BMC Medicine最新文献

{"title":"Evaluating the agreement between sensitivity and primary analyses in observational studies using routinely collected healthcare data: a meta-epidemiology study.","authors":"Jiayue Xu, Yuning Wang, Qiao He, Shuangyi Xie, Sheng Feng, Xiaofei Wang, Wen Wang, Xin Sun","doi":"10.1186/s12916-025-04199-4","DOIUrl":"10.1186/s12916-025-04199-4","url":null,"abstract":"<p><strong>Background: </strong>Sensitivity analysis is a crucial approach to assessing the \"robustness\" of research findings. Previous reviews have revealed significant concerns regarding the misuse and misinterpretation of sensitivity analyses in observational studies using routinely collected healthcare data (RCD). However, little is known regarding how sensitivity analyses are conducted in real-world observational studies, and to what extent their results and interpretations differ from primary analyses.</p><p><strong>Methods: </strong>We searched PubMed for observational studies assessing drug treatment effects published between January 2018 and December 2020 in core clinical journals defined by the National Library of Medicine. Information on sensitivity analyses was extracted using standardized, pilot-tested collection forms. We characterized the sensitivity analyses conducted and compared the treatment effects estimated by primary and sensitivity analyses. The association between study characteristics and the agreement of primary and sensitivity analysis results were explored using multivariable logistic regression.</p><p><strong>Results: </strong>Of the 256 included studies, 152 (59.4%) conducted sensitivity analyses, with a median number of three (IQR: two to six), and 131 (51.2%) reported the results clearly. Of these 131 studies, 71 (54.2%) showed significant differences between the primary and sensitivity analyses, with an average difference in effect size of 24% (95% CI 12% to 35%). Across the 71 studies, 145 sensitivity analyses showed inconsistent results with the primary analyses, including 59 using alternative study definitions, 39 using alternative study designs, and 38 using alternative statistical models. Only nine of the 71 studies discussed the potential impact of these inconsistencies. The remaining 62 either suggested no impact or did not note any differences. Conducting three or more sensitivity analyses, not having a large effect size (0.5-2 for ratio measures, ≤ 3 for standardized difference measures), using blank controls, and publishing in a non-Q1 journal were more likely to exhibit inconsistent results.</p><p><strong>Conclusions: </strong>Over 40% of observational studies using RCD conduct no sensitivity analyses. Among those that did, the results often differed between the sensitivity and primary analyses; however, these differences are rarely taken into account. The practice of conducting sensitivity analyses and addressing inconsistent results between sensitivity and primary analyses is in urgent need of improvement.</p>","PeriodicalId":9188,"journal":{"name":"BMC Medicine","volume":"23 1","pages":"393"},"PeriodicalIF":7.0,"publicationDate":"2025-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12220123/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144538848","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 impact of the COVID-19 pandemic on maternal healthcare costs: a time series analysis of pregnancies of multi-ethnic mothers in South London, United Kingdom.","authors":"Alice McGreevy, Marina Soley-Bori, Florence Tydeman, Kathryn V Dalrymple, Sara L White, Asma Khalil, Lucilla Poston, Emma L Duncan, Tisha Dasgupta, Hiten D Mistry, Julia Fox-Rushby, Peter von Dadelszen, Laura A Magee","doi":"10.1186/s12916-025-04165-0","DOIUrl":"10.1186/s12916-025-04165-0","url":null,"abstract":"<p><strong>Background: </strong>Due to the COVID-19 pandemic, maternity care reconfigurations disrupted in-person care, which shifted towards virtual care and self-monitoring. We assessed the impact of these changes on maternity service provision costs.