Kamille Herskind, Peter Bjødstrup Jensen, Christina Anne Vinter, Lone Krebs, Lene Friis Eskildsen, Anne Broe, Anton Pottegård, Mette Bliddal
Purpose: This study aimed to systematically evaluate the validity of variables related to pregnancy, delivery, and key characteristics of the infant in the Danish National Patient Register using maternal medical records as the reference standard. Patients and Methods: We reviewed medical records of 1264 women giving birth in the Region of Southern Denmark during 2017. We calculated positive (PPV) and negative (NPV) predictive values, sensitivity, and specificity to estimate the validity of 49 selected variables. Results: The PPV was ≥ 0.90 on most pregnancy-related variables including parity, pre-gestational BMI, diabetes disorders, and previous cesarean section, while it was lower for hypertensive disorders, especially mild to moderate preeclampsia (0.49, 95% CI 0.32– 0.66). Sensitivity ranged from 0.80 to 1.00 on all pregnancy-related variables, except hypertensive disorders (sensitivity 0.38– 0.71, lowest for severe preeclampsia). On most delivery-related variables including obstetric surgical procedures (eg cesarean section and induction of labor), pharmacological pain-relief, and gestational age at delivery, PPV’s ranged from 0.98 to 1.00 and the corresponding sensitivities from 0.87 to 1.00. Regarding infant-related variables, both the APGAR score registered five minutes after delivery and birthweight yielded a PPV of 1.00. Conclusion: Obstetric coding in the Danish National Patient Register shows very high validity and completeness making it a valuable source for epidemiologic research.
Plain Language Summary: Danish register data are often used for epidemiological research in reproduction. The registers are based on coded information to the registers based on information from medical records. The quality of the register data is highly dependent of the validity of the codes. Yet there is a lack in our knowledge of the validity of data related to pregnancy, childbirth, and the characteristics of the newborn baby. We therefore aimed to validate the Danish National Patient Registry data related to pregnancy and childbirth by comparing the registered code with information from the medical records. We scrutinized medical records from 1264 women giving birth in the Region of Southern Denmark during 2017. We compared the registration in the medical record with the registered code in the Danish National Patient Registry by calculating how accurate the register data are according to 49 different variables. Results showed that registered codes in the Patient Registry for pregnancy- and childbirth-related conditions and key infant characteristics were to a high degree in agreement with the data from the medical report with few exceptions. In conclusion, the study revealed that the Danish National Patient Register provides highly accurate and comprehensive data for most pregnancy, delivery, and infant-related variables. This underscore
{"title":"Validation of Obstetric Diagnosis and Procedure Codes in the Danish National Patient Registry in 2017","authors":"Kamille Herskind, Peter Bjødstrup Jensen, Christina Anne Vinter, Lone Krebs, Lene Friis Eskildsen, Anne Broe, Anton Pottegård, Mette Bliddal","doi":"10.2147/clep.s441123","DOIUrl":"https://doi.org/10.2147/clep.s441123","url":null,"abstract":"<strong>Purpose:</strong> This study aimed to systematically evaluate the validity of variables related to pregnancy, delivery, and key characteristics of the infant in the Danish National Patient Register using maternal medical records as the reference standard.<br/><strong>Patients and Methods:</strong> We reviewed medical records of 1264 women giving birth in the Region of Southern Denmark during 2017. We calculated positive (PPV) and negative (NPV) predictive values, sensitivity, and specificity to estimate the validity of 49 selected variables.