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- New
- Research Article
- 10.1016/j.jad.2025.120465
- Jan 15, 2026
- Journal of affective disorders
- Chang-Chih Tsou + 2 more
Association of bipolar disorder with new-onset delirium among critically ill patients.
- New
- Research Article
- 10.1016/j.accpm.2025.101618
- Jan 1, 2026
- Anaesthesia, critical care & pain medicine
- Manuel Taboada + 26 more
Universal videolaryngoscopy for double-lumen tube tracheal intubation: Subanalysis of the VIDEOLAR-SURGERY trial.
- New
- Research Article
- 10.1016/j.jclinepi.2025.112012
- Jan 1, 2026
- Journal of clinical epidemiology
- Shi-Jia Wang + 20 more
Methodological and reporting rigor in noninferiority and equivalence trials for multimodality cancer treatment: lessons from breast cancer radiotherapy.
- New
- Research Article
- 10.1016/s2213-2600(25)00330-3
- Jan 1, 2026
- The Lancet. Respiratory medicine
- Prothor Collaborative Group
Effects of intraoperative higher versus lower positive end-expiratory pressure during one-lung ventilation for thoracic surgery on postoperative pulmonary complications (PROTHOR): a multicentre, international, randomised, controlled, phase 3 trial.
- New
- Research Article
- 10.1016/j.pec.2025.109408
- Jan 1, 2026
- Patient education and counseling
- Soyun Kim + 1 more
Effect of presentation formats for direct-to-consumer genetic testing results: A web-based experimental study in South Korea.
- New
- Research Article
- 10.7326/annals-25-00662
- Dec 30, 2025
- Annals of internal medicine
- Vincent Ka Chun Yan + 5 more
Whether statins benefit patients with type 2 diabetes mellitus (T2DM) with low predicted 10-year cardiovascular risk is uncertain. To evaluate the effectiveness and safety of statin initiation for primary prevention among adults with T2DM stratified by predicted 10-year risk for cardiovascular disease (CVD). Cohort study using target trial emulation. U.K. primary care using the IQVIA Medical Research Data database. Persons aged 25 to 84 years with a diagnosis of T2DM between 2005 and 2016 and no history of coronary artery disease, myocardial infarction, stroke, heart failure, myopathy, liver disease, rheumatic heart disease, schizophrenia, or cancer. Statin initiation versus noninitiation, with estimation of the observational analogues of the intention-to-treat effect. Statin initiators were propensity score-matched to noninitiators in a 1:4 ratio within 4 QRISK3 strata of 10-year predicted cardiovascular risk: low (<10%), intermediate (10% to 19%), high (20% to 29%), and very high (≥30%). Absolute risk differences (RDs) and risk ratios (RRs) at 10 years of follow-up for all-cause mortality and major CVD, as well as myopathy and liver dysfunction. Statin initiation was associated with reductions in all-cause mortality and major CVD across QRISK3 strata. In the low-risk stratum, RDs and RRs were -0.53% (95% CI, -0.90% to -0.08%) and 0.80 (95% CI, 0.67 to 0.97), respectively, for all-cause mortality and -0.83% (95% CI, -1.28% to -0.34%) and 0.78 (95% CI, 0.66 to 0.91), respectively, for major CVD. A small increased risk for myopathy was observed in the moderate-risk stratum only, and there was no associated increased risk for liver dysfunction in any stratum. Unmeasured confounding and underascertainment of some hospitalization outcomes. Statin use in T2DM for primary prevention was associated with reductions in all-cause mortality and major CVD across the full spectrum of predicted cardiovascular risk. National Natural Science Foundation of China.
