Category: Statistics

Eur Arch Otorhinolaryngol. 2026 Aug 3. doi: 10.1007/s00405-026-10468-6. Online ahead of print.

ABSTRACT

PURPOSE: To compare real-world initial treatment strategies for pediatric head and neck lymphatic malformations using a multidimensional outcome framework that distinguishes complete radiological response, objective lesion response, progression control, and treatment burden, and to examine how lesion complexity influences treatment selection and outcomes.

METHODS: We conducted a retrospective cohort study of pediatric patients with head and neck lymphatic malformations treated at a tertiary referral center between January 2016 and December 2025. Patients were categorized into surgery alone, interventional therapy alone, medical therapy alone, or combined therapy according to the initial treatment strategy. Radiological outcomes were classified as complete response, partial response, stable disease, or progression/recurrence. Primary outcomes included complete response, objective response rate, progression/recurrence, and progression-free survival. Lesion complexity was classified using an exploratory, literature-informed framework based on De Serres stage, cystic subtype, number of involved anatomical regions, and critical structure involvement. Multivariable logistic regression, generalized propensity score-based overlap weighting, propensity score matching, event-density analysis, and follow-up sensitivity analyses were used to address confounding by indication and unequal follow-up.

RESULTS: Among 210 patients, 40 received surgery alone, 110 interventional therapy alone, 23 medical therapy alone, and 37 combined therapy. Surgery alone achieved the highest complete response rate (75.0%). Interventional therapy alone showed the highest objective response rate (87.3%), highest disease control rate (95.5%), lowest progression/recurrence rate (4.5%), and lowest additional-treatment rate (4.5%). Medical therapy alone had the highest progression/recurrence rate (39.1%), a pattern that may at least partly reflect the selection of systemic therapy for more complex disease, although a contribution from limited treatment effect in this heterogeneous group cannot be excluded. High-complexity lesions were less likely to achieve complete response and had numerically higher progression/recurrence. The main outcome patterns remained directionally consistent after multivariable adjustment, overlap weighting, propensity score-matched sensitivity analysis, and follow-up sensitivity analyses.

CONCLUSION: Initial treatment strategies for pediatric head and neck lymphatic malformations demonstrated distinct outcome profiles rather than a simple hierarchy of effectiveness. Surgery alone was most strongly associated with complete radiological response, whereas interventional therapy alone showed a favorable objective-response and progression-control profile. A multidimensional framework integrating eradication, objective response, lesion complexity, treatment burden, and progression control may better support individualized treatment selection.

PMID:42543425 | DOI:10.1007/s00405-026-10468-6

Eur Arch Otorhinolaryngol. 2026 Aug 3. doi: 10.1007/s00405-026-10519-y. Online ahead of print.

ABSTRACT

PURPOSE: Osteoporosis and osteopenia, characterized by reduced bone mineral density (BMD), particularly affect women during menopause. While research has explored the link between low BMD and hearing loss (HL) in postmenopausal women, understanding this connection in premenopausal women requires further investigation. This study aimed to investigate the association between low BMD and HL in premenopausal women.

METHODS: Sixty premenopausal women, ages 20 to 54, exhibiting diverse BMD levels, underwent dual-energy x-ray absorptiometry (DXA) for BMD assessment alongside comprehensive audiological assessments. BMD was stratified into two categories: “Healthy” and “Low.”

RESULTS: Mild-to-moderate sensorineural HL was identified in the right ear of 26.7% of participants and in the left ear of 36.7% of participants following audiometric evaluation. Chi-square analysis did not establish a statistically significant connection between BMD groups. Comparison of means analysis demonstrated an association between self-perceived hearing difficulty and BMD of the lumbar spine (p < .05).

CONCLUSIONS: Findings suggest that reduced BMD may not be associated with objective hearing sensitivity in premenopausal women. Longitudinal studies are needed to determine whether bone health contributes to auditory changes across the menopausal transition.