<br/><strong>Results:</strong> The PPV was ≥ 0.90 on most pregnancy-related variables including parity, pre-gestational BMI, diabetes disorders, and previous cesarean section, while it was lower for hypertensive disorders, especially mild to moderate preeclampsia (0.49, 95% CI 0.32– 0.66). Sensitivity ranged from 0.80 to 1.00 on all pregnancy-related variables, except hypertensive disorders (sensitivity 0.38– 0.71, lowest for severe preeclampsia). On most delivery-related variables including obstetric surgical procedures (eg cesarean section and induction of labor), pharmacological pain-relief, and gestational age at delivery, PPV’s ranged from 0.98 to 1.00 and the corresponding sensitivities from 0.87 to 1.00. Regarding infant-related variables, both the APGAR score registered five minutes after delivery and birthweight yielded a PPV of 1.00.<br/><strong>Conclusion:</strong> Obstetric coding in the Danish National Patient Register shows very high validity and completeness making it a valuable source for epidemiologic research.<br/><br/><strong>Plain Language Summary:</strong> Danish register data are often used for epidemiological research in reproduction. The registers are based on coded information to the registers based on information from medical records. The quality of the register data is highly dependent of the validity of the codes. Yet there is a lack in our knowledge of the validity of data related to pregnancy, childbirth, and the characteristics of the newborn baby. We therefore aimed to validate the Danish National Patient Registry data related to pregnancy and childbirth by comparing the registered code with information from the medical records.<br/>We scrutinized medical records from 1264 women giving birth in the Region of Southern Denmark during 2017. We compared the registration in the medical record with the registered code in the Danish National Patient Registry by calculating how accurate the register data are according to 49 different variables.<br/>Results showed that registered codes in the Patient Registry for pregnancy- and childbirth-related conditions and key infant characteristics were to a high degree in agreement with the data from the medical report with few exceptions.<br/>In conclusion, the study revealed that the Danish National Patient Register provides highly accurate and comprehensive data for most pregnancy, delivery, and infant-related variables. This underscore","PeriodicalId":10362,"journal":{"name":"Clinical Epidemiology","volume":null,"pages":null},"PeriodicalIF":3.9,"publicationDate":"2024-02-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139923703","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}
Purpose: We investigated the association between self-rated health (SRH) and cancer incidence and SRH and all-cause mortality among Norwegian women. Population and Methods: We used data from 110,104 women in the Norwegian Women and Cancer (NOWAC) cohort aged 41– 70 years at baseline. We used flexible parametric survival analysis with restricted cubic splines to calculate hazard ratios (HRs) and 95% confidence intervals (CIs) for the association between SRH and mortality in the entire cohort. We employed the same method in a multistate design to assess associations between baseline SRH and 1) cancer incidence, and 2) all-cause mortality in subgroups of women who did and did not receive a cancer diagnosis during follow-up. Results: With very good SRH as reference category for all associations and median age at end of follow-up, lower SRH was associated with increased mortality (HRgood SRH 1.19, 95% CI 1.12– 1.26) and HRpoor SRH 1.81, 95% CI 1.66– 1.97). Lower SRH at baseline was associated with cancer incidence (HRgood SRH 1.14, 95% CI 1.08– 1.20 and HRpoor SRH 1.44, 95% CI: 1.32– 1.58). Poor baseline SRH was associated with increased mortality for women who received a cancer diagnosis (HRpoor SRH 1.20, 95% CI 1.04– 1.39), and SRH showed a strong association with increased mortality for women who stayed cancer free (HRgood SRH 1.59, 95% CI 1.44– 1.77 and HRpoor SRH 3.34, 95% CI 2.91– 3.84). Conclusion: Lower SRH at baseline predicted increased cancer risk and all-cause mortality in middle-aged to older women. Poor SRH at baseline predicted all-cause mortality in women who later received a cancer diagnosis. Both good and poor SRH at baseline predicted all-cause mortality in women who stayed cancer-free, and the association was stronger for these women compared to both the entire cohort and to women who were subsequently diagnosed with cancer.