- Research Article
- 10.1007/s00264-025-06726-7
- Dec 18, 2025
- International orthopaedics
- Tai-Long Shi + 8 more
In the context of the widespread implementation of enhanced recovery after surgery (ERAS) in orthopaedics, postoperative supportive interventions for patients with lower limb fractures remain limited. This study aimed to introduce a vibration-stimulation device designed in accordance with ERAS principles and to evaluate its clinical effectiveness. This prospective randomized controlled trial consecutively screened 1,241 patients aged 18-75years with lower limb fractures admitted to a tertiary university-affiliated orthopaedic hospital between January and December 2024, of whom 707 met the inclusion criteria. Patients were randomly assigned in a 1:1 ratio by a random number table to a vibration group or a blank control group. The primary outcomes were the sevenday postoperative pain visual analogue scale (VAS) score and the incidence of lower limb deep vein thrombosis (DVT). Secondary outcomes were radiographic fracture-healing time and postoperative functional scores. The primary analysis followed the intention-to-treat (ITT) principle, comparing all randomized patients with available outcome data according to their original allocation, and a per-protocol (PP) sensitivity analysis was additionally performed. A total of 707 patients completed six to12months of follow-up and were included in the ITT analysis (350 in the vibration group and 357 in the control group). In the overall population, the sevenday postoperative incidence of lower limb DVT was significantly lower in the vibration group than in the control group [10.9% (38/350) vs 22.6% (81/357); absolute risk difference (ARD) = 11.7%]. The sevenday postoperative pain scores were lower in the vibration group (weighted mean approximately 5.1 vs 5.7), radiographic fracture-healing time was shorter (approximately 5.2 vs 5.5months), and functional scores at final follow-up were higher (approximately 127.8 vs 123.2). PP sensitivity analyses yielded results consistent in direction with the ITT analyses, further supporting the robustness of the study conclusions. Vibration-stimulation therapy facilitates rapid postoperative recovery in patients with lower limb fractures and has a favourable safety profile, and may represent a promising component of postoperative ERAS strategies in the future.
- Research Article
- 10.64898/2025.12.14.25342167
- Dec 15, 2025
- medRxiv
- Nada R Abuknesha + 39 more
Background:Recent meta-analyses of randomized controlled trials (RCTs) have raised concerns that treatment with omega-3 fatty acids may increase risk of atrial fibrillation (AF). However, these meta-analyses included at most eight trials. The aim of this current meta-analysis was to expand the search by including other eligible omega-3 RCTs with AF incidence data, incorporating both published and unpublished data.Methods:Eligible studies were RCTs investigating daily doses of ≥500 mg/d of docosahexaenoic acid (DHA) and/or eicosapentaenoic acid (EPA). Additional inclusion criteria included ≥12 months treatment with EPA/DHA, participants ≥ 50 years of age, and where possible, the absence of known AF/atrial flutter at baseline. The primary outcome was occurrence of new-onset AF. Our primary hypothesis was that risk for AF would simultaneously depend on both omega-3 dose (above or below 1500 mg/d) and background cardiovascular disease (CVD) risk status, and that their combined impact on AF risk would be synergistic.Results:A total of 34 RCTs (36 datasets; n=114,326) were included in this meta-analysis. Only studies including patients at high-risk for CVD who were treated with high-doses of EPA/DHA (>1500 mg/day) showed a statistically significant increase in AF risk with a pooled odds ratio (OR) of 1.48 (95% CI, 1.21–1.81) and an absolute risk difference of 0.8% (0.40–1.1%). None of the other three groups showed statistically significant levels of AF risk (ORs 1.07 (high risk, low dose), 1.06 (low risk, low dose) and 0.95 (low risk, high dose).Conclusion:This meta-analysis suggests that treatment with EPA/DHA is most likely to increase risk for AF in patients at high-risk for CVD who are treated with high doses of EPA/DHA. The risk for AF should be balanced against the benefits of EPA/DHA in making treatment decisions.
