Category: Statistics

Clin Trials. 2026 Aug 29:17407745261467982. doi: 10.1177/17407745261467982. Online ahead of print.

ABSTRACT

INTRODUCTION: Randomized controlled trials are the gold standard for evaluating interventions but are resource-intensive and impose considerable burden on participants. Historical control designs, which incorporate data from previous trials into new analyses, could reduce sample size requirements, but their practical application is limited. This study explored the feasibility of constructing a historical control using the Bayesian meta-analytic predictive approach based on data from a systematic review of metformin in type 2 diabetes mellitus.

METHODS: We extracted baseline and end point glycated hemoglobin values and participant characteristics from 25 randomized trials (36 comparisons). Using the RBesT package in the R software, meta-analytic predictive priors were constructed, and their contribution to new data was quantified using the effective sample size metric. Between-trial heterogeneity (τ) was initially set to the default conservative value (0.5) and subsequently estimated and replaced in the analysis using the output from the metafor package based on the reported study-level variances. Additional stratified analyses based on follow-up duration and publication year were conducted.

RESULTS: Initial models yielded low effective sample size values (1-4), indicating minimal information borrowing from historical data. The presence of a high level of heterogeneity (τ = 0.55-0.85) appeared to limit the priors’ influence. Further investigation into a stricter data set showed that four outlier studies reduced the estimated τ from the data to 0.0935, which increased effective sample size from 18 (conservative model) to 52 (data-derived model), while estimated treatment effects remained stable (-1.34% to -1.36% glycated hemoglobin).

DISCUSSION: Between-trial heterogeneity (τ) estimation critically influences the informativeness of meta-analytic predictive-based historical control analysis. Despite having 25 trials with the same condition, the effective sample size was very low. Data-driven τ estimation substantially increased effective sample size without altering the treatment effect estimates and could represent a valid alternative to historical controls in clinical trial design compared with default conservative choices.

PMID:42668260 | DOI:10.1177/17407745261467982

Eur Urol Focus. 2026 Aug 29:S2405-4569(26)00151-3. doi: 10.1016/j.euf.2026.07.005. Online ahead of print.

ABSTRACT

BACKGROUND: Prostate-specific membrane antigen (PSMA)-radioguided surgery (RGS) is an emerging technique providing real-time intraoperative guidance. The prospective TRACE-I trial demonstrated that robot-assisted ^99mtechnetium-PSMA-Investigation & Surgery-RGS ([^99mTc]Tc-PSMA-I&S-RGS) using a DROP-IN gamma probe is feasible and safe in recurrent prostate cancer (PCa).

OBJECTIVE: To report the oncological outcmes of a post hoc analysis of the prospective TRACE-I trial cohort.

DESIGN, SETTING, AND PARTICIPANTS: TRACE-I prospectively enrolled 30 patients with biochemical recurrence (prostate-specific antigen (PSA) ≥0.2 ng/ml after radical prostatectomy (RP) or ≥2 ng/ml above nadir after radiotherapy (RT) and ≤3 pelvic recurrences (nodal and/or local) on PSMA-positron emission tomography/computed tomography (PET/CT; 2020-2023).

INTERVENTION: Patients underwent single-photon emission CT/CT and then robot-assisted PSMA-RGS.

OUTCOMES MEASUREMENTS AND STATISTICAL ANALYSIS: Oncological outcomes were biochemical progression (PSA ≥0.2 ng/ml after RP or ≥2 ng/ml above nadir after RT), radiological recurrence on PSMA-PET/CT, and time to salvage therapy. Biochemical progression-free survival (bPFS), distant metastasis-free survival (dMFS), and therapy-free survival (TFS) were analysed using Kaplan-Meier and univariable Cox regression.

RESULTS AND LIMITATIONS: Among 30 patients (19 RP, 9 RT, and 2 RP + RT), the median age was 68 yr, and the median PSA at RGS was 1.02 ng/ml (interquartile range, 0.46-2.86), 28 (93%) showed PSA decline after RGS, and 20 (66%) reached PSA <0.2 ng/ml or PSA nadir. The 1- and 2-yr bPFS were 40% and 30%; 2-yr dMFS and TFS were 62% and 58%, respectively. Recurrences were pelvic in 37% and distant in 40%. Limitations include single-centre design and small sample size.

CONCLUSIONS: PSMA-RGS in the robotic setting for recurrent PCa shows an early PSA decline in almost all patients. Although biochemical progression after PSMA-RGS is common, PSMA-RGS presents an opportunity to prolong bPFS and TFS in a selection of patients.

