To evaluate the reproducibility of tongue pressure measurements using a low-cost experimental device in adult individuals. Ten adult volunteers of both sexes participated in the study. Tongue pressure was assessed during four distinct movements (elevation, right lateralization, left lateralization, and protrusion), with three repetitions per movement, using an experimental device. Assessments were conducted over a three-week period: the first week was dedicated to familiarization, and the subsequent two weeks to tongue pressure measurements. Reliability was analyzed using the intraclass correlation coefficient, the standard error of measurement, and the minimal detectable difference. Agreement between assessments was verified using Bland-Altman analysis. The reliability of tongue pressure measurements was excellent for elevation (0.900), right lateralization (0.960), and protrusion (0.971) movements, and good for left lateralization (0.887), as demonstrated by the intraclass correlation coefficient values. The lowest standard error of measurement and minimal detectable difference were observed for right lateralization, indicating smaller measurement error. Bland-Altman analysis indicated that measurements obtained on different days showed acceptable agreement. Tongue pressure measurements obtained using the experimental device demonstrated reproducibility (reliability and agreement), supporting its use in clinical practice, particularly in the field of speech-language pathology. Avaliar a reprodutibilidade das medidas de pressão da língua utilizando um dispositivo experimental e de baixo custo em indivíduos adultos. Dez voluntários, adultos de ambos os sexos, participaram do estudo. A pressão da língua foi avaliada em quatro movimentos distintos (elevação, lateralização direita, lateralização esquerda e protrusão), com três repetições de cada movimento, utilizando um dispositivo experimental. Essas medições foram realizadas ao longo de três semanas: a primeira foi destinada à familiarização e as duas semanas seguintes às mensurações da pressão da língua. A confiabilidade foi analisada por meio do coeficiente de correlação intraclasse, erro padrão da medição e diferença mínima detectável. A concordância entre as avaliações foi verificada por meio da análise de Bland-Altman. A confiabilidade das medidas de pressão da língua foi excelente para os movimentos de elevação (0,900), lateralização direita (0,960) e protrusão (0,971) e boa para a lateralização esquerda (0,887), conforme demonstrado pelos valores do coeficiente de correlação intraclasse. O menor erro-padrão da medida e a menor diferença mínima detectável foram observados na lateralização direita, indicando menor erro de medição. A análise de Bland-Altman sugere que as medidas em dias diferentes apresentam concordância aceitável. As medidas de pressão da língua, utilizando o dispositivo experimental apresentam reprodutibilidade (confiabilidade e concordância), possibilitando sua aplicação na prática clínica, especialmente no contexto fonoaudiológico.
An interlaboratory comparison study was conducted among five laboratories for determining 24,25-dihydroxyvitamin D3 (24,25(OH)2D3) in human serum using liquid chromatography-tandem mass spectrometry (LC-MS/MS) methods. The Centers for Disease Control and Prevention (CDC), Imperial College Healthcare NHS Trust, University College Cork, University of Liège, and University of Washington analyzed 50 single-donor samples and two new Standard Reference Materials (SRMs®). The results from each laboratory were compared with target values assigned by the National Institute of Standards and Technology (NIST) using a reference measurement procedure (RMP) and evaluated using Ordinary Deming linear regression and Bland-Altman analysis. Three of the five laboratory methods provided results that were in good agreement with the NIST RMP results showing linear regression slopes ranging from 0.972 to 1.003 and Bland-Altman mean bias of -0.092 nmol/L, 0.025 nmol/L, and 0.035 nmol/L. Two laboratories demonstrated a significant positive bias with linear regression slopes of 1.158 and 1.214 and Bland-Altman mean bias of 0.162 nmol/L and 0.708 nmol/L. The CDC method is currently used to assign "information only" values for 24,25(OH)2D3 in the quarterly distributions of the Vitamin D External Quality Assessment Scheme (DEQAS). Given the agreement (linear regression slope = 0.984, R2 = 0.996 and mean bias of -0.092 nmol/L) between the CDC method and the NIST RMP observed in this study, the CDC-assigned 24,25(OH)2D3 values in DEQAS may provide a more accurate reference than the current participant consensus mean values.
