PLoS Medicine最新文献

{"title":"Inpatient psychiatric bed capacity within CMS-certified U.S hospitals, 2011-2023: A cross-sectional study.","authors":"Zoe Lindenfeld, Jonathan H Cantor, Colleen M McCullough, Jemar R Bather, Ryan K McBain","doi":"10.1371/journal.pmed.1004682","DOIUrl":"https://doi.org/10.1371/journal.pmed.1004682","url":null,"abstract":"<p><strong>Background: </strong>Despite persistently high rates of mental illness and suicide, receipt of treatment for mental health conditions remains low. In this context, it is important to quantify the number of inpatient psychiatric beds (IPBs), and to understand differences in the number of IPBs throughout the U.S, as these provide critical evaluation, medication, and stabilization services.</p><p><strong>Methods and findings: </strong>This study used nationally-representative data drawn from the 2011-2023 Centers for Medicare and Medicaid Services' Healthcare Cost Report Information System (HCRIS). From 2011-2023, while the total number of IPBs-in both psychiatric hospitals (PHs) and short-term acute care hospitals (STACHs)-did not change, the number IPBs within STACHs fell from 11.3 in 2011 to 9.06 in 2023. During this period, 846 counties (in which over 244 million individuals reside) experienced a decline in the rate of IPBs, while another 1,449 counties (in which 59 million individuals reside) never had IPBs. In regression models predicting the number of IPBs in STACHs and PHs, hospitals that received DSH payments (STACHs: IRR:1.93, 95% CI: 1.72, 2.15; PHs: IRR:1.40; 95% CI: 1.06, 1.84), had more full-time employees (STACHs: IRR:1.35, 95% CI: 1.31, 1.38; PHs: IRR:1.77; 95% CI: 1.75, 1.80) and were teaching STACHs (STACHs: IRR:1.78; 95% CI: 1.63, 1.95) had significantly more IPBs. In county-level regression models, counties with a lower percentage of Black residents (β: -21.15; 95% CI: -37.14, -5.16) had a significantly higher rate of IPBs. The absence of a causal design means we cannot assess the reasons behind changes in IPBs across time, and is a limitation of this study.</p><p><strong>Conclusions: </strong>This study provides an overview of the availability of IPBs throughout the U.S, as well as the number of individuals without access to IPBs. Findings indicate a dearth of STACH-based IPBs, particularly in areas with a greater proportion of racial minority residents.</p>","PeriodicalId":49008,"journal":{"name":"PLoS Medicine","volume":"22 7","pages":"e1004682"},"PeriodicalIF":15.8,"publicationDate":"2025-07-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144700188","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Analysis of inter-hospital transfer on clinical outcomes after primary percutaneous coronary intervention for ST-segment elevation myocardial infarction: A secondary analysis of the BRIGHT-4 trial.","authors":"Xiaolin Su, Miaohan Qiu, Chengqi Gu, Xiuhui Yang, Bin Liu, Fanbo Meng, Bin Ning, Wei Li, Zhixiong Zhong, Zhengzhong Wang, Bei Shi, Zhuo Shang, Zhenyang Liang, Yi Li, Yaling Han, Gregg W Stone","doi":"10.1371/journal.pmed.1004679","DOIUrl":"https://doi.org/10.1371/journal.pmed.1004679","url":null,"abstract":"<p><strong>Background: </strong>Previous studies evaluating the influence of inter-hospital transfer on mortality in ST-segment elevation myocardial infarction (STEMI) patients undergoing primary percutaneous coronary intervention (PCI) reported conflicting results. The multicenter BRIGHT-4 trial demonstrated that bivalirudin plus a post-PCI high-dose infusion (1.75 mg/kg/h) reduced the 30-day primary endpoint of all-cause mortality or Bleeding Academic Research Consortium (BARC) types 3-5 bleeding compared with heparin monotherapy in STEMI patients. This study aimed to assess the impact of inter-hospital transfer on clinical outcomes and the effectiveness of bivalirudin versus heparin in STEMI patients undergoing PCI.</p><p><strong>Methods and findings: </strong>In BRIGHT-4, 2,121 (35.7%) patients were transferred to a tertiary hospital for primary PCI while 3,817 (64.3%) were directly admitted to an interventional facility. The primary outcome was the composite of all-cause death or BARC types 3-5 bleeding occurring within 30 days. The secondary outcomes included stent thrombosis. Adjustments were made for baseline covariates and randomized treatments. Transferred patients had a longer median time from symptom onset to wire crossing the infarct-related artery (6.00 versus 3.93 hrs, P < 0.0001). At 30 days, there were no significant between-group differences in the rates of the primary outcome (4.2% versus 3.4%, adjusted hazard ratio [HR] 0.99, 95% confidence intervals [CI] 0.73, 1.33, P = 0.94) or its components. Bivalirudin with a high-dose post-PCI infusion was associated with consistent reductions of the primary outcome in the transfer (3.5% versus 4.8%, adjusted HR 0.66, 95%CI 0.42, 1.05) and direct admission (2.8% versus 4.1%, adjusted HR 0.62, 95% CI 0.43, 0.89) group compared with heparin monotherapy (Pinteraction = 0.78), as well as individually for stent thrombosis. The main limitations of this study are that it is a post hoc analysis, and the long-term prognostic impact of transfer on STEMI patients requires further investigation.