Clinical Epidemiology最新文献

{"title":"Harmonized Data Quality Indicators Maintain Data Quality in Long-Term Safety Studies Using Multiple Sclerosis Registries/Data Sources: Experience from the CLARION Study.","authors":"Jan Hillert, Helmut Butzkueven, Melinda Magyari, Stig Wergeland, Nicholas Moore, Merja Soilu-Hänninen, Tjalf Ziemssen, Jens Kuhle, Luigi Pontieri, Lars Forsberg, Jan Harald Aarseth, Chao Zhu, Nicholas Sicignano, Vasili Mushnikov, Irene Bezemer, Meritxell Sabidó","doi":"10.2147/CLEP.S480525","DOIUrl":"10.2147/CLEP.S480525","url":null,"abstract":"<p><strong>Purpose: </strong>Understanding the long-term safety of disease-modifying therapies for multiple sclerosis (MS) in routine clinical practice can be undertaken through registry-based studies. However, variability of data quality across such sources poses the challenge of data fit for regulatory decision-making. CLARION, a non-interventional cohort safety study of cladribine tablets, combines aggregated data from MS registries/data sources, except in Germany (which utilizes primary data collection). We describe the application of key data quality indicators (DQIs) within CLARION to evaluate data quality over time, as recommended by the European Medicines Agency (EMA) guideline on registry-based studies.</p><p><strong>Methods: </strong>DQIs were defined with participating registries/sources; they were used to assess data quality according to the EMA Data Quality Framework, addressing consistency, accuracy, completeness, and study representativeness. DQIs were associated with potential remedial measures if data quality was not met. DQIs were summarized overall and for individual MS registries/data sources to November 1, 2022.</p><p><strong>Results: </strong>A total of 28 DQIs were analyzed using data from 5069 patients arising from eight MS registries/data sources and 14 countries. The Representativeness DQIs showed that 72.0% of patients were female, median age at MS diagnosis was 29.0 to 43.3 years, and 93.5% had relapsing-remitting MS. Consistency DQIs showed a total of 2899 patients had achieved at least two years of follow-up; 6.9% did not have any recorded visits during this timeframe. Discrepant values were assessed as part of Accuracy DQIs, and improvements over time were noted for recorded dates of MS onset and diagnosis. Regarding Completeness DQIs, 191/5069 (3.8%) patients were lost to follow-up.</p><p><strong>Conclusion: </strong>The application of 28 DQIs within the CLARION study has helped with understanding, not only intrinsic and question-specific determinants of data quality, but also tracking the quality of post-authorization safety data obtained from MS registries/data sources, thereby providing a foundation for the regulatory decision-making process.</p>","PeriodicalId":10362,"journal":{"name":"Clinical Epidemiology","volume":"16 ","pages":"717-732"},"PeriodicalIF":3.4,"publicationDate":"2024-10-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11492909/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142459601","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":"Serum Prealbumin Levels and Risks of Adverse Clinical Outcomes After Ischemic Stroke.","authors":"Mengyao Shi, Xueyu Mao, Xuechun Wu, Min Chu, Huicong Niu, Lulu Sun, Xinyue Chang, Yu He, Yi Liu, Daoxia Guo, Yonghong Zhang, Zhengbao Zhu, Jing Zhao","doi":"10.2147/CLEP.S475408","DOIUrl":"https://doi.org/10.2147/CLEP.S475408","url":null,"abstract":"<p><strong>Background: </strong>Prealbumin is a symbol of protein nutrition and is involved in anti-inflammatory and neuron regeneration, but its association with the prognosis of ischemic stroke remains unclear. We aimed to prospectively explore the associations between serum prealbumin levels and adverse clinical outcomes after ischemic stroke in a large-scale cohort study.</p><p><strong>Methods: </strong>We measured serum prealbumin levels among 6609 ischemic stroke patients admitted at Minhang hospital. The primary outcome was composite of death and major disability (modified Rankin Scale [mRS] score ≥ 3) at 3 months after stroke onset, and secondary outcomes included death and the ordered 7-level categorical score of mRS.