PATIENT SUMMARY: We updated outcomes from TRACE-I patients with recurrent prostate cancer. We found that PSMA-guided surgery led to PSA declines in most patients and delayed disease progression in some, but careful patient selection is essential.

PMID:42668258 | DOI:10.1016/j.euf.2026.07.005

Encephale. 2026 Aug 29:S0013-7006(26)00157-0. doi: 10.1016/j.encep.2026.06.001. Online ahead of print.

ABSTRACT

OBJECTIVES: Mental health disorders and suicidal behaviors are a major public health issue worsened by the COVID-19 pandemic. Social prescribing initiatives such as Art on Prescription aim to integrate artistic activities into healthcare to promote well-being and reduce depressive symptoms. This pilot study aimed to assess the impact of an Art on Prescription program on individuals at risk of suicide.

METHODS: An AoP program was implemented in Montpellier coordinated by the Department of Emergency Psychiatry and Acute Care at Montpellier University Hospital, in partnership with MO.CO. (Montpellier Contemporain). Fifty-one adults, referred after an emergency visit for suicidal ideation or a suicide attempt, were enrolled between 2022 and 2024. The program was delivered through five successive cycles. Each participant was enrolled in one cycle only, led by an artist, and included one museum visit followed by five weekly creative sessions. Depressive symptoms (PHQ-9, Patient Health Questionnaire-9) and well-being (WEMWBS, Warwick-Edinburgh Mental Wellbeing Scale) were assessed at the end of each of the five creative sessions. Wilcoxon tests and Generalized Estimating Equations (GEE) were used for analysis.

RESULTS: Among the 29 participants with complete data from the first to the fifth creative sessions, a significant improvement in well-being was observed (mean WEMWBS increase: +2.24; P=0.02), whereas the decrease in depressive symptoms was not statistically significant (PHQ-9: -0.79; P=0.12). In the full sample (n=51), the comparison between the first and third creative sessions showed a significant decrease in depressive symptoms (-0.65; P=0.05), but a non-significant increase in well-being (+1.22; P=0.11). GEE models confirmed a significant negative association between PHQ-9 and WEMWBS scores (β=-1.1; P<0.001), with no significant effect of time or interaction.

CONCLUSIONS: The Art on Prescription program appears to have a positive impact on well-being and depressive symptoms in individuals at risk of suicide. These findings support the potential value of innovative, non-pharmacological interventions as a complement to traditional psychiatric care, aligned with recovery-oriented approaches.

PMID:42668255 | DOI:10.1016/j.encep.2026.06.001

Encephale. 2026 Aug 29:S0013-7006(26)00158-2. doi: 10.1016/j.encep.2026.04.013. Online ahead of print.

ABSTRACT

BACKGROUND: Post-traumatic stress disorder (PTSD) is a common consequence of traumatic experiences in children, highlighting the need for culturally adapted screening instruments. The objective of this study was to translate and validate the self-report questionnaire, the Children’s Revised Impact of Event Scale-13 (CRIES-13), into Tunisian Arabic.

METHODS: We conducted a cross-sectional study among children aged eight to 18 years, recruited from the Child and Adolescent Psychiatry Department of Mongi Slim Hospital between February 2024 and February 2025, who had experienced a stressful life event. Non-inclusion criteria included insufficient cognitive or linguistic abilities to complete the questionnaire. Exclusion criteria were refusal to participate and incomplete questionnaires. The CRIES-13 questionnaire was translated using the forward-backward translation method. Its psychometric properties were evaluated in terms of content validity, reliability, and construct validity. The internal structure was assessed using confirmatory factor analysis. For preliminary external validation, the Tunisian version of the Clinician-Administered PTSD Scale for Children and Adolescents, Fifth Edition (CAPS-CA-5), was used.

RESULTS: A total of 300 children were included in the study. The translated version was deemed satisfactory. Internal consistency was good, with a Cronbach’s alpha of 0.841. Item – subscale correlations were statistically significant and conceptually coherent. Confirmatory factor analysis supported the three-factor model and demonstrated acceptable model fit indices, as follows: χ²/df=2.78; root mean square error of approximation (RMSEA)=0.077; Standardized Root Mean Square Residual=0.092; Comparative Fit Index=0.897; Tucker-Lewis Index=0.871; Goodness-of-Fit Index=0.918; Adjusted Goodness-of-Fit Index=0.880; and Akaike Information Criterion=230. Statistically significant correlations were found between the CRIES-13 and its external validator, the Clinician-Administered PTSD Scale for Children and Adolescents, Fifth Edition (CAPS-CA-5) (r=0.897; P<0.01).