PMID:42543423 | DOI:10.1007/s00405-026-10519-y

Eur Arch Otorhinolaryngol. 2026 Aug 3. doi: 10.1007/s00405-026-10504-5. Online ahead of print.

ABSTRACT

INTRODUCTION: Total thyroidectomy, a procedure for various thyroid pathologies, is traditionally performed using conventional clamp-and-tie hemostasis (CH). Advanced high-energy devices (HEDs), including the Harmonic Scalpel (HS) and LigaSure (LS), offer energy-based vessel sealing with potential efficiency gains, but safety concerns and cost implications remain. This systematic review and Bayesian network meta-analysis of randomized controlled trials (RCTs) was conducted to compare the efficacy and safety of energy-based hemostasis devices versus CH in total thyroidectomy.

METHODS: This Systematic review included 22 prospective RCTs, published between 2005 and 2022, enrolling 3,824 patients. The primary outcomes included operative time (OT), intraoperative blood loss (IOBL), and transient recurrent laryngeal nerve (RLN) injury and hypocalcemia. Secondary outcomes were postoperative hematoma (POH), postoperative drain output (POD), and length of hospital stay (LOS). Intervention rankings were determined using the Surface Under the Cumulative Ranking Curve (SUCRA), SUCRA values reflect the probability that an intervention ranks higher relative to others for a given outcome and do not indicate a clinical or statistical superiority; therefore, they should be interpreted alongside effect estimates and credible intervals.

RESULTS: In comparison with CH, both HS and LS were statistically significantly superior, reducing OT by approximately 22 min (HS: SUCRA 0.76, LS: SUCRA 0.73). HS demonstrated further significant superiority over CH, reducing LOS by -0.37 days (SUCRA 0.93) and POD output by -24 mL (SUCRA 0.87). While HS showed a numerical reduction in IOBL, this difference did not reach statistical significance, yet HS ranked highest for this outcome (SUCRA 0.91). Importantly, no significant differences were detected among HS, LS, and CH for key safety outcomes, including transient RLN palsy, transient hypocalcemia, and POH.

CONCLUSION: Energy-based hemostasis devices, particularly HS, were associated with shorter operative time and reduced postoperative fluid output and hospital stay compared with conventional clamp-and-tie hemostasis. However, the certainty of evidence for most outcomes was moderate to low, the analysis was underpowered to establish equivalence for rare safety events, and the modest clinical gains should be weighed against device costs and local operating-room efficiency. These findings support conditional, context-dependent use of HEDs rather than routine preference for any single device.

PMID:42543419 | DOI:10.1007/s00405-026-10504-5

Eur Arch Otorhinolaryngol. 2026 Aug 3. doi: 10.1007/s00405-026-10483-7. Online ahead of print.

ABSTRACT

PURPOSE: To describe real-world hearing outcomes after salvage intratympanic corticosteroid (ITC) therapy in patients with idiopathic sudden sensorineural hearing loss (ISSNHL) and incomplete recovery after systemic corticosteroids, emphasizing clinically meaningful recovery.

METHODS: Prospective observational study at a single tertiary center. Patients met ISSNHL diagnostic criteria (≥ 30 dB loss in ≥ 3 consecutive frequencies within 72 h) and received salvage ITC (methylprednisolone 40 mg/mL, weekly for 3 weeks) after absent or incomplete recovery on follow-up audiometry (day 10-15). Primary outcome was PTA4 change from pre-salvage audiogram to last available audiogram (minimum follow-up 1 month). Recovery was categorized using Siegel criteria. Non-parametric methods and Hodges-Lehmann estimators were used.

