Category: Statistics

Dig Liver Dis. 2025 Sep 27:S1590-8658(25)01085-0. doi: 10.1016/j.dld.2025.09.007. Online ahead of print.

ABSTRACT

BACKGROUND AND AIMS: Tofacitinib, commonly used for ulcerative colitis, has shown promising results in the management of chronic pouchitis (CP). We performed a pooled analysis of the efficacy and safety of tofacitinib for CP.

METHODS: We searched multiple databases for articles reporting the outcomes of tofacitinib for the treatment of CP and conducted a meta-analysis.

RESULTS: 8 studies including 99 subjects (mean age: 37.5 years and 55.6 % males) were analyzed. The pooled clinical and endoscopic response rate was 47.7 % [Cl 33.3-62.6 %; I2= 40 %] and 51.7 % [Cl 37.4-65.7 %; I2=34 %], respectively. The remission rate was 41.2 % [Cl 26.6-57.6 %; I2= 0 %]. Clinical PDAI score improved markedly post-tofacitinib (Pre: 3.35 [Cl 2.9-3.7; I2 = 68 %] vs Post: 2.0 [Cl 1.59-2.4; Cl = 0 %], p-value <0.001). There was a significant reduction in endoscopic PDAI score (Pre: 4.5 [Cl 3.7-5.2; I2 = 84 %] vs Post: 2.5 [Cl 1.7-3.3; Cl = 64 %], p-value < 0.001) and total PDAI score (Pre: 7.4 [Cl 5.3-9.6; I2 = 96 %] vs Post: 4.3 [Cl 2.8-5.9; Cl = 84 %], p-value < 0.001). The pooled adverse events and discontinuation rates were 30.9 % [Cl 17.5-48.5; I2=24 %] and 43 % [Cl 25-63.1; I2=40 %] respectively.

CONCLUSION: Based on this meta-analysis, tofacitinib caused statistically significant changes in PDAI scores with favourable response and remission rates. Although adverse event and discontinuation rates are high, this is similar to or less frequent than those of other biologics. Future studies are required to evaluate the long-term safety profile of tofacitinib before considering it as an effective alternative for the treatment of CP.

PMID:41016876 | DOI:10.1016/j.dld.2025.09.007

Med Phys. 2025 Oct;52(10):e70011. doi: 10.1002/mp.70011.

ABSTRACT

BACKGROUND: One of the main challenges of utilizing spot-scanning proton arc therapy (SPArc) is treatment delivery efficiency. Previous studies focus on reducing the number of energy layers by ascending switching to shorten the beam delivery time. However, this is not true of all proton therapy systems. The new energy layer switching system was recently upgraded in the University Medical Center Groningen (UMCG), which enables a fast energy layer ascending switching (ELAS).

PURPOSE: We introduce a novel adaptive energy switching SPArc optimization algorithm (SPArc-_AES) based on the machine-specific delivery characteristics of proton therapy systems.

METHODS: The SPArc-_AES optimization algorithm is based on the polynomial increasing feature of energy layer ascending switching. K-Medoids clustering analysis and simulated annealing algorithm were used to optimize the energy delivery sequence. Ten cases were selected to evaluate the plan quality, plan robustness, and the delivery efficiency compared with the previously SPArc energy sequence optimization algorithm, SPArc_seq.

RESULTS: Without extra constraints in the energy ascending constraints, the SPArc-_AES offers a better plan quality and robustness, while the treatment delivery efficiency was significantly improved compared to the SPArc_seq. More specifically, SPArc-_AES effectively shortened the energy layer switching time and the beam delivery time by 34.03% and 31.10%, respectively, while offering better target dose conformality and generally lower dose to organs-at-risk.

CONCLUSIONS: Based on the machine-specific delivery characteristics, we introduced a novel adaptive energy switching algorithm for efficient SPArc optimization, which could significantly improve delivery efficiency while enhancing the plan quality by eliminating no longer necessary constraints on the total number of energy layer ascending switching.

PMID:41016831 | DOI:10.1002/mp.70011

Nihon Ronen Igakkai Zasshi. 2025;62(3):316-323. doi: 10.3143/geriatrics.62.316.

ABSTRACT

AIM: The dementia support team (DST) is an initiative established based on the knowledge that, when individuals with dementia or older people at risk for delirium are hospitalized because of physical illnesses, there are often cases in which their cognitive symptoms rapidly deteriorate. However, the activities of each hospital are unknown. Therefore, a nation-wide survey of DSTs was conducted.

