Lisbet Grønbæk, Harmony Omeife, Lu Ban, Colin J Crooks, Timothy R Card, Peter Jepsen, Joe West
{"title":"Smoking is a Risk Factor for Autoimmune Hepatitis: An English Registry-Based Case–Control Study","authors":"Lisbet Grønbæk, Harmony Omeife, Lu Ban, Colin J Crooks, Timothy R Card, Peter Jepsen, Joe West","doi":"10.2147/clep.s439219","DOIUrl":"https://doi.org/10.2147/clep.s439219","url":null,"abstract":"<strong>Purpose:</strong> Smoking is a risk factor for some autoimmune diseases, but its association with autoimmune hepatitis remains unknown. We conducted a population-based matched case–control study to examine the association between tobacco smoking and the risk of autoimmune hepatitis in England.<br/><strong>Patients and Methods:</strong> From the Clinical Practice Research Datalink and linked Hospital Episode Statistics, 2005– 2017, we included 987 cases diagnosed with autoimmune hepatitis after age 18 years and up to 10 frequency-matched population controls per case. We used multiple logistic regression to estimate the odds ratio of autoimmune hepatitis in ever-smokers vs never-smokers, adjusting for sex, age, general practice, calendar time of registration with the general practice, and socioeconomic status.<br/><strong>Results:</strong> The autoimmune hepatitis cases were more likely to be ever-smokers than the controls (44% vs 37%). The ever-smokers had an increased risk of autoimmune hepatitis compared with the never-smokers (adjusted odds ratio = 1.20, 95% confidence interval 1.03– 1.39).<br/><strong>Conclusion:</strong> Smoking was associated with an increased risk of autoimmune hepatitis.<br/><br/><strong>Plain Language Summary:</strong> Autoimmune hepatitis is a chronic liver disease associated with genetic variants and environmental exposures, but the causes of autoimmune hepatitis remain unknown. Using registry data, we evaluated the association between tobacco smoking and the risk for autoimmune hepatitis. We found that tobacco smoking was associated with an increased risk of autoimmune hepatitis.<br/><br/><strong>Keywords:</strong> epidemiology, chronic hepatitis, risk factors, tobacco<br/>","PeriodicalId":10362,"journal":{"name":"Clinical Epidemiology","volume":"59 1","pages":""},"PeriodicalIF":3.9,"publicationDate":"2024-01-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139587870","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}
Julie Barberio, Rohini K Hernandez, Ashley I Naimi, Rachel E Patzer, Christopher Kim, Timothy L Lash
{"title":"Characterizing Fit-for-Purpose Real-World Data: An Assessment of a Mother–Infant Linkage in the Japan Medical Data Center Claims Database","authors":"Julie Barberio, Rohini K Hernandez, Ashley I Naimi, Rachel E Patzer, Christopher Kim, Timothy L Lash","doi":"10.2147/clep.s429246","DOIUrl":"https://doi.org/10.2147/clep.s429246","url":null,"abstract":"<strong>Purpose:</strong> Observational postapproval safety studies are needed to inform medication safety during pregnancy. Real-world databases can be valuable for supporting such research, but fitness for regulatory purpose must first be vetted. Here, we demonstrate a fit-for-purpose assessment of the Japan Medical Data Center (JMDC) claims database for pregnancy safety regulatory decision-making.<br/><strong>Patients and Methods:</strong> The Duke-Margolis framework considers a database’s fitness for regulatory purpose based on relevancy (capacity to answer the research question based on variable availability and a sufficiently sized, representative population) and quality (ability to validly answer the research question based on data completeness and accuracy). To assess these considerations, we examined descriptive characteristics of infants and pregnancies among females ages 12– 55 years in the JMDC between January 2005 and March 2022.