- Research Article
- 10.1038/s41598-025-27467-y
- Dec 12, 2025
- Scientific Reports
- Sirarat Ittipuripat + 6 more
Delayed-start contraception may reduce the risk of unintended pregnancy; however, data on newer formulations, such as estetrol (E4)-containing pills are limited. Therefore, this study aimed to evaluate the effectiveness of delayed start combined oral contraceptives (COCs) containing 15 mg E4 and 3 mg drospirenone (E4/DRSP). In this randomized, single-blind, non-inferiority trial, 36 healthy women aged 18–45 years with regular menstrual cycles were assigned to receive either E4/DRSP or 20 µg ethinyl estradiol/75 µg gestodene (EE/GS), starting treatment between cycle day 7 and 9. The primary outcome was ovulation inhibition, assessed using the modified Hoogland score. The secondary outcomes included cervical mucus changes and adverse effects. Baseline characteristics did not differ significantly between the groups. The mean age and menstrual cycle length were 38.75 ± 5.8 years and 28.67 ± 1.96 days, respectively. More than half (55.56%) of the participants began COC use on day 9, with 50% of them showing active follicular development at baseline (Hoogland score of 4). Ovulation was inhibited in 61.11% of participants in both groups (adjusted relative risks: 0.95, 95% confidence interval [CI]: 0.56–1.59, p = 0.841, and absolute risk difference: −0.03, 95% CI: −0.39 to 0.33). Approximately half of the participants who ovulated showed ovarian activity that was not associated with theoretical pregnancy risk. Cervical mucus profiles and adverse events, including unscheduled bleeding, did not differ significantly between the groups. Initiating E4/DRSP on cycle day 7–9 appears comparable to that of EE/GS for ovulation inhibition; however, high ovulation rates limit the confirmation of non-inferiority.Clinical trial registration: ClinicalTrials.gov Registration on April 25, 2024 (ID: NCT06396221; https://clinicaltrials.gov/study/NCT06396221).Supplementary InformationThe online version contains supplementary material available at 10.1038/s41598-025-27467-y.
- Research Article
- 10.1007/s11695-025-08433-z
- Dec 11, 2025
- Obesity surgery
- Juan S Barajas-Gamboa + 15 more
Small bowel obstruction (SBO) represents a serious early complication following Roux-en-Y gastric bypass (RYGB) surgery. With the widespread adoption of robotic platforms in bariatric surgery, understanding the impact of robotic assistance on postoperative complications has become increasingly important. However, the association between robotic assistance and early SBO risk remains unclear in the current literature. This study aimed to evaluate the relationship between robotic assistance and early postoperative small bowel obstruction following primary RYGB procedures. We conducted a retrospective cohort study analyzing the 2020-2023 Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program (MBSAQIP) database from over 900 accredited bariatric surgery centers across the United States and Canada. Patients undergoing primary RYGB were stratified by occurrence of 30-day SBO. The primary outcomes evaluated were early postoperative small bowel obstruction rates, reoperation rates, and readmission rates. Multivariable logistic regression was used to identify independent predictors of SBO, adjusting for patient demographics, comorbidities, and operative factors. A total of 188,213 RYGB procedures were included in the study, with 1,704 patients (0.9%) developing early SBO. Robotic assistance was utilized in 29.2% of cases. Baseline characteristics showed that SBO patients were predominantly female (90.1% vs. 83.4%, p < 0.001) with lower BMI (43.6 vs. 45.5kg/m², p < 0.001) and longer operative times (141.7 vs. 124.7min, p < 0.001). SBO occurred more frequently with robotic assistance compared to conventional approaches (1.2% vs. 0.8%, p < 0.001), representing an absolute risk difference of 0.4% or approximately 4 additional SBO cases per 1,000 robotic procedures. Multivariable analysis confirmed robotic assistance as an independent risk factor for early SBO (OR 1.30, 95% CI 1.17-1.44, p < 0.001), alongside female sex (OR 1.76) and VTE history (OR 1.55). SBO cases showed significantly higher reoperation rates (54.7% vs. 1.2%) and readmission rates (75.1% vs. 4.1%) compared to patients without SBO. Robotic assistance is independently associated with increased early SBO risk following RYGB (OR 1.30, absolute risk 1.2% vs. 0.8%, 4 additional cases per 1,000 procedures). While the absolute risk increase is modest, these findings necessitate balanced patient counseling that incorporates both this increased early SBO risk and potential benefits of robotic approaches. These results support the development of standardized robotic protocols to mitigate SBO occurrence while leveraging the advantages of robotic technology in bariatric surgery centers.