METHODS: A questionnaire survey was conducted among 1,032 hospitals throughout Japan.

RESULTS: A total of 422 responses were obtained, of which 292 were valid. The main results were as follows: number of beds (200 to <500 beds, n=171), number of types of medical staff (≥4 types, n=248), number of patients for intervention/month (30 patients to <100 patients, n=164), number of team meetings/week (1/week, n=240), cognitive function assessment (Hasegawa Dementia Scale Revised [HDS-R], n=141), advice regarding medication (n=279), rehabilitation (n=243), reduction of physical restraint (n=274), nutrition (n=200) and discharge adjustment (n=233). Patients were divided into 2 groups for analyses: those requested by the other divisions (n=121; 41.4%) and those managed by DST (n=171; 58.6%). There was a higher rate of requested by the other divisions than the managed by the DST related advice for medications and rehabilitation. However, the differences were not statistically significant.

CONCLUSIONS: The present study revealed that requests from other divisions involved a higher rate of advice on medication and rehabilitation than the managed by the DST. Further studies are required to confirm this hypothesis.

PMID:41016786 | DOI:10.3143/geriatrics.62.316

Cochrane Database Syst Rev. 2025 Sep 29;9:CD016131. doi: 10.1002/14651858.CD016131.

ABSTRACT

RATIONALE: Respiratory syncytial virus (RSV) is a highly transmissible pathogen that causes varying degrees of respiratory illness across all age groups. The safety and efficacy profiles of available RSV vaccines, a critical consideration for their integration into public health strategies and clinical practice, remain uncertain.

OBJECTIVES: To assess the benefits and harms of RSV vaccines compared to placebo, no intervention, vaccines for other respiratory infections, other RSV vaccines, or monoclonal antibodies (mAbs) across all human populations.

SEARCH METHODS: We conducted a comprehensive literature search of CENTRAL, MEDLINE, Embase, ClinicalTrials.gov, and the WHO ICTRP following standard systematic review methodology from 2000 to April 2024.

ELIGIBILITY CRITERIA: We included both randomised controlled trials (RCTs) and non-randomised studies of interventions (NRSIs) involving all human populations comparing RSV vaccines with placebo, no intervention, vaccines for other respiratory infections, other RSV vaccines, or mAbs. We excluded studies focused on dose-finding schedules and immunogenicity assessment.

OUTCOMES: Benefits included frequency of RSV illness (both lower and upper respiratory illness) confirmed by laboratory tests (RSV-associated lower respiratory tract illness and RSV-associated acute respiratory illness); hospitalisation due to RSV disease (both lower and upper respiratory illness) confirmed by laboratory tests; mortality from illness caused by RSV (confirmed by laboratory test); all-cause mortality; and admission to an intensive care unit. Harms included serious adverse events (SAEs) related to vaccination, including neurological disorders such as Guillain-Barré syndrome.

RISK OF BIAS: We assessed risk of bias in RCTs using Cochrane’s RoB 2 tool.

SYNTHESIS METHODS: We used standard Cochrane methods.

INCLUDED STUDIES: We identified 14 RCTs: five trials (101,825 participants) on older adults; three trials (12,010 participants) on maternal vaccination and effects on infants; one trial (300 participants) on women of childbearing age; and five trials (192 participants) on infants and children. We identified no NRSIs.

