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Nevin Manimala Statistics

Clinical effectiveness of salvage intratympanic corticosteroids for idiopathic sudden sensorineural hearing loss: a real-world observational series

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

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Nevin Manimala Statistics

Intraoperative and postoperative management in endoscopic ear surgery: Perspectives from a worldwide survey

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

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Considering the caregiver in early-phase clinical trials: a review of trial protocols and consent forms

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

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From field to sky: measurement and modeling of transgenic switchgrass pollen dispersal in the atmosphere

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

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Interpretation of reporting standards for target trial emulation and reflections on their application in TCM efficacy evaluation

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

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Distribution patterns and clinical characteristics of traditional Chinese medicine syndromes in diabetic peripheral neuropathy

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

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Development and application of multidimensional comprehensive evaluation system for flowability of TCM powders based on principal component analysis

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

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Heart rate variability and anxiety severity: A systematic review and meta-analysis

Compr Psychiatry. 2026 Jul 27;150:152738. doi: 10.1016/j.comppsych.2026.152738. Online ahead of print.

ABSTRACT

INTRODUCTION: Anxiety is a common mental disorder with high individual and public health costs. Psychometric scales are frequently applied to describe anxiety severity; however, their subjective nature reduces measurement precision. Heart rate variability (HRV) may serve as a complementary tool for assessing anxiety by adding physiological information beyond subjective symptom ratings.

METHODS: We conducted a systematic review and meta-analysis, reported in accordance with PRISMA 2020 (PROSPERO: CRD42024623381). We considered studies on adult populations who had been given validated anxiety scales (BAI, HAM-A and STAI) as well as quantitative HRV parameters (HF, LF, LF/HF, RMSSD, and SDNN). Correlation coefficients quantifying the associations for multiple psychometric scale – HRV parameter pairs were synthesised employing an inverse-variance random- effects meta-analysis framework.

RESULTS: A total of 79 studies were included, of which 39 were eligible in a quantitative analysis. Three statistically significant associations were identified: (1) BAI and HF showed a weak negative correlation (r = -0.09, p = .0239), (2) HAM-A and HF had a moderate negative correlation (r = -0.32, p = .0423), while (3) STAI and LF/HF ratio showed a positive correlation (r = 0.39, p = .0017). Other parameters did not show significant associations.

CONCLUSION: Selected HRV parameters showed associations with anxiety severity, especially HF with BAI and HAM-A, and LF/HF with STAI. While HRV is not a replacement for psychometric scales, it may contribute as a complementary tool for characterising autonomic regulation associated with anxiety severity.

PMID:42543052 | DOI:10.1016/j.comppsych.2026.152738

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Comparison of statin and antiplatelet therapy adherence in primary and secondary cardiovascular prevention patients

Orv Hetil. 2026 Aug 2;167(31):1238-1247. doi: 10.1556/650.2026.33612. Print 2026 Aug 2.

ABSTRACT

INTRODUCTION: According to epidemiological data from Hungary, cardiovascular diseases cause the greatest loss of health among the population and are responsible for a significant proportion of premature deaths. This reinforces the health policy position that cardiovascular prevention, including improving medication adherence, must be given top priority in patient care. Long-term survival in patients who have experienced acute coronary syndrome depends heavily on medication adherence, particularly regarding statins and anticoagulants; however, domestic surveys indicate deficiencies in the use of preventive medications.

OBJECTIVE: The aim of our study was to compare the attitudes and beliefs regarding antiplatelet agents and cholesterol-lowering drugs among patients in the secondary prevention group who underwent percutaneous coronary intervention and those in the primary prevention control group, using the Beliefs about Medicines Questionnaire (BMQ).

METHODS: A cross-sectional, questionnaire-based study included 162 secondary prevention patients and 136 primary prevention patients who had undergone percutaneous coronary intervention. Medication attitudes were measured using the specific and general dimensions of the BMQ, and SPSS 27.0 was used for statistical analysis.

