Annals of clinical epidemiology最新文献

{"title":"Adverse events, including fractures, among older patients receiving mirogabalin versus pregabalin: A retrospective cohort study using a large claims database in Japan.","authors":"Kanako Makito, Akira Okada, Hideo Yasunaga","doi":"10.37737/ace.25008","DOIUrl":"https://doi.org/10.37737/ace.25008","url":null,"abstract":"<p><strong>Background: </strong>Mirogabalin has a mechanism similar to that of pregabalin in the treatment of neuropathic pain. However, it remains unclear whether these drugs differ in terms of serious side effects, such as fall-related fractures, in older patients. This study aimed to investigate whether mirogabalin is associated with a decrease in adverse events, including fall-related fractures, compared with pregabalin.</p><p><strong>Methods: </strong>We performed a retrospective cohort study using the DeSC database, a large administrative claims database in Japan. This study included 130,244 patients ≥65 years taking mirogabalin or pregabalin between April 2019 and May 2021. The primary outcome was defined as the occurrence of fractures or switching to other medications and was compared between those receiving mirogabalin and pregabalin using Kaplan-Meier curves and multivariable Cox proportional hazards models. A sensitivity analysis was performed regarding patients who received mirogabalin or pregabalin without other analgesic medications at the initial dose.</p><p><strong>Results: </strong>During a median follow-up of 2.8 months, 29,686 (22.8%) and 100,558 (77.2%) received mirogabalin and pregabalin, respectively. The rates of the outcome in the mirogabalin and pregabalin groups were 50.1 and 42.8 per 100 person-years. Cox regression analysis showed that mirogabalin was associated with a lower risk of the outcome (hazard ratio, 0.93; 95% confidence interval, 0.87-1.00). However, sensitivity analysis did not demonstrate a difference in the outcome between the mirogabalin and pregabalin groups without other analgesic medications (hazard ratio, 0.93; 95% confidence interval, 0.86-1.01).</p><p><strong>Conclusions: </strong>Our analyses suggest that the outcome may be less likely in the mirogabalin group; however, the difference appears to be clinically insignificant. Further studies are warranted to confirm these findings.</p>","PeriodicalId":517436,"journal":{"name":"Annals of clinical epidemiology","volume":"7 2","pages":"61-68"},"PeriodicalIF":0.0,"publicationDate":"2025-01-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11982630/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144060122","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Estimation of the adjusted risk difference for very rare events, large samples, and extreme exposure frequency: Application of Vaccine Effectiveness, Networking, and Universal Safety study data.","authors":"Shuntaro Sato, Yurika Kawazoe, Fumiko Murata, Megumi Maeda, Haruhisa Fukuda","doi":"10.37737/ace.25007","DOIUrl":"https://doi.org/10.37737/ace.25007","url":null,"abstract":"<p><strong>Background: </strong>The post-authorization safety study of a vaccine is an important public health task, and its results contribute to the decisions about whether to recommend a vaccination by estimating not only the risk ratio but also the risk difference. There are few reports of adjusted risk differences. We evaluated the statistical performance of the adjusted risk difference and its variance under a post-authorization safety study's settings (rare events, large sample, extreme exposure frequency).</p><p><strong>Methods: </strong>Adjusted risk differences were estimated using ordinary least squares estimators in a linear regression model with a binary outcome, and their variances were estimated using the standard error from ordinary least squares and four types of robust variance. In a simulation, we evaluated the risk differences' performances using bias, coverage, and power and using data from the Vaccine Effectiveness, Networking, and Universal Safety study as an example of an actual post-authorization safety study.</p><p><strong>Results: </strong>The adjusted risk difference using ordinary least squares was not biased. Compared to the ordinary least squares' standard error, the robust variance achieved more appropriate coverage and higher power. With actual data, including 2 × 2 tables of exposure and outcome with zero, both the ordinary least squares and robust variance could be estimated.</p><p><strong>Conclusions: </strong>In post-authorization safety study settings, the estimation of the risk difference using ordinary least squares and robust variance showed better performance than the typical ordinary least squares. These findings may prove beneficial for reporting risk difference in extreme settings such as post-authorization safety studies.</p>","PeriodicalId":517436,"journal":{"name":"Annals of clinical epidemiology","volume":"7 2","pages":"50-60"},"PeriodicalIF":0.0,"publicationDate":"2025-01-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11982631/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144014822","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Erratum to: Introduction to Mendelian randomization.","authors":"Shiu Lun Au Yeung, Shan Luo, Masao Iwagami, Atsushi Goto","doi":"10.37737/ace.25004E","DOIUrl":"https://doi.org/10.37737/ace.25004E","url":null,"abstract":"<p><p>[This corrects the article DOI: 10.37737/ace.25004.].