Tag: statistics

Transplant Proc. 2025 Nov 7:S0041-1345(25)00516-0. doi: 10.1016/j.transproceed.2025.09.011. Online ahead of print.

ABSTRACT

BACKGROUND: Kidney transplantation is the preferred treatment for end-stage renal disease. In Pakistan, living related kidney donors constitute the primary source of kidney transplantation. However, data on postdonation outcomes in this population remain limited.

OBJECTIVE: This study aims to evaluate the short- and intermediate-term effects of unilateral nephrectomy on donor kidney function, physical parameters, and glycemic status among living related kidney donors in Pakistan.

METHODS: This retrospective observational cohort study was conducted at the Pakistan Kidney and Liver Institute from March 2018 to February 2021. Predonation data were obtained from hospital records, and postdonation follow-up assessments were conducted at intervals ranging from 6 months to 3 years.

RESULTS: A total of 132 donors donated a kidney, and 100 participated in follow-up assessments. The mean postdonation serum creatinine increased significantly by 0.27 mg/dL (P < .05), while estimated glomerular filtration rate decreased by 30 mL/min (P < .05). Systolic blood pressure increased slightly (by 1.35 mm Hg), while diastolic blood pressure decreased, although neither change was statistically significant (P > .05). Body mass index showed a minor increase of 0.5 kg/m², and HbA1c levels remained stable with no significant postdonation changes (P > .05).

CONCLUSIONS: The study findings suggest that while kidney donation results in a significant decline in renal function in the short term, compensatory mechanisms contribute to gradual improvement over time. These results highlight the importance of continued postdonation monitoring to ensure donor health and identify potential long-term risks.

PMID:41206328 | DOI:10.1016/j.transproceed.2025.09.011

Dent Mater. 2025 Nov 7:S0109-5641(25)00808-5. doi: 10.1016/j.dental.2025.11.001. Online ahead of print.

ABSTRACT

OBJECTIVE: This randomized clinical trial investigated the 96-month clinical performance of a universal adhesive (Adhese Universal Vivapen, Ivoclar Vivadent) applied in etch-and-rinse (ER) and self-etch (SE) modes in Class II bulk-fill composite restorations.

MATERIALS AND METHODS: Thirty-five patients, each with at least two Class II carious lesions, were enrolled. Using a split-mouth design, cavities were randomly assigned to ER or SE adhesive application. All restorations were placed with a high-viscosity bulk-fill resin composite (Tetric EvoCeram Bulk Fill, Ivoclar Vivadent). In total, 84 restorations were evaluated at baseline and at 12, 24, 36, 48, 60, 72, 84 and 96 months by two calibrated, blinded examiners according to modified USPHS criteria. Statistical analyses were performed with Chi-square, Friedman, Cochran’s Q, and McNemar tests (α=0.05).

RESULTS: At 96 months, 74 restorations in 33 participants were examined. No loss of retention/fractures occurred. Seven restorations were replaced (six due to secondary caries-ER: 1, SE: 5 and one due to unacceptable marginal adaptation-SE), yielding crude cumulative replacement rates of 2.4 % (ER) and 14.3 % (SE). Kaplan-Meier analysis showed significantly higher survival for ER than SE (97.4 % vs 85.2 %, p = 0.049). Marginal discoloration was consistently higher with SE from 36 months onward (p < 0.05), whereas marginal adaptation showed no differences between groups at any recall. Other criteria were comparable, and no postoperative sensitivity was recorded.

CONCLUSIONS: Despite a statistically higher incidence of marginal discoloration in the SE approach, both strategies demonstrated comparable long-term outcomes, with no retention loss after 96 months. The ER showed a higher cumulative survival. These findings confirm the clinical acceptability of universal adhesives in Class II bulk-fill composite restorations over extended service periods.

CLINICAL SIGNIFICANCE: Universal adhesives demonstrated durable adhesion and predictable performance in posterior bulk-fill restorations with both strategies, while the ER approach provided additional benefits in marginal discoloration and lower cumulative replacement needs over the long term.

PMID:41206301 | DOI:10.1016/j.dental.2025.11.001

Eur Urol. 2025 Nov 7:S0302-2838(25)04778-5. doi: 10.1016/j.eururo.2025.10.015. Online ahead of print.

ABSTRACT

BACKGROUND AND OBJECTIVE: There is uncertainty over medium-term cancer outcomes for men who avoid biopsy (Bx) after nonsuspicious magnetic resonance imaging (MRI), and men with a negative Bx after suspicious MRI findings. We report on cancer diagnosis, treatment, and Bx rates for this population over a period of 5 yr.