RESULTS: Among patients in the secondary prevention group, both drug groups were characterized by lower levels of concern and more accepting attitudes, whereas in the primary prevention group, sceptical (p<0.05) and ambivalent attitudes were more common (p<0.001). Based on the analysis of respondents by attitude group and the examination of the BMQ’s general subscales, percutaneous coronary intervention significantly influenced beliefs regarding medications. This change was clinically significant in terms of treatment adherence (p<0.001) Discussion and conclusion: Patients who have undergone percutaneous coronary intervention have more favourable attitudes toward medication, which highlights the role of targeted education and psychoeducation in improving adherence in the non-intervention population. However, adherence in the secondary prevention group cannot be considered optimal either, therefore further targeted education is warranted in this patient group as well. Orv Hetil. 2026; 167(31): 1238-1247.

PMID:42543013 | DOI:10.1556/650.2026.33612

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Liposomal Bupivacaine Incisional Infiltration for Postoperative Analgesia After Cytoreductive Surgery with Hyperthermic Intraperitoneal Chemotherapy: A Randomized Placebo-Controlled Trial

Pain Ther. 2026 Aug 2. doi: 10.1007/s40122-026-00876-1. Online ahead of print.

ABSTRACT

INTRODUCTION: Moderate-to-severe postoperative pain is common after cytoreductive surgery (CRS) with hyperthermic intraperitoneal chemotherapy (HIPEC). Evidence that liposomal bupivacaine provides clinically important advantages over conventional local anesthetics is inconsistent, and evidence in CRS + HIPEC remains limited. This trial evaluated the incremental efficacy and safety of liposomal bupivacaine incisional infiltration added to patient-controlled intravenous analgesia (PCIA) compared with saline infiltration plus PCIA.

METHODS: In this single-center, randomized, participant- and assessor-blinded, placebo-controlled trial, adults aged 18-65 years scheduled for elective CRS + HIPEC were assigned 1:1 to standardized PCIA plus liposomal bupivacaine incisional infiltration (PCIA-LB) or PCIA plus normal saline infiltration (PCIA-NS). The primary endpoint was the incidence of moderate-to-severe movement-evoked incisional pain (numeric rating scale > = 4) within 72 h. The prespecified primary efficacy analysis used the per-protocol set (PPS), with a conservative intention-to-treat (ITT) sensitivity analysis. PCIA followed an institutional standard operating procedure. Monitoring was continuous in the intensive care unit (ICU); after transfer to the ward, pulse oximetry was continued through postoperative day 3, with intermittent electrocardiography and noninvasive blood pressure monitoring.

RESULTS: The PPS included 94 patients (PCIA-NS, n = 48; PCIA-LB, n = 46). Moderate-to-severe movement-evoked pain within 72 h was less frequent with PCIA-LB than with PCIA-NS (19.6% versus 70.8%, P < 0.001). The conservative ITT sensitivity analysis supported the same conclusion (26.0% versus 68.0%, P < 0.001). PCIA-LB also produced a modest reduction in cumulative 72-h study-recorded oral morphine milligram equivalents (556.8 [473.4, 600.0] versus 600.0 [557.4, 630.0] mg, P = 0.002) and reduced rescue analgesia (30.4% versus 54.2%, P = 0.020). QoR-15 scores did not differ significantly. Overall analgesia-related adverse events occurred in 23.9% and 10.4% of the PCIA-LB and PCIA-NS groups, respectively (P = 0.143). No participant required naloxone, emergency airway intervention, or ventilatory support for a clinically recognized opioid-related respiratory event, and no local anesthetic systemic toxicity, incisional infection, or fat liquefaction was observed.

CONCLUSIONS: Compared with saline infiltration, liposomal bupivacaine incisional infiltration reduced early movement-evoked incisional pain and rescue analgesia and produced a statistically significant but quantitatively modest reduction in 72-h opioid consumption captured by the study records after CRS + HIPEC. It did not improve QoR-15. These findings do not establish superiority over plain bupivacaine, ropivacaine, or catheter-based regional techniques, and the study was not powered to establish safety.

TRIAL REGISTRATION: Chinese Clinical Trial Registry, ChiCTR2500100826. Registered at 00:00 on 15 April 2025, before enrollment of the first participant later the same day.

PMID:42542999 | DOI:10.1007/s40122-026-00876-1