Keywords: self-rated health, cohort study, multistate, cancer, mortality, women
{"title":"Associations Between Self-Rated Health and Mortality in the Norwegian Women and Cancer (NOWAC) Study","authors":"Ida Løken Killie, Tonje Braaten, Geir Fagerjord Lorem, Kristin Benjaminsen Borch","doi":"10.2147/clep.s433965","DOIUrl":"https://doi.org/10.2147/clep.s433965","url":null,"abstract":"<strong>Purpose:</strong> We investigated the association between self-rated health (SRH) and cancer incidence and SRH and all-cause mortality among Norwegian women.<br/><strong>Population and Methods:</strong> We used data from 110,104 women in the Norwegian Women and Cancer (NOWAC) cohort aged 41– 70 years at baseline. We used flexible parametric survival analysis with restricted cubic splines to calculate hazard ratios (HRs) and 95% confidence intervals (CIs) for the association between SRH and mortality in the entire cohort. We employed the same method in a multistate design to assess associations between baseline SRH and 1) cancer incidence, and 2) all-cause mortality in subgroups of women who did and did not receive a cancer diagnosis during follow-up.<br/><strong>Results:</strong> With very good SRH as reference category for all associations and median age at end of follow-up, lower SRH was associated with increased mortality (HR<sub>good SRH</sub> 1.19, 95% CI 1.12– 1.26) and HR<sub>poor SRH</sub> 1.81, 95% CI 1.66– 1.97). Lower SRH at baseline was associated with cancer incidence (HR<sub>good SRH</sub> 1.14, 95% CI 1.08– 1.20 and HR<sub>poor SRH</sub> 1.44, 95% CI: 1.32– 1.58). Poor baseline SRH was associated with increased mortality for women who received a cancer diagnosis (HR<sub>poor SRH</sub> 1.20, 95% CI 1.04– 1.39), and SRH showed a strong association with increased mortality for women who stayed cancer free (HR<sub>good SRH</sub> 1.59, 95% CI 1.44– 1.77 and HR<sub>poor SRH</sub> 3.34, 95% CI 2.91– 3.84).<br/><strong>Conclusion:</strong> Lower SRH at baseline predicted increased cancer risk and all-cause mortality in middle-aged to older women. Poor SRH at baseline predicted all-cause mortality in women who later received a cancer diagnosis. Both good and poor SRH at baseline predicted all-cause mortality in women who stayed cancer-free, and the association was stronger for these women compared to both the entire cohort and to women who were subsequently diagnosed with cancer.<br/><br/><strong>Keywords:</strong> self-rated health, cohort study, multistate, cancer, mortality, women<br/>","PeriodicalId":10362,"journal":{"name":"Clinical Epidemiology","volume":null,"pages":null},"PeriodicalIF":3.9,"publicationDate":"2024-02-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139910127","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}
M Ellen Kuenzig, Therese A Stukel, Matthew W Carroll, Gilaad G Kaplan, Anthony R Otley, Harminder Singh, Alain Bitton, Stephen G Fung, Sarah Spruin, Stephanie Coward, Yunsong Cui, Zoann Nugent, Anne M Griffiths, David R Mack, Kevan Jacobson, Geoffrey C Nguyen, Laura E Targownik, Wael El-Matary, Charles N Bernstein, Trevor J B Dummer, Jennifer L Jones, Lisa M Lix, Sanjay K Murthy, Juan Nicolás Peña-Sánchez, Soheila Nasiri, Eric I Benchimol
Purpose: The incidence of childhood-onset inflammatory bowel disease (IBD) is rising. We described variation in health services utilization and need for surgery among children with IBD between six and 60 months following IBD diagnosis across Canadian pediatric centers and evaluated the associations between care provided at diagnosis at each center and the variation in these outcomes. Patients and Methods: Using population-based deterministically-linked health administrative data from four Canadian provinces (Alberta, Manitoba, Nova Scotia, Ontario) we identified children diagnosed with IBD < 16 years of age using validated algorithms. Children were assigned to a pediatric center of care using a hierarchical approach based on where they received their initial care. Outcomes included IBD-related hospitalizations, emergency department (ED) visits, and IBD-related abdominal surgery occurring between 6 and sixty months after diagnosis. Mixed-effects meta-analysis was used to pool results and examine the association between center-level care provision and outcomes. Results: We identified 3784 incident cases of pediatric IBD, of whom 2937 (77.6%) were treated at pediatric centers. Almost a third (31.4%) of children had ≥ 1 IBD-related hospitalization and there were 0.66 hospitalizations per person during follow-up. More than half (55.8%) of children had ≥ 1 ED visit and there were 1.64 ED visits per person. Between-center heterogeneity was high for both outcomes; centers where more children visited the ED at diagnosis had more IBD-related hospitalizations and more ED visits during follow-up. Between-center heterogeneity was high for intestinal resection in Crohn’s disease but not colectomy in ulcerative colitis. Conclusion: There is variation in health services utilization among children with IBD and risk of undergoing intestinal resection in those with Crohn’s disease, but not colectomy among children with ulcerative colitis, across Canadian pediatric tertiary-care centers. Improvements in clinical care pathways are needed to ensure all children have equitable and timely access to high quality care.