</p><p><strong>Methods: </strong>Data from October 2018 to April 2023 were used from the population-based early-LIfe data cross-LInkage in Research, Born in South London (eLIXIR-BiSL) platform linking maternity, neonatal, and mental healthcare data from three National Health Service (NHS) hospitals in South London, United Kingdom. Maternity costs were generated from the NHS perspective, using national unit costs and individual-level use of maternity, mental health, and primary care services. Interrupted time series analysis estimated the pandemic impact on monthly mother-newborn costs over time. Cross-sectional pre-pregnancy cost models isolated the impact of virtual care and gestational diabetes (GDM) self-monitoring using the GDm-Health app. Ethnic inequalities in the impact of the pandemic on maternity costs were assessed via interaction terms.</p><p><strong>Results: </strong>Among 36,895 pregnancies, the monthly cost time series level dropped by 4% (£ - 38, 95% confidence interval: [£ - 65 to - 10]), during the first pandemic lockdown, and by 7.6% (£ - 72 [£ - 108 to - 36]), when lockdowns were lifted compared with the pre-pandemic period. However, the pre-pandemic slightly upward timeseries slope of costs (£4 per month, [£0.30 to £6.83]) was unchanged during the pandemic (£0.46 [£ - 2.93 to 3.84]). Monthly costs increased with first lockdown for Black (£103 [£26 to 181]) and Asian women (£128 [£38 to 218]) and increased more slowly during post-lockdown (£ - 12 [£ - 23 to - 2]), for Asian women, remaining higher throughout the pandemic for Black and Asian women compared with White women. A 1% increase in virtual care was associated with a £7 (£3 to 10) increase in maternity costs. GDM self-monitoring via GDm-Health was cost-neutral (£140 [£ - 68 to 348]).</p><p><strong>Conclusions: </strong>The pandemic was associated with temporary reductions in maternity costs due to lower healthcare utilisation. Ongoing, rising maternity costs were unchanged. The pandemic had differential effects on Black and Asian women compared with White women. Further research is needed into clinical outcomes of virtual care (associated with higher costs) and use of GDm-Health (cost-neutral).</p>","PeriodicalId":9188,"journal":{"name":"BMC Medicine","volume":"23 1","pages":"375"},"PeriodicalIF":7.0,"publicationDate":"2025-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12217901/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144538901","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 COVID-19 pandemic increased the incidence of newly diagnosed cancers: evidence from a large cohort study in Southern Italy.","authors":"Valentina Trimarco, Raffaele Izzo, Daniela Pacella, Maria V Manzi, Fahimeh Varzideh, Maria Lembo, Paola Gallo, Roberto Piccinocchi, Carmine Morisco, Francesco Rozza, Gaetano Piccinocchi, Michelangelo Mercogliano, Stanislovas S Jankauskas, Giovanni Esposito, Raffaele Palladino, Gaetano Santulli, Bruno Trimarco","doi":"10.1186/s12916-025-04237-1","DOIUrl":"10.1186/s12916-025-04237-1","url":null,"abstract":"<p><strong>Background: </strong>Recent studies based on hospital and outpatient clinic databases have reported a decline in cancer diagnoses during the COVID-19 pandemic, an observation that has been mainly attributed to halted screenings.</p><p><strong>Methods: </strong>We investigated the impact of COVID-19 on cancer incidence in the Campania Region (Italy) among adults followed by their primary care physicians over a 6-year period (2017-2022). Using a single-cohort design, we employed interrupted time series (ITS) analysis to compare cancer incidence rates during the 3 years preceding the pandemic (2017-2019) with those during the three pandemic years (2020-2022).</p><p><strong>Results: </strong>We analyzed data from 212,656 individuals and found that the incidence of new cancer diagnoses rose from 14.3 to 23.1 per 1000 person-years when comparing the pre-pandemic to the COVID-19 period. ITS analysis revealed a stable trend in cancer diagnoses before the pandemic, followed by a marked increase of ~8 new cases per month beginning in January 2020, with a peak observed in August 2021. Notably, diagnoses of brain and skin cancers increased by 300% in 2022 compared to 2017.