- Research Article
- 10.1093/jsxmed/qdaf320.070
- Dec 9, 2025
- The Journal of Sexual Medicine
- M Hammad + 4 more
Abstract Introduction Minimally invasive surgical treatments (MISTs) for benign prostatic hyperplasia (BPH), including UroLift and Rezūm, are increasingly adopted due to their favorable safety profiles and functional outcomes. While both are marketed as preserving sexual function, direct comparative data on erectile dysfunction (ED) and ejaculatory dysfunction (EJD) are limited. Objective To compare outcomes of ED and EJD following UroLift versus Rezūm using large real-world dataset with long-term follow-up. Methods We conducted a retrospective cohort study using TriNetX research network. Men undergoing UroLift (CPT 52441) or Rezūm (CPT 53854) for BPH (ICD-10 N40) were identified. Prior to matching, the UroLift and Rezūm cohorts included 9,145 and 4,477 patients, respectively, across 90 and 79 health care organizations. Cohorts were propensity score matched (PSM) 1:1 based on demographics and comorbidities: age, race, BMI, hypertension, diabetes, hyperlipidemia, testicular hypofunction. Primary outcomes were incident ED (ICD-10 N52) and EJD (ICD-10 N53.1) within the follow-up period. Risk differences and five-year Kaplan-Meier (KM) survival analyses were used to compare outcomes. Patients with prior diagnoses of ED or EJD were excluded. Results A total of 8,710 patients were included following 1:1 propensity score matching (4,355 per group). Median follow-up duration was approximately 33.7 months (IQR: 18.7–72.3) for UroLift and 25.1 months (IQR: 14.2–64.2) for Rezūm. ED occurred in 11.3% of UroLift patients and 12.3% of Rezūm patients, with a non-significant absolute risk difference of -0.997% (95% CI -2.594%, 0.601%, p=0.2215) and a risk ratio of 0.919 (95% CI 0.802, 1.052). KM excluding patients with baseline ED demonstrated significantly improved ED-free survival in the UroLift cohort compared to Rezūm (82.6% vs. 78.8% at 5 years), with a hazard ratio of 0.787 (95% CI 0.681–0.91, p=0.0012). EJD was significantly lower in the UroLift group (0.683%) compared to Rezūm (1.174%) with an absolute risk reduction of 0.491% (95% CI -0.899% to -0.084%) and risk ratio of 0.582 (95% CI 0.369, 0.917, p = 0.0183). Five-year KM survival analysis demonstrated a significantly higher EJD-free survival probability in the UroLift group (98.996%) versus Rezūm (97.969%), (log-rank p= 0.0024). Conclusions Both UroLift and Rezūm are effective MISTs for BPH with low absolute rates of ED and EJD. In this large, propensity-matched real-world cohort, UroLift was associated with a statistically significant reduction in the risk of both ED and EJD compared to Rezūm. These findings highlight differences in side-effect profiles that may inform individualized procedure selection based on patient preferences and clinical priorities. Disclosure Any of the authors act as a consultant, employee or shareholder of an industry for: Coloplast: Advisory board, speaker; Endo: Advisory board; Haleon: Advisory board; Halozyme: Advisory board, speaker; Masimo: Intellectual property; Softwave: Advisory board; Sprout: Consultant; Vertica: Research investigator; Xialla: Advisory board
- Research Article
- 10.3390/jcm14248704
- Dec 9, 2025
- Journal of Clinical Medicine
- María Rocío Fernández-Ojeda + 5 more
Background: Community-acquired pneumonia (CAP) remains one of the leading causes of infectious mortality worldwide. Variability in diagnosis and management can significantly influence outcomes. Objective: To assess the association between the implementation of a standardized hospital protocol and clinical outcomes in patients hospitalized for bacterial CAP and to identify factors associated with in-hospital and 30-day mortality. Methods: An ambispective before–after study was conducted at Hospital San Juan de Dios del Aljarafe (Seville, Spain), including a retrospective phase (2019) and a prospective intervention period (2022–2023). The intervention consisted of a standardized clinical protocol supported by training sessions and