</p><p><strong>Results: </strong>During 3 months of follow-up, a total of 2118 patients developed the primary outcome. After multivariable adjustment, high prealbumin levels were associated with a decreased risk of primary outcome (odds ratio, 0.71; 95% CI, 0.59-0.85; <i>P</i> _trend< 0.0001) when 2 extreme quartiles were compared. Each unit increase of log-transformed prealbumin was associated with a 42% (95% CI, 28-53%) decreased risk of primary outcome. There was a better shift in the distribution of mRS score at 3 months with higher quartiles of serum prealbumin in ischemic stroke patients (<i>P</i> _trend< 0.0001). Multivariable-adjusted spline regression model showed a linear relationship between prealbumin and the risk of primary outcome (<i>P</i> for linearity = 0.0036).</p><p><strong>Conclusion: </strong>High serum prealbumin level was independently associated with decreased risks of adverse clinical outcomes among ischemic stroke patients. Our findings suggested that prealbumin may be a valuable prognostic biomarker and indicated the importance of keeping nourished in the daily life.</p>","PeriodicalId":10362,"journal":{"name":"Clinical Epidemiology","volume":"16 ","pages":"707-716"},"PeriodicalIF":3.4,"publicationDate":"2024-10-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11471114/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142459603","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":"Incidence of Graves' Disease with Validation and Completeness of the Diagnosis for Registry Extracts in the Danish National Patient Register.","authors":"Frederik Østergaard Klit, Jakob Dal, Stine Linding Andersen, Amar Nikontovic, Peter Vestergaard, Jesper Scott Karmisholt","doi":"10.2147/CLEP.S484335","DOIUrl":"https://doi.org/10.2147/CLEP.S484335","url":null,"abstract":"<p><strong>Purpose: </strong>Graves' disease (GD) is one of the most common causes of thyrotoxicosis. It has been proposed to identify incident GD by using the GD-specific code, E05.0, of the 10th revision of the International Classification of Disease (ICD-10) in the Danish National Patient Register (DNPR). We aimed to report the incidence of GD and to investigate the validity and completeness of E05.0 registration using Aalborg University Hospital (AaUH) as a single centre-sample.</p><p><strong>Patients and methods: </strong>The study included registry data from 2020 to 2022. The study population (n=2,893) comprised all people (15-99 years) in the catchment area of AaUH (n=244,872) with either positive anti-thyroid stimulating hormone receptor antibodies (TRAb), or registered with a thyroid disease related ICD-10 code E03.0-E07.9, O99.2 or O90.5 at the Department of Endocrinology, AaUH. To identify incident cases, all subjects occurring for the first time in 2020 were excluded (n=2,339). The incident subjects were categorized into a general practice (n=63) or hospital care group (n=491) and underwent GD verification by biochemical tests and thyroid imaging. Validity was evaluated by positive (PPV) and negative (NPV) predictive values and completeness of E05.0 registration was estimated to the total number of verified GD subjects in hospital care only and in overall (groups combined).</p><p><strong>Results: </strong>One hundred thirty-one incident GD subjects were identified corresponding to an incidence of 26.8 per 100,000/year. E05.0 had a PPV of 90% [95% CI: 81;96] and a NPV of 90% [95% CI: 85;93] to identify incident cases of GD. Completeness was estimated to be 73% [95% CI: 63;82] in hospital care and 50-60% [95% CI: 41;68] in overall.</p><p><strong>Conclusion: </strong>We report on a similar incidence of GD as previous studies in Denmark. Despite a high PPV, incident cases of GD could not adequately be identified by E05.0 in DNPR due to low completeness. Researchers should rely on biochemical test results to identify incident GD.