</p><p><strong>Conclusions: </strong>Taken together, these findings highlight a concerning increase in cancer diagnoses in the Campania Region during the COVID-19 pandemic, contrasting with earlier reports that pointed to a decline in cases, mostly attributed to interrupted screening services. Several indirect factors might contribute to this trend, including heightened psychosocial stress and shifts in lifestyle behaviors, as well as profound disruptions in access to and continuity of healthcare delivery.</p>","PeriodicalId":9188,"journal":{"name":"BMC Medicine","volume":"23 1","pages":"399"},"PeriodicalIF":7.0,"publicationDate":"2025-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12218094/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144538899","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 promoting effects of digital targeted cognitive training in medication treatment for children with ADHD: a randomized controlled trial.","authors":"Chen Dang, Yu Zhu, Xiangsheng Luo, Lu Liu, Yuan Feng, Guisen Wu, Shaogen Zhong, Xin Wang, Jianzhao Zhang, Yike Zhu, Siqi Liu, Ziqi Liu, Li Qin, Xiaohui Ma, Yufeng Wang, Xiaoyi Wang, Jian Yang, Changming Wang, Li Sun","doi":"10.1186/s12916-025-04192-x","DOIUrl":"10.1186/s12916-025-04192-x","url":null,"abstract":"<p><strong>Background: </strong>Attention deficit hyperactivity disorder (ADHD) is a common neurodevelopmental disorder often managed with medication. Improving cognitive functions alongside medication treatment is crucial for better outcomes. This study mainly aimed to investigate the therapeutic effects of combining digitally targeted cognitive training with medication compared to medication monotherapy on ADHD core symptoms. We hypothesized that targeted cognitive training could enhance treatment efficacy when combined with medication.</p><p><strong>Methods: </strong>This was a randomized parallel-group controlled trial. A total of 124 children with ADHD were randomly allocated to two groups: 64 received medication treatment alone (M), including atomoxetine (ATX) and methylphenidate (MPH); 60 received targeted cognitive training combined with medication (TCT + M), including TCT + ATX and TCT + MPH. Both groups received 8 weeks of treatment. The primary outcome was the changes in ADHD core symptoms measured by the ADHD Rating Scale (ADHD-RS). The secondary outcomes were parent-reported ecological executive functions, social functions, and laboratory cognitive functions.</p><p><strong>Results: </strong>Main results: When compared with M treatment, the TCT + M treatment did not show significant greater improvements in ADHD core symptoms, ecological executive functions, social functions, or laboratory cognitive functions. Post-hoc exploratory analysis results: (1) In patients who received ATX treatment, TCT + ATX led to greater improvement in ADHD-RS total, inattention, and hyperactivity/impulsivity symptoms. Similar between-group differences were observed in ecological executive functions, and the improvements were significantly correlated with changes of ADHD core symptoms. (2) In patients who received MPH treatment, no significant differences in the improvement of primary or secondary outcomes were observed between MPH monotherapy and TCT + MPH groups.</p><p><strong>Conclusions: </strong>These findings demonstrated that, in comparison to medication monotherapy, the TCT + M treatment did not lead to more improvements in the core symptoms of ADHD, nor did it show superiority in other secondary outcomes. Specifically in children treated with atomoxetine, there's a potential promoting effect of targeted cognitive training on medication treatment in terms of the alleviation of ADHD core symptoms.</p><p><strong>Trial registration: </strong>This study was pre-registered with the Chinese Clinical Trial Registry under the identifier ChiCTR2100043525.