a 9-item checklist. Adults (≥18 years) with clinically and radiologically confirmed bacterial CAP were included. Mortality, length of stay, and empirical and targeted antibiotic adequacy were compared between periods. In the prospective cohort (n = 169), mortality-associated factors were analyzed using multivariate logistic regression. Results: A total of 1610 patients were analyzed: 634 in the pre-intervention period and 976 during the intervention period. Hospital mortality was lower during the intervention (11.3% [95% CI 9.3–13.2] vs. 16.6%; [95% CI 13.7–19.5] p = 0.002) with an absolute risk difference of 5.3%, corresponding to an approximate number needed to treat (NNT) of 19. Median length of stay decreased slightly (8.1 vs. 7.9 days; p < 0.001). In the prospective cohort, in-hospital mortality was 7.7% and 30-day mortality 16.6%. The therapeutic effort limitation (aOR 9.10, 95% CI 1.36–121.57; p = 0.021) and lower SaO2/FiO2 (aOR per unit 0.98, 95% CI 0.97–0.99; p < 0.001) were independently associated with in-hospital mortality. The ARDS (aOR 4.29, 95% CI 1.05–19.93; p = 0.043), lower SaO2/FiO2 (aOR 0.99 per unit, 95% CI 0.98–1.00; p = 0.005), older age (aOR 1.06 per year, 95% CI 1.02–1.12; p = 0.005), and lower Barthel Index (aOR 0.97 per point, 95% CI 0.94–0.99; p < 0.001) were associated with higher 30-day mortality. Conclusions: Implementation of a standardized CAP protocol was associated with lower mortality and high antibiotic adequacy in the intervention cohort. While causal inference is limited by the non-contemporaneous before–after design, these findings support the integration of structured, multidisciplinary, protocol-driven strategies—together with periodic audit and feedback cycles—to strengthen CAP management in community hospital settings.
- Research Article
- 10.5694/mja2.70051
- Dec 8, 2025
- The Medical journal of Australia
- Michael L Marinovich + 10 more
To understand whether and how breast magnetic resonance imaging (MRI) at cancer diagnosis influences treatment planning, and whether subpopulations of patients with newly diagnosed breast cancer benefit in terms of most appropriate management. Multicentre prospective observational study. Seven centres across New South Wales, Victoria and Western Australia during the period 15 September 2020 to 14 July 2022. Patients with newly diagnosed early breast cancer meeting predefined criteria for whom multidisciplinary team normal practice deemed MRI would aid treatment planning. Preoperative contrast-enhanced MRI. Reasons for requesting MRI; pre-MRI versus post-MRI changes in treatment plans; changes justified by pathology findings. 387 eligible participants were enrolled. MRI was most frequently requested for dense breasts (252 [65%]), clinical and/or radiological size discrepancy (161 [42%]), multifocality (108 [28%]) and young age (105 [27%]). Change in treatment plan after MRI occurred for 198 participants (51% [95% CI, 46-56%]), including a change in breast surgery plan for 119 participants (31% [95% CI, 26-36%]). More mastectomies were planned after MRI (15% v 28%; absolute risk difference [RD], 13 percentage points [95% CI, 9-17]; P < 0.001), including unilateral mastectomy (14% v 24%; RD, 10 percentage points [95% CI, 6-14]; P < 0.001) and bilateral mastectomy (1% v 4%; RD, 3 percentage points [95% CI, 1-5]; P < 0.001). No increases in planned mastectomies occurred for women aged ≥ 70 years (RD, -3 percentage points [95% CI, -15 to 9]; or in those for whom neoadjuvant therapy was planned (RD, 2 percentage points [95% CI, -11 to 14]). Change in surgery was deemed justified by pathology findings in 75 of 88 women who experienced a change (85% [95% CI, 75-91%]). Preoperative MRI findings led to changes in surgical management for a third of selected women with early breast cancer, increasing the mastectomy rate. In most cases, the changes were deemed appropriate. MRI findings did not change planned mastectomy in those aged ≥ 70 years, indicating that these women may not experience changes in surgical plans after such testing.
