Category: Statistics

Clin Oral Investig. 2025 Jan 23;29(1):78. doi: 10.1007/s00784-025-06163-1.

ABSTRACT

OBJECTIVES: The aim of the study is to compare the clinical efficacy of the application of “Armenicum” paste as an adjunct to SRP for the non-surgical treatment of patients with periodontitis.

METHODS: The current RCT prospective study was conducted on 157 patients with chronic periodontitis. The patients were blind randomly assigned into two groups: Group A (SRP + Armenicum” paste) 81 patients (42 males and 39 females, 37 to 68 years) and Group B (SRP) 76 patients (39 males and 37 females, 37 to 68 years). Periodontal indices BOP, PPD, and DPI within each treatment group were measured before periodontal therapy, 3 and 6 months after the treatment. Group A underwent a periodontal treatment which included: supragingival and subgingival scaling, and additional use of local “Armenicum” paste. The Group B group only received supragingival and subgingival scaling.

RESULTS: In our study, the mean BOP, DPI, and PPD showed a statistically significant difference from baseline to 3 months and 6 months (p ≤ 0.05) in both Group A and Group B. But, mean BOP and mean PPD reduction gain was found to be greater in Group-A than Group B at 3 months and 6 months. No statistical differences in clinical indices were recorded depending on gender and age.

CONCLUSION: These results indicate that topical “Armenicum” paste provides an effective adjunctive treatment of chronic periodontitis.

CLINICAL RELEVANCE: The results of the current study showed that the adjunctive use of “Armenicum” reduced signs of inflammation compared to standard SRP treatment alone. Periodontal therapy using Armenicum paste application can be considered as a promising method in the treatment of periodontitis.

PMID:39849187 | DOI:10.1007/s00784-025-06163-1

J Neurol. 2025 Jan 23;272(2):161. doi: 10.1007/s00415-024-12878-0.

ABSTRACT

BACKGROUND: Conventional medical management, while essential, cannot address all multifaceted consequences of Parkinson’s disease (PD). This pilot study explores the potential of a co-designed creative arts therapy on health-related quality of life, well-being, and pertinent non-motor symptoms.

METHODS: We conducted an exploratory pilot study with a pre-post design using validated questionnaires. Eight individuals with PD participated in the program. The investigated intervention was a 10-week creative arts therapy with weekly 90-120-min sessions, guided by three creative therapists. Participants were allowed to autonomously select from multiple creative media based on their personal preferences. Explored co-primary outcomes included health-related quality of life (PDQ-39), well-being (ICECAP-A), anxiety/depression (HADS), executive functioning (BRIEF-A), resilience/mental flexibility (FIT-60), and self-efficacy (GSES). We used paired sample t tests for pre-post analysis of the co-primary outcomes and Wilcoxon signed-rank tests for PDQ-39 sub-scores. We also included aesthetic responsiveness (AReA) and healthcare consumption (IMCQ adapted for PD) questionnaires reported as descriptive statistics.

RESULTS: The results showed a significant reduction in anxiety and an increase in well-being. We also observed a slight improvement in cognitive functioning. Finally, we noted a reduction in healthcare consumption (fewer visits at neurologists, specialized PD nurses, and allied healthcare professionals).

CONCLUSION: These findings cautiously suggest that our co-designed, multi-media creative arts therapy has the potential to increase well-being and reduce anxiety, while reducing healthcare consumption. These preliminary findings support the need for a larger, randomized controlled trial to explore the therapeutic potential of creative arts therapy in PD care.

PMID:39849173 | DOI:10.1007/s00415-024-12878-0

Sci Rep. 2025 Jan 23;15(1):3006. doi: 10.1038/s41598-025-87396-8.