</p>","PeriodicalId":517436,"journal":{"name":"Annals of clinical epidemiology","volume":"7 2","pages":"69"},"PeriodicalIF":0.0,"publicationDate":"2025-01-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11982634/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144056662","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Cross-sectional Survey of Allergic Diseases in Staff and Their Families at Designated Allergic Disease Medical Hospitals in Japan: Calculation of Age-adjusted Prevalence.","authors":"Yasunori Ito, Taisuke Kato, Koichi Yoshida, Kyohei Takahashi, Yuma Fukutomi, Mizuho Nagao, Tatsuki Fukuie, Hiroshi Matsuzaki, Minoru Gotoh, Akio Tanaka, Satoshi Konno, Junichiro Tezuka, Naoki Kajita, Yuri Matsubara, Masakazu Takahashi, Yosikazu Nakamura, Yuichi Adachi","doi":"10.37737/ace.25005","DOIUrl":"https://doi.org/10.37737/ace.25005","url":null,"abstract":"<p><strong>Background: </strong>Continuous epidemiological surveys using consistent methodologies are essential for assessing the prevalence of allergic diseases. In 2021, a cross-sectional survey on allergic diseases was conducted, targeting staff and their families at Designated Allergic Disease Medical Hospitals across 41 prefectures in Japan. By 2022, these hospitals had been established in all 47 prefectures of Japan.</p><p><strong>Methods: </strong>A prevalence survey of allergic diseases was conducted in 2022 using the same questionnaire as that used in 2021, encompassing hospitals across all 47 prefectures. Age-adjusted prevalence rates were calculated using the 2015 population model for comparison with the 2021 survey data.</p><p><strong>Results: </strong>The 2022 survey included 76 hospitals and 24,444 participants (males, 10,668; women, 13,776; median age, 35 years; interquartile range, 18-50 years). The overall prevalence of allergic diseases was 63.0% (95% confidence interval:62.3-63.6). Age-adjusted prevalence of a history per 100,000 people for each allergic disease was as follows (; 95% confidence interval): bronchial asthma (13,279; 12,776-13,782), atopic dermatitis (12,786; 12,379-13,193), food allergies (13,143; 12,689-13,596), perennial allergic rhinitis (28,132; 27,673-28,982), pollinosis (38,959; 38,216-39,703), allergic conjunctivitis (19,751; 19,188-20,313), metal allergies (2,111; 1,898-2,325), drug allergies (4,478; 4,149-4,806), and anaphylaxis (1,602; 1,417-1,787). The prevalence of perennial allergic rhinitis, pollinosis, and allergic conjunctivitis was higher than that in 2021.</p><p><strong>Conclusions: </strong>This survey is the first in Japan to calculate the age-adjusted prevalence of allergic diseases. Moreover, pollinosis is the most common allergic disease in Japan.</p>","PeriodicalId":517436,"journal":{"name":"Annals of clinical epidemiology","volume":"7 2","pages":"39-45"},"PeriodicalIF":0.0,"publicationDate":"2025-01-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11982633/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144057064","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"DeSC database.","authors":"Hideo Yasunaga","doi":"10.37737/ace.25006","DOIUrl":"https://doi.org/10.37737/ace.25006","url":null,"abstract":"<p><p>The DeSC database is a commercially available administrative claims and health checkup database in Japan. The DeSC database contains health insurance claims data from three types of health insurers: the National Health Insurance (Kokuho), Health Insurance Societies (Kempo), and the Advanced Elderly Medical Service System. A previous study has shown that the population in the DeSC database is representative of the entire population of Japan. Our literature search identified 56 original articles conducted using the DeSC database between April 2022 and September 2024. Although the number of studies using the DeSC database is increasing, there are still opportunities to enhance research on various topics.</p>","PeriodicalId":517436,"journal":{"name":"Annals of clinical epidemiology","volume":"7 2","pages":"46-49"},"PeriodicalIF":0.0,"publicationDate":"2025-01-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11982632/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144061686","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Introduction to Mendelian randomization.","authors":"Shiu Lun Au Yeung, Shan Luo, Masao Iwagami, Atsushi Goto","doi":"10.37737/ace.25004","DOIUrl":"10.37737/ace.25004","url":null,"abstract":"<p><p>Mendelian randomization (MR), i.e. instrumental variable analysis using genetic instruments, is an approach that incorporates population genetics to improve causal inference. Given that genetics are randomly allocated at conception, this resembles the randomization process in randomized controlled trials and hence is more resistant to unobserved confounding compared to conventional observational studies (e.g. cohort studies). The seminar paper briefly described the origin of MR and its underlying assumptions (relevance, independence, and exclusion restriction). This was followed by introducing one sample MR designs (in which instrument-exposure and instrument-outcome associations are derived from the same sample) and one sample MR design (in which instrument-exposure and instrument-outcome associations are derived from different samples). The seminar paper then summarized key aspects of MR studies, such as instrument selection, data sources for conducting MR studies, and statistical analyses. Variations of MR design were also introduced, such as how this design can inform the effect of drug targets (drug target MR). The STROBE-MR checklist and relevant MR guidelines were introduced. The seminar paper concluded by discussing the credibility crisis of MR studies.