METHODS: This single-centre cohort study followed men discharged from the RAPID prostate cancer diagnostic pathway between 2017 and 2023 with either negative MRI or negative prostate Bx, with at least 3 mo of follow-up. Patients with a Prostate Imaging-Reporting and Data System (PI-RADS) or Likert score of 1-2 on MRI or a score of 3 and prostate-specific antigen (PSA) density (PSAD) of <0.12 ng/ml² underwent PSA monitoring, while those with a score of 3 and PSAD >0.12 ng/ml² or a score of 4-5 were offered prostate Bx. Primary outcomes were grade group (GG) ≥2 diagnosis-free survival (Dx-FS) and treatment-free survival (TFS). Secondary outcomes were GG ≥3 Dx-FS, GG 1 Dx-FS, Bx-free survival (Bx-FS), cancer-specific survival, metastasis, and re-referral. Data were collected using a prospective data registry and electronic clinical records; patients with no recent follow-up (>1 yr) were directly contacted. Kaplan-Meier plots and multivariable Cox regression were used for statistical analysis.

KEY FINDINGS AND LIMITATIONS: Of 2334 men investigated within the RAPID pathway, 1266 (927 no Bx, 339 negative Bx) were evaluated. Median follow-up was 3.4 yr (interquartile range 2.4-4.9). Seventy-four had GG ≥2 cancer and seven had GG 1 cancer. The 5-yr Dx-FS rates were 91.9% (95% confidence interval [CI] 90.0-93.9%) GG ≥2, 96.3% (95% CI 95.0-97.7%) for GG ≥3, and 99.4% (95% CI 98.9-99.8%) for GG 1. The 5-yr TFS rate was 94.4% (95% CI 92.6-95.9%). The 5-yr Bx-FS rate in the no-Bx group was 79.6% (95% CI 73.7-85.8%), leaving 39% (899/2334) of the original cohort Bx-free. No metastases or cancer-related deaths occurred. Higher PSAD and PI-RADS score and negative Bx, including atypical small acinar proliferation and high-grade prostatic intraepithelial neoplasm findings, did not predict GG ≥2 diagnosis and treatment. Limitations include data excluded because of short follow-up (19%) and the single-centre evaluation.

CONCLUSIONS AND CLINICAL IMPLICATIONS: The RAPID MRI-directed pathway is safe in triaging men for Bx. At 5 yr, only one in 13 patients discharged from the RAPID pathway had GG ≥2 cancer and one in 20 required cancer treatment, while four in ten avoided Bx.

PMID:41206290 | DOI:10.1016/j.eururo.2025.10.015

Australas Emerg Care. 2025 Nov 7:S2588-994X(25)00085-5. doi: 10.1016/j.auec.2025.10.004. Online ahead of print.

ABSTRACT

BACKGROUND: First-line pharmacological management of acute renal colic pain may vary influenced by preference, structural and staffing issues with emergency departments. The aim of this study was to explore the variation in renal colic pain management and contributing factors within emergency departments in Australia METHODS: A specifically designed survey was sent to relevant national professional colleges and organisations for distribution. The survey presented respondents with four acute renal colic scenarios. Descriptive statistics summarised quantitative data, while free text responses were explored using content analysis.

RESULTS: Responses from 180 nurses, paramedics and medical doctors were analysed. Opioids were the most commonly prescribed analgesia (4 scenarios) in combination with either paracetamol (3 scenarios) or rectal NSAIDs (1 scenario). Free text responses provided context to the preference of opioids and identified workload, clinician availability and scope of practice limitations to timely analgesia provision. Most respondents (91.2 %) would support research into non-pharmacological alternatives to opioids.

CONCLUSION: Opioids remain the first line preference for many clinicians in managing acute renal colic pain despite current guideline recommendations for NSAIDs. Departmental and clinician capacity, and practice limitations contribute to delays in providing analgesia. Greater consistency and predictability in prescribing, review of limitations on nurse prescribing and exploring novel low risk first line non-pharmacological analgesics may improve management of acute renal colic.

PMID:41206284 | DOI:10.1016/j.auec.2025.10.004

Acad Radiol. 2025 Nov 7:S1076-6332(25)00988-2. doi: 10.1016/j.acra.2025.10.030. Online ahead of print.