RESULTS: Of 83 ISSNHL patients, 41 received salvage ITC and were analyzed. In the salvage cohort, 63.4% were women; mean age was 53.3 years (95% CI 46.7-59.9); median follow-up was 11 months (IQR 3-15). Median PTA gain attributed to ITC rescue was 5.0 dB (IQR – 3.8 to 18.8; padj = 0.043). After salvage ITC, 71% showed ≤ 15 dB improvement; 29% achieved ≥ 15 dB. By Siegel criteria, normal hearing was achieved in 7%, mild-to-moderate loss in 34%, and severe loss in 59%.

CONCLUSION: Salvage ITC was associated with a statistically significant but clinically modest hearing gain and a low proportion of complete recovery. Standardized, patient-relevant outcome definitions are needed to support realistic counseling.

PMID:42543417 | DOI:10.1007/s00405-026-10483-7

Eur Arch Otorhinolaryngol. 2026 Aug 3. doi: 10.1007/s00405-026-10485-5. Online ahead of print.

ABSTRACT

PURPOSE: To examine intraoperative and postoperative practices (antibiotic and antithrombotic prophylaxis, ear packing, behavioural recommendations, follow-up strategies) in exclusive endoscopic ear surgery management, based on a global survey of experienced surgeons.

METHODS: The setting is an international survey distributed via personal mailing lists and the International Working Group on endoscopic ear surgery. Anonymous responses were collected through Google Forms and analyzed using descriptive statistics, logistic regression models, and Kruskal-Wallis tests with post-hoc analyses to explore associations between geographic origin, surgical practices, and postoperative protocols. The result is a cross-sectional descriptive study.

RESULTS: We collected responses from 44 surgeons across 21 different countries. Significant variability in surgical management practices was observed, often diverging from the current literature. Geographic origin and surgeon experience showed a limited association with specific practices. Notably, North American surgeons reported longer follow-up durations and more consistent use of cefazolin, whereas European surgeons demonstrated greater variability in antibiotic regimens.

CONCLUSION: The survey reveals wide variability in the intraoperative and postoperative management of exclusive endoscopic ear surgery, driven more by individual preferences than by scientific evidence. The absence of consistent patterns based on geography or expertise highlights the lack of standardized, evidence-based protocols.

PMID:42543412 | DOI:10.1007/s00405-026-10485-5

Support Care Cancer. 2026 Aug 3;34(8):821. doi: 10.1007/s00520-026-11050-w.

ABSTRACT

BACKGROUND: Informal caregivers of patients enrolled in early-phase clinical trials (EP-CTs) devote an average of fifty or more hours per week to providing care, but qualitative studies suggest they perceive receiving limited instruction about their role. However, no work has evaluated what formal guidance EP-CT caregivers might receive during enrollment. This study characterized the type and granularity of information provided to EP-CT caregivers in study documents.

METHODS: We manually reviewed informed consent and study protocol documents for adult EPCTs registered on ClinicalTrials.gov completed 1990-2025 with both documents available. Using a structured codebook from prior work [26], we identified whether trials delineated expectations for caregivers regarding: (1) participation in informed consent processes and learning about the study, (2) structured education in trial tasks (i.e., medication administration), (3) attendance at trial visits, (4) monitoring trial adherence, (5) symptom surveillance/management, (6) communicating with the study team, and (7) available supportive care resources. Descriptive statistics summarized provided caregiver content.

RESULTS: Overall, 145 EP-CT trials (66.9% solid only, 26.2% hematologic only, 6.9% mixed) were evaluated. Regarding EP-CT learning, only 8/145 (5.5%) of studies delineated study team commitment to explicitly discussing study details with caregivers if desired. Only 14/145 (9.7%) of studies referenced structured education in trial tasks. Less than 5% of studies outlined potential caregiver roles in supporting trial attendance, trial adherence, symptom surveillance/management, or study team communication. No trials referenced available supportive care resources for either patients or caregivers.

CONCLUSION: Overall, despite the demands that EP-CTs place on caregivers and their pivotal role in patient participation, formal trial documents provide limited delineation of caregiver roles and responsibilities. Future work should assess the supplemental role of informal caregiver resources and whether further caregiver consideration can enhance preparedness or care delivery.