ABSTRACT

Anthropogenic activities such as industrial pollution of water bodies possess threat to floras leading to extinction and endangerment. This study investigates the impact of industrial pollution on vegetation along River Chenab and its associated drains. Rivers and channels transporting industrial effluents have been determined to be significantly contaminated. The contamination was evidenced by the acidic and alkaline nature of industrial effluents, salinity, total dissolved solids, and the sodium absorption ratio. The research revealed that the pollution in the region severely impacts the native vegetation, resulting in a marked decline in density, frequency, relative density, and relative frequency across 10 sites, including three drain sites and one non-polluted site. Four plant species, Calotropis procera, Eclipta alba, Phyla nodiflora, and Ranunculus sceleratus exhibited tolerance to pollution and were present at all sites during all seasons. Anatomical modifications, such as increased root aerenchyma and vascular bundles, enabled these plants to thrive in polluted environments. The study highlights the importance of these species in phytoremediation and their potential for use in restoring degraded ecosystems.

PMID:39849168 | DOI:10.1038/s41598-025-87396-8

Sci Rep. 2025 Jan 23;15(1):3007. doi: 10.1038/s41598-025-87474-x.

ABSTRACT

The traditional Chinese medicine compound preparation known as Jinbei Oral Liquid (JBOL) consists of 12 herbs, including Astragalus membranaceus (Fisch.) Bge, Codonopsis pilosula (Franch.) Nannf, et al. Having been used for over 30 years in the treatment of pulmonary diseases, JBOL was evaluated in this study in order to assess its effect on idiopathic pulmonary fibrosis as well as its safety (ChiCTR2000035351, Chictr.org.cn.09/08/2020). A double-blind, multicenter, randomized, proof-of-concept trial was conducted to assess the efficacy of oral JBOL 40 ml and Corbrin Capsules 1 g compared to a placebo and Corbrin Capsules in patients with idiopathic pulmonary fibrosis (IPF). Over a 26-week period, patients received the active treatment or placebo three times daily, in a 1:1 ratio. This clinical study uses a randomized method, with a cycle of every 4 patients. TCM doctors at or above the deputy director level of the research center conduct TCM dialectics on IPF patients. To assess efficacy, over the duration of the trial, we measured serial changes in a composite indicator encompassing time to first acute exacerbation of IPF (first hospitalization or death due to respiratory cause), total lung capacity (TLC) (mL), predicted forced vital capacity (FVC%), forced vital capacity (FVC) (mL), predicted diffusing capacity of the lungs for carbon monoxide (predicted DLco%), 6-minute walk distance (6MWD), St. George’s Respiratory Questionnaire (SGRQ) total score, and arterial oxygen partial pressure (PaO₂) from baseline to week 26 versus placebo. A total of 103 patients were screened, and 72 received the study medication. Of these, 68 patients were included in the analysis set, with 34 receiving JBOL and 34 receiving a placebo. After 26 weeks, a statistically significant reduction in total lung capacity (TLC) was observed for the JBOL group, with a change of 136 mL compared to -523 mL for the placebo group (difference 659 mL, 95% CI -1215 to -104 mL, p = 0.02). The study found that the change in FVC% predicted was – 1.48% and – 3.58% for the JBOL and placebo groups, respectively (difference of 2.10%, 95% CI -7.13 to 2.93, p = 0.41). Additionally the differences between the two groups in changes in FVC (mL), DLCO % predicted, PaO₂ (mmHg) measures were – 67 mL (95% CI -238 to 104), -7.74% (95% CI -17.26 to 1.79), and – 3.57 mmHg (95% CI -10.02 to 2.87), respectively. Treatment with JBOL compared to placebo resulted in sequential changes in acute exacerbation, with no significant difference in SGRQ scores. It was not found that there was a statistically significant difference between the JBOL and placebo groups in TEAE reporting and serious TEAE reporting. Compared to the placebo group, there was a statistically significant reduction (p < 0.021) in TLC (mL) after 26 weeks for JBOL. The rates of FVC % predicted, FVC, DLCO % predicted, and PaO₂ in the group treatment with JBOL were numerically lower than those in the placebo treatment group, although these differences did not reach statistical significance. JBOL exhibited comparable safety to placebo. This study has preliminarily shown the efficacy and safety of JBOL for IPF, but this is an exploratory clinical trial, more patient-involved studies should be needed in the near future.Trial registration: Chictr.org.cn ChiCTR2000035351; the trial was prospective clinical studies registered on August 9, 2020.