</p>","PeriodicalId":10362,"journal":{"name":"Clinical Epidemiology","volume":"16 ","pages":"699-705"},"PeriodicalIF":3.4,"publicationDate":"2024-10-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11471073/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142459602","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 Venous Thromboembolism in Statin Users Compared to Fibrate Users in the United Kingdom Clinical Practice Research Datalink (UK CPRD) GOLD.","authors":"Olulade Ayodele, Howard J Cabral, David D McManus, Susan S Jick","doi":"10.2147/CLEP.S481448","DOIUrl":"10.2147/CLEP.S481448","url":null,"abstract":"<p><strong>Background: </strong>A substantial proportion of adults receive statins for treatment of hypercholesterolemia and cardiovascular risk, and statins have been found to improve outcomes in this patient population. However, studies have not consistently demonstrated the potential benefits of statins in preventing venous thromboembolism (VTE). Therefore, we conducted this study to investigate this association.</p><p><strong>Methods: </strong>We conducted a cohort analysis in a study sample comprised of 40-79-year-old patients with hyperlipidemia who received at least one fibrate or statin prescription between January 1995 and December 2018 in the United Kingdom Clinical Practice Research Datalink (CPRD) GOLD. We evaluated the association between statin use and incident unprovoked VTE, compared to fibrate use, an active comparator, using Kaplan-Meier (KM) analysis, Poisson regression (with and without propensity score matching), and inverse probability of treatment weights (IPTW) marginal structural models (MSM).</p><p><strong>Results: </strong>In this cohort of 166,292 patients with hyperlipidemia, 0.81% (N=1,353) developed incident unprovoked VTE. In analyses using the KM method, patients who received statins had a slightly lower risk of VTE compared to those who received fibrates (Log rank test: p=0.0524). The adjusted incident rate ratio (95% CI) for VTE, calculated using Poisson regression, controlling for serum cholesterol and other baseline covariates, in patients prescribed statins compared to fibrates was 0.77 (0.45-1.33) in the full cohort, 0.74 (0.38-1.45) in the propensity score matched analysis, and 0.51 (95% conservative CI: 0.34-0.76) in the IPTW MSM analysis.</p><p><strong>Conclusion: </strong>While the magnitude of effect varied across the different analytic methods, there is consistent evidence for a protective effect of statin use on the occurrence of unprovoked VTE.</p>","PeriodicalId":10362,"journal":{"name":"Clinical Epidemiology","volume":"16 ","pages":"683-697"},"PeriodicalIF":3.4,"publicationDate":"2024-10-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11463176/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142388538","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":"Recording of Alcohol Use Disorder in Electronic Health Records: Developing a Recommended Codelist for Research.","authors":"Sarah Cook, David Osborn, Arti Maini, Ravi Parekh, Shamini Gnani, Thomas Beaney, Ana Luisa Neves, Sonia Saxena, Jennifer K Quint","doi":"10.2147/CLEP.S477778","DOIUrl":"https://doi.org/10.2147/CLEP.S477778","url":null,"abstract":"<p><strong>Purpose: </strong>Electronic health records (EHR) are valuable resources for health research; however, their use is challenging. A validated alcohol use disorder (AUD) codelist for UK primary care is needed to improve population-based research in this patient group. We aimed to develop an AUD codelist for use in the Clinical Practice Research Datalink (CPRD) Aurum database, a UK EHR primary-care database.</p><p><strong>Methods: </strong>The CPRD code browser was searched using keywords related to alcohol use using a previously developed search strategy. The resulting codes were categorised as AUD if they were: a) diagnostic of AUD, b) indicated alcohol withdrawal, or c) indicated chronic alcohol-related harm (physical or mental). Codes related to alcohol use but not used to define AUD were also classified into relevant categories (alcohol status, acute harm, and alcohol screening). All codes were categorised independently by at least two reviewers (one person reviewed all codes and five reviewers (all practising GPs) each reviewed a subset of codes (100-200 codes each). Disagreements in categorisation were discussed by at least three coders and a consensus was reached. The reliability of categorisation was assessed using kappa statistics.</p><p><strong>Results: </strong>In total, 556 potential codes related to alcohol use were identified. The Kappa for reliability between coders was moderate for both AUD (0.72) and across all categories (0.62), with substantial variability between coders (AUD: 0.33-0.97; all categories 0.36-0.74). In the final codelist, 138 codes were included as indicating AUD: 38 codes identified which indicated diagnosis of AUD, 14 indicating withdrawal plus 85 codes indicating chronic alcohol-related harm (41 physical health and 44 mental health).