Ali Al-Kassab-Córdova, Anna B C Humphreys, Camila Olarte Parra, Maria Feychting, Anthony A Matthews
{"title":"Endocrine therapies and mortality risk in postmenopausal women with breast cancer: benchmarking an observational analysis against a randomized trial.","authors":"Ali Al-Kassab-Córdova, Anna B C Humphreys, Camila Olarte Parra, Maria Feychting, Anthony A Matthews","doi":"10.1093/aje/kwaf183","DOIUrl":"https://doi.org/10.1093/aje/kwaf183","url":null,"abstract":"<p><p>Benchmarking an observational analysis against a randomized trial increases our confidence in the use of observational data for causal inference. The Breast International Group (BIG 1-98) randomized trial compared the effect of letrozole and tamoxifen on the risk of death in postmenopausal women with hormone-receptor positive breast cancer. We designed a target trial that aimed to ask the same question as the one asked in BIG 1-98 and emulated it in Swedish registry data. The primary results from our observational analysis showed an increased risk of death in those who initiated aromatase inhibitors compared with tamoxifen [5-year risk difference = 2.5% (95% CI, 0.2%-4.6%)], which was discordant to the results from BIG 1-98. However, estimates were more closely aligned when our observational analysis was restricted to non-users of opioids or antidepressants [risk difference = -0.9 (95% CI, -4.2-2.0)]. In conclusion, when benchmarking an observational analysis against a trial, alignment of eligibility criteria with the index trial is not always sufficient and further study population restrictions may be required to address unmeasured confounding.</p>","PeriodicalId":7472,"journal":{"name":"American journal of epidemiology","volume":" ","pages":""},"PeriodicalIF":4.8,"publicationDate":"2025-08-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144938832","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Selection bias and competing risk.","authors":"C Mary Schooling","doi":"10.1093/aje/kwaf174","DOIUrl":"https://doi.org/10.1093/aje/kwaf174","url":null,"abstract":"","PeriodicalId":7472,"journal":{"name":"American journal of epidemiology","volume":" ","pages":""},"PeriodicalIF":4.8,"publicationDate":"2025-08-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144938726","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}
Sarah F Ackley, Ryan M Andrews, Christopher Seaman, Michael Flanders, Ruijia Chen, Jingxuan Wang, Grissel Lopes, Kendra D Sims, Peter Buto, Erin Ferguson, Isabel Elaine Allen, M Maria Glymour
{"title":"Trends in the Distribution of P Values in Epidemiology Journals: A Statistical, P-Curve, and Simulation Study.","authors":"Sarah F Ackley, Ryan M Andrews, Christopher Seaman, Michael Flanders, Ruijia Chen, Jingxuan Wang, Grissel Lopes, Kendra D Sims, Peter Buto, Erin Ferguson, Isabel Elaine Allen, M Maria Glymour","doi":"10.1093/aje/kwaf184","DOIUrl":"10.1093/aje/kwaf184","url":null,"abstract":"<p><p>Epidemiologists have advocated for reporting confidence intervals and deemphasizing P values to address long-standing concerns about null-hypothesis statistical-significance testing, P hacking, and reproducibility. It is unknown if efforts to reduce reliance on P values have altered the distribution of P values. For 21,332 abstracts published 2000-2024 in 4 major epidemiology journals, two-sided P values (N=25,288) were calculated from estimates and confidence intervals scraped using ChatGPT's 4o model. We evaluated trends over time to determine whether the empirical distribution of P values changed. We fitted to expected P value distributions and simulated these distributions with and without assuming changes in statistical power over time. Average P values decreased from 2000 to 2024; the fraction of P values just below the 0.05 threshold also decreased. Fits to models indicate that statistical power increased. Increasing power would reduce average P value while also decreasing P values near the 0.05 threshold-precisely the trends observed in epidemiology journals. Although the frequency of P values near the 0.05 threshold has declined modestly, this likely reflects increases in statistical power rather than decreases in P hacking.</p>","PeriodicalId":7472,"journal":{"name":"American journal of epidemiology","volume":" ","pages":""},"PeriodicalIF":4.8,"publicationDate":"2025-08-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144938772","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"A cross-national comparison of obesity using BMI-for-age percentiles: results from the Canadian longitudinal study on aging (CLSA) and the United States health and retirement study (HRS).","authors":"Claire E Cook, Chris Kim, Hailey R Banack","doi":"10.1093/aje/kwaf181","DOIUrl":"https://doi.org/10.1093/aje/kwaf181","url":null,"abstract":"<p><p>Obesity prevalence is increasing in both the United States (US) and Canada concurrently with demographic shifts, resulting in increasingly older populations with a high prevalence of obesity. Older adults have unique risks factors and outcomes related to obesity, such as age-related physiologic changes over