (2009– 2011) and 870 at follow-up 4 (2018– 2019), of whom 784 (38.9%) and 440 (50.6%) had CKD G3-5, respectively. At baseline, sensitivity for CKD in claims data ranged from 0.25 (95%-confidence interval [CI] 0.22– 0.28) to 0.51 (95%-CI 0.48– 0.55) for G3-5, depending on the included ICD-10 codes, 0.20 (95%-CI 0.18– 0.24) for G3, and 0.36 (95%-CI 0.25– 0.49) for G4-5. Over the course of 10 years, sensitivity increased by 0.17 to 0.29 in all groups. Specificity, PPVs, and NPVs remained mostly stable over time and ranged from 0.82– 0.99, 0.47– 0.89, and 0.66– 0.98 across all study visits, respectively.<br/><strong>Conclusion:</strong> German claims data showed overall agreeable performance in identifying older adults with CKD, while differentiation between stages was limited. Our results suggest increasing sensitivity over time possibly attributable to improved CKD diagnosis and awareness.<br/><br/><strong>Keywords:</strong> CKD, diagnostic validity, health claims data, sensitivity, specificity<br/>","PeriodicalId":10362,"journal":{"name":"Clinical Epidemiology","volume":null,"pages":null},"PeriodicalIF":3.9,"publicationDate":"2024-02-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139923687","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}
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