Category: Statistics

EBioMedicine. 2025 Oct 29:105967. doi: 10.1016/j.ebiom.2025.105967. Online ahead of print.

ABSTRACT

BACKGROUND: It is unclear whether pro-dopaminergic drugs reduce anhedonia in major depressive disorder (MDD) and further, if so, to what extent this is the case.

METHODS: With lived experienced experts we co-produced two living systematic reviews of randomised controlled trials (RCTs) investigating the relative efficacy of pro-dopaminergic interventions in reducing symptoms of anhedonia in people with MDD (versus placebo) and in relevant non-human animal models (versus vehicle control/no intervention). Multiple electronic databases were searched until June 9, 2024. The primary outcomes were subjective anhedonia symptoms in humans and sucrose preference test (a measure of reward sensitivity and proxy for anhedonia) in animals. We evaluated other important domains and clinical aspects closely related to anhedonia, such as reward/reinforcement tasks, anxiety symptoms, acceptability, tolerability, and adverse events. We performed pairwise meta-analyses separately for human and non-human studies. We also estimated the relative effects of pro-dopaminergic versus non-dopaminergic antidepressants in human studies on anhedonia and overall depressive symptoms using a series of random-effects network meta-analyses of both aggregate and patient-level data. A multidisciplinary panel of international experts (including people with lived experience) then interpreted the overall results and produced a list of recommendations via a triangulation process. This study is part of GALENOS (Global Alliance for Living Evidence in aNxiety, depressiOn, and pSychosis). PROSPERO registration: CRD42023451821.

FINDINGS: Pro-dopaminergic interventions were associated with a small reduction of anhedonia symptoms (6 RCTs, n = 2076; SMD -0.24, 95% CI -0.46 to -0.03) in people with MDD and increased sucrose preference in animal models (27 RCTs; SMD 1.34, 0.88 to 1.79). We did not find data about reward/reinforcement tasks in humans. Evidence was rated as low to moderate. In the network meta-analysis, some antidepressants with a non-dopaminergic mechanism of action showed reduction in anhedonia symptoms, which was larger than pro-dopaminergic drugs and probably independent of overall depression improvement.

INTERPRETATION: Our findings provide some support for the role of dopamine in anhedonia. However, the precise neurobiological mechanisms of anhedonia in major depression are still poorly understood and we posit that they may be possibly related to altogether different or more general effects of antidepressants on these symptoms. Therefore, data on reward, including reward-related learning and memory, are needed to properly examine the relationship between dopamine modulation and anhedonia.

FUNDING: Wellcome (GALENOS project).

PMID:41168072 | DOI:10.1016/j.ebiom.2025.105967

J Craniomaxillofac Surg. 2025 Oct 29:S1010-5182(25)00319-1. doi: 10.1016/j.jcms.2025.10.004. Online ahead of print.

ABSTRACT

Cleft lip and palate(CLP) is a deformity that affects the anatomical structure of the nose and the maxillary sinus(MS). In the management of MS pathologies, the prelacrimal recess approach(PLRA), a minimally invasive technique within endoscopic sinus surgery, holds significant importance. This study aims to evaluate the morphometric characteristics of the nasolacrimal duct(NLD) and the prelacrimal recess(PLR), as well as the feasibility of the prelacrimal recess approach(PLRA), in patients with unilateral cleft lip and palate(UCLP) using cone-beam computed tomography(CBCT). CBCT images of both the cleft and non-cleft sides of 60 patients with UCLP were retrospectively analyzed. Morphometric measurements related to the anatomy of the NLD and the PLR were performed and statistically compared.In these patients, the mediolateral diameter of the NLD was found to be significantly narrower on the cleft side(5.10 ± 1.29 mm) compared to the non-cleft side(5.74 ± 1.28 mm)(p = 0.03). The mediolateral thickness of the PLR was also significantly thinner on the cleft side(1.89 ± 1.46 mm) than on the non-cleft side(2.91 ± 1.95 mm)(p = 0.01). However, no significant difference was observed in the anteroposterior length of the PLR between the cleft side(5.08 ± 2.54 mm) and the non-cleft side(4.64 ± 2.67 mm)(p = 0.35).The prelacrimal recess and nasolacrimal canal on the cleft side may be affected in patients with UCLP. CBCT serves as a valuable tool in identifying these anatomical variations, which are frequently associated with congenital deformities such as UCLP and should be carefully considered during surgical planning.