PMID:39849152 | DOI:10.1038/s41598-025-87474-x

Diabetologia. 2025 Jan 23. doi: 10.1007/s00125-024-06355-6. Online ahead of print.

ABSTRACT

AIMS/HYPOTHESIS: UK standard care for type 2 diabetes is structured diabetes education, with no effects on HbA_1c, small, short-term effects on weight and low uptake. We evaluated whether remotely delivered tailored diabetes education combined with commercial behavioural weight management is cost-effective compared with current standard care in helping people with type 2 diabetes to lower their blood glucose, lose weight, achieve remission and improve cardiovascular risk factors.

METHODS: We conducted a pragmatic, randomised, parallel two-group trial. Participants were adults (≥18 years) with overweight or obesity (BMI≥25 kg/m²) and recently diagnosed with type 2 diabetes (≤3 years), recruited from 159 primary care practices in England. We randomised participants to a tailored diabetes education and behavioural weight management programme (DEW; delivered by Weight Watchers) or to current standard care diabetes education (DE; Diabetes Education and Self Management for Ongoing and Newly Diagnosed [DESMOND] programme), using a computer-generated randomisation sequence in a 1:1 allocation stratified by gender and diabetes duration, unknown to those collecting and analysing the data. Participants could not be blinded due to the nature of the interventions. Participants completed assessments at 0, 6 and 12 months. The primary outcome was 12 month change from baseline in HbA_1c. We also assessed bodyweight, blood pressure, cholesterol (total, HDL, LDL), glucose-lowering medication, behavioural measures (physical activity, food intake), psychosocial measures (eating behaviour, diabetes-related quality of life, wellbeing) and within-trial and modelled lifetime cost effectiveness.

RESULTS: We randomised 577 participants (DEW: 289, DE: 288); 398 (69%) completed 12 month follow-up. We found no evidence for an intervention effect on change in HbA_1c from baseline to 12 months (difference: -0.84 [95% CI -2.99, 1.31] mmol/mol, p=0.44) or 6 months (-1.83 [-4.05, 0.40] mmol/mol). We found an intervention effect on weight at 6 (-1.77 [-2.86, -0.67] kg) and 12 months (-1.38 [-2.56, -0.19] kg). Participants in DEW had a higher likelihood of achieving diabetes remission than participants in DE (6 months: RR 2.10 [95% CI 1.03, 4.47]; 12 months: RR 2.53 [1.30, 5.16]). DEW was cost-effective compared with DE in within-trial and lifetime analyses, in the latter generating an incremental cost effectiveness ratio of £2290 per quality-adjusted life year gained.

CONCLUSIONS/INTERPRETATION: A commercial behavioural weight management programme combined with remote dietary counselling after diagnosis of type 2 diabetes did not improve HbA_1c up to 12 months post intervention in this trial. The intervention could help people achieve weight loss and be cost-effective compared with current standard National Health Service care.

TRIAL REGISTRATION: ISRCTN 18399564 FUNDING: National Institute for Health and Care Research (NIHR; RP-PG-0216-20010), Medical Research Council (MC_UU_00006/6), NIHR Cambridge Biomedical Research Centre (NIHR203312).

PMID:39849151 | DOI:10.1007/s00125-024-06355-6

Nat Methods. 2025 Jan 23. doi: 10.1038/s41592-024-02503-3. Online ahead of print.

ABSTRACT

Spatially resolved transcriptomics technologies provide high-throughput measurements of gene expression in a tissue slice, but the sparsity of these data complicates analysis of spatial gene expression patterns. We address this issue by deriving a topographic map of a tissue slice-analogous to a map of elevation in a landscape-using a quantity called the isodepth. Contours of constant isodepths enclose domains with distinct cell type composition, while gradients of the isodepth indicate spatial directions of maximum change in expression. We develop GASTON (gradient analysis of spatial transcriptomics organization with neural networks), an unsupervised and interpretable deep learning algorithm that simultaneously learns the isodepth, spatial gradients and piecewise linear expression functions that model both continuous gradients and discontinuous variation in gene expression. We show that GASTON accurately identifies spatial domains and marker genes across several tissues, gradients of neuronal differentiation and firing in the brain, and gradients of metabolism and immune activity in the tumor microenvironment.