Plain Language Summary: Inflammatory bowel disease (IBD) is a chronic health condition of the gastrointestinal system, which is becoming more common in children. They require lifelong treatment and receiving high quality care is important for preventing complications. We determined if outcomes of children with IBD was different across Canada. We also tested if differences in care at diagnosis was related to outcomes. More than three-quarters of children with IBD were treated at pediatric hospitals. Children treated at some hospitals were more likely to be hospitalized and visit the emergency room when compared to children treated at other hospitals. Children with Crohn’s disease (one type of IBD) were more likely to have surgery at some hospitals whe
{"title":"Variation in the Care of Children with Inflammatory Bowel Disease Within and Across Canadian Provinces: A Multi-Province Population-Based Cohort Study","authors":"M Ellen Kuenzig, Therese A Stukel, Matthew W Carroll, Gilaad G Kaplan, Anthony R Otley, Harminder Singh, Alain Bitton, Stephen G Fung, Sarah Spruin, Stephanie Coward, Yunsong Cui, Zoann Nugent, Anne M Griffiths, David R Mack, Kevan Jacobson, Geoffrey C Nguyen, Laura E Targownik, Wael El-Matary, Charles N Bernstein, Trevor J B Dummer, Jennifer L Jones, Lisa M Lix, Sanjay K Murthy, Juan Nicolás Peña-Sánchez, Soheila Nasiri, Eric I Benchimol","doi":"10.2147/clep.s449183","DOIUrl":"https://doi.org/10.2147/clep.s449183","url":null,"abstract":"<strong>Purpose:</strong> The incidence of childhood-onset inflammatory bowel disease (IBD) is rising. We described variation in health services utilization and need for surgery among children with IBD between six and 60 months following IBD diagnosis across Canadian pediatric centers and evaluated the associations between care provided at diagnosis at each center and the variation in these outcomes.<br/><strong>Patients and Methods:</strong> Using population-based deterministically-linked health administrative data from four Canadian provinces (Alberta, Manitoba, Nova Scotia, Ontario) we identified children diagnosed with IBD < 16 years of age using validated algorithms. Children were assigned to a pediatric center of care using a hierarchical approach based on where they received their initial care. Outcomes included IBD-related hospitalizations, emergency department (ED) visits, and IBD-related abdominal surgery occurring between 6 and sixty months after diagnosis. Mixed-effects meta-analysis was used to pool results and examine the association between center-level care provision and outcomes.<br/><strong>Results:</strong> We identified 3784 incident cases of pediatric IBD, of whom 2937 (77.6%) were treated at pediatric centers. Almost a third (31.4%) of children had ≥ 1 IBD-related hospitalization and there were 0.66 hospitalizations per person during follow-up. More than half (55.8%) of children had ≥ 1 ED visit and there were 1.64 ED visits per person. Between-center heterogeneity was high for both outcomes; centers where more children visited the ED at diagnosis had more IBD-related hospitalizations and more ED visits during follow-up. Between-center heterogeneity was high for intestinal resection in Crohn’s disease but not colectomy in ulcerative colitis.<br/><strong>Conclusion:</strong> There is variation in health services utilization among children with IBD and risk of undergoing intestinal resection in those with Crohn’s disease, but not colectomy among children with ulcerative colitis, across Canadian pediatric tertiary-care centers. Improvements in clinical care pathways are needed to ensure all children have equitable and timely access to high quality care.<br/><br/><strong>Plain Language Summary:</strong> Inflammatory bowel disease (IBD) is a chronic health condition of the gastrointestinal system, which is becoming more common in children. They require lifelong treatment and receiving high quality care is important for preventing complications. We determined if outcomes of children with IBD was different across Canada. We also tested if differences in care at diagnosis was related to outcomes. More than three-quarters of children with IBD were treated at pediatric hospitals. Children treated at some hospitals were more likely to be hospitalized and visit the emergency room when compared to children treated at other hospitals. Children with Crohn’s disease (one type of IBD) were more likely to have surgery at some hospitals whe","PeriodicalId":10362,"journal":{"name":"Clinical Epidemiology","volume":null,"pages":null},"PeriodicalIF":3.9,"publicationDate":"2024-02-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139770504","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}
Pub Date : 2024-02-10eCollection Date: 2024-01-01DOI: 10.2147/CLEP.S448980
Vincent Lo Re Iii, Noelle M Cocoros, Rebecca A Hubbard, Sarah K Dutcher, Craig W Newcomb, John G Connolly, Silvia Perez-Vilar, Dena M Carbonari, Maria E Kempner, José J Hernández-Muñoz, Andrew B Petrone, Allyson M Pishko, Meighan E Rogers Driscoll, James T Brash, Sean Burnett, Catherine Cohet, Matthew Dahl, Terese A DeFor, Antonella Delmestri, Djeneba Audrey Djibo, Talita Duarte-Salles, Laura B Harrington, Melissa Kampman, Jennifer L Kuntz, Xavier Kurz, Núria Mercadé-Besora, Pamala A Pawloski, Peter R Rijnbeek, Sarah Seager, Claudia A Steiner, Katia Verhamme, Fangyun Wu, Yunping Zhou, Edward Burn, J Michael Paterson, Daniel Prieto-Alhambra
Purpose: Few studies have examined how the absolute risk of thromboembolism with COVID-19 has evolved over time across different countries. Researchers from the European Medicines Agency, Health Canada, and the United States (US) Food and Drug Administration established a collaboration to evaluate the absolute risk of arterial (ATE) and venous thromboembolism (VTE) in the 90 days after diagnosis of COVID-19 in the ambulatory (eg, outpatient, emergency department, nursing facility) setting from seven countries across North America (Canada, US) and Europe (England, Germany, Italy, Netherlands, and Spain) within periods before and during COVID-19 vaccine availability.