PMID:42543409 | DOI:10.1007/s00520-026-11050-w

Environ Monit Assess. 2026 Aug 3;198(8):901. doi: 10.1007/s10661-026-15632-3.

ABSTRACT

Accurate tracking and measurement of pollen dispersal in the atmosphere are essential for assessing cross-pollination risks, particularly in the case of genetically engineered (GE) crops. We conducted a series of unique release-recapture field studies with GE switchgrass in Oliver Springs, TN, USA. Two hundred transgenic switchgrass plants (Panicum virgatum L. “Performer”) were planted at the center of a clear-cut field, with one block of 100 plants expressing orange fluorescent protein (OFP) under a switchgrass ubiquitin promoter (PvUBI1) and another block of 100 plants expressing OFP driven by a maize pollen-specific promoter (Zm13). Pollen was sampled from the atmosphere using fixed (ground-based) and mobile (drone-based) sampling devices at different distances from the source field, with Lagrangian stochastic dispersal simulations run for sampling periods using high-resolution wind measurements. The pollen emission rate was estimated by combining simulated and measured pollen concentrations, and strong diurnal trends were observed. Diurnal emission rate trends were positively correlated with wind speed, temperature, and vapor pressure deficit, while negatively correlated with relative humidity. In low-wind meandering conditions, incorporating changing wind direction into the dispersal modeling improved pollen emission rate estimation and model-measurement comparisons. This study assesses the effectiveness of high- and low-volume pollen samplers in relation to source strength up to 1 km from the source, enhancing understanding of pollen measurement techniques. Additionally, it is a proof-of-concept for drone-based pollen sampling and GMO pollen tracking using fluorescence measurements. Results from our experiments have significant implications for cross-pollination risk assessment, prediction, and management of airborne allergens.

PMID:42543389 | DOI:10.1007/s10661-026-15632-3

Zhongguo Zhong Yao Za Zhi. 2026 Jul;51(13):3911-3916. doi: 10.19540/j.cnki.cjcmm.20260407.501.

ABSTRACT

Target trial emulation(TTE) has emerged in recent years as a key framework for causal inference, providing a methodological foundation for generating evidence with higher quality by using real-world data in situations where conducting a randomized controlled trial(RCT) is impossible. Transparent reporting of observational studies emulating a target trial: the TARGET statement published in 2025, proposed 21 core reporting items that systematically standardized the definition of the target trial, the emulation process, the identification assumptions, and the presentation of causal estimands, thereby providing a standardized foundation for the transparency, reproducibility, and criticizability of TTE research. For research on complex interventions in traditional medicine, the TARGET statement provided a directly applicable methodological framework for the transformation of complex TCM intervention research toward a standardized causal inference system, and it was conducive to establish a TCM evidence system anchored by target trials and supported by structured real-world data, thereby improving the efficacy evaluations for Chinese patent medicines and the evidence quality and interpretability of analyses of human use experience from renowned senior TCM experts. This paper comprehensively interpreted the TARGET statement, including its formulation context, scope of application, and key items, elucidated its methodological connotations, and focused on the mapping methods, statistical methods, and identification assumption requirements between target trial specifications and observational data. Building on this basis, this paper designated RCT of Chinese patent medicines or in-hospital preparations in clinical research as target trials and explored a TTE strategy for analyzing the human-use experience of TCM compound prescriptions by renowned senior TCM experts based on the prospective real-world disease-specific registration registries, thereby providing an operable research paradigm for its application in the field of clinical efficacy evaluation of TCM.

PMID:42543380 | DOI:10.19540/j.cnki.cjcmm.20260407.501

Zhongguo Zhong Yao Za Zhi. 2026 Jul;51(13):3899-3910. doi: 10.19540/j.cnki.cjcmm.20260401.501.