Accurate measurement of resected colorectal polyps is essential for clinical management, research, and the development of artificial intelligence-based size estimation systems. Despite widespread use of caliper-based measurement for specimen sizing, formal validation against a reference standard is lacking. This study aimed to validate caliper-based measurement of resected small and diminutive colorectal polyps against high-resolution digital microscopy, a previously validated reference method. At the Centre hospitalier de l'Université de Montréal, 143 polyps from 92 patients were measured immediately after resection using vernier digital calipers in the endoscopy suite. Independent measurements were subsequently obtained using high-resolution digital microscopy under blinded conditions. Agreement between methods was assessed using bias analysis, Bland-Altman limits of agreement, intraclass correlation coefficient (ICC), and categorical size concordance. Caliper-based measurements demonstrated a mean bias of -0.22 mm (95% CI: -0.34 to -0.11; P < .001) relative to the reference standard. The noninferiority hypothesis with a 0.5-mm margin was not rejected (lower 95% CI > -0.5 mm). Bland-Altman's limits of agreement were -1.57 to 1.12 mm, and the ICC was 0.88 (95% CI: 0.82-0.92). Correct categorical classification occurred in 94.4% of cases (95% CI: 0.89-0.97; κ = 0.81). Caliper-based measurement provides accurate and reproducible estimates of polyp size when compared with digital microscopy, supporting its use for clinical and research applications requiring direct specimen measurement.
To assess correlation, agreement and diagnostic accuracy of a new tablet-based 24-degree, 52-point online circular contrast perimetry application (OCCP), compared to computer-based OCCP and standard automated perimetry (SAP). Seventy-five participants (26 controls, 49 glaucomatous) were tested via SAP using Humphrey field analyzer (Zeiss), then by computer OCCP on a 24-inch monitor, followed by two OCCP tests on a tablet (iPad Air 5th gen). Key outcome measures included pattern standard deviation (PSD), mean deviation (MD), mean sensitivity per point, and visual field index (VFI)/visual index (VI). Agreement and correlation of VFI, PSD, and MD between OCCP tablet and SAP were very strong, with spearman's ρ and intra-class correlation coefficients between 0.81-0.86 and 0.80-0.93, respectively. MD Bland-Altman bias was greater for OCCP tablet against SAP-0.53 to 0.68 dB-compared to OCCP computer against SAP at 0.05 dB. 95% limits of agreement were comparable for OCCP versus SAP. Point-by-point Bland-Altman bias demonstrated tighter agreements between OCCP tablet and OCCP personal computer (PC) compared to OCCP generally and SAP. Receiver-operating-characteristic curves were comparable across outcomes between all OCCP tests, SAP, and cirrus optical coherence tomography parameters with no significant differences. Test duration was longer for OCCP tablet than SAP, whereas OCCP PC was shorter than SAP (p < 0.001). OCCP tablet has strong correlation, agreement, and similar area-under-curve in identifying glaucomatous eyes from controls to both SAP and OCCP computer, demonstrating prospect as a tool for glaucoma perimetry testing in low-resource settings, with further enhancements to reduce test duration.
With waning vaccine-induced immunity and the continued emergence of immune-evasive SARS-CoV-2 variants, booster vaccination has become essential for sustaining population-level protection. However, scalable and reliable serological tools for monitoring post-booster humoral immunity across different vaccine platforms remain insufficiently evaluated. We conducted a cross-sectional study and a booster cohort study to systematically compare the performance and concordance of surrogate virus neutralization test (sVNT), pseudovirus neutralization test (pVNT), and binding IgG antibody assays. In the cross-sectional analysis, serum samples from 259 individuals collected 1-2 months after a third dose of inactivated vaccine were used to compare sVNT and pVNT. In the booster cohort, paired sera from 288 participants receiving a fourth dose with different vaccine platforms were analyzed to evaluate the relationship between sVNT and IgG responses. Correlation and agreement were assessed using Spearman correlation and Bland-Altman analyses. In the cross-sectional study, sVNT showed strong concordance with pVNT, demonstrated by a very high correlation (r = 0.97) and good agreement in Bland-Altman analysis. In the booster cohort study, IgG antibody levels correlated strongly with sVNT overall (r = 0.91). The correlation strength remained highly consistent across different vaccine platforms, with no statistically significant differences observed. Collectively, these findings demonstrate that sVNT closely reflects functional neutralizing activity, supporting its utility for large-scale immune monitoring. sVNT offers an optimal balance of analytical performance and scalability for high-throughput monitoring without requiring cell-based assays. Consequently, we propose a tiered immune monitoring strategy: utilizing sVNT for broad population-level surveillance and reserving pVNT for targeted, precise functional assessment.
