Pub Date : 2024-06-27eCollection Date: 2024-01-01DOI: 10.2147/CLEP.S463571
Nadia R Gadgaard, Katalin Veres, Victor W Henderson, Alma B Pedersen
Background: Frozen shoulder may be an early preclinical symptom of Parkinson's disease (PD).
Objective: To examine PD risk after frozen shoulder diagnosis and to evaluate this disorder as a possible manifestation of parkinsonism preceding the clinical recognition of PD and possible target for screening.
Methods: Danish population-based medical registries were used to identify patients aged ≥40 years with a first-time frozen shoulder diagnosis (1995-2016). A comparison cohort was randomly selected from the general population matched on age and sex. To address detection bias and the specificity of frozen shoulder diagnosis, we performed a sensitivity analysis, using similar matching criteria to select a cohort of patients with back pain diagnosis. The outcome was incident PD. Cumulative incidences and adjusted hazard ratios (HRs) were estimated with 95% confidence intervals (CIs).
Results: We identified 37,041 individuals with frozen shoulder, 370,410 general population comparators, and 111,101 back pain comparators. The cumulative incidence of PD at 0-22 years follow-up was 1.51% in the frozen shoulder cohort, 1.03% in the general population cohort, and 1.32% in the back pain cohort. For frozen shoulder versus general population, adjusted HRs were 1.94 (CI: 1.20-3.13) at 0-1 years and 1.45 (CI: 1.24-1.70) at 0-22 years follow-up. For frozen shoulder versus back pain, adjusted HRs were 0.89 (CI: 0.54-1.46) and 1.01 (CI: 0.84-1.21), respectively.
Conclusion: Patients with frozen shoulder had an increased PD risk compared with the general population, although the absolute risks were low. Frozen shoulder might sometimes represent early manifestations of PD. Detection bias probably cannot account for the increased PD risk during the long-term follow-up.
{"title":"Frozen Shoulder and the Risk of Parkinson's Disease: A Danish Registry-Based Cohort Study.","authors":"Nadia R Gadgaard, Katalin Veres, Victor W Henderson, Alma B Pedersen","doi":"10.2147/CLEP.S463571","DOIUrl":"10.2147/CLEP.S463571","url":null,"abstract":"<p><strong>Background: </strong>Frozen shoulder may be an early preclinical symptom of Parkinson's disease (PD).</p><p><strong>Objective: </strong>To examine PD risk after frozen shoulder diagnosis and to evaluate this disorder as a possible manifestation of parkinsonism preceding the clinical recognition of PD and possible target for screening.</p><p><strong>Methods: </strong>Danish population-based medical registries were used to identify patients aged ≥40 years with a first-time frozen shoulder diagnosis (1995-2016). A comparison cohort was randomly selected from the general population matched on age and sex. To address detection bias and the specificity of frozen shoulder diagnosis, we performed a sensitivity analysis, using similar matching criteria to select a cohort of patients with back pain diagnosis. The outcome was incident PD. Cumulative incidences and adjusted hazard ratios (HRs) were estimated with 95% confidence intervals (CIs).</p><p><strong>Results: </strong>We identified 37,041 individuals with frozen shoulder, 370,410 general population comparators, and 111,101 back pain comparators. The cumulative incidence of PD at 0-22 years follow-up was 1.51% in the frozen shoulder cohort, 1.03% in the general population cohort, and 1.32% in the back pain cohort. For frozen shoulder versus general population, adjusted HRs were 1.94 (CI: 1.20-3.13) at 0-1 years and 1.45 (CI: 1.24-1.70) at 0-22 years follow-up. For frozen shoulder versus back pain, adjusted HRs were 0.89 (CI: 0.54-1.46) and 1.01 (CI: 0.84-1.21), respectively.</p><p><strong>Conclusion: </strong>Patients with frozen shoulder had an increased PD risk compared with the general population, although the absolute risks were low. Frozen shoulder might sometimes represent early manifestations of PD. Detection bias probably cannot account for the increased PD risk during the long-term follow-up.</p>","PeriodicalId":10362,"journal":{"name":"Clinical Epidemiology","volume":"16 ","pages":"447-459"},"PeriodicalIF":3.4,"publicationDate":"2024-06-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11216321/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141476070","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}