PMID:39849132 | DOI:10.1038/s41592-024-02503-3

Arch Gynecol Obstet. 2025 Jan 24. doi: 10.1007/s00404-024-07862-y. Online ahead of print.

ABSTRACT

INTRODUCTION: PD1/PD-L1 inhibition (ICi) has recently become a new standard of care for patients with advanced MMR-deficient (MMRd) endometrial cancers. Nevertheless, response to immunotherapy is more complex than the presence of a single biomarker and therefore it remains challenging to predict patients response to ICi beyond MMRd tumors. Elevated PD-L1 expression (CPS ≥ 1) is often used as a prognostic marker as well as a predictive biomarker of response to ICi in different tumor types. In a retrospective, patient derived study, we analyzed PD1- and PD-L1 staining and correlated the results of different scores to clinical data to evaluate the prognostic impact of these scores.

MATERIALS AND METHODS: Immunohistochemical analysis of the receptor PD1 and the receptor ligand PD-L1 were performed on TMAs of primary paraffin‑embedded tumor samples. All patients were treated for primary endometrial cancer in the Department of Gynecology and Obstetrics, University Medical Center Schleswig-Holstein, Campus-Lübeck, Germany between the years 2006-2018. The evaluation and determination of the tumor proportion scoring (TPS), the combined positive score (CPS) and the immune cell scoring (IC) was automatically assessed semi-quantitatively, and results were correlated with clinicopathological characteristics and survival.

RESULTS: 130 samples were evaluable and 64% showed a positivity (IC > 0) for the receptor PD1 and 56% for the receptor ligand PD-L1. Patients with a PD1 IC Score ≥ 1 showed a significant longer disease-free survival of 140 months (95% confidence interval (CI): 124-158) compared to patients with a lower IC < 1 for PD1 of 89 months (95% confidence interval (CI): 69-110); p = 0.017). Furthermore, the disease-free survival for patients with a CPS ≥ 5 for PD1 was longer (153.7 months (95% confidence interval (CI): 134-173.6) vs. 98.6 months (95% confidence interval (CI): 83-114); p = 0.036). Additionally, a PD1 CPS ≥ 5 showed a better overall survival but the result was not statistically significant. No difference in survival was found between patients with PD-L1 higher or lower than CPS 5.

CONCLUSION: In this study we pointed out that there are significant clinical differences among several immunohistochemical scoring systems. In our trial, a PD1-positivity with CPS ≥ 5 and IC ≥ 1 were significantly associated to a better disease-free survival while there was no association with TPS. The PD1-IC scoring was associated with MMRd while the TPS scoring was not. Therefore, PD1-IC could be more appropriate for endometrial carcinomas compared to TPS and could also add prognostic information beside the more established PD-L1-staining. Further prospective studies are needed for a validation of these scores in combination with other biomarkers.

PMID:39849119 | DOI:10.1007/s00404-024-07862-y

Dis Colon Rectum. 2025 Feb 1;68(2):227-233. doi: 10.1097/DCR.0000000000003550. Epub 2024 Nov 8.

ABSTRACT

BACKGROUND: Patients with Crohn’s disease face an elevated risk of colorectal cancer, in part due to underlying chronic inflammation. Biologic therapy is the mainstay of medical treatment; however, the impact of treatment on colorectal cancer-related outcomes remains unclear.

OBJECTIVE: To investigate the association between prior exposure to biologic treatment and colorectal cancer-related outcomes in patients with underlying Crohn’s disease.

DESIGN: Retrospective cohort study.

SETTINGS: High volume, tertiary colorectal surgery department.