Patients and methods: We conducted cohort studies of patients initially diagnosed with COVID-19 in the ambulatory setting from the seven specified countries. Patients were followed for 90 days after COVID-19 diagnosis. The primary outcomes were ATE and VTE over 90 days from diagnosis date. We measured country-level estimates of 90-day absolute risk (with 95% confidence intervals) of ATE and VTE.
Results: The seven cohorts included 1,061,565 patients initially diagnosed with COVID-19 in the ambulatory setting before COVID-19 vaccines were available (through November 2020). The 90-day absolute risk of ATE during this period ranged from 0.11% (0.09-0.13%) in Canada to 1.01% (0.97-1.05%) in the US, and the 90-day absolute risk of VTE ranged from 0.23% (0.21-0.26%) in Canada to 0.84% (0.80-0.89%) in England. The seven cohorts included 3,544,062 patients with COVID-19 during vaccine availability (beginning December 2020). The 90-day absolute risk of ATE during this period ranged from 0.06% (0.06-0.07%) in England to 1.04% (1.01-1.06%) in the US, and the 90-day absolute risk of VTE ranged from 0.25% (0.24-0.26%) in England to 1.02% (0.99-1.04%) in the US.
Conclusion: There was heterogeneity by country in 90-day absolute risk of ATE and VTE after ambulatory COVID-19 diagnosis both before and during COVID-19 vaccine availability.
{"title":"Risk of Arterial and Venous Thrombotic Events Among Patients with COVID-19: A Multi-National Collaboration of Regulatory Agencies from Canada, Europe, and United States.","authors":"Vincent Lo Re Iii, Noelle M Cocoros, Rebecca A Hubbard, Sarah K Dutcher, Craig W Newcomb, John G Connolly, Silvia Perez-Vilar, Dena M Carbonari, Maria E Kempner, José J Hernández-Muñoz, Andrew B Petrone, Allyson M Pishko, Meighan E Rogers Driscoll, James T Brash, Sean Burnett, Catherine Cohet, Matthew Dahl, Terese A DeFor, Antonella Delmestri, Djeneba Audrey Djibo, Talita Duarte-Salles, Laura B Harrington, Melissa Kampman, Jennifer L Kuntz, Xavier Kurz, Núria Mercadé-Besora, Pamala A Pawloski, Peter R Rijnbeek, Sarah Seager, Claudia A Steiner, Katia Verhamme, Fangyun Wu, Yunping Zhou, Edward Burn, J Michael Paterson, Daniel Prieto-Alhambra","doi":"10.2147/CLEP.S448980","DOIUrl":"10.2147/CLEP.S448980","url":null,"abstract":"<p><strong>Purpose: </strong>Few studies have examined how the absolute risk of thromboembolism with COVID-19 has evolved over time across different countries. Researchers from the European Medicines Agency, Health Canada, and the United States (US) Food and Drug Administration established a collaboration to evaluate the absolute risk of arterial (ATE) and venous thromboembolism (VTE) in the 90 days after diagnosis of COVID-19 in the ambulatory (eg, outpatient, emergency department, nursing facility) setting from seven countries across North America (Canada, US) and Europe (England, Germany, Italy, Netherlands, and Spain) within periods before and during COVID-19 vaccine availability.</p><p><strong>Patients and methods: </strong>We conducted cohort studies of patients initially diagnosed with COVID-19 in the ambulatory setting from the seven specified countries. Patients were followed for 90 days after COVID-19 diagnosis. The primary outcomes were ATE and VTE over 90 days from diagnosis date. We measured country-level estimates of 90-day absolute risk (with 95% confidence intervals) of ATE and VTE.