PMID:41168059 | DOI:10.1016/j.jcms.2025.10.004

J Sci Med Sport. 2025 Oct 10:S1440-2440(25)00453-0. doi: 10.1016/j.jsams.2025.10.004. Online ahead of print.

ABSTRACT

OBJECTIVES: To conduct a qualitative document and content analysis of publicly available tackle safety guidance amongst national and international rugby organisations, across both Rugby Union and Rugby League, in order to determine the number, type, and focus of current tackle safety guidance.

DESIGN: Qualitative document and content analysis.

METHODS: Tackle safety guidance was identified through (1) a structured online search via Google using targeted search terms and synonyms, and (2) a comprehensive manual search of national and international rugby organisation websites, at all levels of competition, conducted between September 2024 and January 2025. Resources, including documents, videos, e-learning modules, and other relevant materials, were included if they addressed tackle safety in rugby. Qualitative content analysis of each resource was performed, organising the information into themes and subthemes.

RESULTS: A total of 123 documents were identified from 18 rugby organisations’ websites. Portable Document Formats (PDFs) (n = 55) and webpages (n = 51) were the most common type of resources followed by infographics (n = 9) and eLearning (n = 8). Four themes emerged based on the content of the documents; these were tackle safety laws (35 %), tackle preparation (33 %), concussion specific guidance (20 %), and protective equipment (13 %).

CONCLUSIONS: Whilst substantial efforts have been made in tackle safety resource development, few have been rigorously evaluated, and there is variation in the number, type, focus and implementation. Future tackle safety efforts should address key areas such as law variations, contact training loads, return-to-contact protocols, and education, with a particular focus on evaluations for underserved groups. Ongoing research and collaboration between knowledge creators and users are essential to optimise tackle safety for all.

PMID:41168048 | DOI:10.1016/j.jsams.2025.10.004

Oral Surg Oral Med Oral Pathol Oral Radiol. 2025 Oct 6:S2212-4403(25)01256-8. doi: 10.1016/j.oooo.2025.09.017. Online ahead of print.

ABSTRACT

OBJECTIVES: This study evaluates the implications of clinical and radiographic diagnostic errors on the treatment of non-endodontic and truly endodontic periapical lesions, as determined by histopathologic findings.

STUDY DESIGN: A retrospective review was conducted on 236 histopathological reports of periapical lesions collected via apical surgery, extraction, or cystectomy (2020-2024). Clinical diagnoses based on 2-dimensional radiographs and CBCT were compared with histopathological results. Cases with soft tissue lesions, lesions with no detectable radiographic findings, or non-periapical pathoses were excluded. Data were categorized and statistically analyzed to determine diagnostic accuracy.

RESULTS: Of 236 cases, 136 (57.62%) were of endodontic origin (apical granulomas and radicular cysts), while 100 (42.37%) were nonendodontic, including 56 (23.73%) odontogenic cysts, 18 (7.63%) tumors, 16 (6.78%) non-odontogenic cysts, and 10 (4.24%) fibro-osseous lesions. Misdiagnosis led to inappropriate treatments such as unnecessary extractions or ineffective root canal therapy. CBCT with histopathological confirmation significantly improved diagnostic precision. Notably, 63 (26.79%) of teeth linked to odontogenic cysts were vital, indicating that root canal therapy was unwarranted.

CONCLUSIONS: Based on the findings of this retrospective study, a substantial proportion of periapical lesions are non-endodontic, emphasizing the importance of clinical evaluation, including vitality testing, alongside imaging in the differential diagnosis as opposed to reliance on imaging alone. Reliance solely on imaging can cause treatment errors. Improved protocols and further research are essential to optimize outcomes.

PMID:41168040 | DOI:10.1016/j.oooo.2025.09.017

J Voice. 2025 Oct 29:S0892-1997(25)00429-1. doi: 10.1016/j.jvoice.2025.10.013. Online ahead of print.

ABSTRACT

BACKGROUND: In addition to impairing the lung function, chronic obstructive pulmonary disease (COPD) also affects phonatory characteristics. Recent research highlights the potential of voice as a digital biomarker to support clinical decision-making. While machine learning (ML) can detect disease patterns from acoustic features, clinical relevance requires understanding the relationship between the disorder and acoustic features.