</p><p><strong>Conclusions: </strong>In this post hoc analysis, 30-day clinical outcomes for STEMI patients transferred for PCI were not significantly worse than direct admission patients. Bivalirudin with a post-PCI high-dose infusion for 2-4 hrs was associated with lower rates of 30-day all-cause mortality, major bleeding and stent thrombosis, consistently observed in transfer and direct admission patients.</p><p><strong>Trial registration: </strong>BRIGHT-4 trial NCT03822975 http://www.clinicaltrials.gov.</p>","PeriodicalId":49008,"journal":{"name":"PLoS Medicine","volume":"22 7","pages":"e1004679"},"PeriodicalIF":15.8,"publicationDate":"2025-07-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144700187","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Absolute risk-based versus individualized benefit approaches for determining statin eligibility in primary prevention of cardiovascular diseases in Chinese populations: A modeling study.","authors":"Qiuping Liu, Chao Gong, Tianjing Zhou, Minglu Zhang, Xiaofei Liu, Xun Tang, Pei Gao","doi":"10.1371/journal.pmed.1004556","DOIUrl":"https://doi.org/10.1371/journal.pmed.1004556","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Background: &lt;/strong&gt;Current guidelines for statin use in primary prevention of cardiovascular disease (CVD) predominantly rely on absolute 10-year CVD risk scores. However, this approach may not adequately capture heterogeneity in the potential benefit of low-density lipoprotein cholesterol (LDL-C) reduction. This study compares the absolute risk-based approach with an individualized benefit approach, based on the Causal-Benefit model considering predicted lipid-lowering effects, for statin eligibility in Chinese populations.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Methods and findings: &lt;/strong&gt;We analyzed nationally representative data from the China Health and Retirement Longitudinal Study, including adults aged 40-80 years, free of diabetes and CVD history, with LDL-C levels between 1.8 mmol/L and 4.9 mmol/L, and no prior statin use. Statin eligibility was determined using two strategies: (i) the absolute risk-based approach (10-year CVD risk), and (ii) the individualized benefit approach (using the Causal-Benefit model framework incorporating predicted individual absolute risk reduction [iARR]). We estimated eligible populations, CVD events averted, and number needed to treat (NNT) both at population and individual level (iNNT) over 10 years versus no treatment, assessed discordance, and primarily calibrated the benefit threshold to match event prevention by the risk-based approach for comparison. A total of 7,287 adults were analyzed, forming a cohort reflective of 324.6 million Chinese adults (mean age 57 years; 51.7% women). To prevent a similar number of CVD events (2.19 million vs. 2.16 million), 49.2 million (95% confidence interval [CI]: 45.3,53.0) and 50.3 million (95% CI: 46.0,54.6) adults would be eligible for statins therapy under the individualized benefit and absolute risk-based approaches, respectively. Among 58.9 million adults eligible for either strategy, the concordance was only 68.9%. The benefit approach alone identified 8.6 million people highly benefit from statin therapy, who would not be eligible for statin therapy under the absolute risk-based approach, and this includes 1.3 million people with borderline risk (5% to 7.5%). Conversely, the risk-based approach selected more individuals with low predicted benefit (minimum iARR: 2.5% vs. 3.4%), resulting in a less efficient individual-level targeting profile (maximum iNNT: 41 vs. 29). A key limitation of this study is that benefit was estimated primary from LDL-C reduction, which may neglect other biological mechanisms of statin effects and underestimate the total benefit.