Clinical Epidemiology最新文献

{"title":"Feedback on \"Recording of Alcohol Use Disorder in Electronic Health Records: Developing a Recommended Codelist for Research\" [Letter].","authors":"Avid Wijaya, Diniyah Kholidah, Elystia Vidia Marselina","doi":"10.2147/CLEP.S516603","DOIUrl":"10.2147/CLEP.S516603","url":null,"abstract":"","PeriodicalId":10362,"journal":{"name":"Clinical Epidemiology","volume":"17 ","pages":"51-52"},"PeriodicalIF":3.4,"publicationDate":"2025-01-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11784331/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143078604","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Increased Mortality After Lower Extremity Amputation in a Danish Nationwide Cohort: The Mediating Role of Postoperative Complications.","authors":"Anna Trier Heiberg Brix, Tanja Gram Petersen, Tine Nymark, Hagen Schmal, Martin Lindberg-Larsen, Katrine Hass Rubin","doi":"10.2147/CLEP.S499167","DOIUrl":"10.2147/CLEP.S499167","url":null,"abstract":"<p><strong>Objective: </strong>Patients who undergo major lower extremity amputation (MLEA) have the highest postoperative mortality among orthopedic patient groups. The comorbidity profile for MLEA patients is often extensive and associated with elevated postoperative mortality. This study primarily aimed to investigate the increased short- and long-term mortality following first and subsequent major lower extremity amputation. Secondarily, to examine the mediation role of post-amputation complications.</p><p><strong>Study design and setting: </strong>With data from the Danish National Patient Registry, 11,695 first-time MLEAs in patients aged ≥50 years were identified between January 1, 2010, and December 31, 2021, along with 58,466 unamputated persons matched 1:5 by year of birth, sex, and region of residence. Mediators were identified through diagnosis codes (ICD-10) present in 6 months following MLEA.</p><p><strong>Results: </strong>The increased mortality following MLEA was highest in the month following MLEA, hazard ratio (HR) 38.7 (95% confidence interval (CI) 30.5-48.9) in women and HR 55.7 (CI 44.3-70.2) in men compared to a matched unamputated cohort. Subsequent amputation resulted in an increased mortality the month after a subsequent amputation (overall HR 3.2 (CI 2.8-3.7) in women and HR 3.2 (CI 2.8-3.6) in men) and almost normalized after the first year. The proportion of the mortality risk that potentially could be reduced by preventing sepsis was 16% (CI 11.7-20.3) for women and 17% (CI 13.4-20.4) for men. For pneumonia, it was 10.5% (CI 7.1-13.9) in women and 14.9% (11.6-18.2) in men.</p><p><strong>Conclusion: </strong>We observed an increased mortality in the month following MLEA, which remained elevated for years compared to the matched unamputated cohort. A subsequent amputation results in increased mortality in the following year, but declined and normalized after the first year. Sepsis and pneumonia arising after the amputation appeared to be important factors that contributed to the increased postoperative mortality.</p>","PeriodicalId":10362,"journal":{"name":"Clinical Epidemiology","volume":"17 ","pages":"27-40"},"PeriodicalIF":3.4,"publicationDate":"2025-01-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11776520/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143063885","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Risk of Subclinical Hypothyroidism in Breast Cancer Patients Treated With CT-Guided Radiation Therapy: A Prospective Observational Study.","authors":"Lau Amdisen, Carsten Brink, Ebbe Laugaard Lorenzen, Jeanette Dupont Roenlev, Marianne Ewertz, Deirdre Cronin-Fenton","doi":"10.2147/CLEP.S496579","DOIUrl":"10.2147/CLEP.S496579","url":null,"abstract":"<p><strong>Purpose: </strong>The thyroid gland is an organ at risk in breast cancer survivors who receive radiation therapy to the supraclavicular lymph nodes. We investigated the effect of radiation dose to the thyroid gland on the incidence of hypothyroidism in early-stage breast cancer patients treated with CT-guided radiation therapy.