</p><p><strong>Conclusion: </strong>Many codes are used in primary care to record alcohol use and associated harms, and there is substantial variability in how clinicians categorise them. While future work formally validating the codelist against gold standard clinical reviews and qualitative work with General Practitioners is needed for a deeper understanding of coding processes, we have documented here the process used for the development of an AUD codelist within primary care which can be used as a reference for future research.</p>","PeriodicalId":10362,"journal":{"name":"Clinical Epidemiology","volume":"16 ","pages":"673-681"},"PeriodicalIF":3.4,"publicationDate":"2024-10-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11460355/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142388537","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":"Survival in Thyroid Cancer in Sweden From 1999 To 2018.","authors":"Frantisek Zitricky, Anni Koskinen, Kristina Sundquist, Jan Sundquist, Vaclav Liska, Asta Försti, Akseli Hemminki, Kari Hemminki","doi":"10.2147/CLEP.S467874","DOIUrl":"10.2147/CLEP.S467874","url":null,"abstract":"<p><strong>Introduction: </strong>Thyroid cancer (TC) is diagnosed in several histological types which differ in their clinical characteristics and survival. We aim to describe how they influence TC survival in Sweden.</p><p><strong>Methods: </strong>Cancer data were obtained from the Swedish cancer registry between years 1999 and 2018, and these were used to analyze relative survival.</p><p><strong>Results: </strong>Relative survival for all TC improved when analyzed in 10-year periods, and female survival improved more than male survival. Female survival advantage appeared to be present also for specific histological types, although case numbers were low for rare types. Female 5-year relative survival for TC was 100% for follicular, 95.1% for oncocytic, 93.4% for papillary, 89.7% for medullary, and 6.1% for anaplastic cancer. Among the clinical TNM classes, only T4 and M1 stages were associated with decreased survival compared to T1-3 and M0. Anaplastic cancer presented most often at high T and M1 stages, in contrast to other TC. Curiously, the diagnostic age for anaplastic M1 patients was lower than that for M0 patients. Both anaplastic and medullary cancers did not show age-dependent increases in the probability of metastases, in contrast to the main histological types. This could indicate the presence of several types of anaplastic and medullary cancers.</p><p><strong>Conclusion: </strong>The poor survival for anaplastic TC is an extreme contrast to the excellent survival of differentiated TC. As less than 20% of anaplastic cancer patients survived one year, urgent diagnosis and initiation of treatment are important. Facilitated treatment pathways have been instituted in Denmark resulting in improved survival. Anaplastic cancer should be a target of a major research focus.</p>","PeriodicalId":10362,"journal":{"name":"Clinical Epidemiology","volume":"16 ","pages":"659-671"},"PeriodicalIF":3.4,"publicationDate":"2024-10-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11456301/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142380187","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":"Using Routinely Collected Electronic Healthcare Record Data to Investigate Fibrotic Multimorbidity in England [Response to Letter].","authors":"Georgie M Massen, Jennifer K Quint","doi":"10.2147/CLEP.S494770","DOIUrl":"10.2147/CLEP.S494770","url":null,"abstract":"","PeriodicalId":10362,"journal":{"name":"Clinical Epidemiology","volume":"16 ","pages":"657-658"},"PeriodicalIF":3.4,"publicationDate":"2024-09-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11444052/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142361232","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":"The Danish Centre for Strategic Research in Type 2 Diabetes (DD2) Project Cohort and Biobank from 2010 Through 2023-A Cohort Profile Update.","authors":"Frederik