</p>","PeriodicalId":9188,"journal":{"name":"BMC Medicine","volume":"23 1","pages":"371"},"PeriodicalIF":7.0,"publicationDate":"2025-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12219606/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144538902","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":"Maternal immune-mediated conditions and ADHD risk in offspring.","authors":"Kjersti Mæhlum Walle, Kristin Gustavson, Siri Mjaaland, Ragna Bugge Askeland, Per Magnus, Ezra Susser, W Ian Lipkin, Camilla Stoltenberg, Michaeline Bresnahan, Ted Reichborn-Kjennerud, Mady Hornig, Helga Ask","doi":"10.1186/s12916-025-04227-3","DOIUrl":"10.1186/s12916-025-04227-3","url":null,"abstract":"<p><strong>Background: </strong>Maternal immune-mediated conditions during pregnancy have been linked with increased risk of attention-deficit/hyperactivity disorder (ADHD) in offspring. The relative contributions of maternal inflammatory/immune responses versus shared genetic predispositions remain unclear. This study uses paternal immune-mediated conditions as a negative control to explore these factors, as we investigate associations between maternal immune-mediated conditions during pregnancy and offspring ADHD.</p><p><strong>Methods: </strong>Prospective data from the Norwegian Mother, Father, and Child Cohort Study (MoBa) was linked with the Medical Birth Registry of Norway (MBRN) and the Norwegian Patient Registry (NPR) to assess associations between prenatal exposure to maternal immune-mediated conditions and offspring ADHD risk up to age 18. Nationwide recruitment from 1999 to 2008 yielded 104,270 eligible mother-child pairs, with 21,340 children exposed to maternal allergic conditions (asthma, allergies, atopic conditions) and 7478 to other immune conditions (autoimmune, inflammatory). Paternal self-reported immune conditions served as negative controls. Children's ADHD diagnoses were obtained from NPR, and Cox proportional hazard models estimated hazard ratios for ADHD.</p><p><strong>Results: </strong>Both overall categories were associated with increased offspring ADHD risk (allergic conditions HR 1.23, 95% CI, 1.14-1.34; other immune conditions HR 1.36, 95% CI, 1.21-1.53). Specific associations included maternal asthma (HR 1.47, 95% CI, 1.30-1.67), allergies (HR 1.20, 95% CI, 1.10-1.31), rheumatologic/musculoskeletal conditions (HR 1.64, 95% CI, 1.28-2.10), Crohn's disease/ulcerative colitis (adjusted HR 1.95, 95% CI, 1.23-3.09), and endocrine conditions (HR 1.42, 95% CI, 1.15-1.77), specifically, type 1 diabetes (adjusted HR 2.50, 95% CI, 1.66-3.75). Although some paternal immune-mediated conditions (psoriasis, ulcerative colitis, Crohn's disease) showed similar trends in ADHD risk, only paternal asthma was significantly associated (adjusted HR 1.26, 95% CI, 1.10-1.45).</p><p><strong>Conclusions: </strong>Several maternal immune-mediated conditions were associated with increased offspring ADHD risk. The higher, more consistent ADHD risk estimates with maternal conditions compared to paternal ones indicate that unmeasured genetic confounding does not fully explain these associations. These results suggest direct effects on fetal development through events at the maternal-fetal interface which may alter fetal immune responses and lead to greater ADHD risk in offspring. Asthma may be an exception to this mechanism, as paternal asthma was also linked with offspring ADHD risk.</p>","PeriodicalId":9188,"journal":{"name":"BMC Medicine","volume":"23 1","pages":"348"},"PeriodicalIF":7.0,"publicationDate":"2025-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12210767/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144538880","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":"Comparative risk of severe constipation in patients treated with opioids for non-cancer pain: a retrospective cohort study in Northwest England.","authors":"Belay Birlie Yimer, Mehreen Soomro, John McBeth, Carlos Raul Ramirez Medina, Mark Lunt, William G Dixon, Meghna Jani","doi":"10.1186/s12916-025-04118-7","DOIUrl":"10.1186/s12916-025-04118-7","url":null,"abstract":"<p><strong>Background: </strong>Constipation is a frequent adverse event associated with opioid medications that can have a considerable impact on patients' quality of life. In patients who require opioids for pain relief, less is known about the risk conferred by specific opioids given their diverse pharmacology and the effect of daily dose and potency. The aim of the study was to evaluate the comparative risk of severe constipation by opioid type and dose in patients with non-cancer pain admitted to hospital.