</p>","PeriodicalId":517436,"journal":{"name":"Annals of clinical epidemiology","volume":"7 1","pages":"27-37"},"PeriodicalIF":0.0,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11799858/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143384887","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Blood hemoglobin levels of the general population residing at low range altitudes.","authors":"Mami Mizuta, Hiroshi Nishi, Motoki Odawara, Yasuhiro Oda, Masaomi Nangaku","doi":"10.37737/ace.25002","DOIUrl":"10.37737/ace.25002","url":null,"abstract":"<p><strong>Background: </strong>Polycythemia often develops in the highland areas. However, it remains to be clarified whether blood hemoglobin levels in the general population are affected by elevations above sea level of <1,000 m.</p><p><strong>Methods: </strong>This ecological study targeting secondary medical areas in Japan considered residential altitude at 0-800 m as the exposure and the mean hemoglobin level of the inhabitants aged between 40-44 years as the main outcome, based on the data extracted from the nationwide Special Health Checkup for 2021. The secondary outcome was the proportion of examinees with low hemoglobin levels. The results were validated using a 2018 dataset.</p><p><strong>Results: </strong>Individual data from approximately 1.21 million women and 1.93 million men in 335 secondary medical areas were summarized. When these areas were categorized into four groups by their altitude, the mean hemoglobin level at 600-800 m was elevated with a mean difference of 0.27 g/dL in women (p for trend <0.01) and with a mean difference of 0.21 g/dL in men (p for trend <0.01), compared to that at 0-200 m in 2021 dataset. Moreover, the proportion of women examinees with hemoglobin level <12.0 g/dL was 21.3% at 0-200 m and 17.6% at 600-800 m in 2021 (p for trend <0.01). These results were confirmed using the 2018 dataset.</p><p><strong>Conclusions: </strong>As the residential altitude increased from sea level to 800 m, blood hemoglobin levels were slightly elevated, and anemia prevalence in women decreased, implying caution in hemoglobin measurements.</p>","PeriodicalId":517436,"journal":{"name":"Annals of clinical epidemiology","volume":"7 1","pages":"10-16"},"PeriodicalIF":0.0,"publicationDate":"2024-10-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11799857/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143384882","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Changes in treatments and outcomes of out-of-hospital cardiac arrest between the SOS-KANTO 2012 and 2017 studies.","authors":"","doi":"10.37737/ace.25003","DOIUrl":"10.37737/ace.25003","url":null,"abstract":"<p><strong>Background: </strong>The current report shows a comparison of changes in pre- and in-hospital procedures, treatments and outcomes of patients with out-of-hospital cardiac arrest (OHCA) during the SOS-KANTO study periods.</p><p><strong>Method: </strong>This study included patients aged ≥18 years who experienced bystander-witnessed OHCA of cardiac etiology, which was confirmed by emergency medical service (EMS) providers at the scene, received cardiopulmonary resuscitation (CPR) from EMS providers, and were subsequently transported to the participating institutions.The primary outcome measure was patient survival with favorable neurological outcomes at 1 month from cardiac arrest. The secondary outcomes were the proportions of bystander CPR cases, advanced CPR procedures performed by EMS providers, pre-hospital return of spontaneous circulation (ROSC) rates, and post-resuscitation treatment administration.</p><p><strong>Results: </strong>Data of 1,515 patients from the SOS-KANTO 2017 study and 2,189 patients from the 2012 study were analyzed. Bystander CPR and advanced CPR procedures were performed more frequently and reliably by EMS providers in the 2017 than in the 2012 study. The rate of pre-hospital ROSC to total ROSC was higher in the 2017 study (35.7% vs 29.0%), and in-hospital treatments and post-resuscitation care was provided more frequently in the 2017 study. However, the 2017 study showed no significant difference in the survival rate with favorable neurological outcomes at 1 month, compared with the 2012 study. (9.0% vs 8.5%).</p><p><strong>Conclusion: </strong>High quality of prior to ROSC and post-resuscitation care following ROSC was maintained in the 2017 study. However, the 2017 study showed no significant difference in the survival rate with favorable neurological outcomes at 1 month, compared with the 2012 study.