P B Kristensen, Sia K Nicolaisen, Jens S Nielsen, Diana H Christensen, Kurt Højlund, Henning Beck-Nielsen, Jørgen Rungby, Søren G Friborg, Ivan Brandslund, Jens S Christiansen, Peter Vestergaard, Niels Jessen, Michael H Olsen, Mette K Andersen, Torben Hansen, Charlotte Brøns, Allan Vaag, Reimar W Thomsen, Henrik T Sørensen","doi":"10.2147/CLEP.S469958","DOIUrl":"https://doi.org/10.2147/CLEP.S469958","url":null,"abstract":"<p><strong>Purpose: </strong>This paper provides an overview of the Danish Centre for Strategic Research in Type 2 Diabetes (DD2) cohort and biobank, including baseline characteristics of participants enrolled up to 2023, and post-enrollment rates of cardiovascular disease outcomes and mortality.</p><p><strong>Methods: </strong>Since 2010, the DD2 project has enrolled individuals with type 2 diabetes mellitus (T2DM) recently diagnosed by general practitioners and by hospital-based clinicians across Denmark. Data from questionnaires, clinical examinations, and biological samples are collected at enrollment. Additional baseline and longitudinal follow-up data are accessed via linkage to health registries.</p><p><strong>Results: </strong>Between 2010 and 2023, the DD2 project enrolled 11,369 participants (41.3% women, median age 61.4 years). Median T2DM duration at enrollment was 1.3 years, and median BMI was 31.6 kg/m² for women and 30.5 kg/m² for men. 18.3% were smokers, 5.7% consumed more than 14/21 units of alcohol weekly (women/men), and 17.9% reported leisure-time physical inactivity. Original midwife records dating back >80 years revealed that 20.2% of cohort participants had birth weights <3000 g. Based on complete hospital contact history 10 years before enrollment, 20.7% of cohort participants had macrovascular complications, 17.0% had microvascular complications, and 21.7% had kidney disease based on eGFR or urine albumin-creatinine measurements. At enrollment, statins were used by 68.2%, antihypertensive drugs by 69.9%, and glucose-lowering drugs by 86.5% of individuals. Median HbA1c was 48 mmol/mol and median LDL cholesterol 2.2 mmol/L. Genome-wide genotyping and biomarker data have been analyzed for over 9000 individuals. During the current follow-up time from the enrollment date (median 7.9 years), incident cardiovascular disease rate has been 13.8 per 1000 person-years and the mortality rate has been 17.6 per 1000 person-years.</p><p><strong>Conclusion: </strong>The DD2 cohort, with its detailed information and long-term follow up, can improve our understanding of the progression and prevention of complications among individuals with newly diagnosed T2DM.</p>","PeriodicalId":10362,"journal":{"name":"Clinical Epidemiology","volume":"16 ","pages":"641-656"},"PeriodicalIF":3.4,"publicationDate":"2024-09-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11439366/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142342835","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":"Excess Risk of Mortality and Hospitalization in Patients with Heart Failure According to Age and Comorbidity - A Nationwide Register Study.","authors":"Christian Madelaire, Thomas Gerds, Lars Køber, Finn Gustafsson, Charlotte Andersson, Søren Lund Kristensen, Jawad Haider Butt, Deewa Zahir Anjum, Ann Banke, Emil Loldrup Fosbøl, Gunnar Gislason, Christian Torp-Pedersen, Morten Schou","doi":"10.2147/CLEP.S469816","DOIUrl":"https://doi.org/10.2147/CLEP.S469816","url":null,"abstract":"<p><strong>Background: </strong>Heart failure (HF) is associated with increased risk of death and a hospitalization, but for patients initiating guideline directed medical therapy, it is unknown how high these risks are compared to the general population - and how this may vary depending on age and comorbidity.</p><p><strong>Methods: </strong>In this retrospective cohort study, we identified patients diagnosed with HF in the period 2011-2017, surviving the initial 120 days after diagnosis. Patients who were on angiotensin converting enzyme inhibitor (ACEi)/ angiotensin receptor blocker (ARB) and beta-blocker were included and matched to 5 non-HF individuals from the background population each based on age and sex. We assessed the 5-year risk of all-cause death, HF and non-HF hospitalization according to sex and age and baseline comorbidity.