Pre-analytical conditions are critical to ensure the reliability of laboratory results, as emphasized by ISO 15189 standards. Drone transport has emerged as a promising alternative to conventional logistics, but its impact on sample integrity remains insufficiently characterized. This pilot study aimed to assess the pre-analytical stability of blood samples transported by drone versus ground transport. In this prospective study, 30 healthy volunteers were included. Six blood tubes per participant were collected simultaneously and assigned to ground or drone transport (20 min). A panel of 23 biochemical, hematological, and hemostatic parameters was analyzed. Agreement between transport modalities was assessed using paired comparisons, coefficients of variation, intraclass correlation coefficients (ICC), Pearson correlation, and Bland-Altman analysis. No clinically meaningful differences were observed between transport modalities. Mean values and variability were comparable across parameters. Most analytes showed excellent agreement, with ICC and Pearson correlation coefficients >0.90. Although ALT and LDH showed statistically significant differences (p = 0.039), these were small and clinically negligible. Bland-Altman analysis confirmed minimal bias for ALT (-0.63 U/L), whereas LDH exhibited wider limits of agreement, suggesting increased sensitivity to transport-related factors (-9.7 U/L). No hemolysis, temperature deviation, or safety incidents were observed. Drone transport ensures robust pre-analytical stability of blood samples across a wide range of laboratory parameters. However, analyte-specific variability, particularly for LDH, highlights the need for targeted validation. These findings support the integration of drone-based logistics into laboratory workflows, while emphasizing the importance of analyte-dependent evaluation.
CD4+ T-cell enumeration remains critical for management of people with HIV (PWH). In resource-limited settings, point-of-care CD4 testing can increase accessibility and decrease turnaround time compared to flow cytometry. This study evaluated the performance of VITA™ point-of-care CD4 (Accesso Biotech; VITA™ CD4) compared to AQUIOS™ (Beckman Coulter; AQUIOS™) flow cytometry. Remnant venous blood samples from PWH with known CD4 counts on FDA-cleared AQUIOS™ flow cytometry were tested twice with VITA™ CD4. Statistical analyses included descriptive statistics, correlation analysis, Bland-Altman agreement analysis, and Passing-Bablok regression. The coefficient of variation was calculated on duplicate measurements. The University of San Francisco Institutional Review Board approved the study. VITA™ CD4 results showed strong correlation with AQUIOS flow cytometry (r = 0.973, p < 0.001). Bland-Altman analysis revealed a mean bias of -48.9 cells/μl (95% CI: -61.8 to -36.0), with limits of agreement from -231.1 to 133.3 cells/μl. For samples <500 CD4 cells/μL (n = 137), the mean bias was reduced to -8.6 cells/μl (95% CI: -17.8 to 0.6). Passing-Bablok regression suggested a small constant positive bias and proportional bias at counts above 500 cells/μl [y = 30.2 (95% CI: 19.3 to 44.2) + 0.83× (95% CI: 0.80-0.86)]. The coefficient of variation for duplicate VITA POC CD4 measurements was 11.86%. VITA™ CD4 results correlated strongly with flow cytometry at clinically relevant CD4 values. Its diagnostic performance and applicability at point-of-care make it a promising CD4 tool, also in settings with limited laboratory infrastructure. Further clinical validation and assessment of user acceptability is recommended.