</p><p><strong>Methods: </strong>We conducted a retrospective cohort study using hospital electronic health records in Northwest England between December 1, 2009, and December 31, 2020. Patients who were ≥ 18 years and without a history of cancer were included. Opioid exposure was measured using administered drug information in hospital. The outcome was a severe constipation event defined as administration of an enema or suppository. Incidence rates by opioid use status, type of opioid class and morphine milligram equivalent (MME) per day were calculated, and a Cox regression model was used to determine associations with incident constipation after adjusting for confounders.</p><p><strong>Results: </strong>The study included 80,475 eligible patients who were administered an opioid in hospital. Compared to codeine, morphine (HR 1.59, 95% CI 1.45-1.74), oxycodone (HR 1.46, 95% CI 1.32-1.63), fentanyl (HR 1.37, 95% CI 1.14-1.64) and combination opioids (HR 1.85, 95% CI 1.66-2.06) were associated with a higher risk of constipation in the fully adjusted models. Tramadol demonstrated a significantly lower risk compared to codeine (HR 0.80, 95% CI 0.64-1.00). Higher opioid doses of more than ≥ 50 MME/day in comparison to < 50 MME/day were associated with an increased risk of constipation (compared to < 50 MME/day, 50 to < 120 MME/day: HR 1.95, 95% CI 1.78-2.15; ≥ 120 MME/day: HR 1.45, 95% CI 1.32-1.60).</p><p><strong>Conclusions: </strong>Morphine, oxycodone, fentanyl and combination opioids administration were associated with a significantly higher risk of severe constipation compared to codeine. Tramadol was associated with the lowest risk of the outcome compared to codeine. Patients on ≥ 50 MME/day experienced a higher risk of severe constipation compared to those on < 50 MME/day. These results can be used to guide better shared decisions with patients to balance benefit and harms of specific opioid types and doses.</p>","PeriodicalId":9188,"journal":{"name":"BMC Medicine","volume":"23 1","pages":"288"},"PeriodicalIF":7.0,"publicationDate":"2025-06-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12168406/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144301151","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":"Longitudinal plasma amino acids during pregnancy and neonatal anthropometry: findings from the NICHD Fetal Growth Studies-Singleton Cohort.","authors":"Claire Guivarch, Jing Wu, Ruijin Lu, Jagteshwar Grewal, Guoqi Yu, Ling-Jun Li, Jiaxi Yang, Wei Wei Pang, Dong D Wang, Natalie L Weir, Zhen Chen, Michael Y Tsai, Cuilin Zhang","doi":"10.1186/s12916-025-04146-3","DOIUrl":"10.1186/s12916-025-04146-3","url":null,"abstract":"<p><strong>Background: </strong>Amino acids (AAs) during pregnancy are crucial for fetal growth. Prior studies measured AA concentrations at single time points in pregnancy, despite their fluctuations throughout pregnancy. We measured plasma AA profiles in blood samples longitudinally collected from early through late pregnancy and evaluated their associations with neonatal anthropometry.</p><p><strong>Methods: </strong>Concentrations of plasma aromatic AAs, branched-chain AAs, and AAs involved in one-carbon metabolism were assessed at 10-14, 15-26, 23-31, and 33-39 gestational weeks (GW) among 321 women from a case-control study from the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Fetal Growth Studies-Singleton Cohort. Associations between AA concentrations in tertiles at each visit and neonatal anthropometric measures were assessed using weighted generalized estimating equations models, after adjusting for major confounders.</p><p><strong>Results: </strong>Women with higher concentrations of glutamine (3rd vs. 1st tertile) at 10-14 GW had offspring with greater birthweight z-score (β [95% CI] = 0.31 [0.06, 0.56], p-trend = 0.04) and birth length (1.35 cm [0.32, 2.37], p-trend = 0.04). Women with higher concentrations of aspartic acid (3rd vs. 1st tertile) at 23-31 GW, however, had offspring with smaller sum of skinfolds (- 3.9 mm [- 6.0, - 1.7], p-trend = 0.007). Similarly, women with higher concentrations of glycine (3rd vs. 1st tertile) at 10-14 GW had offspring with lower birthweight z-score (- 0.37 [- 0.65, - 0.08], p-trend = 0.04).