</p><p><strong>Results: </strong>The seven cohorts included 1,061,565 patients initially diagnosed with COVID-19 in the ambulatory setting before COVID-19 vaccines were available (through November 2020). The 90-day absolute risk of ATE during this period ranged from 0.11% (0.09-0.13%) in Canada to 1.01% (0.97-1.05%) in the US, and the 90-day absolute risk of VTE ranged from 0.23% (0.21-0.26%) in Canada to 0.84% (0.80-0.89%) in England. The seven cohorts included 3,544,062 patients with COVID-19 during vaccine availability (beginning December 2020). The 90-day absolute risk of ATE during this period ranged from 0.06% (0.06-0.07%) in England to 1.04% (1.01-1.06%) in the US, and the 90-day absolute risk of VTE ranged from 0.25% (0.24-0.26%) in England to 1.02% (0.99-1.04%) in the US.</p><p><strong>Conclusion: </strong>There was heterogeneity by country in 90-day absolute risk of ATE and VTE after ambulatory COVID-19 diagnosis both before and during COVID-19 vaccine availability.</p>","PeriodicalId":10362,"journal":{"name":"Clinical Epidemiology","volume":null,"pages":null},"PeriodicalIF":3.9,"publicationDate":"2024-02-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10865892/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139734585","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}
Background: Male breast cancer (MBC) comprises less than 1% of all breast cancer cases globally and remains understudied with persisting sex-specific survival disadvantages. We aim to contribute to better understanding of MBC with a comprehensive analysis of time-trends over several decades in Austria. Methods: We used Austrian National Cancer Registry data on 1648 cases of MBC cases diagnosed between 1983 and 2017 in Austria. Overall incidence, mortality, and survival rates, as well as age-, stage-, and period-specific incidence and survival rates were calculated. Joinpoint regression was performed to assess trends. Results: MBC incidence rates increased throughout the whole observation period (1983– 2017) with an annual percent change (APC) of 1.44% (95% confidence interval, CI: 0.77 to 2.11). During the same period, morality rates were stable (APC: – 0.25, 95% CI: – 0.53 to 0.60). Ten-year survival rates showed three phases of decreasing increases with an average APC of 2.45%, 1983– 2009 (95% CI: 2.1 to 2.74). Five-year survival rates improved until 2000 (APC: 2.31, 95% CI: 1.34 to 3.30) and remained stable thereafter (APC: 0.10, 95% CI: – 0.61 to 0.80). Stage-specific analyses showed a single trend of stable incidence rates of distant disease MBC (APC: – 0.03, 95% CI: – 1.67 to 1.65). Further, we observed increases in localised, regional, and unknown stage cancer incidence and increases in incidence rates across all age groups over the whole observation period. However, the estimates on these subgroup-specific trends (according to age- and stage) show wider 95% CIs and lower bounds closer to zero or negative in comparison to our findings on overall incidence, mortality, and survival. Conclusion: Despite improvements in survival rates, MBC mortality rates remained largely stable between 1983 and 2017 in Austria, possibly resulting from a balance between increasing overall incidence and stable incidence rates of distant disease MBC.