<br/><strong>Results:</strong> For relevancy, we determined that critical data fields (maternal medications, infant major congenital malformations, covariates) are available. Family identification codes permitted linkage of 385,295 total mother–infant pairs, 57% of which were continuously enrolled during pregnancy. The prevalence of specific congenital malformation subcategories and maternal medical conditions were representative of the general population, but preterm births were below expectations (3.6% versus 5.6%) in this population. For quality, our methods are expected to accurately identify the complete set of mothers and infants with a shared health insurance plan. However, validity of gestational age information was limited given the high proportion (60%) of missing live birth delivery codes coupled with suppression of infant birth dates and inaccessibility of disease codes with gestational week information.<br/><strong>Conclusion:</strong> The JMDC may be well suited for descriptive studies of pregnant people in Japan (eg, comorbidities, medication usage). More work is needed to identify a method to assign pregnancy onset and delivery dates so that in utero medication exposure windows can be defined more precisely as needed for many regulatory postapproval pregnancy safety studies.<br/><br/><strong>Keywords:</strong> routine health care data, international databases, database evaluation<br/>","PeriodicalId":10362,"journal":{"name":"Clinical Epidemiology","volume":"67 1","pages":""},"PeriodicalIF":3.9,"publicationDate":"2024-01-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139647582","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}
Anne-Marie Ellegaard, Martin L Kårhus, Filip K Knop, Line L Kårhus
{"title":"Author Response to Letter to the Editor regarding “the Epidemiology of Bile Acid Diarrhea in Denmark” [Response to Letter]","authors":"Anne-Marie Ellegaard, Martin L Kårhus, Filip K Knop, Line L Kårhus","doi":"10.2147/clep.s455103","DOIUrl":"https://doi.org/10.2147/clep.s455103","url":null,"abstract":"Response to Letter in regards to The Epidemiology of Bile Acid Diarrhea in Denmark [Letter]","PeriodicalId":10362,"journal":{"name":"Clinical Epidemiology","volume":"5 1","pages":""},"PeriodicalIF":3.9,"publicationDate":"2024-01-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139475033","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}
Martin L Kårhus, Anne-Marie Ellegaard, Filip K Knop, Line L Kårhus
{"title":"The Epidemiology of Bile Acid Diarrhea in Denmark [Response to Letter]","authors":"Martin L Kårhus, Anne-Marie Ellegaard, Filip K Knop, Line L Kårhus","doi":"10.2147/clep.s455102","DOIUrl":"https://doi.org/10.2147/clep.s455102","url":null,"abstract":"Response to Letter in regards to The Epidemiology of Bile Acid Diarrhea in Denmark [Letter]","PeriodicalId":10362,"journal":{"name":"Clinical Epidemiology","volume":"5 1","pages":""},"PeriodicalIF":3.9,"publicationDate":"2024-01-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139475080","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}
Jan P Vandenbroucke, Henrik Toft Sørensen, David H Rehkopf, Jaimie L Gradus, Johan P Mackenbach, M Maria Glymour, Sandro Galea, Victor W Henderson
{"title":"Report on the Joint Workshop on the Relations between Health Inequalities, Ageing and Multimorbidity, Iceland, May 3–4, 2023","authors":"Jan P Vandenbroucke, Henrik Toft Sørensen, David H Rehkopf, Jaimie L Gradus, Johan P Mackenbach, M Maria Glymour, Sandro Galea, Victor W Henderson","doi":"10.2147/clep.s443152","DOIUrl":"https://doi.org/10.2147/clep.s443152","url":null,"abstract":"<strong>Abstract:</strong> This paper is a summary of key presentations from a workshop in Iceland on May 3– 4, 2023 arranged by Aarhus University and with participation of the below-mentioned scientists.