PATIENTS: Adults (older than 18 years) diagnosed with Crohn’s disease and colorectal cancer who underwent curative operation between 1998 and 2020.

INTERVENTIONS: Exposure to any biologic IBD medication before cancer diagnosis.

MAIN OUTCOME MEASURES: Survival and recurrence outcomes.

RESULTS: A total of 56 patients were included with a median age of 52.5 years (interquartile range, 18.9 years) at the time of surgery; 19 patients (33.9%) were treated with biologics before surgery; 10 (52.6%) received infliximab, 2 (10.5%) received adalimumab, and 7 (36.8%) received multiple biologics. Rectal cancer (57% vs 43.2%, p = 0.02) and well-differentiated or moderately differentiated tumors (93% vs 50%, p = 0.005) were more common in the biologic exposure group. Exposure to biologics was associated with a higher 5-year disease-free survival rate (80% vs 45%, p = 0.048), whereas the 5-year overall survival (93% vs 57%, p = 0.19) and 5-year recurrence rates (7% vs 31%, p = 0.18) were numerically but not statistically significant.

LIMITATIONS: Retrospective, single-center study.

CONCLUSIONS: In patients with Crohn’s disease and colorectal adenocarcinoma who underwent curative surgery, those previously exposed to biologic therapy were more likely to have well-differentiated or moderately differentiated tumors, which were more likely to be distal to the splenic flexure. Biologic exposure was associated with significantly higher 5-year disease-free survival. These findings suggest that treatment of inflammation in patients with Crohn’s disease fundamentally alters carcinogenesis pathways. See Video Abstract.

LA TERAPIA BIOLGICA SE ASOCIA CON MEJORES RESULTADOS ONCOLGICOS EN EL CNCER COLORRECTAL ASOCIADO A LA ENFERMEDAD DE CROHN: ANTECEDENTES:Los pacientes con enfermedad de Crohn enfrentan un riesgo elevado de cáncer colorrectal, en parte debido a la inflamación crónica subyacente. La terapia biológica es el pilar del tratamiento médico; sin embargo, el impacto del tratamiento en los resultados relacionados con el cáncer colorrectal sigue sin estar claro.OBJETIVO:Investigar la asociación entre la exposición previa al tratamiento biológico y los resultados relacionados con el cáncer colorrectal en pacientes con enfermedad de Crohn subyacente.DISEÑO:Estudio de cohorte retrospectivo.ESCENARIO:Departamento de cirugía colorrectal de alto volumen de tercer nivelPACIENTES:Adultos (>18 años) diagnosticados con enfermedad de Crohn y cáncer colorrectal que se sometieron a una operación curativa entre 1998 y 2020.INTERVENCIÓN(ES):Exposición a cualquier medicamento biológico para la EII antes del diagnóstico de cáncer.PRINCIPALES MEDIDAS DE RESULTADOS:Resultados de supervivencia y recurrenciaRESULTADOS:Se incluyeron 56 pacientes, con una mediana de edad de 52.5 años (RIC: 18.9 años) en el momento de la cirugía; 19 (33.9%) pacientes fueron tratados con agentes biológicos antes de la cirugía; 10 (52.6%) recibieron infliximab, 2 (10.5%) recibieron adalimumab y 7 (36.8%) habían recibido múltiples agentes biológicos. El cáncer rectal (57% frente a 43.2%, p = 0.02) y los tumores bien o moderadamente diferenciados (93% frente a 50%, p = 0.005) fueron más comunes en el grupo de exposición a agentes biológicos. La exposición a agentes biológicos se asoció con una mayor tasa de supervivencia libre de enfermedad a 5 años (80% frente a 45%, p = 0.048), mientras que la supervivencia general a 5 años (93% frente a 57%, p = 0.19) y las tasas de recurrencia a 5 años (7% frente a 31%, p = 0.18) fueron numéricamente, pero no estadísticamente significativas.LIMITACIONES:Estudio retrospectivo de un solo centro.CONCLUSIONES:En pacientes con enfermedad de Crohn y adenocarcinoma colorrectal que se sometieron a cirugía curativa, aquellos expuestos previamente a terapia biológica tuvieron más probabilidades de tener tumores bien/moderadamente diferenciados, y tenían más probabilidades de estar distales al ángulo esplénico, asociados con una supervivencia libre de enfermedad a 5 años significativamente mayor. Estos hallazgos sugieren que el tratamiento de la inflamación en pacientes con enfermedad de Crohn altera fundamentalmente las vías de la carcinogénesis. (Traducción-Dr. Jorge Silva Velazco).