OBJECTIVE: This study investigates both statistical and clinical significance using Baseline Acoustic (BLA) and Mel-Frequency Cepstral Coefficient (MFCC) features with focusing on individuals with COPD and healthy controls (HC).

METHOD: Acoustic features derived from Swedish utterances of the vowel [a:], recorded via mobile phones from 48 age-matched participants (24 COPD, 24 HC; equal gender distribution), were analyzed. To reduce bias from varying recording counts, features were aggregated by averaging 10 randomly selected recordings per participant over 100 iterations. Vowel articulation was visualized in the vowel quadrilateral space using F1 (tongue height) and F2 (tongue advancement). Group differences were assessed using the Shapiro-Wilk test, Mann-Whitney U test (α = 0.05), Benjamini-Hochberg (BH) and Bonferroni corrections, Permutational Multivariate Analysis of Variance (PERMANOVA) test, and Cliff’s Delta (δ).

RESULTS: Of 101 features, 29 remained significant after BH correction and one after Bonferroni. Multivariate testing (p = 0.019) showed group separation. Additionally, 34 features demonstrated large effect sizes, suggesting potential as digital biomarkers.

CONCLUSION: Voice data recorded via mobile phones capture meaningful acoustic differences associated with COPD. These findings support the integration of voice-based assessments into eHealth platforms for noninvasive COPD screening and monitoring, which is pending further validation on larger populations.

CLINICAL TRIAL: NCT06705647.

PMID:41168019 | DOI:10.1016/j.jvoice.2025.10.013

J Clin Anesth. 2025 Oct 29:111878. doi: 10.1016/j.jclinane.2025.111878. Online ahead of print.

ABSTRACT

STUDY OBJECTIVES: Alerts for vital sign abnormalities seek to identify meaningful patient instability while limiting alarm fatigue. Optimal vital sign alarm settings for postoperative patients remain unknown, as is whether alerts lead to effective clinical responses reducing vital sign disturbances. We conducted a 2-phase pilot study to identify thresholds and delays and test the hypothesis that alerts from continuous monitoring reduce the duration of vital sign abnormalities.

DESIGN: Two-phase pilot.

PATIENTS: 250 adults having major non-cardiac surgery.

SETTING: Surgical wards.

INTERVENTION: All patients had routine vital sign monitoring by nurses at 4-h intervals. We initially continuously recorded clinician-blinded saturation, heart rate, and respiratory rate in 100 patients. In the second phase, we randomized 150 patients to blinded versus unblinded continuous vital sign monitoring. In unblinded patients, nurses were verbally alerted to abnormal vital signs.

MEASUREMENTS: In the first phase, we modeled expected alarm counts using 6082 h of continuous oxygen saturation, heart rate, and respiratory rate data. Thresholds and delays targeting a limited number of meaningful alerts were selected for phase two. The primary analysis in phase 2 assessed the effect of unblinded monitoring across a 5-component composite of cumulative durations of vital sign abnormalities. Secondary outcomes included a fraction of alerts deemed meaningful by nurses and number of clinical interventions.

RESULTS: In phase one, we identified alarm settings that yielded an average of 1.0 alerts per patient per day. In phase two, there were an average of 0.45 alerts per patient per day, with fewer alerts presumably resulting because nurses were allowed to alter the initial notification thresholds. The median [Q1, Q3] duration of SpO₂ <85 % was 6.7 [1.2, 18] minutes in unblinded patients vs. 4.6 [0.83, 40] in the blinded group. For RR <4 breaths/min, durations were 0 [0,0] vs. 0 [0, 0.15] (unblinded vs. blinded). RR >30 was 9.0 [2.4, 23] vs. 11 [2.6, 22] minutes. HR <45 bpm lasted 0.02 [0, 1.2] vs. 0.44 [0, 2.2] minutes. HR >130 bpm was 0 [0, 1.3] vs. 0 [0, 0.9] minutes. The average relative effect ratio of geometric means for duration of vital signs exceeding thresholds was 0.72 [95 % CI: 0.47, 1.1], P = 0.11. Among the 73 alarms, 60 (82 %) were considered useful in unblinded patients, leading to 49 interventions in the unblinded group, compared to 30 interventions in the blinded group.