</p><p><strong>Conclusions: </strong>Plasma AA concentrations during pregnancy appear to play a crucial role in neonatal anthropometry. Associations were observed as early as 10 GW and varied by type of AAs and gestational age.</p><p><strong>Trial registration: </strong>Clinical Trial Registry number: NCT00912132.</p>","PeriodicalId":9188,"journal":{"name":"BMC Medicine","volume":"23 1","pages":"343"},"PeriodicalIF":7.0,"publicationDate":"2025-06-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12147351/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144246457","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":"Microbiota boost immunotherapy? A meta-analysis dives into fecal microbiota transplantation and immune checkpoint inhibitors.","authors":"Anqi Lin, Lihaoyun Huang, Aimin Jiang, Lingxuan Zhu, Weiming Mou, Yu Li, Chunyan Zhang, Zaoqu Liu, Jian Zhang, Quan Cheng, Ting Wei, Peng Luo","doi":"10.1186/s12916-025-04183-y","DOIUrl":"10.1186/s12916-025-04183-y","url":null,"abstract":"<p><strong>Background: </strong>Immune checkpoint inhibitors (ICIs) are a cornerstone of modern cancer treatment, but their effectiveness is limited. Fecal microbiota transplantation (FMT), which alters the gut microbiome, has shown promise in enhancing ICIs' therapeutic effects.</p><p><strong>Methods: </strong>We conducted a comprehensive search of relevant studies available up to September 30, 2024, to analyze the clinical efficacy and safety of combining FMT with ICIs in cancer treatment. The primary endpoint was the objective response rate (ORR), with secondary evaluations of survival outcomes and safety.</p><p><strong>Results: </strong>A total of 10 studies involving 164 patients with solid tumors were included. The pooled ORR was 43% (95% CI: 0.35-0.51). Subgroup analysis revealed that the combination of anti-PD-1 and anti-CTLA-4 therapies was associated with a significantly higher ORR (60%) compared to anti-PD-1 monotherapy (37%; P = 0.01). The incidence of grade 1-2 adverse events (AEs) was 42% (95% CI: 0.32-0.52), while grade 3-4 AEs occurred in 37% of patients (95% CI: 0.28-0.46).</p><p><strong>Conclusions: </strong>This meta-analysis provides preliminary evidence supporting the use of FMT as a strategy to enhance the efficacy of ICIs in patients with advanced or refractory solid tumors. However, larger-scale randomized controlled trials with long-term follow-up are required to confirm and optimize treatment protocols.</p>","PeriodicalId":9188,"journal":{"name":"BMC Medicine","volume":"23 1","pages":"341"},"PeriodicalIF":7.0,"publicationDate":"2025-06-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12147380/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144246458","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":"Artificial intelligence-assisted diagnosis and prognostication in low ejection fraction using electrocardiograms in inpatient department: a pragmatic randomized controlled trial.","authors":"Dung-Jang Tsai, Chin Lin, Wei-Ting Liu, Chiao-Chin Lee, Chiao-Hsiang Chang, Wen-Yu Lin, Yu-Lan Liu, Da-Wei Chang, Ping-Hsuan Hsieh, Chien-Sung Tsai, Yuan-Hao Chen, Yi-Jen Hung, Chin-Sheng Lin","doi":"10.1186/s12916-025-04190-z","DOIUrl":"10.1186/s12916-025-04190-z","url":null,"abstract":"<p><strong>Background: </strong>Early diagnosis of low ejection fraction (EF) remains challenging despite being a treatable condition. This study aimed to evaluate the effectiveness of an electrocardiogram (ECG)-based artificial intelligence (AI)-assisted clinical decision support tool in improving the early diagnosis of low EF among inpatient patients under non-cardiologist care.</p><p><strong>Methods: </strong>We conducted a pragmatic randomized controlled trial at an academic medical center in Taiwan. 13,631 inpatient patients were randomized to either the intervention group (n = 6,840) receiving AI-generated ECG results or the control group (n = 6,791) following standard care. The primary outcome was the incidence of newly diagnosed low EF (≤ 50%) within 30 days following the ECG. Secondary outcomes included echocardiogram utilization rates, positive predictive value for low EF detection, and cardiology consultation rates. Statistical analysis included hazard ratios (HR) with 95% confidence intervals (CI) for time-to-event outcomes and chi-square tests for categorical variables.