</p><p><strong>Results: </strong>We included 35,367 patients with HF and 176,835 matched non-HF individuals. Patients with HF had a five-year excess risk (absolute risk difference) of death of 13% (31% [for HF] - 18% [for non-HF]), of HF hospitalization of 17% and of non-HF hospitalization of 24%. Excess risk of death increased with increasing age, whereas the relative risk decreased - for women in their twenties, the excess risk was 7%, risk ratio 7.2, while the excess risk was 18%, risk ratio 1.5 for women in their eighties. Having HF as a 60-year old man was associated with a five-year risk of death similar to a 75-year old man without HF. Further, HF was associated with an excess risk of non-HF hospitalization, ranging from 8% for patients >85 years to 30% for patients <30 years.</p><p><strong>Conclusion: </strong>Regardless of age, sex and comorbidity, HF was associated with excess risk of mortality and non-HF hospitalizations, but the relative risk ratio diminishes sharply with advancing age, which may influence allocation of resources for medical care across populations.</p>","PeriodicalId":10362,"journal":{"name":"Clinical Epidemiology","volume":"16 ","pages":"631-640"},"PeriodicalIF":3.4,"publicationDate":"2024-09-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11439342/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142342834","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":"Drug-Induced Gynecomastia: Data Mining and Analysis of the FDA Adverse Event Reporting System Database","authors":"Xiuli Yang, Xiaochun Zheng, Miaomiao Zhang, Jinlong Huang, Ping Huang, Jiangfeng Wang","doi":"10.2147/clep.s470959","DOIUrl":"https://doi.org/10.2147/clep.s470959","url":null,"abstract":"<strong>Purpose:</strong> Drug-induced gynecomastia significantly affects patient health and quality of life. This study aimed to perform an exploratory analysis of gynecomastia reports and the most commonly associated medications within the FAERS database.<br/><strong>Patients and Methods:</strong> A comprehensive analysis of the FAERS from January 2004 to December 2023 was conducted. Disproportionality analysis and subsequent sensitivity analysis were performed to identify drugs potentially associated with gynecomastia, utilizing the reported odds ratio (ROR). Logistic regression analysis was employed to assess potential risk factors. The Weibull shape parameter (WSP) test was used to assess the time-to-onset characteristics of the top drugs associated with gynecomastia.<br/><strong>Results:</strong> The study identified 30,265 cases of gynecomastia, primarily associated with nervous system drugs, accounting for 85.50% of cases. Notably, risperidone accounted for 80.81% of the total cases. Among the 165 agents with ≥ 5 cases of gynecomastia, the strongest signals were exhibited by risperidone (ROR 602.38, 95% CI 585.07– 620.20), dutasteride (ROR 17.18, 95% CI 15.55– 18.89), spironolactone (ROR 15.8, 95% CI 13.99– 17.83), and paliperidone (ROR 7.16, 95% CI 6.55– 7.84). In the sensitivity analysis of disproportionality, unexpected associations were observed, such as montelukast (n = 21, ROR 1.94, 95% CI 1.26– 2.98). The logistic regression analysis indicated that the risk of risperidone-induced gynecomastia was significantly lower in adults compared to pediatric patients (OR 0.12, 95% CI 0.09– 0.15) and in patients with higher body weight than in those with lower body weight (OR 5.24, 95% CI 3.62– 7.76). The WSP test showed that gynecomastia induced by most of the top 10 common agents tends to occur in an early failure mode.<br/><strong>Conclusion:</strong> The rankings and signal strengths of drugs associated with gynecomastia were extracted from the FAERS. The age distribution and time-to-onset distribution of the top 10 drugs linked to gynecomastia were investigated, which can facilitate accurate clinical recognition of drug-induced gynecomastia.<br/><br/><strong>Keywords:</strong> drug-induced, gynecomastia, FAERS, risperidone, time-to-onset<br/>","PeriodicalId":10362,"journal":{"name":"Clinical Epidemiology","volume":"26 1","pages":""},"PeriodicalIF":3.9,"publicationDate":"2024-09-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142203746","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}