</p>","PeriodicalId":517436,"journal":{"name":"Annals of clinical epidemiology","volume":"7 1","pages":"17-26"},"PeriodicalIF":0.0,"publicationDate":"2024-10-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11799855/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143384884","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Comparison of reoperation incidence after fusion versus decompression for lumbar degenerative disease: A propensity score-weighted study.","authors":"Soichiro Masuda, Toshiki Fukasawa, Shunsuke Fujibayashi, Bungo Otsuki, Koichi Murata, Takayoshi Shimizu, Shuichi Matsuda, Koji Kawakami","doi":"10.37737/ace.25001","DOIUrl":"10.37737/ace.25001","url":null,"abstract":"<p><strong>Background: </strong>Reoperation after lumbar spine surgery is a major issue for both patients and physicians. It is uncertain whether fusion is superior to decompression alone for lumbar degenerative disease regarding reoperation rate. We aim to evaluate the reoperation rate after fusion surgery for lumbar degenerative disease compared with decompression alone.</p><p><strong>Methods: </strong>This study was conducted under a retrospective cohort design in patients undergoing fusion or decompression alone in one or two levels for lumbar degenerative disease using a Japanese claims-based database. Primary outcome was reoperation incidence during the follow-up period, and secondary outcome was reoperation incidence within 90 days postoperatively. Confounding factors were handled using propensity score overlap weighting. Cumulative incidence of reoperation was calculated from the Kaplan-Meier curve and hazard ratios (HRs) and 95% confidence intervals (CIs) for reoperation were estimated using Cox proportional hazards regression models.</p><p><strong>Results: </strong>8497 patients (2051 patients in the fusion group and 6446 in the decompression alone group) were included in the study. There was no difference in reoperation rate between fusion and decompression alone (weighted HR 0.85 [95% CI 0.69 to 1.04]; p = 0.11).</p><p><strong>Conclusions: </strong>Among patients with lumbar degenerative disease who underwent fusion or decompression alone, no significant difference was observed between the two groups.</p>","PeriodicalId":517436,"journal":{"name":"Annals of clinical epidemiology","volume":"7 1","pages":"1-9"},"PeriodicalIF":0.0,"publicationDate":"2024-10-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11799856/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143384886","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Evaluating optimal rehabilitation strategies in ICU: study protocol for a multicentre cohort study to assess Physical Activity dosing, Muscle mass, and physICal outcomeS (IPAMICS study).","authors":"Yasunari Morita, Shinichi Watanabe, Nobuto Nakanishi, Akihito Tampo, Kenzo Ishii, Keisuke Suzuki, Yoshie Hirota, Yuji Naito, Naoya Sato, Hiroyoshi Yano, Tomohiro Yoshikawa, Atsushi Ishihara, Hiroyasu Inoue, Keibun Liu, Shigeru Koba, Kasumi Satoh, Kensuke Nakamura","doi":"10.37737/ace.24014","DOIUrl":"10.37737/ace.24014","url":null,"abstract":"<p><strong>Background: </strong>Many patients who get discharged from the intensive care unit experience physical dysfunction that persists even after discharge. Physical dysfunction is associated with skeletal muscle atrophy and accompanying intensive care unit-acquired weakness in the early stages of intensive care unit admission, and early diagnosis and prevention with early mobilization are crucial. However, the amount of physical activity required for early mobilization remains controversial in critically ill patients. This study aims to reveal the optimal mobilization quantification score dose associated with physical dysfunction after hospital discharge.</p><p><strong>Methods: </strong>This is a multicenter prospective cohort study planned in 22 facilities; all consecutive patients admitted to the participating facilities between June 2024 and May 2025 will be included. Adult patients on ventilator management for at least 2 days and who will consent to this study will be included. Patients' mobility level and duration will be documented by the mobilization quantification score during their intensive care unit stay, and physical dysfunction will be assessed using muscle mass changes from day one to seven with ultrasonography and the Short-Form 12 Health Survey at 3 months after hospital discharge. The primary outcome is physical dysfunction at 3 months.</p><p><strong>Results and conclusion: </strong>Mobilization quantification score dose and muscle mass evaluation with ultrasonography will enable the quantification of the early mobilization intervention. This study will lay the foundation for future randomised studies.</p>","PeriodicalId":517436,"journal":{"name":"Annals of clinical epidemiology","volume":"6 4","pages":"97-105"},"PeriodicalIF":0.0,"publicationDate":"2024-09-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11668687/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142901389","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}