CONCLUSION: The Tunisian Arabic version of the CRIES-13 demonstrated satisfactory psychometric properties. It can be considered a reliable and valid screening tool for PTSD among Tunisian children.

PMID:42668253 | DOI:10.1016/j.encep.2026.04.013

Biosystems. 2026 Aug 29:105935. doi: 10.1016/j.biosystems.2026.105935. Online ahead of print.

NO ABSTRACT

PMID:42668219 | DOI:10.1016/j.biosystems.2026.105935

Food Microbiol. 2027 Jan;141:105266. doi: 10.1016/j.fm.2026.105266. Epub 2026 Aug 12.

ABSTRACT

To achieve precise control of kiwifruit wine fermentation, this study integrated non-targeted metabolomics and multivariate statistical analysis to systematically analyze dynamic metabolic trajectories and microbial functional contributions across two fermentation stages: alcoholic fermentation and malolactic fermentation. The results indicated that both processes had critical contributions to the quality of kiwifruit wine, acting synergistically through interconnected metabolic pathways. The metabolic pathway and correlation analysis showed that alcoholic fermentation mainly involved the decomposition and utilization of nutrients, with non-Saccharomyces yeasts proliferating extensively and producing most esters and alcohols, while malolactic fermentation mainly concerned energy supply and organic synthesis, in which Lactiplantibacillus plantarum adapted to nutrient-limited and stressful conditions while producing aroma-active volatiles. Correlation and pathway enrichment analyses further demonstrated tight associations between non-volatile metabolite turnover and the generation of volatile compounds, highlighting the integrated role of microbial metabolism in shaping flavor and quality attributes of kiwifruit wine.

PMID:42668203 | DOI:10.1016/j.fm.2026.105266

Food Microbiol. 2027 Jan;141:105242. doi: 10.1016/j.fm.2026.105242. Epub 2026 Jul 10.

ABSTRACT

Fruits and vegetables are vital to a healthy diet; however, consuming unwashed or improperly prepared produce can lead to parasitic infections. This study aims to provide evidence-based information on the extent of parasitic contamination and its associated factors on fruits and vegetables from the Gedeo Zone, Ethiopia. A community-based cross-sectional study was conducted from March 26 to July 25, 2025, in Dilla, Gedeo Zone, Ethiopia, to assess parasitic contamination of fruits and vegetables. A multistage sampling technique was employed. Socio-demographic data and potential contamination risk factors were gathered using structured questionnaires. About 200 g of each sample was examined for intestinal parasites using direct wet mount and Modified Ziehl-Neelsen staining techniques. Data were analyzed using SPSS version 25. Among the 442 fruit and vegetable samples examined, 148 (33.5%) were found to be contaminated with intestinal parasites. Among the 148 samples found to be positive by iodine wet mount examination, Entamoeba histolytica/dispar was the predominant parasite (13.8%). Moreover, produces displayed on the floor had significantly higher contamination than those on shelves/tables (AOR = 6.85; p < 0.001). Contamination was also significantly associated with samples from open markets, collected from the farms, and vendors with untrimmed fingernails. Parasitic contamination in fruits and vegetables was found to be high. Therefore, food and drug authorities and public health institutions should raise awareness among vendors and consumers about safe handling and consumption, while city administrations and the agricultural sector promote hygienic markets and proper farming and transportation practices.

PMID:42668179 | DOI:10.1016/j.fm.2026.105242

Food Microbiol. 2027 Jan;141:105235. doi: 10.1016/j.fm.2026.105235. Epub 2026 Jul 8.

ABSTRACT

Synanthropic flies are recognized as mobile reservoirs of enteric foodborne pathogens, yet their utility as antimicrobial resistance (AMR) sentinels within livestock production systems remains under-explored. This study aimed recovered the enteric foodborne pathogen Salmonella enterica from whole-body fly homogenates and characterized phenotypic AMR patterns across sampled Texas counties differing by livestock production intensity groups (low, medium, and high). Each livestock intensity group consisted of two counties. Flies were collected from five sampling locations throughout each county at multiple distances (0-15 km) from a designated epicenter. Collected flies were identified to at least family level, homogenized and then screened for Salmonella. Pathogens were biochemically presumptively confirmed molecularly. Confirmed pathogens were subjected to serotyping and phenotypic AMR screening. Besides descriptive statistical analyses, logistic regression evaluated associations between individual counties, Salmonella serovar, and AMR patterns. Overall, 89/230 samples (38.7%) yielded confirmed Salmonella. Elevated AMR frequencies for isolated Salmonella were observed for tetracycline (77.5%), streptomycin (61.8%), amoxicillin/clavulanic acid (56.2%), azithromycin (39.3%), and cefoxitin (41.6%) across sampled counties. Heatmaps revealed clear spatial differences in AMR patterns. Generalized estimating equations (GEE) analysis showed counties Go and S, both belonging to the high livestock intensity group, and the antimicrobial tetracycline were strongly associated (FDR p < 0.05) with the occurrence of AMR in Salmonella isolated from flies. Synanthropic flies demonstrated the presence of variability in Salmonella AMR patterns, and thus may be a useful sentinel for surveiling localized differences in AMR patterns of human pathogens in food animal production environments.