SYNTHESIS OF RESULTS: RSV prefusion vaccine versus placebo in older adults These vaccines reduced RSV-associated lower respiratory tract illness with vaccine efficacy (VE) of 77% (95% confidence interval (CI) 0.70 to 0.83; risk ratio (RR) 0.23, 95% CI 0.17 to 0.30; 4 RCTs, 99,931 participants; high-certainty evidence) and RSV-associated acute respiratory illness with VE of 67% (95% CI 0.60 to 0.73; RR 0.33, 95% CI 0.27 to 0.40; 3 RCTs, 94,339 participants; high-certainty evidence). There may be little to no difference in mortality from illness caused by RSV, all-cause mortality, and SAEs related to vaccination (low-certainty evidence). RSV postfusion F protein-based vaccine versus placebo in older adults There is probably little to no difference in RSV-associated lower respiratory tract illness with VE of -0.37% (95% CI -1.96 to 0.37; RR 1.37, 95% CI 0.63 to 2.96; 1 RCT, 1894 participants; moderate-certainty evidence) and RSV-associated acute respiratory illness with VE of -0.07% (95% CI -1.15 to 0.47; RR 1.07, 95% CI 0.53 to 2.15; 1 RCT, 1894 participants; moderate-certainty evidence). There may be little to no difference in mortality from illness caused by RSV, all-cause mortality, and SAEs related to vaccination (low-certainty evidence). Maternal RSV F protein-based vaccine versus placebo in infants These vaccines reduced medically attended RSV-associated lower respiratory tract illness with VE of 54% (95% CI 0.28 to 0.71; RR 0.46, 95% CI 0.29 to 0.72; 3 RCTs, 12,010 participants; high-certainty evidence), medically attended RSV-associated severe lower respiratory tract illness with VE of 74% (95% CI 0.44 to 0.88; RR 0.26, 95% CI 0.12 to 0.56; 3 RCTs, 12,010 participants; high-certainty evidence), and hospitalisation due to RSV disease with VE of 54% (95% CI 0.27 to 0.71; RR 0.46, 95% CI 0.29 to 0.73; 2 RCTs, 11,502 participants; high-certainty evidence) in infants. There may be little to no difference in mortality from illness caused by RSV, all-cause mortality, and SAEs related to vaccination in mothers and infants (low-certainty evidence). Live-attenuated RSV vaccines versus placebo in infants and children The evidence is very uncertain regarding all-cause medically attended acute respiratory illness (MAARI) with VE of 26% (95% CI -0.01 to 0.46; RR 0.74, 95% CI 0.54 to 1.01; 5 RCTs, 171 participants; very low-certainty evidence) and RSV-associated MAARI with VE of 38% (95% CI -0.24 to 0.69; RR 0.62, 95% CI 0.31 to 1.24; 5 RCTs, 192 participants; very low-certainty evidence). There may be little to no difference in SAEs related to vaccination (low-certainty evidence). RSV recombinant F nanoparticle vaccine versus placebo in women of childbearing age The evidence is very uncertain regarding new RSV infections with VE of 50% (95% CI 0.08 to 0.73; RR 0.50, 95% CI 0.27 to 0.92; 1 RCT, 300 participants; very low-certainty evidence). There may be little to no difference in mortality from illness caused by RSV, all-cause mortality, and SAEs related to vaccination (low-certainty evidence). Phase III trials consistently demonstrated low risk of bias. Whilst phase I and II trials occasionally raised concerns about selection bias in the randomisation process, the overall evidence was deemed robust.

AUTHORS’ CONCLUSIONS: RSV prefusion vaccines reduced RSV-associated lower respiratory tract illness and acute respiratory illness in older adults. There may be little to no difference in SAEs related to vaccination in older adults. Maternal vaccination with RSV F protein-based vaccines reduced medically attended RSV-associated lower respiratory tract illness and severe cases in infants. There may be little to no difference in SAEs related to vaccination in mothers and infants. The evidence is very uncertain regarding the effects of RSV vaccine on women of childbearing age, and the effects of live-attenuated RSV vaccines on infants and children; there may be little to no difference in SAEs related to vaccination.

FUNDING: This review was funded by the EU4Health Programme under a service contract with the European Health and Digital Executive Agency (HaDEA).

REGISTRATION: The review was registered in the International Prospective Register of Systematic Reviews (PROSPERO) (CRD42023439128).

PMID:41016728 | DOI:10.1002/14651858.CD016131

Intellect Dev Disabil. 2025 Oct 1;63(5):414-427. doi: 10.1352/1934-9556-63.5.414.

ABSTRACT

Respite is a priority for caregivers of people with neurodevelopmental disabilities across the lifespan. The present study aimed to characterize respite availability and frequency of use among 126 caregivers of young people with neurodevelopmental disabilities (from ages 16-22) using an ongoing longitudinal sample. Results indicated that the availability of respite support was greater and more consistent over time for caregivers of those with lower verbal abilities compared to those with higher verbal abilities. On average, the frequency of respite use from household members declined over time, with overall higher frequency of use reported by caregivers of those with a lower verbal intelligence quotient (VIQ). Our findings indicate that respite remains an important resource for caregivers of young people with neurodevelopmental disabilities well into adulthood, particularly for those caring for higher needs individuals.

PMID:41016722 | DOI:10.1352/1934-9556-63.5.414

Eur J Vasc Endovasc Surg. 2025 Sep 26:S1078-5884(25)00939-6. doi: 10.1016/j.ejvs.2025.09.052. Online ahead of print.

ABSTRACT

OBJECTIVE: This study aimed to evaluate national level differences in in hospital outcomes among patients with autoimmune rheumatic diseases (AIRDs) undergoing endovascular interventions for lower extremity arterial disease (LEAD).