{"title":"Time Trends in Male Breast Cancer Incidence, Mortality, and Survival in Austria (1983–2017)","authors":"Lazo Ilic, Judit Simon, Monika Hackl, Gerald Haidinger","doi":"10.2147/clep.s428824","DOIUrl":"https://doi.org/10.2147/clep.s428824","url":null,"abstract":"<strong>Background:</strong> Male breast cancer (MBC) comprises less than 1% of all breast cancer cases globally and remains understudied with persisting sex-specific survival disadvantages. We aim to contribute to better understanding of MBC with a comprehensive analysis of time-trends over several decades in Austria.<br/><strong>Methods:</strong> We used Austrian National Cancer Registry data on 1648 cases of MBC cases diagnosed between 1983 and 2017 in Austria. Overall incidence, mortality, and survival rates, as well as age-, stage-, and period-specific incidence and survival rates were calculated. Joinpoint regression was performed to assess trends.<br/><strong>Results:</strong> MBC incidence rates increased throughout the whole observation period (1983– 2017) with an annual percent change (APC) of 1.44% (95% confidence interval, CI: 0.77 to 2.11). During the same period, morality rates were stable (APC: – 0.25, 95% CI: – 0.53 to 0.60). Ten-year survival rates showed three phases of decreasing increases with an average APC of 2.45%, 1983– 2009 (95% CI: 2.1 to 2.74). Five-year survival rates improved until 2000 (APC: 2.31, 95% CI: 1.34 to 3.30) and remained stable thereafter (APC: 0.10, 95% CI: – 0.61 to 0.80). Stage-specific analyses showed a single trend of stable incidence rates of distant disease MBC (APC: – 0.03, 95% CI: – 1.67 to 1.65). Further, we observed increases in localised, regional, and unknown stage cancer incidence and increases in incidence rates across all age groups over the whole observation period. However, the estimates on these subgroup-specific trends (according to age- and stage) show wider 95% CIs and lower bounds closer to zero or negative in comparison to our findings on overall incidence, mortality, and survival.<br/><strong>Conclusion:</strong> Despite improvements in survival rates, MBC mortality rates remained largely stable between 1983 and 2017 in Austria, possibly resulting from a balance between increasing overall incidence and stable incidence rates of distant disease MBC.<br/><br/>","PeriodicalId":10362,"journal":{"name":"Clinical Epidemiology","volume":null,"pages":null},"PeriodicalIF":3.9,"publicationDate":"2024-02-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139662901","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}
Purpose: The 5-year cancer survival rate among Chinese patients is lower than that among patients in developed countries and varies widely across geographic regions. The aim of this study was to analyse the 5-year relative cancer survival rate in southeastern China, between 2011 and 2021. Patients and Methods: We utilised population-based statistics from 12 cancer registries in Fujian, China. Study population data were up to date as of Dec 31, 2019, and survival outcome status was updated as of Dec 31, 2021. We used the ICD-10 and the ICD-O-3 to categorize all cancer cases. We analysed the 5-year relative survival for cancers combined and different cancer types stratified by sex, urban and rural areas, and age. Survival estimates were stratified according to calendar period (2011– 13, 2014– 15, 2016– 18 and 2019– 21). Results: Ultimately, a total of 160,294 cancer patients were enrolled in the study. In 2011– 13, 2014– 15, 2016– 18 and 2019– 21, the age-standardised 5-year relative survival for cancers combined were 29.1% (95% CI: 28.6– 29.7), 31.5% (95% CI: 31.0– 32.0), 36.8% (95% CI: 36.4– 37.3) and 39.1% (95% CI: 38.7– 39.6), respectively. The age-standardised 5-year relative survival for lung, prostate, larynx, colon-rectum, kidney and bone cancers increased 4.3%, 4.0%, 3.8%, 3.4%, 3.4% and 2.70%, respectively. Cancers with high 5-year relative survival rates (> 60%) in 2019– 21 included thyroid, testis, breast, bladder, cervix, prostate and uterus cancers. The 5-year survival rates in 2019– 2021 was higher for females than for males (47.8% vs 32.0%) and higher in urban areas than in rural areas (41.7% vs 37.1%). Relative survival rates decreased with increasing age. Conclusion: The 5-year cancer survival in Fujian Province increased between 2011 and 2021 but remained at a low level. Building a strong primary public health system may be a key step in reducing the cancer burden in Fujian Province.