To assess the precision (repeatability and reproducibility) and agreement of central corneal thickness (CCT) measurements by a high-resolution ultrasound (E-pach), a standard ultrasound, and two Scheimpflug pachymeters in healthy eyes. Instrument diagnostic test study. A total of 100 healthy volunteers were enrolled to measure right-eye CCT by a high-resolution ultrasound (E-pach), a standard ultrasound (A-scan device), and two Scheimpflug pachymeters (Pentacam and Corvis ST). To assess repeatability and reproducibility, the test-retest repeatability (TRT) and intraclass correlation coefficient (ICC) were calculated. The agreement among the four devices was evaluated with Bland-Altman plots. The high-resolution ultrasound (E-pach) showed repeatability (ICC = 0.9981), interobserver reproducibility (ICC = 0.9971), and intersession reproducibility (ICC = 0.9825); the standard ultrasound and two Scheimpflug pachymeters also showed similar repeatability (all ICC ≥ 0.9679), interobserver reproducibility (all ICC ≥ 0.9730), and intersession reproducibility (all ICC ≥ 0.9647). However, the high-resolution ultrasound yielded CCT values that were obviously lower than those of the standard ultrasound and Pentacam (p < 0.001) but higher than those of the Corvis ST (p < 0.001). The 95% limits of agreement (LoA) in the Bland-Altman plots were 44.5 µm (high-resolution ultrasound vs. standard ultrasound), 34.9 µm (high-resolution ultrasound vs. Corvis CT), and 32.5 µm (high-resolution ultrasound vs. Pentacam). The high-resolution ultrasound is a portable, reliable, and inexpensive pachymeter. However, the CCT values obtained from the high-resolution ultrasound are not interchangeable with those from Pentacam, Corvis ST, and standard ultrasound.
Quantitative detection of human immunodeficiency virus-type 1 (HIV-1) and hepatitis C virus (HCV) RNA plays a crucial role in the diagnosis, monitoring of the therapy and evaluation of the treatment response. The ELITe BeGenius® platform (ELITechGroup, Turin, Italy) is a fully automated sample-toresult molecular system integrating extraction, amplification and detection within a single workflow. The HIV-1 ELITe MGB® and HCV ELITe MGB® assays are real-time polymerase chain reaction tests designed for plasma viral-load quantification. This study aimed to verify their analytical performance under routine clinical laboratory conditions. Verification included assessments of accuracy, intra- and inter-assay precision, linearity and method correlation. A total of 70 plasma samples for HIV-1 RNA and 52 for HCV RNA were analyzed using previously tested and stored patient specimens, reference materials, and external quality controls. Results were compared with established reference assays used in accredited laboratories. Statistical analyses included positive, negative, and overall percent agreement (PPA, NPA, OPA), coefficients of variation (CV%), correlation and regression analyses and Bland-Altman bias estimation. For HIV-1 RNA, 19 of 20 positive and all 20 negative plasma samples were correctly identified by the ELITe MGB® assay, yielding a PPA of 95.0%, NPA of 100.0% and OPA of 97.5% (κ= 0.95). Intra-assay precision showed strong repeatability, with CVs of <1-3.9% for low-positive, 0.4-6.4% for medium-positive and <2% for high-positive specimens. Inter-assay reproducibility was consistent with CVs of 12.8% at low, 2.4% at medium, and 1.4% at high viral loads. Correlation analysis showed excellent concordance with the reference assay (p= 0.975, p< 0.001; R²= 0.95) and a mean bias of -0.40 log10 copies/mL in Bland-Altman analysis. Linearity was strong (R²= 0.97), confirming accurate quantification across the dynamic range with minor underestimation at higher dilutions. For HCV RNA, all 14 positive and 14 negative samples were correctly classified (PPA, NPA, and OPA= 100%; κ= 1.00). Intra-assay precision was excellent, with CVs around 2% for both low- and medium-positive samples, confirming consistent repeatability within a single run. Inter-assay reproducibility was equally robust, with CVs of 0.4-3.3% for low positives, 1.0-2.5% for medium and <1.1% for high-titer specimens. Correlation with the comparator method was strong (r= 0.956, p< 0.001; R²= 0.91) with a mean bias of -0.38 log10 IU/mL. Linearity analysis confirmed high proportionality between expected and measured concentrations (R²= 0.96). Deviations were negligible at low titers and slightly elevated at high loads but remained within acceptable limits. The HIV-1 and HCV ELITe MGB® assays on the BeGenius® platform demonstrated high accuracy, reproducibility and linearity, showing excellent correlation with reference methods. These results confirm that the ELITe BeGenius® system provides reliable and clinically valid viral-load measurements suitable for routine diagnostic use. Comprehensive laboratory verification of molecular assays under real-world conditions is crucial to ensure consistent performance, cross-platform comparability and reliable viral-load monitoring.