time, that need to be considered when assessing obesity. In a comparison of data from the Canadian Longitudinal Study on Aging (CLSA) and the United States Health and Retirement Study (HRS), we use BMI-for-age percentile curves to examine obesity in the US and Canada in individuals 50+ years. Overall, BMI values were higher among individuals in the US and declined with chronological age in both countries. BMI values were higher among women than men in both countries. BMI-for-age percentiles reached a peak at a younger age among women in Canada compared to in individuals in the US. Using a novel measurement of obesity, the present work describes differences in obesity in older adults in Canada and the US and highlights the need for future work in obesity research in age- and sex- disaggregated contexts.</p>","PeriodicalId":7472,"journal":{"name":"American journal of epidemiology","volume":" ","pages":""},"PeriodicalIF":4.8,"publicationDate":"2025-08-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144938800","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}
Laura Botta, Riccardo Capocaccia, Alice Bernasconi, Silvia Rossi, Jaume Galceran, Luigino Dal Maso, Come Lepage, Florence Molinié, Anne-Marie Bouvier, Rafael Marcos-Gragera, Claudia Vener, Marcela Guevara, Deirdre Murray, Rosalia Ragusa, Gemma Gatta, Valerie Jooste, The Eurocare- Wg
{"title":"The impact of cancer survivors' extra risk of non-cancer mortality on net survival estimation.","authors":"Laura Botta, Riccardo Capocaccia, Alice Bernasconi, Silvia Rossi, Jaume Galceran, Luigino Dal Maso, Come Lepage, Florence Molinié, Anne-Marie Bouvier, Rafael Marcos-Gragera, Claudia Vener, Marcela Guevara, Deirdre Murray, Rosalia Ragusa, Gemma Gatta, Valerie Jooste, The Eurocare- Wg","doi":"10.1093/aje/kwaf148","DOIUrl":"10.1093/aje/kwaf148","url":null,"abstract":"<p><p>Relative survival with the general population as the reference (RS) is commonly used to estimate net survival (NS). However, cancer patients may face an increased risk of non-cancer death compared to cancer-free individuals. We evaluate the impact of considering this relative risk (RR) on NS estimation. First, we compared selected NS values to generated RS under various theoretical scenarios, considering different RR, NS, age at diagnosis, time since diagnosis, and sex. Then, differences between NS and RS for three cancers were analyzed from cure model based estimates using EUROCARE-6 data. We observed differences between RS and the true value of NS, larger for longer time since diagnosis, older patients and higher NS. For head and neck cancer, the smallest differences were for young female patients at 5 years from diagnosis (4%) and the highest (32%) for older patients. For colorectal cancer, differences were <7% for all ages, both sexes, and times since diagnosis and for breast cancer, differences were <5% except for older patients after 5 years. If RR>1, RS underestimates NS. Our findings aim to correctly interpret the differences between RS and NS, and contextualise the possible biases of assuming RS as a proxy for cancer-specific survival.</p>","PeriodicalId":7472,"journal":{"name":"American journal of epidemiology","volume":" ","pages":""},"PeriodicalIF":4.8,"publicationDate":"2025-08-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144870857","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Why we should Be prioritizing the average treatment effect on the treated over other Estimands when evaluating drug and device safety.","authors":"Guy Cafri","doi":"10.1093/aje/kwaf175","DOIUrl":"10.1093/aje/kwaf175","url":null,"abstract":"<p><p>When a drug or medical device is suspected of having a safety problem, observational studies are often utilized with and active comparator cohort design and covariate balancing using the propensity score. Each covariate balancing method is an estimator for a particular estimand, with each estimand characterizing the target population of interest differently as it relates to the treatment effect. In this article I argue that characterizing the average treatment effect in the treated population (ATT), has a distinct inferential advantage over estimands characterizing the treatment effect in either the comparator population, entire population and the overlap population, and as such the ATT should be prioritized. Regulatory guidance offers little direction with respect to estimand selection in observational studies, and a review of recent pharmacoepidemiology studies suggests that the ATT is infrequently used. Guidance is offered with respect to selecting among ATT estimators and identifying contexts where alternative estimands might be more informative. An empirical example is used to illustrate the implementation of the described methods. The implications of adopting the recommendations set forth in this article are considered.</p>","PeriodicalId":7472,"journal":{"name":"American journal of epidemiology","volume":" ","pages":""},"PeriodicalIF":4.8,"publicationDate":"2025-08-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144870858","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}