Pub Date : 2024-06-26eCollection Date: 2024-01-01DOI: 10.2147/CLEP.S482719
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
{"title":"Comment on \"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\". [Response to Letter].","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.S482719","DOIUrl":"10.2147/CLEP.S482719","url":null,"abstract":"","PeriodicalId":10362,"journal":{"name":"Clinical Epidemiology","volume":"16 ","pages":"445-446"},"PeriodicalIF":3.4,"publicationDate":"2024-06-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11214794/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141474635","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}
Pub Date : 2024-06-24eCollection Date: 2024-01-01DOI: 10.2147/CLEP.S463499
Georgie M Massen, Hannah R Whittaker, Sarah Cook, Gisli Jenkins, Richard J Allen, Louise V Wain, Iain Stewart, Jennifer K Quint
Background: Electronic healthcare records (EHRs) are used to document diagnoses, symptoms, tests, and prescriptions. Though not primarily collected for research purposes, owing to the size of the data as well as the depth of information collected, they have been used extensively to conduct epidemiological research. The Clinical Practice Research Datalink (CPRD) is an EHR database containing representative data of the UK population with regard to age, sex, race, and social deprivation measures. Fibrotic conditions are characterised by excessive scarring, contributing towards organ dysfunction and eventual organ failure. Fibrosis is associated with ageing as well as many other factors, it is hypothesised that fibrotic conditions are caused by the same underlying pathological mechanism. We calculated the prevalence of fibrotic conditions (as defined in a previous Delphi survey of clinicians) as well as the prevalence of fibrotic multimorbidity (the proportion of people with multiple fibrotic conditions).
Methods: We included a random sample of 993,370 UK adults, alive, and enrolled at a UK general practice, providing data to the CPRD Aurum database as of 1st of January 2015. Individuals had to be eligible for linkage to hospital episode statistics (HES) and ONS death registration. We calculated the point prevalence of fibrotic conditions and multi-morbid fibrosis on the 1st of January 2015. Using death records of those who died in 2015, we investigated the prevalence of fibrosis associated death. We explored the most commonly co-occurring fibrotic conditions and determined the settings in which diagnoses were commonly made (primary care, secondary care or after death).
Results: The point prevalence of any fibrotic condition was 21.46%. In total, 6.00% of people had fibrotic multimorbidity. Of the people who died in 2015, 34.82% had a recording of a fibrotic condition listed on their death certificate.
Conclusion: The key finding was that fibrotic multimorbidity affects approximately 1 in 16 people.
{"title":"Using Routinely Collected Electronic Healthcare Record Data to Investigate Fibrotic Multimorbidity in England.","authors":"Georgie M Massen, Hannah R Whittaker, Sarah Cook, Gisli Jenkins, Richard J Allen, Louise V Wain, Iain Stewart, Jennifer K Quint","doi":"10.2147/CLEP.S463499","DOIUrl":"10.2147/CLEP.S463499","url":null,"abstract":"<p><strong>Background: </strong>Electronic healthcare records (EHRs) are used to document diagnoses, symptoms, tests, and prescriptions. Though not primarily collected for research purposes, owing to the size of the data as well as the depth of information collected, they have been used extensively to conduct epidemiological research. The Clinical Practice Research Datalink (CPRD) is an EHR database containing representative data of the UK population with regard to age, sex, race, and social deprivation measures. Fibrotic conditions are characterised by excessive scarring, contributing towards organ dysfunction and eventual organ failure. Fibrosis is associated with ageing as well as many other factors, it is hypothesised that fibrotic conditions are caused by the same underlying pathological mechanism. We calculated the prevalence of fibrotic conditions (as defined in a previous Delphi survey of clinicians) as well as the prevalence of fibrotic multimorbidity (the proportion of people with multiple fibrotic conditions).