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Conclusions: &lt;/strong&gt;The individualized benefit approach prioritizes individuals most likely to benefit from statin therapy, differing from conventional risk-based selection through its superior individual-level precision. This approach can enhance the capacity to discriminate treatment effects at the individual level, making it particularly valuable for shared decision-making in resource-constrained","PeriodicalId":49008,"journal":{"name":"PLoS Medicine","volume":"22 7","pages":"e1004556"},"PeriodicalIF":15.8,"publicationDate":"2025-07-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144692187","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Trastuzumab in early curative breast cancer: A target trial emulation benchmarked against two randomized clinical trials.","authors":"Vanessa Voelskow, Xabier Garcia-Albeniz, Anita Berglund, Maria Feychting, Tobias Kurth, Anthony A Matthews","doi":"10.1371/journal.pmed.1004661","DOIUrl":"https://doi.org/10.1371/journal.pmed.1004661","url":null,"abstract":"<p><strong>Background: </strong>Benchmarking an observational analysis against a randomized trial can increase confidence in the use of observational data to complement inferences made in trials. Until now, few examples of benchmarking have been within oncology. However, benchmarking trials of a cancer treatment poses a unique set of challenges, such as defining composite outcomes like disease-free survival.</p><p><strong>Methods and findings: </strong>We designed a target trial with a protocol as similar as possible to the B-31 and N9831 randomized trials, which estimated the effect of adjuvant trastuzumab plus chemotherapy compared with chemotherapy alone in individuals with early human epidermal growth factor receptor 2-positive breast cancer. We then carried out an observational analysis by emulating the target trial using routinely collected data from Swedish registries to understand if we can estimate a similar effect of trastuzumab as the trial. The primary endpoint was the composite of disease-free survival consisting of the earliest of (1) local or regional recurrences, (2) distant recurrences, (3) contralateral breast cancer, (4) other second primary cancer, or (5) death from any cause. Individuals who had data compatible with both treatment strategies at baseline were cloned and one copy was assigned to each arm. We applied inverse probability weights to adjust for baseline and time-varying confounding (e.g., age and hematological events like neutropenia).. Our observational analysis included 1,578 women, with a median age of 59 years, and who were diagnosed between 2008 and 2015. We estimated a similar effect after five years of follow-up (RR: 0.54, 95% CI [0.44, 0.67]) for the composite endpoint of disease-free survival as the two jointly analyzed B-31 and N9831 trials (HR: 0.48, 95% CI [0.39, 0.59]). While the comparability of results increases confidence in our estimates, there remains a risk of residual and unmeasured confounding, as is the case with all observational analyses.</p><p><strong>Conclusions: </strong>We successfully benchmarked an observational analysis against the B-31 and N9831 trials. By aligning protocols and using appropriate methodological approaches, we show that observational data can be used to estimate similar results as randomized trials of cancer treatments, like trastuzumab. This opens the door to using observational data to complement results from randomized trials of cancer treatments which can provide quick, cheap, and robust evidence to support decision-making where trials leave evidence gaps.</p>","PeriodicalId":49008,"journal":{"name":"PLoS Medicine","volume":"22 7","pages":"e1004661"},"PeriodicalIF":15.8,"publicationDate":"2025-07-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144683526","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Long-term outcomes after unilateral salpingo-oophorectomy: A registry-based retrospective cohort study.","authors":"Huan Yi, Naiqi Zhang, Jan Sundquist, Kristina Sundquist, Xiangqin Zheng, Jianguang Ji","doi":"10.1371/journal.pmed.1004639","DOIUrl":"10.1371/journal.pmed.1004639","url":null,"abstract":"<p><strong>Background: </strong>Opportunistic bilateral salpingo-oophorectomy (BSO) is recommended in women who have undergone a hysterectomy due to gynecological carcinomas and/or in women with genetic indications, especially for women who do not intend to conceive. However, there is ongoing debate about whether BSO should be recommended in premenopausal women, due to the early cessation of estradiol because of BSO which is linked to several health concerns, including coronary artery disease (CAD) and osteoporosis. This study aims to explore whether ovarian cancer can be prevented by unilateral salpingo-oophorectomy (USO) while not affecting the long-term risk of CAD and osteoporosis.