Keywords: relative survival, cancer, population-based study, cancer registry
{"title":"Cancer Survival Trends in Southeastern China, 2011–2021: A Population-Based Study","authors":"Yan Zhou, Yeying Wen, Zhisheng Xiang, Jingyu Ma, Yongtian Lin, Yongying Huang, Chuanben Chen","doi":"10.2147/clep.s442152","DOIUrl":"https://doi.org/10.2147/clep.s442152","url":null,"abstract":"<strong>Purpose:</strong> The 5-year cancer survival rate among Chinese patients is lower than that among patients in developed countries and varies widely across geographic regions. The aim of this study was to analyse the 5-year relative cancer survival rate in southeastern China, between 2011 and 2021.<br/><strong>Patients and Methods:</strong> We utilised population-based statistics from 12 cancer registries in Fujian, China. Study population data were up to date as of Dec 31, 2019, and survival outcome status was updated as of Dec 31, 2021. We used the ICD-10 and the ICD-O-3 to categorize all cancer cases. We analysed the 5-year relative survival for cancers combined and different cancer types stratified by sex, urban and rural areas, and age. Survival estimates were stratified according to calendar period (2011– 13, 2014– 15, 2016– 18 and 2019– 21).<br/><strong>Results:</strong> Ultimately, a total of 160,294 cancer patients were enrolled in the study. In 2011– 13, 2014– 15, 2016– 18 and 2019– 21, the age-standardised 5-year relative survival for cancers combined were 29.1% (95% CI: 28.6– 29.7), 31.5% (95% CI: 31.0– 32.0), 36.8% (95% CI: 36.4– 37.3) and 39.1% (95% CI: 38.7– 39.6), respectively. The age-standardised 5-year relative survival for lung, prostate, larynx, colon-rectum, kidney and bone cancers increased 4.3%, 4.0%, 3.8%, 3.4%, 3.4% and 2.70%, respectively. Cancers with high 5-year relative survival rates (> 60%) in 2019– 21 included thyroid, testis, breast, bladder, cervix, prostate and uterus cancers. The 5-year survival rates in 2019– 2021 was higher for females than for males (47.8% vs 32.0%) and higher in urban areas than in rural areas (41.7% vs 37.1%). Relative survival rates decreased with increasing age.<br/><strong>Conclusion:</strong> The 5-year cancer survival in Fujian Province increased between 2011 and 2021 but remained at a low level. Building a strong primary public health system may be a key step in reducing the cancer burden in Fujian Province.<br/><br/><strong>Keywords:</strong> relative survival, cancer, population-based study, cancer registry<br/>","PeriodicalId":10362,"journal":{"name":"Clinical Epidemiology","volume":null,"pages":null},"PeriodicalIF":3.9,"publicationDate":"2024-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139647583","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}
Lisbet Grønbæk, Harmony Omeife, Lu Ban, Colin J Crooks, Timothy R Card, Peter Jepsen, Joe West
Purpose: 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. Patients and Methods: 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. Results: 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). Conclusion: Smoking was associated with an increased risk of autoimmune hepatitis.
Plain Language Summary: 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.
目的：吸烟是某些自身免疫性疾病的危险因素，但吸烟与自身免疫性肝炎的关系仍不清楚。我们在英格兰开展了一项基于人群的匹配病例对照研究，以探讨吸烟与自身免疫性肝炎风险之间的关系：我们从 2005 年至 2017 年的临床实践研究数据链（Clinical Practice Research Datalink）和相关的医院病例统计（Hospital Episode Statistics）中纳入了 987 例 18 岁以后诊断为自身免疫性肝炎的病例，以及每例病例最多 10 个频率匹配的人群对照。我们使用多元逻辑回归估算了曾经吸烟者与从不吸烟者患自身免疫性肝炎的几率比例，并对性别、年龄、全科医生、在全科医生处登记的日历时间和社会经济状况进行了调整：与对照组相比，自身免疫性肝炎病例更有可能是曾经吸烟者（44% 对 37%）。与从不吸烟者相比，曾经吸烟者患自身免疫性肝炎的风险更高（调整后的几率比=1.20，95% 置信区间为 1.03-1.39）：白话摘要：自身免疫性肝炎是一种与基因变异和环境暴露有关的慢性肝病，但自身免疫性肝炎的病因仍不清楚。我们利用登记数据评估了吸烟与自身免疫性肝炎风险之间的关系。关键词：流行病学、慢性肝炎、风险因素、烟草
{"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":null,"pages":null},"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
Purpose: 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. Patients and Methods: 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. Results: 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. Conclusion: 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.
Keywords: routine health care data, international databases, database evaluation
{"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":null,"pages":null},"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
Response to Letter in regards to The Epidemiology of Bile Acid Diarrhea in Denmark [Letter]
对有关丹麦胆汁酸腹泻流行病学的信件的回复 [信件]
{"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":null,"pages":null},"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
Response to Letter in regards to The Epidemiology of Bile Acid Diarrhea in Denmark [Letter]
回复有关丹麦胆汁酸腹泻流行病学的信函[信函]
{"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":null,"pages":null},"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}
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