</p><p><strong>Methods: </strong>We included a random sample of 993,370 UK adults, alive, and enrolled at a UK general practice, providing data to the CPRD Aurum database as of 1st of January 2015. Individuals had to be eligible for linkage to hospital episode statistics (HES) and ONS death registration. We calculated the point prevalence of fibrotic conditions and multi-morbid fibrosis on the 1st of January 2015. Using death records of those who died in 2015, we investigated the prevalence of fibrosis associated death. We explored the most commonly co-occurring fibrotic conditions and determined the settings in which diagnoses were commonly made (primary care, secondary care or after death).</p><p><strong>Results: </strong>The point prevalence of any fibrotic condition was 21.46%. In total, 6.00% of people had fibrotic multimorbidity. Of the people who died in 2015, 34.82% had a recording of a fibrotic condition listed on their death certificate.</p><p><strong>Conclusion: </strong>The key finding was that fibrotic multimorbidity affects approximately 1 in 16 people.</p>","PeriodicalId":10362,"journal":{"name":"Clinical Epidemiology","volume":"16 ","pages":"433-443"},"PeriodicalIF":3.4,"publicationDate":"2024-06-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11215821/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141476071","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}
Pub Date : 2024-06-11eCollection Date: 2024-01-01DOI: 10.2147/CLEP.S463160
Nicola L Barclay, Theresa Burkard, Edward Burn, Antonella Delmestri, Andrea Miquel Dominguez, Asieh Golozar, Carlos Guarner-Argente, Francesc Xavier Avilés-Jurado, Wai Yi Man, Àlvar Roselló Serrano, Andreas Weinberger Rosen, Eng Hooi Tan, Ilona Tietzova, Daniel Prieto Alhambra, Danielle Newby
Purpose: The COVID-19 pandemic profoundly affected healthcare systems and patients. There is a need to comprehend the collateral effects of the pandemic on non-communicable diseases. We examined the impact of the pandemic on short-term survival for common solid tumours, including breast, colorectal, head and neck, liver, lung, oesophageal, pancreatic, prostate, and stomach cancer in the UK.
Methods: This was a population-based cohort study of electronic health records from the UK primary care Clinical Practice Research Datalink GOLD database. In sum, 12,259,744 eligible patients aged ≥18 years with ≥1 year's history identified from January 2000 to December 2022 were included. We estimated age-standardised incidence and short-term (one- and two-year) survival for several common cancers from 2000 to 2019 (in five-year strata) and compared these to 2020-2022 using the Kaplan-Meier method.
Results: Incidence decreased for most cancers in 2020 and recovered to different extents in 2021-2022. Short-term survival improved for most cancers between 2000 and 2019, but then declined, albeit minimally, for those diagnosed in 2020-2022. This was most pronounced for colorectal cancer, with one-year survival falling from 78.8% (95% CI 78%-79.6%) in 2015-2019 to 77% (95% CI 75.6-78.3%) for those diagnosed in 2020-2022.
Conclusion: Short-term survival for many cancers was impacted, albeit minimally, by the pandemic in the UK, with reductions in survivorship from colorectal cancer equivalent to returning to the mortality seen in the first decade of the 2000s. While data on longer-term survival are needed to fully comprehend the impact of COVID-19 on cancer care, our findings illustrate the need for an urgent and substantial commitment from the UK National Health Service to address the existing backlog in cancer screening and diagnostic procedures to improve cancer care and mortality.