Shaoming Xiao, Ni Zhao, Myriam Doyon, Luigi Bouchard, Patrice Perron, Renée Guérin, Catherine Allard, Eric Massé, Brianna Moore, Marie-France Hivert, Noel T Mueller
{"title":"Drinking water source and the gut microbiome of 5-year-old children: findings from Gen3G birth cohort.","authors":"Shaoming Xiao, Ni Zhao, Myriam Doyon, Luigi Bouchard, Patrice Perron, Renée Guérin, Catherine Allard, Eric Massé, Brianna Moore, Marie-France Hivert, Noel T Mueller","doi":"10.1093/aje/kwaf168","DOIUrl":"https://doi.org/10.1093/aje/kwaf168","url":null,"abstract":"","PeriodicalId":7472,"journal":{"name":"American journal of epidemiology","volume":" ","pages":""},"PeriodicalIF":4.8,"publicationDate":"2025-08-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144870854","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}
Sylvia E Badon, J F Winkles, Alicia Colvin, Erin E Dooley, Carrie Karvonen-Gutierrez, Christopher E Kline, Kelley Pettee Gabriel
{"title":"Minimum wear time criteria for reliable estimates of device-measured 24-hour movement in older women.","authors":"Sylvia E Badon, J F Winkles, Alicia Colvin, Erin E Dooley, Carrie Karvonen-Gutierrez, Christopher E Kline, Kelley Pettee Gabriel","doi":"10.1093/aje/kwaf171","DOIUrl":"https://doi.org/10.1093/aje/kwaf171","url":null,"abstract":"<p><p>The objective of this study was to identify the minimum wear time criteria to produce reliable estimates of 24-hour movement behaviors and compositions in a study of older women. We used data collected in 2015-2017 in a subsample (n=1,282) of The Study of Women's Health Across the Nation (SWAN). Data from hip-worn accelerometers and wrist-worn actigraphy devices were harmonized into sleep-wake activity cycles. We identified minimum sleep-wake interval duration for 24 hour-equivalent estimates (reference (23, 25] hour range) and minimum number of sleep-wake cycles for 7 day-equivalent estimates using tests of equivalence with a confidence approach for duration and percent of the sleep-wake interval for each behavior. For intervals in the 23-25 hour range, participants spent a mean 7.8 hours (32.8%) in sleep, 7.4 hours (31.2%) in sedentary behavior, 4.9 hours (20.7%) in low light intensity physical activity (PA), 2.6 hours (10.8%) in high light intensity PA, and 1.1 hours (4.5%) in moderate/vigorous intensity PA. The minimum wear time criteria to produce reliable estimates was at least one day with a minimum of 6 hours of data. Our results are likely driven by high adherence to device wear protocols and are likely applicable to other studies of midlife and older adults.</p>","PeriodicalId":7472,"journal":{"name":"American journal of epidemiology","volume":" ","pages":""},"PeriodicalIF":4.8,"publicationDate":"2025-08-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144870855","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}
Luis C Correia, Amit J Shah, Valeria M Moncayo, Yi-An Ko, Nicholas Smith, Jeffery Osei, Louis Li, Arshed A Quyyumi, J Douglas Bremner, Jack Goldberg, Timothy L Lash, Viola Vaccarino
{"title":"Lack of Relationship between Posttraumatic Stress Disorder and Coronary Atherosclerotic Burden among Twin Veterans from the Vietnam Era.","authors":"Luis C Correia, Amit J Shah, Valeria M Moncayo, Yi-An Ko, Nicholas Smith, Jeffery Osei, Louis Li, Arshed A Quyyumi, J Douglas Bremner, Jack Goldberg, Timothy L Lash, Viola Vaccarino","doi":"10.1093/aje/kwaf037","DOIUrl":"https://doi.org/10.1093/aje/kwaf037","url":null,"abstract":"<p><p>Post-traumatic stress disorder (PTSD) has been related to ischemic heart disease (IHD), and the primary substrate for IHD is atherosclerotic burden. We aim to estimate the association between exposure to PTSD and atherosclerotic burden in PTSD-discordant twin pairs. This is a cross-sectional examination of 212 male twins during the 2016-2019 study visit of the Vietnam Era Twin Registry. Current PTSD symptom severity was assessed with the Clinician-Administered PTSD Scale for DSM-IV. PTSD-discordant twins were defined as pairs with different values of the PTSD Symptoms Scale. We regressed the log-transformed CAC Score on the PTSD Scale adjusted for potential confounders using linear mixed models and reported exponentiated coefficients. The sample had a median age of 68 (IQR67-70) years, a 15% prevalence of PTSD (median Symptom Score of 61; IQR53-81), and a median CAC Score of 111 (IQR5-346). The median CAC Score was 69 (IQR0.40-229) in twins with higher PTSD symptoms and 89 (IQR6.6-243) in their brothers with lower PTSD symptoms. The model estimated a -0.95% difference in CAC Score per unit increment in PTSD Symptoms Score within pairs (95%CI -2.6%;+0.7%), not implying a relationship between PTSD and coronary atherosclerosis in a design that inherently controls for familial and early environmental factors.</p>","PeriodicalId":7472,"journal":{"name":"American journal of epidemiology","volume":" ","pages":""},"PeriodicalIF":4.8,"publicationDate":"2025-08-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144833620","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}