<br/>Below you will find the key messages from the presentations made by:Professor Jan Vandenbroucke, Department of Clinical Epidemiology, Aarhus University, Emeritus Professor, Leiden University; Honorary Professor, London School of Hygiene & Tropical Medicine, UKProfessor, Chair Henrik Toft Sørensen, Department of Clinical Epidemiology, Aarhus University and Aarhus University Hospital, DenmarkProfessor David H. Rehkopf, Director, the Stanford Center for Population Health Sciences, Stanford University, CA., USProfessor Jaimie Gradus, Department of Epidemiology, School of Public Health, Boston University, Boston, Massachusetts, USProfessor Johan Mackenbach, Emeritus Professor, Department of Public Health, Erasmus University Rotterdam, HollandProfessor, Chair M Maria Glymour, Department of Epidemiology, Boston University School of Public Health, Boston University, Boston, Massachusetts, USProfessor, Dean Sandro Galea, School of Public Health, Boston University, Boston, Massachusetts, USProfessor Victor W. Henderson, Departments of Epidemiology & Population Health and of Neurology & Neurological Sciences, Stanford University, Stanford, CA, US; Department of Clinical Epidemiology, Aarhus University, Aarhus, DK<br/><br/><strong>Keywords:</strong> Ageing, Multimorbidity, Social inequality<br/>","PeriodicalId":10362,"journal":{"name":"Clinical Epidemiology","volume":"30 1","pages":""},"PeriodicalIF":3.9,"publicationDate":"2024-01-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139474963","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}
Lars Frost, Albert Marni Joensen, Ulla Dam-Schmidt, Ina Qvist, Margit Brinck, Axel Brandes, Ulla Davidsen, Ole Dyg Pedersen, Dorte Damgaard, Inge Mølgaard, Robert Bedsted, Anders Damgaard Møller Schlünsen, Miriam Grijota Chousa, Julie Andersen, Asger Roer Pedersen, Søren Paaske Johnsen, Nicklas Vinter
{"title":"The Danish Atrial Fibrillation Registry: A Multidisciplinary National Pragmatic Initiative for Monitoring and Supporting Quality of Care Based on Data Retrieved from Administrative Registries","authors":"Lars Frost, Albert Marni Joensen, Ulla Dam-Schmidt, Ina Qvist, Margit Brinck, Axel Brandes, Ulla Davidsen, Ole Dyg Pedersen, Dorte Damgaard, Inge Mølgaard, Robert Bedsted, Anders Damgaard Møller Schlünsen, Miriam Grijota Chousa, Julie Andersen, Asger Roer Pedersen, Søren Paaske Johnsen, Nicklas Vinter","doi":"10.2147/clep.s443473","DOIUrl":"https://doi.org/10.2147/clep.s443473","url":null,"abstract":"<strong>Aim:</strong> The Danish Atrial Fibrillation (AF) Registry monitors and supports improvement of quality of care for all AF patients in Denmark. This report describes the registry’s administrative and organizational structure, data sources, data flow, data analyses, annual reporting, and feedback between the registry, clinicians, and the administrative system. We also report the selection process of the quality indicators and the temporal trends in results from 2017– 2021.<br/><strong>Methods and Results:</strong> The Danish AF Registry aims for complete registration and monitoring of care for all patients diagnosed with AF in Denmark. Administrative registries provide data on contacts to general practice, contacts to private cardiology practice, hospital contacts, medication prescriptions, updated vital status information, and biochemical test results. The Danish Stroke Registry provides information on stroke events. From 2017 to 2021, the proportion with a reported echocardiography among incident AF patients increased from 39.9% (95% CI: 39.3– 40.6) to 82.6% (95% CI: 82.1– 83.1). The initiation of oral anticoagulant therapy among patients with incident AF and a CHA<sub>2</sub>DS<sub>2</sub>-VASc score of ≥ 1 in men and ≥ 2 in women increased from 85.3% (95% CI: 84.6– 85.9) to 90.4% (95% CI: 89.9– 91.0). The 1-year and 2-year persistence increased from 85.2% (95% CI: 84.5– 85.9) to 88.7% (95% CI: 88.0– 89.3), and from 85.4% (95% CI: 84.7– 86.2) to 88.2% (95% CI: 87.5– 88.8), respectively. The 1-year risk of ischemic stroke among prevalent patients with AF decreased from 0.88% (95% CI: 0.83– 0.93) to 0.71% (95% CI: 0.66– 0.75). Variation in clinical performance between the five administrative Danish regions was reduced.