</p><p><strong>Methods and findings: </strong>By accessing the Swedish national registries, this retrospective cohort study included 42,306 women who underwent USO between 1993 and 2018 before the age of 50 years. These women were randomly matched with 211,530 women who had not undergone USO using a propensity score matching approach to ensure comparability between the groups. Follow-up started on the date of USO operation and continued until the earliest occurrence of the following events: diagnosis of specific outcomes of interest, death from any cause, or the end of the study period (31st December 2018). Cox regression models were used to calculate hazard ratios (HRs) and 95% confidence intervals (CIs) of overall and histology-specific ovarian cancer, CAD, and osteoporosis associated with USO. After a median follow-up of 13 years, our analyses revealed that USO was not associated with subsequent risk of CAD (HR = 1.02, 95% CI [0.95, 1.09]) and osteoporosis (HR = 1.06, 95% CI [0.98, 1.16]). However, USO was significantly associated with a reduced risk of high-grade serous ovarian carcinoma (HR = 0.64, 95% CI [0.45, 0.92]). No differences were found when the analyses were stratified by hysterectomy. The main limitation of the study was that some confounding factors, such as BRCA1/2 pathological mutant status, were not available in our database.</p><p><strong>Conclusions: </strong>Our study suggests that USO reduces the risk of HGSCs but was not associated with CAD or osteoporosis after a median 13-year follow-up. These results suggest that USO may be a safer option than BSO for lowering ovarian cancer risk in premenopausal women, as it could avoid the negative health effects of early menopause.</p>","PeriodicalId":49008,"journal":{"name":"PLoS Medicine","volume":"22 7","pages":"e1004639"},"PeriodicalIF":15.8,"publicationDate":"2025-07-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12233271/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144585456","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Passive immunotherapy for adults hospitalized with COVID-19: An individual participant data meta-analysis of six randomized controlled trials.","authors":"Kirk U Knowlton, Lianne K Siegel, Christina E Barkauskas, Sanjay Bhagani, Nila J Dharan, Edward M Gardner, Robert L Gottlieb, Marie Helleberg, Helene C Highbarger, Thomas L Holland, Christian Kjer Heerfordt, Susana Lazarte, Lindsey M Leither, Joseph Lutaakome, Magdalena Ardelt, Eleftherios Mylonakis, Sean W X Ong, Jeffrey Scott Overcash, Hassan Taha, Phyllis C Tien, Barbara W Trautner, David Vallee, Amy C Weintrob, Giota Touloumi, Abdel G Babiker","doi":"10.1371/journal.pmed.1004616","DOIUrl":"10.1371/journal.pmed.1004616","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Background: &lt;/strong&gt;Anti-SARS-CoV-2 monoclonal antibodies (mAb) reduce the risk of hospitalization in outpatients with mild-to-moderate COVID-19. However, the efficacy of treatment with mAbs and other passive immunotherapies in patients hospitalized with severe COVID-19 is not clear. The objective of this study was to assess the clinical effect of passive immunotherapy and its heterogeneity according to baseline endogenous neutralizing antibody status and SARS-CoV-2 antigen level, in adults hospitalized with SARS-CoV-2 infection and severe COVID-19.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Methods and findings: &lt;/strong&gt;We carried out a two-stage individual participant data meta-analysis of six double-blind, randomized, placebo-controlled trials conducted under the Therapeutics for Inpatients with COVID-19 (TICO) and the similarly designed Inpatient Treatment with Anti-Coronavirus Immunoglobulin (ITAC) master protocols. Within each trial, three major outcomes (sustained recovery, mortality, and a composite safety outcome) were compared between treatment and placebo using Fine-Gray and Cox proportional hazards models. Trial-specific treatment differences for each of the three outcomes were pooled using a common effect meta-analysis. A total of 3,079 patients hospitalized for COVID-19 were enrolled in the six trials. Only 18% had received at least one dose of an anti-SARS-CoV-2 vaccine. Overall, the median plasma SARS-CoV-2 antigen level was 1,421 (IQR: 231-4,568) pg/mL, and 51% of patients were endogenous neutralizing antibody positive at study entry. The overall summary estimate of sustained recovery rate ratio (RRR) of the treatment versus placebo group was 1.06 (95% CI [0.99,1.14]), but this varied significantly by antibody serostatus. The RRR was 1.16 (95% CI [1.04,1.29]) among seronegative patients and 0.97 (95% CI [0.88,1.07]) in seropositive patients [p = 0.02 for interaction (the difference in RRR between seropositive and seronegative patients)]. The summary hazard ratio (HR) for mortality comparing treatment to placebo was 0.81 (95% CI [0.64,1.03]) overall, 0.69 (95% CI [0.50,0.95]) in seronegative patients, and 0.96 (95% CI [0.66,1.39]) in seropositive patients (interaction p = 0.18). There was no evidence that the treatment effect on any outcome differed according to antigen level, whether overall or within serostatus subgroups. In regards to the composite safety outcome, the overall summary HR comparing treatment group to placebo was 0.89 (95% CI [0.66,1.21]; Q = 3.47 [p = 0.63], I2 = 0.0%), and it was 0.83 (95% CI [0.70,0.99]) and 1.04 (95% CI [0.86,1.26]) in seronegative and seropositive patients, respectively. The main limitation of the methodology is that these results are limited to the analysis of the six trials in ACTIV-3/TICO and ITAC and are not intended to be a complete summary of all trials of passive immunotherapy.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Conclusions: &lt;/strong&gt;Passive immunotherapy might be a useful treatment option for hospitalized patients with C","PeriodicalId":49008,"journal":{"name":"PLoS Medicine","volume":"22 7","pages":"e1004616"},"PeriodicalIF":15.8,"publicationDate":"2025-07-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12282900/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144585457","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"The potential global health impact and cost-effectiveness of next-generation influenza vaccines: A modelling analysis.","authors":"Lucy Goodfellow, Simon R Procter, Mihaly Koltai, Naomi R Waterlow, Johnny A N Filipe, Carlos K H Wong, Edwin van Leeuwen, Rosalind M Eggo, Mark Jit","doi":"10.1371/journal.pmed.1004655","DOIUrl":"10.1371/journal.pmed.1004655","url":null,"abstract":"<p><strong>Background: </strong>Next-generation influenza vaccines (NGIVs) are in development and have the potential to achieve substantial reductions in influenza burden, with resulting widespread health and economic benefits. The prices at which their market can be sustained and which vaccination strategies may maximise health impact and cost-effectiveness, particularly in low- and middle-income countries, are unknown, yet such an understanding could provide a valuable tool for vaccine development and investment decision-making at a national and global level. To address this evidence gap, we projected the health and economic impact of NGIVs in 186 countries and territories.</p><p><strong>Methods and findings: </strong>We inferred current influenza transmission parameters from World Health Organization (WHO) FluNet data in regions defined by their seasonal influenza timing and positivity, and projected 30 years of influenza epidemics, accounting for demographic changes. We considered vaccines including current seasonal vaccines, vaccines with increased efficacy, duration, and breadth of protection, and universal vaccines, defined in line with WHO Preferred Product Characteristics. We estimated cost-effectiveness of different vaccination scenarios using novel estimates of key health outcomes and costs. NGIVs have the potential to substantially reduce influenza burden: compared to no vaccination, vaccinating 50% of children aged under 18 annually prevented 1.3 (95% uncertainty range (UR): 1.2-1.5) billion infections using current vaccines, 2.6 (95% UR: 2.4-2.9) billion infections using vaccines with improved efficacy or breadth, and 3.0 (95% UR: 2.7-3.3) billion infections using universal vaccines. In many countries, NGIVs were cost-effective at higher prices than typically paid for existing seasonal vaccines. However, tiered prices may be necessary for improved vaccines to be cost-effective in lower income countries. This study is limited by the availability of accurate data on influenza incidence and influenza-associated health outcomes and costs. Furthermore, the model involves simplifying assumptions around vaccination coverage and administration, and does not account for societal costs or budget impact of NGIVs. How NGIVs will compare to the vaccine types considered in this model when developed is unknown. We conducted sensitivity analyses to investigate key model parameters.</p><p><strong>Conclusions: </strong>This study highlights the considerable potential health and economic benefits of NGIVs, but also the variation in cost-effectiveness between high-income and low- and middle-income countries. This work provides a framework for long-term global cost-effectiveness evaluations, and the findings can inform a pathway to developing NGIVs and rolling them out globally.