METHODS: This was a retrospective, observational cohort study using a large nationwide administrative database. Adult patients diagnosed with LEAD who underwent percutaneous endovascular interventions were analysed using the 2012 – 2020 Nationwide Inpatient Sample. Patients were stratified into four groups: systemic lupus erythematosus (SLE); rheumatoid arthritis (RA); systemic sclerosis (SSc); and a reference group without these conditions. Multivariable logistic regression was used to assess associations between AIRDs and in hospital mortality, discharge to a long term care facility (LTCF), prolonged hospital length of stay (LoS), and in hospital complications RESULTS: Among 71 436 weighted patients, 1 739 (2.4%) had an AIRD (SLE, 0.4%; RA, 1.8%; SSc, 0.2%). Compared with the reference group, patients with RA had a statistically significantly higher risk of discharge to an LTCF (adjusted odds ratio [aOR] 1.41), prolonged LoS (aOR 1.39), and any in hospital complication (aOR 1.33), including sepsis, infections, and below knee amputation. Patients with SSc exhibited higher odds of pneumonia (aOR 2.02), respiratory failure (aOR 1.77), and minor amputations (aOR 2.89). No statistically significant differences were observed in mortality or total hospital costs among groups. Patients with SLE had outcomes comparable with those of the general population.

CONCLUSION: Although in hospital mortality rates were similar across all groups, patients with RA were at a significantly higher risk of infectious complications and major amputation during hospitalisation following endovascular intervention for LEAD. These findings underscore the need for proactive peri-operative planning and multidisciplinary care strategies tailored to the unique risks and needs of this patient population.

PMID:41016682 | DOI:10.1016/j.ejvs.2025.09.052

Respir Med. 2025 Sep 26:108386. doi: 10.1016/j.rmed.2025.108386. Online ahead of print.

ABSTRACT

AIM: The aim of this study was to determine the effect of preoperative use of different respiratory exercise devices on postoperative outcomes in elderly lung lobectomy patients.

METHODS: This study was retrospectively conducted between 03.12.2024 and 5.02.2025 in the Thoracic Surgery Clinic of a university with 82 patients using 41 Triflow and 41 Acapella. The information obtained from the online files of the patients was entered into the SPSS program using the Patient Introduction Form and Patient Follow-up Form. Descriptive analyses, independent sample t-tests, Mann-Whitney U tests, and chi-square tests were used to evaluate the data.

RESULTS: In the study, the postoperative hospitalization time of the acapella group was higher than that of the triflow group, and this difference was statistically significant (p: 0.042). In addition, the saturation value on the 3rd postoperative day (p:0.023) was significantly higher in the triflow group than in the acapella group. On postoperative days 4 and 7, the pain score (p:0.012) was significantly lower in the Triflow group than in the Acapella group.

CONCLUSION: In the study, it was determined that the hospitalization period was shorter, the saturation value was higher on the 3rd postoperative day, and the pain score was lower on the 4th and 7th postoperative days in the Triflow group compared to the Acapella group as a respiratory exercise device in elderly patients with lung lobectomy.

PMID:41016641 | DOI:10.1016/j.rmed.2025.108386

Urologia. 2025 Sep 28:3915603251376393. doi: 10.1177/03915603251376393. Online ahead of print.

ABSTRACT

OBJECTIVE: This study investigates the diagnostic potential of nicotinamide N-methyltransferase (NNMT) and NM23A as biomarkers for renal cell carcinoma (RCC), focusing on their ability to facilitate early detection and improve diagnostic precision.

METHODS: A prospective observational study was conducted over 24 months, enrolling patients with RCC, benign renal tumors, and healthy controls. Biomarker levels were measured using enzyme-linked immunosorbent assays (ELISA). Diagnostic performance was evaluated through statistical analyses, including ROC curve analysis and Mann-Whitney U tests. Additionally, machine learning models such as Random Forest and Gradient Boosting were employed to identify key predictors of RCC.

RESULTS: NNMT and NM23A demonstrated significant diagnostic accuracy, with area under the curve (AUC) values of 0.933 and 0.915, respectively. Both biomarkers showed substantial differences across RCC, benign, and control groups (p < 0.001). Machine learning analyses highlighted NNMT as the most influential predictor for RCC diagnosis, further supporting its clinical relevance.

CONCLUSIONS: NNMT and NM23A emerge as promising non-invasive biomarkers for RCC, offering substantial diagnostic accuracy and reducing reliance on invasive procedures. Their integration into clinical workflows, supported by advanced machine learning methodologies, could transform RCC diagnostics. Further research with diverse populations is recommended to validate these findings and expand their clinical applicability.