</p><p><strong>Patients and methods: </strong>We recruited women aged ≤75 years diagnosed with breast cancer from March 2016 through August 2017 at Odense University Hospital, Denmark. Thyroid function was measured in blood samples drawn at baseline, 6, 12, and 18 months. We delineated the thyroid gland using CT scans to estimate thyroid volume and radiation dose to the thyroid. Subclinical hypothyroidism was defined as a thyroid-stimulating hormone (TSH) level of >4 milli-international units per liter (mIU/l) in the presence of normal free thyroxine. We also conducted a subanalysis with a threshold resulting in approximately 20% events within the cohort. We used mixed logistic regression to estimate associations between radiation dose to the thyroid and subclinical hypothyroidism.</p><p><strong>Results: </strong>Among 102 patients, four developed subclinical hypothyroidism. There was no association between increasing radiation dose to the thyroid and incidence of subclinical hypothyroidism. However, a trend was observed suggesting that higher mean radiation dose to the thyroid was associated with elevated risk of subclinical hypothyroidism at a TSH threshold of >2.5mIU/l.</p><p><strong>Conclusion: </strong>Using current reference levels, increasing radiation dose to the thyroid was not associated with subclinical hypothyroidism, but at lower TSH thresholds, radiation therapy may predispose to hypothyroidism.</p>","PeriodicalId":10362,"journal":{"name":"Clinical Epidemiology","volume":"17 ","pages":"41-49"},"PeriodicalIF":3.4,"publicationDate":"2025-01-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11776524/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143063891","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Similar Survival Between Non-Western Immigrant Patients and Danish-Born Patients with Lymphoma: A Danish Population-Based Study.","authors":"Mikkel Runason Simonsen, Eva Futtrup Maksten, Lasse Hjort Jakobsen, Marianne Tang Severinsen, Eldad J Dann, Henrik Frederiksen, Carsten Utoft Niemann, Judit Mészáros Jørgensen, Michael Roost Clausen, Jørn Starklint, Søren Paaske Johnsen, Tarec Christoffer El-Galaly, Joachim Baech","doi":"10.2147/CLEP.S484797","DOIUrl":"10.2147/CLEP.S484797","url":null,"abstract":"<p><strong>Purpose: </strong>This nationwide Danish cohort study compared overall survival (OS) between non-Western immigrant patients and Danish-born patients with lymphoma in Denmark. Furthermore, differences in clinical and socioeconomic variables were compared, and mediators of OS differences were explored to explain possible outcome differences.</p><p><strong>Patients and methods: </strong>The study included a total of 540 non-Western patients and 16,294 Danish-born patients diagnosed with lymphoma in the period 2000-2020. Inverse probability weighting and mediation analysis using a natural effects Cox model were used to investigate the causal relationship between immigration status and OS.</p><p><strong>Results: </strong>Indirect effects mediated through differences in performance status and income indicated a trend towards inferior OS for non-Western immigrant patients with HRs of 1.06 (0.99-1.14) and 1.06 (0.99-1.14). However, no total causal effect of immigration status on OS was observed overall (HR: 0.94 [0.79-1.12]) and within subtype-specific analyses, except for classical Hodgkin lymphoma.</p><p><strong>Conclusion: </strong>No significant differences in OS between non-Western immigrant patients and Danish-born patients were discovered.</p>","PeriodicalId":10362,"journal":{"name":"Clinical Epidemiology","volume":"17 ","pages":"19-25"},"PeriodicalIF":3.4,"publicationDate":"2025-01-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11771513/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143051880","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Treatment of Proximal Humeral Fractures in Older Patients During COVID-19 Pandemic in Germany.","authors":"Julia Sußiek, Jeanette Koeppe, Karen Fischhuber, Janette Iking, Ursula Marschall, Michael J Raschke, J Christoph Katthagen, Josef Stolberg-Stolberg","doi":"10.2147/CLEP.S486852","DOIUrl":"10.2147/CLEP.S486852","url":null,"abstract":"<p><strong>Purpose: </strong>The COVID-19 pandemic had a severe influence on the entire health sector. Until today, the effect of a SARS-CoV-2 infection on older patients with a proximal humeral fracture (PHF) is unknown. This study examined the following questions: Did the incidence of PHF of older people in Germany vary during the pandemic? Did the treatment change between the lockdown and non-lockdown periods? Was a SARS-CoV-2 infection associated with a worse outcome?