CONCLUSIONS: Using the continuous saturation, heart rate, and respiratory rate thresholds established in Phase 1, we generated approximately 0.45 alerts per patient per day during Phase 2, nearly all of which were considered useful by nurses Although the difference in vital sign abnormalities between the unblinded and blinded groups was not statistically significant, unblinded monitoring and nursing alerts led to more interventions (mostly increasing oxygen delivery).

CLINICALTRIALS: govregistration:NCT05280574.

PMID:41168018 | DOI:10.1016/j.jclinane.2025.111878

Dent Mater. 2025 Oct 29:S0109-5641(25)00800-0. doi: 10.1016/j.dental.2025.10.011. Online ahead of print.

ABSTRACT

OBJECTIVES: This study was conducted to examine the biocompatibility, regenerative potential, and immunomodulatory effects of three formulated calcium silicate-containing sealers (CSCS)-TotalFill BC Sealer (TFbc), NeoSEALER Flo (NS Flo), and NeoSEALER EZ Flo (NS EZ Flo)-on human periodontal ligament stem cells (hPDLSCs).

MATERIALS AND METHODS: Third molars extracted from healthy patients (n = 15) were used to isolate hPDLSCs. Dilutions of 1:1, 1:2, and 1:4 were prepared, along with set sample discs of TFbc, NS Flo, and NS EZ Flo. The following assays were conducted: cell phenotyping, metabolic activity assessment (MTT assay), evaluation of cell attachment and morphology (scanning electron microscopy, SEM), cell migration analysis (wound-healing assay), cytoskeletal organization (phalloidin staining), proinflammatory cytokine release (IL-6 and IL-8, via ELISA), expression of differentiation markers (RT-qPCR), and assessment of cellular mineralization (Alizarin Red S staining). Statistical significance was set at p < 0.05.

RESULTS: The metabolic activity assay demonstrated that cell viability increased over time with the use of bioceramic sealers.These sealers also promoted remarkable cell confluence and a higher number of focal adhesion complexes, as evidenced by the phalloidin assay. Furthermore, they demonstrated enhanced cell adhesion and anti-inflammatory effects compared to the negative control group (untreated cells), with the latter effect being more pronounced in the case of TotalFill BC Sealer. NS Flo, followed by NS EZ Flo, were the bioceramic sealers that most significantly promoted mineralized nodule formation, comparable to the positive control (Osteodiff), thus contributing to osteogenic and cementogenic differentiation.

CONCLUSION: This study demonstrates that all the bioceramic sealers investigated exhibit adequate cytocompatibility. NS Flo and NS EZ Flo demonstrate a strong ability to induce differentiation of hPDLSCs into osteogenic and cementogenic phenotypes. NS Flo significantly supports extracellular matrix mineralization. However, TFbc had a less substantial impact on these processes than the sealers. The effect was comparable during the first three days but decreased thereafter. In addition, the calcium silicate-containing sealers investigated exhibited relevant anti-inflammatory effects, offering potential therapeutic benefits in the field of regenerative endodontics.

PMID:41168012 | DOI:10.1016/j.dental.2025.10.011

J Pediatr Nurs. 2025 Oct 29:S0882-5963(25)00365-3. doi: 10.1016/j.pedn.2025.10.020. Online ahead of print.

ABSTRACT

BACKGROUND AND PURPOSE: This study aimed to determine the effect of kangaroo care on vital signs in infants undergoing cardiac surgery.

DESIGN AND METHODS: This randomized controlled study was conducted in the pediatrics cardiovascular surgery intensive care unit of a training research hospital between December 2023 and March 2024. The sample consisted of 60 infants who had undergone cardiac surgery, with 30 assigned to the experimental group and 30 to the control group. The experimental group received kangaroo care during the procedure. Data was collected via the Descriptive Information Form about sample characteristics and the Vital Signs and Pain Recording Form. The data were analyzed using descriptive statistics, Chi-square, independent sample t-tests, ANOVA, and mixed effect model variance analysis. The study was recorded in the Clinicaltrials.gov PRS system.