</p>","PeriodicalId":49008,"journal":{"name":"PLoS Medicine","volume":"22 6","pages":"e1004655"},"PeriodicalIF":15.8,"publicationDate":"2025-06-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12237265/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144530661","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Cardiovascular-kidney-metabolic syndrome and all-cause and cardiovascular mortality: A retrospective cohort study.","authors":"Min-Kuang Tsai, Juliana Tze-Wah Kao, Chung-Shun Wong, Chia-Te Liao, Wei-Cheng Lo, Kuo-Liong Chien, Chi-Pang Wen, Mai-Szu Wu, Mei-Yi Wu","doi":"10.1371/journal.pmed.1004629","DOIUrl":"10.1371/journal.pmed.1004629","url":null,"abstract":"<p><strong>Background: </strong>The American Heart Association recently issued guidelines introducing the concept of cardiovascular-kidney-metabolic (CKM) syndrome to emphasize the importance of multidisciplinary approaches to prevention, risk stratification, and treatment for these diseases. This study assessed the prevalence of CKM syndrome stages and the mortality risk associated with its components in a large Asian cohort.</p><p><strong>Methods and findings: </strong>We analyzed a retrospective cohort of 515,602 participants aged ≥20 years from a health screening program conducted between 1996 and 2017 in Taiwan. We assessed the associations of all-cause mortality, cardiovascular disease (CVD) mortality, and cause-specific mortality with CKM stages and its components-hypertension, diabetes mellitus, chronic kidney disease (CKD), metabolic syndrome, and hyperlipidemia. All participants were followed for a median of 16.5 years (interquartile range: 11.5, 21.2 years). Multivariate Cox proportional hazards models, adjusted for age, sex, educational level, smoking status, alcohol drinking status, and physical activity groups, were used to calculate hazard ratios (HRs). We used Chiang's life table method to estimate years of life lost due to each CKM component. Among all participants, 257,535 (49.9%) were female. The majority of participants (n = 368,578 participants, (71.5%)) met criteria for CKM syndrome, with prevalence rates of 19.5%, 46.3%, 1.9%, and 3.8% for stages 1, 2, 3, and 4, respectively. CKM syndrome was associated with higher risks of all-cause mortality (HR: 1.33; 95% confidence interval, CI: 1.28, 1.39), CVD mortality (HR: 2.81; 95% CI: 2.45, 3.22), and incident end-stage kidney disease (ESKD) (HR: 10.15; 95% CI: 7.54, 13.67). Each additional CKM component was associated with a 22% increase in the risk of all-cause mortality (HR: 1.22; 95% CI: 1.21, 1.23), a 37% increase in the risk of CVD mortality (HR: 1.37; 95% CI: 1.35, 1.40) compared with those without any CKM components. In addition, each additional component reduced average life expectancy by 3 years. The population-attributable fractions of CKM syndrome were 18.7% (95% CI: 15.8, 21.7) for all-cause mortality and 55.0% (95% CI: 49.0, 60.4) for CVD mortality. We estimated that failing to include CKD in CKM syndrome could result in the missed attribution of 11% of CVD deaths. The primary limitation is that our analysis relied on baseline measurements only, without accounting for longitudinal changes.</p><p><strong>Conclusions: </strong>In the large cohort study, the prevalence of CKM syndrome and its components were associated with risks of all-cause mortality, CVD mortality, and ESKD. These findings highlight the clinical need for integrated care within CKM health.</p>","PeriodicalId":49008,"journal":{"name":"PLoS Medicine","volume":"22 6","pages":"e1004629"},"PeriodicalIF":15.8,"publicationDate":"2025-06-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12200875/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144508969","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Natural cycle versus hormone replacement therapy as endometrial preparation in ovulatory women undergoing frozen-thawed embryo transfer: The compete open-label randomized controlled trial.","authors":"Xitong Liu, Wentao Li, Wen Wen, Ting Wang, Tao Wang, Ting Sun, Na Zhang, Dan Pan, Jinlin Xie, Xiaojuan Liu, He Cai, Xiaofang Li, Zan Shi, Rui Wang, Na Lu, Haiyan Bai, Rong Pan, Li Tian, Bin Meng, Xin Mu, Hongran Jia, Hanying Zhou, Xu Cao, Tianxing Liu, Pengfei Qu, Danmeng Liu, Ben W Mol, Juanzi Shi","doi":"10.1371/journal.pmed.1004630","DOIUrl":"10.1371/journal.pmed.1004630","url":null,"abstract":"<p><strong>Background: </strong>Different endometrial preparation protocols are used prior to frozen-thawed embryo transfer (FET). Optimization of endometrial preparation protocols is mandatory to improve live birth rate and obstetric and perinatal outcomes. In the Comparison of Endometrial Preparation Protocols for Frozen Embryo Transfer (COMPETE) trial, our primary objective is to evaluate whether natural cycles (NCs) lead to a higher live birth rate after the first FET cycle compared to hormone replacement therapy (HRT) cycles in women with a regular ovulatory cycle.