ABSTRACT

Using multiple statistical methods, this study investigated the core diagnostic information from the four diagnostic methods, the distribution patterns of syndrome elements, and their relationship with laboratory biochemical indicators in diabetic peripheral neuropathy(DPN). The aim is to deepen the understanding of the disease-symptom-syndrome relationship in DPN. A retrospective study was conducted on 1 420 inpatients diagnosed with DPN patients at the Department of Endocrinology, the First Affiliated Hospital of Anhui University of Chinese Medicine, from June 2014 and June 2023. Data mining techniques, including frequency statistics, association rule analysis, factor analysis, cluster analysis, and Bayesian network analysis, were applied to examine general patient information, TCM diagnostic data from the four diagnostic methods, and laboratory biochemical indicators. The core clinical manifestations in DPN patients were dry mouth, limb numbness, blurred vision, fatigue, thirst, and a thready pulse. Association rule analysis indicated Yin deficiency leading to blood stasis is the core pathogenesis. Factor analysis indicated that the disease location primarily involved the spleen, kidney, and liver, while main disease nature elements were Yin deficiency, Qi deficiency, and blood stasis, often complicated by concomitant phlegm turbidity, Yang deficiency, and essence depletion. Cluster analysis identified five syndrome patterns: Yin deficiency with blood stasis syndrome, Qi deficiency with blood stasis syndrome, Yang deficiency with cold aggregation syndrome, phlegm stasis obstructing collateral syndrome, and liver-kidney deficiency syndrome. Among these, Yin deficiency with blood stasis syndrome and Qi deficiency with blood stasis syndrome were the most prevalent. Bayesian network analysis revealed associations between abnormal fasting blood glucose(FBG) and symptoms such as chest tightness, palpitations, dizziness, insomnia, and constipation. Abnormal glycosylated hemoglobin(HbA1c) was associated with frequent urination, polyphagia, polydipsia, thirst and dry mouth. Abnormal total cholesterol(TC) was linked to emaciation, fear of cold and cold limbs, and a weak pulse. Abnormal serum creatinine(SCr) was associated with slow reaction, a wiry pulse, and limb pain. The distribution of TCM syndromes in DPN primarily involves Yin deficiency with blood stasis syndrome and Qi deficiency with blood stasis syndrome. The core pathogenesis is Yin deficiency leading to blood stasis, with the disease location in the spleen, kidney, and liver. The identified associations between FBG, HbA1c, TC, SCr and specific TCM syndromes provide an objective basis for the microscopic syndrome differentiation of DPN and its integrated diagnosis and treatment combining Chinese and western medicine.

PMID:42543379 | DOI:10.19540/j.cnki.cjcmm.20260401.501

Zhongguo Zhong Yao Za Zhi. 2026 Jul;51(13):3687-3696. doi: 10.19540/j.cnki.cjcmm.20260416.302.

ABSTRACT

To address the problem that conventional evaluation methods struggle to comprehensively characterize the complex flow behavior of TCM powders, this study utilized an FT4 powder rheometer to perform a multidimensional characterization of 24 representative samples, including decoction pieces, extracts, excipients, and granules. In addition to traditional static parameters like angle of repose(α) and Carr index(IC), the study focused on dynamic rheological characteristics, specifically basic flow energy(BFE) and flow rate index(FRI),alongside shear and bulk property indicators such as cohesion(C_o) and flow function coefficient(FFc). Data analysis revealed that individual indicators frequently yield conflicting assessments for the same sample, underscoring the dimensional limitations of isolated metrics. By leveraging correlation analysis and principal component analysis(PCA), the study extracted core contributing factors to construct a weighted flowability comprehensive index(FCI). The results indicated that the FCI successfully integrated multi-source heterogeneous data, showing strong alignment with core flowability parameters and enabling precise classification of powder flow grades. This index offers a robust quantitative framework for enhancing stability assessment and quality control in TCM powder preparation processes.

PMID:42543358 | DOI:10.19540/j.cnki.cjcmm.20260416.302