PMID:42668176 | DOI:10.1016/j.fm.2026.105235

Fungal Biol. 2026 Oct;130(6):101810. doi: 10.1016/j.funbio.2026.101810. Epub 2026 Jul 2.

ABSTRACT

Endophytic fungi associated with medicinal plants represent an important and largely untapped source of structurally diverse secondary metabolites. This study explores the tissue-specific metabolic diversity of endophytic fungi isolated from aerial and root tissues of Thymus vulgaris using LC-MS/MS-based untargeted metabolomics to enable the accelerated prioritization of biosynthetically competent strains for natural product discovery. A total of eighteen fungal endophytes were isolated and taxonomically characterized by 18S rDNA sequencing, followed by metabolomic profiling of extracellular extracts. Comprehensive data analysis of more than 11,000 detected molecular features led to the annotation of 1164 metabolites. Among these, 269 metabolites exhibited significant differential abundance between tissue-derived groups, with 230 showing marked upregulation in root-associated isolates. Multivariate statistical analyses revealed clear metabolic segregation according to tissue origin. Functional pathway enrichment analysis demonstrated that root-derived fungi possess enhanced tyrosine metabolism and terpenoid biosynthesis potential compared with aerial counterparts. Notably, Ganoderiol C emerged as a defining chemometric marker metabolite for subterranean endophytes. Subsequent in silico target prediction indicated strong binding and stable interactions of Ganoderiol C with NF-κB1 and GLRA1, suggesting potential biological relevance. Collectively, these results demonstrate pronounced metabolic compartmentalization between aerial and root endophytes in T. vulgaris and highlight the utility of metabolomics-driven strategies for niche-informed strain selection. This integrative approach provides a robust framework for prioritizing endophytic fungi with elevated biosynthetic capacity and strengthens the prospects of discovering novel bioactive compounds from plant-associated microbial communities.

PMID:42668156 | DOI:10.1016/j.funbio.2026.101810

J Oral Maxillofac Surg. 2026 Aug 10:S0278-2391(26)00838-4. doi: 10.1016/j.joms.2026.07.028. Online ahead of print.

ABSTRACT

BACKGROUND: Advanced practice providers (APPs) are now eligible to become associate fellows of the American Academy of Craniomaxillofacial Surgeons (AACMFS) as of 2024. As APPs have joined the organization, there was recognition that APPs within oral and maxillofacial surgery (OMS) have a wide range of roles and responsibilities.

PURPOSE: The purpose of this study was to assess and describe the roles, responsibilities, training, and practice patterns of APPs within OMS in the United States. A survey was utilized as the research methodology to collect data from APPs currently practicing within OMS.

STUDY DESIGN, SETTING, SAMPLE: A cross-sectional descriptive study utilized a survey to assess APP roles, responsibilities, and practice patterns within OMS in the United States. Eligible participants included APPs currently practicing who were identified through the AACMFS membership network during the study period.

PREDICTOR VARIABLES: Not applicable.

MAIN OUTCOME VARIABLES: These variables include demographics (state of practice, APP type, and years in practice), practice characteristics, scope of practice, practice productivity, and onboarding characteristics.

COVARIATES: None.

ANALYSES: Descriptive statistics, including frequencies and percentages, were used to summarize survey responses.

RESULTS: Twenty-three eligible participants received the survey, and 14 completed responses were analyzed (response rate 60.9%). Respondents were equally divided between nurse practitioners (n = 7, 50%) and physician assistants (n = 7, 50%). Seven respondents (50%) practiced exclusively in adult care, while 5 respondents (35.7%) practiced exclusively in pediatrics. The most common subspecialties were head and neck oncology (n = 5, 35.7%), followed by pediatric craniomaxillofacial surgery (n = 3, 21.4%).

CONCLUSION AND RELEVANCE: The role of the APP varies across specialties. Within OMS, particularly among AAMCFS affiliated practices, there is variability in APP roles, responsibilities, and scope of practice across institutions. Further studies evaluating APP roles beyond AACMFS and longitudinal assessment of role development are warranted.

PMID:42668138 | DOI:10.1016/j.joms.2026.07.028