</p><p><strong>Methods: </strong>Retrospective claims data of the BARMER health insurance were analysed. All in- and outpatient cases of insurance holders ≥65 years from 01/2010 to 09/2022, with coded diagnosis of PHF were analysed. Primary endpoints were the 1-month incidence of PHF per 100,000 insurance holders, number of operative therapies, in-hospital death and in-hospital major adverse events (MAEs).</p><p><strong>Results: </strong>174,898 inpatient PHF cases were included. During the lockdown periods, the total incidence fell, while the outpatient incidence partially increased during the pandemic-period. Regarding the therapy allocation, there were no relevant persisting changes. In a detailed analysis of 23,979 PHF cases from 01/2020 to 09/2022, 4.1% patients suffered from a SARS-CoV-2 infection and showed a notably higher in-hospital mortality (8.1% vs 2.5%; risk adjusted OR 2.79, 95% CI 2.11-3.70, p < 0.001) and more MAEs (17.0% vs 7.8%; risk adjusted OR 1.43, 95% CI 1.15-1.77, p < 0.001).</p><p><strong>Conclusion: </strong>During the COVID-19 pandemic, the overall incidence of PHF in older patients was reduced. The treatment allocation did not change between the pre- and intra-pandemic period. An infection with SARS-CoV-2 was associated with higher mortality and more MAEs.</p>","PeriodicalId":10362,"journal":{"name":"Clinical Epidemiology","volume":"17 ","pages":"9-18"},"PeriodicalIF":3.4,"publicationDate":"2025-01-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11748757/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143001351","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Validating ICD-10 Diagnosis Codes for Guillain-Barré Syndrome in Taiwan's National Health Insurance Claims Database [Letter].","authors":"Harinto Nur Seha, Savitri Citra Budi, Ahmad Yani Noor, I Gusti Agung Ngurah Putra Pradnyantara","doi":"10.2147/CLEP.S492187","DOIUrl":"10.2147/CLEP.S492187","url":null,"abstract":"","PeriodicalId":10362,"journal":{"name":"Clinical Epidemiology","volume":"17 ","pages":"7-8"},"PeriodicalIF":3.4,"publicationDate":"2025-01-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11740568/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143001352","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Acetaminophen Use in Pregnancy: A Comparison of Self-Reported Intake with Maternal and Newborn Biomarker Measures.","authors":"Pengfei Guo, Caroline H Johnson, Hong Yan, Jingyuan Xiao, Courtney Dennis, Kerry A Pierce, Andrew T DeWan, Zeyan Liew","doi":"10.2147/CLEP.S484953","DOIUrl":"10.2147/CLEP.S484953","url":null,"abstract":"","PeriodicalId":10362,"journal":{"name":"Clinical Epidemiology","volume":"17 ","pages":"1-6"},"PeriodicalIF":3.4,"publicationDate":"2025-01-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11705965/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142945786","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Comparative Algorithms for Identifying and Counting Hospitalisation Episodes of Care for Coronary Heart Disease Using Administrative Data.","authors":"Derrick Lopez, Juan Lu, Frank M Sanfilippo, Judith M Katzenellenbogen, Tom Briffa, Lee Nedkoff","doi":"10.2147/CLEP.S497760","DOIUrl":"10.2147/CLEP.S497760","url":null,"abstract":"<p><strong>Purpose: </strong>Measures of disease burden using hospital administrative data are susceptible to over-inflation if the patient is transferred during their episode of care. We aimed to identify and compare measures of coronary heart disease (CHD) and myocardial infarction (MI) episodes using six algorithms that account for transfers.</p><p><strong>Patient and methods: </strong>We used person-linked hospitalisations for CHD and MI for 2000-2016 in Western Australia based on the interval between discharge and subsequent admission (date, datetime algorithms), pathway (admission source, discharge destination) and any combination to generate machine learning models (random forest [RF], gradient boosting machine [GBM]). The date and datetime algorithms used deidentified patient identifiers to identify records belonging to the same individual. We calculated counts, age-standardised rates (ASR) and age-adjusted trends for CHD and MI for each algorithm.</p><p><strong>Results: </strong>Counts of CHD increased from 11,733 in 2000 to 13,274 in 2016, while MI increased from 2605 to 4480 using the date algorithm. Correspondingly ASR for CHD decreased from 2086.2 to 1463.1 while MI increased from 468.2 to 498.1 per 100,000 person-years. ASR for CHD and MI for datetime algorithm were consistently 1-2% higher than the date algorithm. Differences in ASR of CHD and MI counts increased over time with the admission source, RF and GBM algorithms relative to the date algorithm. Age-adjusted trends in CHD and MI episode rates using RF and GBM differed significantly from all other algorithms. Only 86.7% and 87.6% of MI episodes identified by the date algorithm were identified by the admission source and discharge destination algorithms, respectively.