<br/><strong>Conclusion:</strong> Continuous nationwide monitoring of quality indicators for AF originating from administrative registries is feasible and supportive of improvements of quality of care.<br/><br/><strong>Keywords:</strong> atrial fibrillation, quality indicators, quality of care<br/>","PeriodicalId":10362,"journal":{"name":"Clinical Epidemiology","volume":"10 1","pages":""},"PeriodicalIF":3.9,"publicationDate":"2023-12-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139030525","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":"Screening History and 7-Year Survival in 32,099 Colorectal Cancer Patients: A Population-Based Cohort Study [Response to Letter]","authors":"Bo-Yu Hsiao, Wen-Chung Lee","doi":"10.2147/clep.s453596","DOIUrl":"https://doi.org/10.2147/clep.s453596","url":null,"abstract":"<strong>","PeriodicalId":10362,"journal":{"name":"Clinical Epidemiology","volume":"199 1","pages":""},"PeriodicalIF":3.9,"publicationDate":"2023-12-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"138820834","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}
Daniel Hsiang-Te Tsai, J Simon Bell, Shahab Abtahi, Brenda N Baak, Marloes T Bazelier, Ruth Brauer, Adrienne YL Chan, Esther W Chan, Haoqian Chen, Celine SL Chui, Sharon Cook, Stephen Crystal, Poonam Gandhi, Sirpa Hartikainen, Frederick K Ho, Shao-Ti Hsu, Jenni Ilomäki, Ju Hwan Kim, Olaf H Klungel, Marjaana Koponen, Wallis CY Lau, Kui Kai Lau, Terry YS Lum, Hao Luo, Kenneth KC Man, Jill P Pell, Soko Setoguchi, Shih-Chieh Shao, Chin-Yao Shen, Ju-Young Shin, Patrick C Souverein, Anna-Maija Tolppanen, Li Wei, Ian CK Wong, Edward Chia-Cheng Lai
{"title":"Cross-Regional Data Initiative for the Assessment and Development of Treatment for Neurological and Mental Disorders","authors":"Daniel Hsiang-Te Tsai, J Simon Bell, Shahab Abtahi, Brenda N Baak, Marloes T Bazelier, Ruth Brauer, Adrienne YL Chan, Esther W Chan, Haoqian Chen, Celine SL Chui, Sharon Cook, Stephen Crystal, Poonam Gandhi, Sirpa Hartikainen, Frederick K Ho, Shao-Ti Hsu, Jenni Ilomäki, Ju Hwan Kim, Olaf H Klungel, Marjaana Koponen, Wallis CY Lau, Kui Kai Lau, Terry YS Lum, Hao Luo, Kenneth KC Man, Jill P Pell, Soko Setoguchi, Shih-Chieh Shao, Chin-Yao Shen, Ju-Young Shin, Patrick C Souverein, Anna-Maija Tolppanen, Li Wei, Ian CK Wong, Edward Chia-Cheng Lai","doi":"10.2147/clep.s426485","DOIUrl":"https://doi.org/10.2147/clep.s426485","url":null,"abstract":"<strong>Purpose:</strong> To describe and categorize detailed components of databases in the Neurological and Mental Health Global Epidemiology Network (NeuroGEN).<br/><strong>Methods:</strong> An online 132-item questionnaire was sent to key researchers and data custodians of NeuroGEN in North America, Europe, Asia and Oceania. From the responses, we assessed data characteristics including population coverage, data follow-up, clinical information, validity of diagnoses, medication use and data latency. We also evaluated the possibility of conversion into a common data model (CDM) to implement a federated network approach. Moreover, we used radar charts to visualize the data capacity assessments, based on different perspectives.<br/><strong>Results:</strong> The results indicated that the 15 databases covered approximately 320 million individuals, included in 7 nationwide claims databases from Australia, Finland, South Korea, Taiwan and the US, 6 population-based electronic health record databases from Hong Kong, Scotland, Taiwan, the Netherlands and the UK, and 2 biomedical databases from Taiwan and the UK.