</p><p><strong>Results: </strong>The intervention significantly increased the detection of newly diagnosed low EF in the overall cohort (1.5% vs. 1.1%, HR 1.50, 95% CI: 1.11-2.03, P = 0.023), with a more pronounced effect among AI-identified high-risk patients (13.0% vs. 8.9%, HR 1.55, 95% CI: 1.08-2.21). While overall echocardiogram utilization remained similar between groups (17.1% vs. 17.3%, HR 1.00, 95% CI: 0.92-1.09), the intervention group demonstrated higher positive predictive value for identifying low EF among patients receiving echocardiogram (34.2% vs. 20.2%, p < 0.001). Post-hoc analysis revealed increased cardiology consultation rates among high-risk patients in the intervention group (29.3% vs. 23.5%, p = 0.027).</p><p><strong>Conclusions: </strong>Implementation of an AI-ECG algorithm enhanced the early diagnosis of low EF in the inpatient setting, primarily by improving diagnostic efficiency rather than increasing overall healthcare utilization. The tool was particularly effective in identifying high-risk patients who benefited from increased specialist consultation and more targeted diagnostic testing.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov Identifier: NCT05117970.</p>","PeriodicalId":9188,"journal":{"name":"BMC Medicine","volume":"23 1","pages":"342"},"PeriodicalIF":7.0,"publicationDate":"2025-06-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12147261/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144246454","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":"Projected health and economic effects of nonavalent versus bivalent human papillomavirus vaccination in preadolescence in the Netherlands.","authors":"Birgit Sollie, Johannes Berkhof, Johannes A Bogaards","doi":"10.1186/s12916-025-04170-3","DOIUrl":"10.1186/s12916-025-04170-3","url":null,"abstract":"<p><strong>Background: </strong>Most European countries offer human papillomavirus (HPV) vaccination through organised immunisation programmes, but the choice of vaccine varies. We compared the expected health and economic effects of the currently used bivalent vaccine, targeting HPV-16/18, and the nonavalent vaccine, targeting seven additional genotypes, for the Netherlands.</p><p><strong>Methods: </strong>We estimated the incremental impact of nonavalent versus bivalent vaccination in a cohort of 100,000 girls and 100,000 boys offered vaccination at age 10, by projecting type-specific infection risk reductions onto expected number of cervical screening outcomes, HPV-related cancers, and treatments for anogenital warts and recurrent respiratory papillomatosis (RRP). In the base-case, we assumed two-dose vaccination with 60% uptake, lifelong partial cross-protection against HPV-31/33/45 for the bivalent vaccine and EUR 25 extra cost per dose for the nonavalent vaccine. Cost-effectiveness was assessed from a healthcare provider perspective by comparing the incremental cost-effectiveness ratio (ICER) per life-year gained (LYG) with the Dutch threshold of EUR 20,000/LYG.</p><p><strong>Results: </strong>Compared with bivalent vaccination, nonavalent vaccination prevents an additional 1320 high-grade cervical lesions, 70 cancers, 34,000 anogenital warts episodes and 30 RRPs and generates EUR 4.1 million discounted savings from fewer treatments. The ICER is EUR 5489 (95% credible interval: 3765; 7019)/LYG in the base-case and exceeds the cost-effectiveness threshold only if the cross-protection for the bivalent vaccine extends permanently to non-31/33/45 genotypes or if the vaccine efficacy wanes past age 20 for both vaccines.</p><p><strong>Conclusions: </strong>Sex-neutral vaccination with the nonavalent vaccine is likely to be cost-effective. Long-term monitoring of type-specific vaccine effectiveness is essential because of the impact of cross-protection and waning efficacy on cost-effectiveness.</p>","PeriodicalId":9188,"journal":{"name":"BMC Medicine","volume":"23 1","pages":"339"},"PeriodicalIF":7.0,"publicationDate":"2025-06-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12147306/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144246460","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}