ABSTRACT

RATIONALE AND OBJECTIVES: To assess the impact of a deep learning-based noise reduction (DLD) technique on image quality and diagnostic accuracy for the evaluation of coronary arteries in transcatheter aortic valve implantation (TAVI) CT imaging.

MATERIALS AND METHODS: Two hundred patients with severe aortic stenosis who underwent CT scans for pre-TAVI planning between October 2022 and April 2024 were retrospectively enrolled. Conventional images were reconstructed and denoised images were generated using dedicated software. Objective image quality was evaluated by measuring the mean Hounsfield unit (HU) and standard deviation (SD) in regions of interest within the aortic root, coronary arteries, and subcutaneous fat to calculate signal-to-noise ratio (SNR) and contrast-to-noise ratio (CNR). For subjective assessment, two readers used a 5-point Likert scoring system to evaluate sharpness, noise, contrast and overall image quality. The diagnostic performance of both datasets was assessed using invasive coronary angiography as reference standard.

RESULTS: Denoised reconstructions showed significantly higher SNR (37.5±12.8 vs.12.3±4.1) and CNR (45.3±15.4 vs. 14.7±4.4), and lower noise (16.9±7.9 vs. 47.9±11.6 HU) (all p<0.001). Subjective assessment demonstrated that denoised images received the highest score for sharpness, noise, contrast and overall image quality (all p<0.001). For the evaluation of diagnostic accuracy, a total of 800 vessels and 1787 segments were analyzed. The per-segment diagnostic performance of the DLD for detection of CAD revealed an AUC of 90% (95% CI: 88.5-91.3), with accuracy of 93.9% (95% CI: 92.7-95), 85.7% (95% CI: 78.7-90.4) sensitivity and 94.7% (95% CI: 93.5-95.7) specificity, in the absence of a statistically significant difference compared with the evaluation performed on standard images (p=0.056).

CONCLUSION: The DLD substantially improves image quality without affecting diagnostic accuracy for the evaluation of coronary arteries in patients undergoing pre-TAVI CT scans.

PMID:41206269 | DOI:10.1016/j.acra.2025.10.030

J Pediatr Urol. 2025 Oct 28:S1477-5131(25)00580-7. doi: 10.1016/j.jpurol.2025.10.017. Online ahead of print.

ABSTRACT

INTRODUCTION: Serum cystatin C is increasingly recognized as a valuable biomarker for estimating glomerular filtration rate (eGFR) in adults and children, due to its lower susceptibility to extrarenal influences compared to serum creatinine. Pediatric patients, particularly those with posterior urethral valves (PUV), pose challenges in accurately assessing kidney function due to variability in age, muscle mass, and nutritional status. Accurate eGFR measurement is crucial for managing chronic kidney disease (CKD) progression in these patients.

OBJECTIVE: The objective of this study was to evaluate and compare eGFR estimates using serum cystatin C and serum creatinine in children diagnosed with PUV, utilizing established pediatric formulae.

STUDY DESIGN: We conducted a retrospective analysis of pediatric patients (<18 years) diagnosed with PUV and treated with valve ablation or vesicostomy within the first year of life between 2000 and 2020. Patients included had paired serum cystatin C and creatinine measurements (not standardized to timing, fasting, or hydration status) within a three-month interval. eGFR was calculated using the Chronic Kidney Disease in Children (CKiD) bedside creatinine (Schwartz) formula and the CKiD Under 25 (U25) equations (creatinine-based, cystatin C-based, and combined creatinine-cystatin C). Differences between formulae were evaluated using statistical tests for paired measurements.

RESULTS: Twenty-four patients met inclusion criteria, yielding 93 measurement pairs. Median age at cystatin C measurement was 11.5 years. The CKiD bedside creatinine (Schwartz) formula consistently yielded slightly higher eGFR values (median differences ranging from 1.5 to 2.6 mL/min/1.73 m²) compared to the CKiD U25 formulas. Cystatin C-based eGFR resulted in higher CKD stage classification (upstaging) for 11-27 % of the children. However, longitudinal analyses showed consistent trends in eGFR across all formulae.

DISCUSSION: Our findings support previous literature demonstrating slightly higher eGFR estimates with creatinine-based formulas compared to cystatin C-based formulas, potentially reflecting creatinine’s susceptibility to extrarenal factors, notably muscle mass. While differences were statistically significant, clinical implications were limited due to small absolute differences. Limitations include the study’s retrospective nature, small sample size, absence of direct GFR measurement, and lack of long-term clinical outcomes, potentially affecting generalizability and prognostic evaluation.