</p><p><strong>Methods and findings: </strong>We performed a single-center, parallel, open-label randomized controlled trial between December 2020 and December 2022 in a single assisted reproduction center in Xi'an, China. Women with a regular menstrual cycle undergoing in vitro fertilization (IVF) scheduled for FET were randomly assigned (1:1) to endometrial preparation in the NC or with HRT, using a web-based electronic data capture system. The primary outcome was live birth rate after the initial FET. The analysis was conducted based on the intention-to-treat principle. Obstetric and perinatal outcomes in all randomly assigned women were reported in this study. We randomly assigned 902 women to receive either NC (n = 448) or HRT (n = 454). In the NC group, 101 women received HRT because of no ovulation, while in the HRT group, 29 women received NC because of spontaneous ovulation. The number of live births was 242 (54.0%) in the NC group versus 195 (43.0%) in the HRT group (absolute difference, 11.1 percentage points, 95% CI 4.6 to 17.5; risk ratio (RR) 1.26, 95% CI 1.10 to 1.44). Miscarriage rates (RR 0.61, 95% CI 0.41 to 0.89) and the antepartum hemorrhage rates (RR 0.63, 95%CI 0.42 to 0.93) were lower in the NC group, with other obstetric and perinatal outcomes not significantly different.</p><p><strong>Conclusions: </strong>In women with a regular menstrual cycle undergoing FET, a strategy starting with NC endometrial preparation results in higher live birth rates than endometrial preparation with HRT. However, the permitted cross-over between arms limits certainty in directly assessing NC versus HRT efficacy.</p><p><strong>Trial registration: </strong>Chinese Clinical Trial Registry: ChiCTR2000040640.</p>","PeriodicalId":49008,"journal":{"name":"PLoS Medicine","volume":"22 6","pages":"e1004630"},"PeriodicalIF":15.8,"publicationDate":"2025-06-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12193059/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144498817","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Analysis of retinal markers and incident amyotrophic lateral sclerosis: An optical coherence tomography-based cohort study.","authors":"Chunyang Pang, Yaojia Li, Wenhua Jiang, Haobo Xie, Wen Cao, Huan Yu, Zhiyang Lin, Yifan Cheng, Dongsheng Fan, Binbin Deng","doi":"10.1371/journal.pmed.1004545","DOIUrl":"10.1371/journal.pmed.1004545","url":null,"abstract":"<p><strong>Background: </strong>Biomarkers are widely recognized as crucial breakthroughs in tackling amyotrophic lateral sclerosis (ALS). Among them, retina markers may hold promise due to the close retina-brain connection and non-invasive, portable detection methods. Thus, using optical coherence tomography (OCT), we investigated the link between baseline cell-level retinal features and future ALS risk.</p><p><strong>Methods and findings: </strong>Participants from the UK Biobank underwent OCT scans to assess retinal layers, macula, and optic disc parameters. Follow-up commenced two years after the baseline period (2006-2010), during which ALS cases were identified using International Classification of Diseases (ICD) codes from medical and assessment records. Cox proportional hazards models were applied to examine the relationship between retinal markers and incident ALS. Over a median follow-up of 14.11 years, 70 ALS cases occurred among 53,824 participants (incidence 10.58 per 100,000 person-years). Most participants were White (94.6%), 44.8% male, with a median age of 58 years. After adjusting for demographics and comorbidities affecting the retina, a standard deviation (SD) decrease of 15.19 µm in photoreceptor layer (PRL) thickness was associated with a 19% (95% confidence interval [7, 29]; p = 0.002) increased risk of ALS, while a SD increase of 26.11 µm in retinal pigment epithelium (RPE) thickness corresponded to a 20% (95% CI [7, 34]; p = 0.002) higher risk. Sensitivity analyses excluding follow-ups of less than 4 and 6 years yielded consistent results. Subgroup analyses showed these findings were more pronounced in smokers. The main limitation of this study is its single time point observational design.</p><p><strong>Conclusion: </strong>A thinner PRL and thicker RPE may precede the clinical diagnosis of ALS, offering potential clues for early diagnosis and insights into the disease's pathogenesis.</p>","PeriodicalId":49008,"journal":{"name":"PLoS Medicine","volume":"22 6","pages":"e1004545"},"PeriodicalIF":15.8,"publicationDate":"2025-06-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12193630/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144498816","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}