PMID:41015874 | DOI:10.1177/03915603251376393

Clin Chem Lab Med. 2025 Sep 29. doi: 10.1515/cclm-2025-0581. Online ahead of print.

ABSTRACT

OBJECTIVES: Regulatory guidelines recommend non-parametric Passing-Bablok regression for evaluating the agreement between two measurement methods in laboratory settings. However, concluding for the agreement if the 95 % CI of the slope and of the intercept include 1 and 0, respectively is incorrect since the agreement assessment must focus on a null hypothesis of not equivalence and an alternative hypothesis of equivalence.

METHODS: We exhaustively simulated appropriate structural models with several values of slope, intercept and measurement error by keeping equal variances and means of the two methods. We calculated the slope and intercept bias of four regressions: non-parametric Passing-Bablok, Theil, Ordinary Least Squares and Deming. In addition, we calculated the percentages of the agreement according to the not shareable Passing-Bablok suggestion. Furthermore, we calculated the percentages of the 95 % CI of the slope and of the intercept included within sensible equivalence thresholds for assessing the agreement.

RESULTS: Passing-Bablok procedure gives unbiased estimates, a little more and less biased than those from Deming’s regression. The percentages of rejecting the hypothesis of no-agreement, according to the wrong Passing-Bablok’s approach are correctly near to 0.05 Type I error under the agreement and also for 0.990≤slopes≤1.005. However, they are too low for slopes >1.05 and <0.950.

CONCLUSIONS: The Passing-Bablok 95 % CIs are too wide for being included in sensible agreement thresholds according to a population equivalence model and, finally, this approach cannot be considered under the best agreement model of the individual equivalence.

PMID:41015873 | DOI:10.1515/cclm-2025-0581

Korean J Radiol. 2025 Oct;26(10):924-937. doi: 10.3348/kjr.2025.0440.

ABSTRACT

OBJECTIVE: To evaluate and compare scan times, measurement accuracy, and image quality (IQ) of free-breathing (FB) and breath-hold (BH) deep learning (DL) cine MRI sequences versus standard cine MRI, with a specific focus on patients with arrhythmia and dyspnea.

MATERIALS AND METHODS: Seventy participants were prospectively enrolled, including 24 with arrhythmia, 17 with dyspnea, and 29 with normal sinus rhythm and eupnea (mean age, 49 ± 17 years). Each patient underwent three cine MRI acquisitions (standard cine, BHDL, and FBDL) on a 3T scanner. Quantitative assessments of biventricular function, left ventricular mass, and myocardial strain were independently performed by three radiologists, blinded to image acquisition techniques. IQ was evaluated by the same readers using both a five-point Likert scale and objective metrics.

RESULTS: Both BHDL and FBDL significantly reduced total examination times compared to standard cine (BHDL: 58 ± 5 s; FBDL: 88 ± 12 s; standard cine: 208 ± 12 s; adjusted P < 0.001). Quantitative measurements from BHDL and FBDL showed no statistically significant differences compared to standard cine and showed strong correlations (correlation coefficients > 0.85) with standard cine. BHDL consistently demonstrated narrower 95% limits of agreement (LOA) than FBDL across all parameters. For BHDL, the 95% LOA for left and right ventricular ejection fractions were -3.5% to 3.9% and -3.4% to 4.0%, respectively; for FBDL, they were -4.6% to 5.8% and -7.8% to 9.3%, respectively. In patients with arrhythmia, BHDL achieved significantly higher IQ Likert scores (4.44 ± 0.56) than both standard cine (4.00 ± 0.99; adjusted P = 0.043) and FBDL (3.94 ± 0.56; adjusted P = 0.030). In patients with dyspnea, FBDL received the highest IQ scores (4.24 ± 0.47), outperforming standard cine (3.41 ± 0.97; adjusted P = 0.028) and BHDL (3.68 ± 0.56; adjusted P = 0.028).

CONCLUSION: Both FBDL and BHDL significantly reduced scan times compared to standard cine without compromising quantitative measurement accuracy. BHDL offered superior measurement accuracy and shorter scan time than FBDL. Furthermore, BHDL demonstrated robust suitability for patients with arrhythmia by minimizing arrhythmia-related artifacts, whereas FBDL was more effective in patients with dyspnea by mitigating respiratory motion artifacts.

PMID:41015857 | DOI:10.3348/kjr.2025.0440