{"title":"The Impact of the COVID-19 Pandemic on Incidence and Short-Term Survival for Common Solid Tumours in the United Kingdom: A Cohort Analysis.","authors":"Nicola L Barclay, Theresa Burkard, Edward Burn, Antonella Delmestri, Andrea Miquel Dominguez, Asieh Golozar, Carlos Guarner-Argente, Francesc Xavier Avilés-Jurado, Wai Yi Man, Àlvar Roselló Serrano, Andreas Weinberger Rosen, Eng Hooi Tan, Ilona Tietzova, Daniel Prieto Alhambra, Danielle Newby","doi":"10.2147/CLEP.S463160","DOIUrl":"10.2147/CLEP.S463160","url":null,"abstract":"<p><strong>Purpose: </strong>The COVID-19 pandemic profoundly affected healthcare systems and patients. There is a need to comprehend the collateral effects of the pandemic on non-communicable diseases. We examined the impact of the pandemic on short-term survival for common solid tumours, including breast, colorectal, head and neck, liver, lung, oesophageal, pancreatic, prostate, and stomach cancer in the UK.</p><p><strong>Methods: </strong>This was a population-based cohort study of electronic health records from the UK primary care Clinical Practice Research Datalink GOLD database. In sum, 12,259,744 eligible patients aged ≥18 years with ≥1 year's history identified from January 2000 to December 2022 were included. We estimated age-standardised incidence and short-term (one- and two-year) survival for several common cancers from 2000 to 2019 (in five-year strata) and compared these to 2020-2022 using the Kaplan-Meier method.</p><p><strong>Results: </strong>Incidence decreased for most cancers in 2020 and recovered to different extents in 2021-2022. Short-term survival improved for most cancers between 2000 and 2019, but then declined, albeit minimally, for those diagnosed in 2020-2022. This was most pronounced for colorectal cancer, with one-year survival falling from 78.8% (95% CI 78%-79.6%) in 2015-2019 to 77% (95% CI 75.6-78.3%) for those diagnosed in 2020-2022.</p><p><strong>Conclusion: </strong>Short-term survival for many cancers was impacted, albeit minimally, by the pandemic in the UK, with reductions in survivorship from colorectal cancer equivalent to returning to the mortality seen in the first decade of the 2000s. While data on longer-term survival are needed to fully comprehend the impact of COVID-19 on cancer care, our findings illustrate the need for an urgent and substantial commitment from the UK National Health Service to address the existing backlog in cancer screening and diagnostic procedures to improve cancer care and mortality.</p>","PeriodicalId":10362,"journal":{"name":"Clinical Epidemiology","volume":"16 ","pages":"417-429"},"PeriodicalIF":3.9,"publicationDate":"2024-06-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11179647/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141330507","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}
Pub Date : 2024-06-06eCollection Date: 2024-01-01DOI: 10.2147/CLEP.S458661
Lotte Sahin Levison, Peter Jepsen, Henning Andersen
Purpose: 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).
Patients and methods: 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.
Results: 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).
Conclusion: 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.
目的:如果诊断代码有效,医疗保健数据库是肌萎缩性脊髓侧索硬化症(ALS)流行病学研究的重要来源。我们评估了丹麦全国患者登记处(DNPR)中 ALS 诊断代码的有效性:我们从 DNPR 中获得了 1987 年至 2022 年期间丹麦所有登记的 ALS 成人患者(大于 17 岁)的数据(研究期间的中位人口为 420 万)。我们随机选取了居住在北丹麦大区和中丹麦大区(中位数人口为 140 万)的成年患者,他们的主要出院诊断代码为 ALS,并在三个神经内科确诊。我们检索并审查了医疗记录,估算了 ALS 诊断的阳性预测值 (PPV):36 年间,我们共发现了 5679 名患者。从 300 名患者的验证队列中,我们检索到 240 份(80%)病历,确诊了 215 例 ALS 患者。总体阳性预测值为 89.6%(95% 置信区间 (CI):85.1-92.8)。与年龄≥70 岁的患者相比,年龄≥70 岁患者登记的诊断 PPV 最高(93.8;95% CI:86.2-97.3):我们发现丹麦神经内科对 ALS 的主要诊断代码具有很高的 PPV 值,显示出很高的有效性。因此,DNPR 是 ALS 大规模流行病学研究的理想数据源。
{"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":"16 ","pages":"409-415"},"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}
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
<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