</p><p><strong>Conclusion: </strong>The date and datetime algorithms produced the most valid measures of CHD and MI episodes. Findings underscore the importance of identifying admission and discharge dates/times belonging to the same individual in enumerating these episodes.</p>","PeriodicalId":10362,"journal":{"name":"Clinical Epidemiology","volume":"16 ","pages":"921-928"},"PeriodicalIF":3.4,"publicationDate":"2024-12-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11687321/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142913645","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Patient Safety Climate in Danish Primary Care: Adaption and Validation of the Danish Safety Attitudes Questionnaire (SAQ-DK-PRIM) [Response to Letter].","authors":"Marie Haase Juhl, Anne Estrup Olesen, Ellen Tveter Deilkås, Niels Henrik Bruun, Kirsten Høgh Obling, Nikoline Rytter, Maya Damgaard Larsen, Solvejg Kristensen","doi":"10.2147/CLEP.S508313","DOIUrl":"10.2147/CLEP.S508313","url":null,"abstract":"","PeriodicalId":10362,"journal":{"name":"Clinical Epidemiology","volume":"16 ","pages":"917-919"},"PeriodicalIF":3.4,"publicationDate":"2024-12-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11656326/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142863279","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Development of Real-Time Surveillance for Serious Adverse Events in a Pragmatic Clinical Trial Using National Registers in Finland.","authors":"Tuomo A Nieminen, Arto A Palmu, Raija Auvinen, Sangita Kulathinal, Kari Auranen, Ritva K Syrjänen, Heta Nieminen, Tamala Mallett Moore, Stephanie Pepin, Jukka Jokinen","doi":"10.2147/CLEP.S483034","DOIUrl":"10.2147/CLEP.S483034","url":null,"abstract":"<p><strong>Purpose: </strong>We developed a hybrid safety surveillance approach for a large, pragmatic clinical trial of a high-dose quadrivalent influenza vaccine (QIV-HD), using both active and passive data collection methods. Here, we present the methods and results for the passive register-based surveillance of serious adverse events (SAEs), which replaced conventional SAE reporting during the trial.</p><p><strong>Patients and methods: </strong>The trial recruited over 33,000 older adults of whom 50% received the QIV-HD while the rest received a standard-dose vaccine (QIV-SD) as a control vaccine. We collected diagnoses related to all acute hospitalizations during the six months following vaccination from national registers. During the blinded phase of the trial, we utilized a cohort study design and compared the incidences of 1811 ICD10 diagnosis groups (SAE categories) between the trial population and older adults vaccinated with the QIV-SD outside the trial, either during the study or the previous influenza season. Based on a real-time probabilistic comparison, we flagged SAE categories with higher incidence in the trial population and then evaluated possible causal associations between each flagged category and the trial intervention.</p><p><strong>Results: </strong>Our novel approach to safety surveillance provided information, which we could evaluate in real-time during the trial. The trial participants experienced 1217 hospitalizations related to any SAE categories, contributed by 941 patients. We flagged 10 SAE categories for further analysis during the study but based on further data review, none presented strong evidence of causality with vaccination.</p><p><strong>Conclusion: </strong>Safety signals can be detected and evaluated in real-time during a pragmatic vaccine trial with register-based follow-up, utilizing passive data collection and population level comparison. Compared to conventional methods of safety follow-up, this method is likely to be more comprehensive, objective and resource effective.</p>","PeriodicalId":10362,"journal":{"name":"Clinical Epidemiology","volume":"16 ","pages":"901-915"},"PeriodicalIF":3.4,"publicationDate":"2024-12-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11651140/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142845879","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}