- Research Article
- 10.1001/jamanetworkopen.2025.47618
- Dec 8, 2025
- JAMA Network Open
- Anders Hviid + 3 more
Respiratory syncytial virus (RSV) infection has recently been recognized as common among adults, but data on the burden of cardiovascular disease (CVD) beyond the immediate acute phase are lacking. To estimate the 365-day absolute excess risk (risk difference) of composites of CVD and their individual components following laboratory-confirmed RSV infection in adults. This nationwide, registry-based, matched cohort study was conducted using Danish national health registries. Adults aged 45 years or older on January 1, 2019, with a laboratory-confirmed RSV infection between January 1, 2019, and December 31, 2024, were matched 1:1 on age, sex, and preexisting comorbid conditions to individuals without RSV infection. Similar matched cohorts were established for influenza infection, hip fracture, and urinary tract infection without sepsis as control groups. Laboratory-confirmed RSV infection. The primary outcomes were major adverse cardiovascular events, comprising ischemic heart disease, stroke, and heart failure, and any cardiovascular event, comprising major adverse cardiovascular events together with arrhythmias, venous thromboembolism, and inflammatory heart disease. Matched individuals were followed up for up to 365 days after the index date. Absolute risk differences and 95% CIs were calculated at 30 and 365 days using cumulative incidences derived from the Aalen-Johansen estimator. The study included 17 494 matched individuals (mean [SD] age, 71.8 [12.0] years; 57.6% female). At 365 days, 665 any cardiovascular events had occurred among 8747 individuals with RSV infection and 257 among 8747 individuals without infection, corresponding to a risk difference of 4.69 percentage points (95% CI, 4.02-5.36 percentage points). The largest 365-day risk differences for any cardiovascular event were observed in hospitalized patients (6.61 percentage points [95% CI, 5.70-7.52 percentage points]), older individuals (eg, 7.93 percentage points [95% CI, 5.34-10.53 percentage points] for those aged 85-94 years), and preexisting CVD (11.95 percentage points [95% CI, 8.80-15.10 percentage points ]) or diabetes (7.50 percentage points [95% CI, 4.53-10.47 percentage points]). The 1-year cardiovascular event risk following RSV was comparable to that following influenza infection. This cohort study of adults aged 45 years or older with RSV infection found a significant excess risk of cardiovascular events over 1 year, comparable in magnitude to influenza infection. These findings underscore the importance of RSV as a potential risk factor for cardiovascular morbidity and highlight the need for vaccination to mitigate this burden.
- Research Article
- 10.1136/bmjopen-2025-107636
- Dec 1, 2025
- BMJ Open
- Habtie Bantider Wubet + 11 more
ObjectiveTo assess how preoperative anaemia affects surgical outcomes in elderly patients within a resource-limited setting.DesignProspective cohort study.SettingTwo comprehensive specialised hospitals in Ethiopia.ParticipantsParticipants consisted of 224 patients aged 65 years and older who underwent surgery between 1 December 2024 and 29 March 2025.Primary and secondary outcome measuresPerioperative blood transfusions were the primary outcome. Secondary outcomes included intensive care unit (ICU) admission, risk of postoperative complications, prolonged hospitalisation, poor recovery quality and in-hospital mortality.ResultsThe anaemic group required transfusions of three or more units more frequently than the non-anaemic group (10.5% vs 2.6%; absolute risk difference 8.0%). Their perioperative transfusion rates were significantly higher (42.3% vs 18.4%; p<0.001; absolute risk difference 24.0%). This included intraoperative transfusions (31.5% vs 8.1%; p<0.001; absolute risk difference 23.4%) and postoperative transfusions (17.1% vs 9.9%; p=0.007; absolute risk difference 7.2%). Perioperative transfusion was associated with increased risks of in-hospital mortality (Relative Risk [RR]=3.60; 95% CI 2.40 to 6.80), postoperative complications (RR=2.42; 95% CI 1.25 to 4.70), ICU admission (RR=3.89; 95% CI 1.21 to 12.48), extended hospitalisation (RR=2.14; 95% CI 1.15 to 3.97) and poor recovery (RR=2.87; 95% CI 1.54 to 5.36).Conclusion and recommendationPreoperative anaemia significantly increases the risk of transfusion, poor recovery, ICU admission, prolonged hospitalisation and in-hospital mortality in older patients who underwent surgery. In resource-limited settings, improving perioperative outcomes should prioritise the early detection and treatment of anaemia.