CONCLUSION: This study confirms that creatinine-based formulas slightly overestimate eGFR compared to cystatin C-based methods in children with PUV. Despite these discrepancies, consistent trends across methods emphasize the importance of maintaining a consistent biomarker for patient monitoring. Prospective research is needed to fully elucidate cystatin C’s role in clinical practice and prognostication.

PMID:41206265 | DOI:10.1016/j.jpurol.2025.10.017

J Pediatr Urol. 2025 Oct 22:S1477-5131(25)00570-4. doi: 10.1016/j.jpurol.2025.10.008. Online ahead of print.

ABSTRACT

BACKGROUND: Rhythmic bladder contractions (RBCs) are routinely observed in neurogenic bladders (NB) during urodynamic studies (UDS), often below the standard clinical threshold. These rhythmic bladder contractions may contribute to bladder hypertrophy despite low measured pressures, highlighting the need for objective quantification of this intrinsic activity.

OBJECTIVE: This study aimed to validate Fast Fourier Transform (FFT) analysis for precisely characterizing RBCs in NB patients, assessing its relationship to visual inspection and its stability across varying bladder filling rates and motion artifact.

METHODS: We retrospectively analyzed 115 UDS from 70 NB patients (0.5-18 years). Python-based FFT was applied to detrusor pressure data to derive the Highest Amplitude Frequency (HAF). The HAF was compared for reproducibility between same-day studies performed at identical and different filling rates. We used Bayes Factor (BF) analysis for robust statistical evaluation, Bland Altman analysis and Receiver Operating Characteristic (ROC) analysis to determine the lowest discernible amplitude measured on FFT.

RESULTS: The HAF was the most reproducible measure (r = 0.85)and highly consistent across same-day UDS, irrespective of changes in filling rate (moderate evidence, BF). This key finding suggests the underlying RBC mechanism is filling rate independent. HAF closely aligned with the visually measured frequency (mean difference ≅ 5 %), validating the FFT method. ROC analysis determined the optimal amplitude cutoff for visually confirming a contraction was overall 1.06, and 1.53 when motion artifact was significant, demonstrating FFT’s efficacy in penetrating noise.

CONCLUSION: FFT analysis is a reliable, objective, and reproducible method for quantifying bladder rhythmic activity, yielding an HAF that is stable regardless of filling rate or movement. The HAF is introduced as a robust, reproducible urodynamic parameter to objectively monitor neurogenic bladders.

PMID:41206264 | DOI:10.1016/j.jpurol.2025.10.008

JAMA. 2025 Nov 8. doi: 10.1001/jama.2025.21358. Online ahead of print.

ABSTRACT

IMPORTANCE: Lower extremity peripheral artery disease (PAD) is a disabling cardiovascular condition that impairs walking ability. Few effective therapies improve walking performance in people with PAD. Metformin is a widely available and inexpensive therapy for type 2 diabetes with pleiotropic effects that include activating AMP-activated protein kinase, reducing oxidative stress, and stimulating endothelial nitric oxide synthase (eNOS).

OBJECTIVE: To determine whether metformin improves 6-minute walk distance, compared with placebo, in people with PAD and without diabetes at 6-month follow-up.

DESIGN, SETTING, AND PARTICIPANTS: Randomized double-blind clinical trial involving 4 centers in the US. Enrollment began May 23, 2017, and ended on February 17, 2025, with 202 of the targeted 212 (95%) enrolled, due to funding limitations. Participants were adults aged 50 years and older with PAD. Final follow-up occurred August 19, 2025.

INTERVENTIONS: Participants with PAD were randomized to receive either metformin (n = 97) or placebo (n = 105) for 6 months.

MAIN OUTCOMES AND MEASURES: The primary outcome was 6-month change in 6-minute walk distance (minimum clinically important difference, 8 to 20 m). Secondary outcomes were maximal treadmill walking time, pain-free treadmill walking time, the Walking Impairment Questionnaire distance and speed scores, the Short-Form 36 physical functioning score, and brachial artery flow-mediated dilation. Results were adjusted for site and the baseline value for each outcome measure.