目的:本研究旨在开发和验证一种 META 算法,该算法结合了针对个别免疫介导炎症性疾病(IMID)的算法,可从意大利 VALORE 项目的理赔数据中识别出生物药使用者的确切 IMID 适应症:从意大利拉齐姆大区的理赔数据库(观察期:2010-2020 年)中确定了所有至少配发过一次 TNF-α 抑制剂、抗白细胞介素制剂和经批准用于 IMID 的选择性免疫抑制剂的受试者。从已发表的文献中找到了用于从索赔数据库中识别单个 IMID 的经过验证的编码算法,并将其合并为 META 算法。以拉齐奥地区的电子治疗计划(ETPs)为参考标准,对每个适应症的阳性预测值(PPV)、灵敏度(Se)、阴性预测值(NPV)、特异性(Sp)和准确性(Acc)进行了估算。最后,将各生物药的使用适应症频率与意大利其他三个大区(伦巴第大区、阿普利亚大区和威尼托大区)报告的频率进行了比较:结果:总共发现了 9755 名具有单一 IMID 适应症的生物药使用者。使用新开发的 META 算法,在全部人群中,95%(n=9255)的人检测到了使用指征。与参考标准相比,估计的Acc、Se、Sp、PPV和NPV如下:克罗恩病为 0.96、0.86、0.97、0.82 和 0.98,溃疡性结肠炎为 0.96、0.80、0.98、0.85 和 0.97,类风湿性关节炎为 0.93、0.76、0.99、0.95 和 0.92。类风湿性关节炎分别为 0.93、0.76、0.99、0.95 和 0.92,脊柱关节炎分别为 0.97、0.75、0.99、0.85 和 0.98,银屑病关节炎/银屑病分别为 0.91、0.92、0.91、0.88 和 0.94。此外,拉齐奥大区和研究中的其他三个意大利大区在按有效成分划分的使用适应症频率方面没有发现实质性差异:新开发的 META 算法在意大利索赔数据中显示出较高的有效性估计值,并能以良好的性能区分最常见的 IMID 适应症。本研究旨在开发并验证一种 META 算法,该算法能准确识别治疗各种免疫介导炎症性疾病的生物药物的确切适应症。利用拉齐奥地区的报销数据库,我们开发并验证了一种 META 算法。META 算法结合了针对不同免疫介导的炎症性疾病(即克罗恩病、溃疡性结肠炎、类风湿性关节炎、脊柱关节炎、银屑病和银屑病关节炎)的特定疾病算法,并与参考标准(拉齐奥地区的电子治疗计划)进行了测试。META算法报告了较高的有效性估计值,并能以良好的性能区分作为使用适应症的最常见IMID。在意大利环境下,应用该 META 算法可促进对 TNF-α 抑制剂、抗白细胞介素和选择性免疫抑制剂等生物药物在特定治疗领域的上市后监测。 关键词:免疫介导的炎症性疾病;生物药物;验证;索赔数据;META 算法;使用适应症
{"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":"72 1","pages":""},"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}
Oluwasolape Olawore, Lindsey E Turner, Michael D Evans, Steven G Johnson, Jared D Huling, Carolyn T Bramante, John B Buse, Til Stürmer
<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
{"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":"42 1","pages":""},"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}
Xicong Li, Yubiao Chen, Baiyun Liu, Mingyuan Ye, Bei Liu, Lifei Lu, Ruiwei Guo
Aim: 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. Methods: 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. Results: 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< 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< 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]. Conclusion: A high level of ePWV signified a higher risk of 5-year mortality in ASCVD patients with and without SMuRFs.
{"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< 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< 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":"1 1","pages":""},"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}
Søren Korsgaard, Frederikke Schønfeldt Troelsen, Katalin Veres, Cecilia Hvitfeldt Fuglsang, Henrik Toft Sørensen
Purpose: In the Danish National Patient Registry (DNPR), covering all Danish hospitals and widely used in research, diseases have been recorded using International Classification of Diseases (ICD) codes, transitioning from the Eighth to the Tenth revision 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. Patients and Methods: 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 (ie, the ICD-8 record would be left-truncated by not using ICD-8 codes), ICD-8 plus ICD-10 codes (ie, 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 (ie, 500,000 people) and the total number of people with the disease across all ICD groups. Results: 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 < 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. Conclusion: 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.
{"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 < 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":"20 1","pages":""},"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}
Mohab Basem, Kasper Bonnesen, Lars Pedersen, Henrik Toft Sørensen, Morten Schmidt
Aim: 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). Methods: 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 (< 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). Results: 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. Conclusion: 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.
{"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 (< 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":"12 1","pages":""},"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}