<br/><strong>Conclusion:</strong> The 15 databases showed good potential for a federated network approach using a common data model. Our study provided publicly accessible information on these databases for those seeking to employ real-world data to facilitate current assessment and future development of treatments for neurological and mental disorders.<br/><br/><strong>Keywords:</strong> meta-data, data repository, Neurological and Mental Health Global Epidemiology Network, NeuroGEN<br/>","PeriodicalId":10362,"journal":{"name":"Clinical Epidemiology","volume":"16 1","pages":""},"PeriodicalIF":3.9,"publicationDate":"2023-12-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"138821226","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}
Henrik Toft Sørensen, Tina Christensen, Hans Erik Bøtker, Christian Fynbo Christiansen, Cecilia H Fuglsang, Sigrid B Gribsholt, Frederik Pagh Bredahl Kristensen, Kristina Laugesen, Anne Sofie D Laursen, Mette Nørgaard, Morten Schmidt, Nils Skajaa, Frederikke S Troelsen, Lars Pedersen
{"title":"Cohort Profile: Better Health in Late Life","authors":"Henrik Toft Sørensen, Tina Christensen, Hans Erik Bøtker, Christian Fynbo Christiansen, Cecilia H Fuglsang, Sigrid B Gribsholt, Frederik Pagh Bredahl Kristensen, Kristina Laugesen, Anne Sofie D Laursen, Mette Nørgaard, Morten Schmidt, Nils Skajaa, Frederikke S Troelsen, Lars Pedersen","doi":"10.2147/clep.s436617","DOIUrl":"https://doi.org/10.2147/clep.s436617","url":null,"abstract":"<strong>Purpose:</strong> Humans are living longer and may develop multiple chronic diseases in later life. The Better Health in Late Life cohort study aims to improve our understanding of the risks and outcomes of multimorbidity in the Danish population.<br/><strong>Methods:</strong> A randomly-selected sample of Danish residents who were 50– 65 years of age received a questionnaire and an invitation to participate in this study. Respondents completed an online survey between October 2021 and January 2022 which addressed topics that included self-assessed health, mental health, sleep, specific medical conditions, use of painkillers, diet, alcohol consumption, smoking, physical activity, and body composition. This information was linked to the Danish health and social registries (some established in 1943 and onwards) that maintain data on filled prescriptions, hospital records, socioeconomic status, and health care utilization.<br/><strong>Results:</strong> Responses were received from 115,431 of the 301,244 residents invited to participate (38%). We excluded respondents who answered none of the questions as well as those who provided no information on sex or indicated an age other than 50– 65 years. Of the 114,283 eligible respondents, 54.8% were female, 30.3% were overweight, and 16.7% were obese. Most participants reported a weekly alcohol consumption of less than seven units and 13.3% were current smokers; 5.2% had a history of hospitalization for solid cancer, and 3.0%, 2.3%, 2.0%, and 0.9% reported chronic pulmonary disease, diabetes, stroke, and myocardial infarction, respectively. The most frequently filled prescriptions were for medications used to treat the nervous system and cardiovascular diseases (38.1% and 37.4%, respectively).<br/><br/><strong>Keywords:</strong> aging, epidemiology, health registries, life course epidemiology, multimorbidity, prospective cohort<br/>","PeriodicalId":10362,"journal":{"name":"Clinical Epidemiology","volume":"73 1","pages":""},"PeriodicalIF":3.9,"publicationDate":"2023-12-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"138820888","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}