RESULTS: The mixed-method comparison showed a high level of significance in the intervention group regarding heart rate and respiratory rate reductions, pain score reduction, and increased peripheral saturation levels in both time and group measurements (p < 0.001). Additionally, the decrease in systolic blood pressure in the intervention group was significant in the group measurements (p < 0.001), whereas time-based comparisons showed no significant changes in diastolic blood pressure (p > 0.05). Comparison of changes in pre-test and post-test vital signs between the intervention and control groups were significant, except for diastolic blood pressure (p < 0.05).

CONCLUSIONS: The study demonstrated that post-surgical kangaroo care in infants undergoing cardiac surgery reduced heart rate, systolic arterial pressure, and respiratory rate, while increasing peripheral saturation levels and decreasing pain scores.

IMPLICATIONS FOR PRACTICE: The integration of kangaroo care into post-cardiac surgery care practices may lead to improvements in infants’ vital signs and promote relaxation through mother-infant skin-to-skin contact. This, in turn, could potentially enhance family-centered care practices in cardiac surgery units, and, in the future, improve the quality of care outcomes for both mothers and infants.

PMID:41168010 | DOI:10.1016/j.pedn.2025.10.020

Transplant Proc. 2025 Oct 30:S0041-1345(25)00517-2. doi: 10.1016/j.transproceed.2025.10.025. Online ahead of print.

ABSTRACT

BACKGROUND: There is a need to improve knowledge of the health-related quality of life (HRQoL) in the post-heart transplantation (HTx) period and the factors affecting it. This qualitative study aimed to identify the most important domains of HRQoL for heart transplant recipients and the factors that impact it.

METHODS: This was a qualitative study across 5 geographically diverse large HTx centers in France from July 2022 to January 2023. We gathered a purposive sample of individuals who had undergone HTx. A face-to-face semi-structured interview guide was used for individual interviews. All interviews were audio-recorded and transcribed verbatim.

RESULTS: A total of 14 individuals (10 men) were interviewed. The data analysis led to the development of 8 main themes (with sub-themes) that were relevant to participants: HRQoL perception (mental health, physical capacity, symptoms and comorbidities), participants’ experience during the HTx process, immunosuppressive treatments, relationship with the healthcare team, external and internal resources, socio-economic aspects and feelings about the donor. Recipients, spontaneously made connections between these themes.

CONCLUSIONS: Heart transplant recipients had diverse perceptions of their HRQoL in the post-HTx period. The rich variety of themes identified from the review highlights that recipients have a complex HRQoL profile which is not currently captured by standard HRQoL tools that are commonly employed. These aspects should be taken into account in the clinical follow-up and in the selection of the most appropriate Patient Reported Outcome Measures (PROMs).

PMID:41168008 | DOI:10.1016/j.transproceed.2025.10.025

J Natl Med Assoc. 2025 Oct 29:S0027-9684(25)00329-3. doi: 10.1016/j.jnma.2025.10.002. Online ahead of print.

ABSTRACT

BACKGROUND: Early childhood developmental assessment is a continuous process that involves observing, collecting, recording, and analyzing information about young children. This helps educators and health professionals evaluate the children’s growth and development their instruction accordingly. However, there are limited standardized assessment tools that are widely adopted. The goal of this study was to explore how health professionals at public health institutions assess developmental milestones in early childhood METHODS: The study used an institution-based cross-sectional design. 356 study participants from public health facilities were selected by using a simple random sampling technique. Questionnaires and observational checklists were employed to evaluate the practice and related elements. An SPSS version 27 program was used to clean, code, and enter the data after it had been verified as consistent and complete. The binary logistic regression model was used to analyze bivariate and multivariable and the model fitness was checked. The p-value was <0.05, indicating a significant association. Lastly, texts, tables, and graphs are used to present the results.

RESULTS: Only 33.8 % of health professionals had good practice with early childhood developmental milestone assessment. Professions (Physicians and Health officers), training, standardized assessment tools available and supervision were factors that significantly related to good practices.

CONCLUSION: Assessment of the practice of developmental milestones assessment in early childhood was still done poorly. Standardized assessment tools available, training, supportive supervision, and the type of types of profession (physician or health officer) were all statistically significant determinants. As a result, providing health workers with training, carrying out ongoing supporting supervision, and making standardized assessment tools are crucial.

PMID:41168007 | DOI:10.1016/j.jnma.2025.10.002