RESULTS: Of 202 randomized patients (mean [SD] age, 69.6 [8.4] years, 56 [28%] female, 79 [39%] Black), 179 (89%) completed 6-month follow-up. Metformin did not significantly improve 6-minute walk distance compared with placebo (metformin: 358.6 to 353.2 m, within-group change: -5.4 m; placebo: 359.8 to 354.5 m, within-group change: -5.3 m, adjusted between-group difference: 1.1 m [95% CI, -16.3 to 18.6 m]; P = .90). Compared with placebo, metformin did not significantly improve any secondary outcomes. The most common serious adverse events were cardiovascular events (3.1% for metformin and 1.9% for placebo). The most common nonserious adverse events were indigestion/stomach upset (64.9% for metformin and 40.6% for placebo) and headache (37.2% for metformin and 49.5% for placebo).

CONCLUSIONS AND RELEVANCE: Among people with PAD without diabetes, metformin did not improve 6-minute walk distance at 6-month follow-up compared with placebo. These results do not support metformin for improving walking performance in patients with PAD.

TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT03054519.

PMID:41205146 | DOI:10.1001/jama.2025.21358

Ophthalmol Ther. 2025 Nov 8. doi: 10.1007/s40123-025-01260-6. Online ahead of print.

ABSTRACT

INTRODUCTION: This study characterized the prevalence of thin corneas and identified tomographic patterns following Descemet membrane endothelial keratoplasty (DMEK) in patients with Fuchs endothelial corneal dystrophy (FECD).

METHODS: We conducted a retrospective observational study at a tertiary referral center, including 88 eyes with FECD treated by DMEK and an age- and sex-matched control group. Tomographic parameters such as central corneal thickness (CCT), pachymetric progression indices including Belin-Ambrosio D index (BAD-D), and anterior corneal asymmetry indices were analyzed using Scheimpflug imaging (Pentacam HR). Statistical analyses were performed to compare the DMEK and control groups and to examine correlations between clinical characteristics and CCT values.

RESULTS: At 1 year, the mean CCT in the DMEK group was 525 ± 36 µm, compared with 561 ± 32 µm in healthy controls (p < 0.001). Women were much more likely than men to have thin corneas (40% vs. 3.6% with CCT below 500 µm, p < 0.001) and higher BAD-D values (2.71 vs. 1.99, p = 0.007). In multivariate analysis, baseline CCT (β = -0.001, p < 0.001), age (β = -0.001, p = 0.032), and sex (β = 0.046, p < 0.001) were the strongest predictors of percentage pachymetric reduction, indicating that thicker preoperative corneas, older patients, and women experienced greater deswelling and thinner 1-year CCT. Postoperative endothelial cell density had no impact on pachymetry outcomes.

CONCLUSION: Patients with FECD undergoing DMEK often present with postoperative corneal thinning, particularly among women. Although the underlying cause is not fully understood, these findings suggest a potential link between chronic preoperative corneal edema and the likelihood of stromal remodeling. Further research is required to elucidate the mechanisms underlying this thinning phenomenon.

PMID:41205143 | DOI:10.1007/s40123-025-01260-6

CVIR Endovasc. 2025 Nov 8;8(1):99. doi: 10.1186/s42155-025-00588-1.

ABSTRACT

BACKGROUND: There have been several analyses conducted demonstrating a sharp decrease in general physician fulfillment and satisfaction. Other studies have demonstrated that burnout, anxiety, and moral injury are prevalent among interventional radiologists specifically, however there is a paucity of literature examining professional fulfillment within the profession. The purpose of this study was to characterize professional fulfillment through job, career, and specialty satisfaction scores among interventional radiologists using a validated assessment tool.

RESULTS: There were 106 respondents included in the analysis: 97 (91.5%) practicing interventional radiologists and 9 (8.5%) interventional radiology trainees, including 87 (82.1%) males and 19 (17.9%) females. Respondents included those in academic (40; 37.7%), private practice (46; 43.4%), and hybrid/other settings (20; 18.9%), as well as at various lengths of practice. The mean job satisfaction score was 3.48, with 38 (35.8%) of respondents expressing a mean score of ≥ 4, which has been established as being “satisfied”. The mean career satisfaction score was 3.40, with 38 (35.8%) of respondents reporting a mean score of ≥ 4. The mean global specialty satisfaction was 3.63 with 53 (50.0%) of respondents reporting a mean score of ≥ 4.

CONCLUSIONS: Professional fulfillment is low among interventional radiologists, with half expressing global specialty satisfaction and with minority percentages signaling job and career satisfaction. Patient interaction and work-life balance were identified as significant factors positively affecting professional fulfillment.

PMID:41205135 | DOI:10.1186/s42155-025-00588-1