This study aims to compare the performance of two serum free light chain (FLC) assays, Freelite by The Binding Site and Diazyme, on the Cobas 6000 analyser in a North Indian tertiary care centre, focusing on patients with chronic kidney disease (CKD) and plasma cell dyscrasias (PCD). A total of 65 patient samples, including those with CKD, PCD, and both conditions coexisting, were analysed. The correlation between the two assays was assessed using Spearman correlation analysis, and bias was evaluated using the Bland-Altman method. Concordance rates for kappa FLC, lambda FLC, and the kappa/lambda ratio were also calculated. The study found strong correlations between the Freelite and Diazyme assays for kappa and lambda FLCs (Spearman coefficients: 0.96 and 0.98, respectively). The Bland-Altman analysis revealed minimal bias, and the concordance rates for kappa FLC, lambda FLC, and the kappa/lambda ratio were 95%, 93.4%, and 82.5%, respectively. Variable concordance rates were found in subgroups of PCD, CKD and both. Discrepancies were observed in patients with extremely high FLC levels. Freelite and Diazyme FLC assays show strong correlation and concordance in PCD and/or CKD patients. However, differences at high FLC levels highlight the need for assay-specific reporting and consistent follow-up with the same assay. This study highlights the importance of context-specific evaluation of FLC assays, particularly in resource-limited settings like India, where assay availability and compatibility with existing analysers may influence diagnostic outcomes.
The optimal protocol for clinical liver 31P-magnetic resonance spectroscopy (MRS) remains unclear. Single-voxel 31P-MRS using image-selected in vivo spectroscopy (ISIS) employs respiratory-triggering (RT) or free-breathing (FB) acquisition. RT provides robust data but prolongs scan duration; FB allows faster acquisition but may suffer from low signal-to-noise ratio (SNR). Yet, direct comparison using a regulatory-approved coil in a clinical setting has not been reported. To compare 31P-MRS data stability and robustness between RT and FB. Prospective. 24 volunteers (19 male/5 female). 3 T MRI; single-voxel 31P-MRS using ISIS (free induction decay-based) with approved 31P coil. 31P-MRS was performed using RT and FB techniques (128 and 192 signal averages, respectively; expected scan duration ~13 min each). Spectra were analyzed using jMRUI. SNR and peak areas for PME, Pi, PDE, α-ATP, and NADPH, normalized using γ-ATP, were compared. PME/PDE and NADPH/(PME + PDE) ratios were also compared. Paired t-tests and Bland-Altman analysis were used. A p value < 0.05 was considered significant. Scan duration was significantly longer for RT (15 min 44 s) than FB (12 min 56 s). No significant differences were observed for SNR (p = 0.570), NADPH/(PME + PDE) (p = 0.931), PME/γ-ATP (p = 0.556), Pi/γ-ATP (p = 0.931), α-ATP/γ-ATP (p = 0.332), or NADPH/γ-ATP (p = 0.394). Significant differences were noted for PDE/γ-ATP (RT 1.68 vs. FB 1.35, p = 0.003) and PME/PDE (RT 0.434 vs. FB 0.489, p = 0.046). Bland-Altman analysis showed near-zero fixed biases and no proportional bias, with limits of agreement from -0.53 to 0.62 (PME), -0.30 to 0.30 (Pi), -0.41 to 1.07 (PDE), -0.45 to 0.43 (α-ATP), and -0.80 to 0.90 (NADPH). 31P-MRS of the liver showed equivalent stability and robustness for RT and FB. FB yielded comparable data within a shorter, predictable scan duration. 2. 1. The liver plays a central role in the body's metabolism, and phosphorus magnetic resonance spectroscopy (31P‐MRS) is a noninvasive technique that can measure liver energy and membrane metabolism without a biopsy. A recently approved commercial coil now makes it possible to perform 31P‐MRS on standard clinical MRI systems at any facility. However, the optimal acquisition protocol for obtaining stable, high‐quality data within a clinically acceptable scan time has not yet been established. This study compared two approaches in 24 healthy volunteers, both designed to complete within approximately 13 min: respiratory triggering and free breathing. Both methods produced equivalent measurements of key liver metabolites, but free breathing consistently delivered a fixed, predictable scan duration, making it more practical for routine clinical use.