- Research Article
- 10.2337/dc25-1440
- Dec 1, 2025
- Diabetes care
- Julian W Sacre + 3 more
Evidence that the calcium channel blocker (CCB) verapamil slows type 1 diabetes progression suggests possible preventive benefits among people at risk of developing type 2 diabetes. We compared type 2 diabetes incidence between users of verapamil versus other CCBs in a population-based cohort. From a random sample of Australians in national subsidized health care databases, we identified 90,026 individuals who initiated treatment with a CCB (at least two supplies) between July 2003 and December 2014. Incident diabetes was captured by subsequent receipt of glucose-lowering treatment or registration with the National Diabetes Services Scheme. Individuals were followed from first CCB supply until discontinuation, diabetes onset, death, or end of 2014. Multistate Poisson regression models characterized associations of CCB subclass with type 2 diabetes incidence and death (the competing event), after multivariable propensity score adjustment. The cohort comprised 4,485 verapamil users (5.0%) and 85,541 treated with other CCBs (mostly dihydropyridines). During a median 1.6-year follow-up, 101 individuals treated with verapamil developed type 2 diabetes (8.8 per 1,000 person-years) compared with 2,622 people treated with other CCBs (11.4 per 1,000 person-years). This translated to an incidence rate ratio of 0.77 (95% CI 0.63-0.94) in favor of verapamil (fully adjusted) and a lower probability of type 2 diabetes at 6 years (4.2% [95% CI 3.3-5.3] vs. 5.4% [4.7-6.3] for a typical clinical profile; absolute risk difference 1.3% [95% CI -0.1-2.4]). Results were robust across multiple sensitivity analyses. Verapamil use is associated with a lower incidence of type 2 diabetes compared with other CCBs.
- Research Article
1
- 10.1001/jama.2025.19843
- Dec 1, 2025
- JAMA
- Alain Combes + 16 more
Levosimendan may facilitate weaning from venoarterial extracorporeal membrane oxygenation (VA-ECMO) and improve survival, but supporting evidence remains limited. To assess whether early administration of levosimendan reduces the time to successful VA-ECMO weaning in patients with severe but potentially reversible cardiogenic shock. Randomized, double-blind, placebo-controlled trial conducted across 11 intensive care units (ICUs) in France. Between August 27, 2021, and September 10, 2024, 205 adult patients with acute cardiogenic shock who had started VA-ECMO in the preceding 48 hours were enrolled. Final follow-up was completed on November 10, 2024. Patients were randomized in a 1:1 ratio to receive levosimendan, 0.15 μg/kg per minute, to be increased to 0.20 μg/kg per minute after 2 hours (n = 101), or placebo (n = 104). The primary outcome was time to successful ECMO weaning within 30 days following randomization. Secondary outcomes included ECMO-, mechanical ventilation-, and organ failure-free days, ICU and hospital lengths of stay, serious adverse events, and all-cause 30- and 60-day mortality. Among the 205 randomized patients (median age, 58 [IQR, 50-67] years; 149 [72.7%] male), main cardiogenic shock etiologies were postcardiotomy (79 [38.5%]), acute myocardial infarction (56 [27.3%]), and myocarditis (28 [13.7%]). Treatment dose was increased to 0.20 ± 0.01 μg/kg per minute in 93% of patients receiving levosimendan and in 96% of those receiving placebo. Within 30 days, 69 of 101 patients (68.3%) had a successful ECMO weaning in the levosimendan group compared with 71 of 104 (68.3%) in the placebo group (risk difference, 0.0% [95% CI, -12.8% to 12.7%]; subdistribution hazard ratio, 1.02 [95% CI, 0.74-1.39]; P = .92). In the levosimendan and placebo groups, respectively, median