PMID:39847800 | DOI:10.1097/DCR.0000000000003550

Am J Manag Care. 2025 Jan 1;31(1):e26-e30. doi: 10.37765/ajmc.2025.89668.

ABSTRACT

OBJECTIVES: Patient experience surveys are essential to measuring patient-centered care, a key component of health care quality. Low response rates in underserved groups may limit their representation in overall measure performance and hamper efforts to assess health equity. Telephone follow-up improves response rates in many health care settings, yet little recent work has examined this for surveys of Medicare enrollees, including those with Medicare Advantage. Our objective was to describe response rates to the 2022 Medicare Consumer Assessment of Healthcare Providers and Systems (MCAHPS) surveys and the completion mode (mail or telephone), overall and by person-level characteristics.

STUDY DESIGN: Cross-sectional survey.

METHODS: Participants were 1,092,434 individuals with Medicare who were selected to receive the 2022 MCAHPS survey in the 50 states and the District of Columbia and who were representative of the Medicare population. Study measures were survey response and completion mode.

RESULTS: The overall response rate was 33.7% (31.3% by mail and 2.3% by telephone), with 6.9% of responses by telephone. Despite the low overall telephone response rate, the phone was used at markedly higher rates by respondents in some groups with lower overall response rates who are thus underrepresented among respondents, including those who were younger than 65 years (eligible for Medicare due to disability: 16.5% of responses by telephone), Black (16.1%), or Hispanic (14.1%) or had limited income and assets (14.6%).

CONCLUSIONS: Including a telephone component in the administration of the MCAHPS survey continues to have value because several groups still show a relative preference for survey completion by telephone. Steps should be taken to improve response rates by telephone.

PMID:39847792 | DOI:10.37765/ajmc.2025.89668

Am J Manag Care. 2025 Jan 1;31(1):e20-e25. doi: 10.37765/ajmc.2025.89667.

ABSTRACT

OBJECTIVES: Patients who revisit the emergency department (ED) shortly after discharge are a high-risk group for complications and death, and these revisits may have been seriously affected by the COVID-19 pandemic. Detecting suspected COVID-19 cases in EDs is resource intensive. We examined the associations of screening workload for suspected COVID-19 cases with in-hospital mortality and intensive care unit (ICU) admission during short-term ED revisits.

STUDY DESIGN: We conducted a retrospective cohort study using electronic health record data from a tertiary teaching hospital.

METHODS: We analyzed all 72-hour ED-revisiting patients at the Taipei Veterans General Hospital ED in Taiwan between January 27, 2020, and December 31, 2020. Screening workload for suspected COVID-19 cases was measured with the daily number of suspected COVID-19 cases. Multivariate logistic regression models were used after adjustment for patient characteristics to examine the associations of screening workload with in-hospital mortality and ICU admission.

RESULTS: A total of 1107 patients were included. The mean number of daily suspected COVID-19 cases was 9.4. The rates of subsequent in-hospital mortality and ICU admission were 2.1% and 3.2%, respectively. The volume of daily suspected COVID-19 cases was significantly associated with increased subsequent in-hospital mortality (adjusted OR, 1.073 with each additional daily suspected COVID-19 case; P = .005).

CONCLUSIONS: This is the first study to our knowledge to identify that screening for suspected COVID-19 cases in EDs can adversely affect patient outcomes during short ED revisits. Identifying this association could enable ED providers and policy makers to optimize emergency service delivery during an epidemic and help patients.

PMID:39847791 | DOI:10.37765/ajmc.2025.89667