ECMO duration (5 [IQR, 4-7] days vs 6 [IQR, 4-11] days; P = .53), mean ICU length of stay (18 [SD, 15] days vs 19 [SD, 15] days; P = .42), and 60-day mortality (27.7% vs 25.0%; risk difference, 2.7% [95% CI, -9.0% to 15.3%]; P = .78) did not differ significantly. Ventricular arrhythmias occurred more frequently with levosimendan (18 [17.8%] vs 9 [8.7%]; absolute risk difference, 9.2% [95% CI, 0.4%-18.1%]). Among patients with severe but potentially reversible cardiogenic shock supported by VA-ECMO, early levosimendan administration did not significantly reduce the time to successful weaning of ECMO compared with placebo. ClinicalTrials.gov Identifier: NCT04728932.
- Abstract
- 10.1017/s0266462325102304
- Dec 1, 2025
- International Journal of Technology Assessment in Health Care
- Carolina Latorraca + 9 more
IntroductionOne way of communicating the effect of interventions is by converting relative effects, such as relative risk, into absolute effects. Guidelines from the GRADE working group and the Cochrane Handbook for Systematic Reviews of Interventions recommend this conversion for summarizing and concluding evidence syntheses. However, this conversion can lead to errors, and previous research has indicated that inadequacies are frequent in Cochrane reviews that convert hazard ratios to absolute effect measures.MethodsA descriptive study outlined the development of the abseff program, created using the ado programming language of the Stata software and R. This program was developed in the context of two projects conducted by the Center of Health Technology Assessment, Hospital Sírio-Libanês, São Paulo-SP, Brazil in collaboration with the Ministry of Health, the National Supplementary Health Agency, and the National Council of Justice through the Support Program for Institutional Development of the Unified Health System (PROADI-SUS). Both projects involve drawing up evidence summaries, and the abseff program aims to convert relative effect into corresponding absolute effect measures.ResultsAbseff converts data on relative effects (relative risks, odds ratios, hazard ratios) into absolute effects, including 95 percent confidence intervals (CI). Researchers input a relative effect and its confidence interval with a baseline risk for the calculation. For example, the command abseff rr 0.83 0.63 1.03 50 130 converts a relative risk of 0.83 (95% CI: 0.63, 1.03) with a baseline risk of 50/130 (38%). The result is presented in absolute anticipated effects and absolute risk difference, and calculations account for bases of 100 and 1,000. The program is freely available via Stata and R. For more details access https://rlpacheco.github.io/abseff/; https://github.com/rlpacheco/abseff_R.ConclusionsEffective communication of evidence can be challenging, and translating scientific knowledge can be facilitated by presenting absolute effect measures to the decision maker. The abseff program standardizes these conversions, minimizing errors and ensuring reproducibility in analyses. Originally created as part of two projects funded by PROADI-SUS, abseff is now available for use by all health technology assessment researchers.
- Research Article
- 10.1016/j.resuscitation.2025.110893
- Dec 1, 2025
- Resuscitation
- Tommaso Scquizzato + 12 more
Temporary mechanical circulatory support after return of spontaneous circulation following cardiac arrest: a systematic review and meta-analysis.
- Research Article
- 10.1016/j.ahj.2025.107325
- Dec 1, 2025
- American heart journal
- Mathias Holm Sørgaard + 18 more
Coronary computed tomography angiography versus invasive coronary angiography for interventional triage in acute coronary syndrome: Design of the randomized TRACTION trial.