Spontaneous intracerebral hemorrhage (sICH) with intraventricular hemorrhage (IVH) extension is a neurological emergency associated with high mortality, where separate quantification of intraparenchymal hemorrhage (IPH) and IVH volumes is essential for risk stratification and treatment decisions. While commercial artificial intelligence (AI) tools increasingly promise to automate this task, head-to-head comparisons of their separate volumetric accuracy and the clinical utility of AI-assisted correction workflows remain poorly characterized. In this retrospective multicenter diagnostic accuracy study, 189 sICH patients with IVH extension from seven institutions in China were included. Non-contrast CT scans were analyzed by two commercial AI platforms: Vendor A (uAI-HematomaCare, U-Net-based) and Vendor B (Strokedoc, Trans-UNet-based). A blinded AI-assisted manual correction workflow performed by two senior neuroradiologists established the reference standard. Agreement was assessed using intraclass correlation coefficients (ICC) and Bland-Altman analysis, with predefined clinical thresholds of ±6 mL for IPH and ±2 mL for IVH. Processing times were compared. Both AI platforms achieved excellent ICC for IPH (Vendor A: 0.979; Vendor B: 0.991) and good-to-excellent ICC for IVH (Vendor A: 0.855; Vendor B: 0.935) versus the reference standard. However, Bland-Altman analysis revealed that 95% limits of agreement for both AI systems exceeded predefined clinical thresholds for both compartments (IPH: Vendor A -9.96-9.08 mL; Vendor B -6.84-5.04 mL; IVH: Vendor A -7.02-7.52 mL; Vendor B -5.18-4.39 mL), indicating clinically significant individual-level errors. In contrast, the AI-assisted manual correction workflow achieved near-perfect inter-rater reproducibility (ICC >0.99 for both compartments) with 95% limits of agreement entirely within acceptable thresholds, completing corrections in approximately one minute. Automated processing was 65-75% faster than manual correction. Fully automated AI volumetry for sICH with IVH demonstrates high group-level correlation but may produce individual errors exceeding clinically acceptable ranges for treatment decisions. An 'AI-assisted human correction' collaborative model achieves clinical-grade accuracy within approximately one minute and represents the optimal current practice pathway for integrating AI into acute stroke precise volume measurement.
Accurate measurement of body temperature is essential in clinical practice; however, direct assessment of core temperature is invasive. Consequently, there is an increasing demand for non-invasive yet accurate methods. In this study, we compared two non-invasive techniques - a wired zero-heat-flux sensor (W⁺ZHF) and a wireless thermistor patch (W⁻TP) - against core temperature measurements obtained from an esophageal probe (EP). This prospective study included consecutive subjects who underwent esophagogastroduodenoscopy for health screening. The EP served as the reference for core temperature. Simultaneously, paired temperature readings were taken using W⁺ZHF and W⁻TP. Agreement between EP and each wearable device (W⁺ZHF and W⁻TP) was evaluated using subject-level Bland-Altman analysis, Pearson correlation coefficients, and intraclass correlation coefficients (ICC). Paired t-tests were used for descriptive comparison, and linear mixed-effects models were applied to account for repeated measurements within subjects. Among the 24 subjects, 5 (20.8%) were male and 19 (79.2%) were female, with a mean age of 32.8 ± 7.4 years. The mean temperatures measured by W⁺ZHF, W⁻TP, and EP were 36.56 ± 0.30°C, 36.61 ± 0.32°C, and 36.50 ± 0.26°C, respectively. Subject-level Bland-Altman analysis demonstrated a small bias between W⁺ZHF and EP (0.06°C; 95% confidence interval [CI], -0.04-0.15), with 95% limits of agreement (-0.42-0.53°C). The Pearson correlation coefficient between W⁺ZHF and EP was 0.63, and the ICC indicated moderate to high agreement (ICC, 0.62; 95% CI, 0.31-0.82). In contrast, W⁻TP showed greater variability in agreement with EP. Direct comparison between W⁺ZHF and W⁻TP revealed differences in agreement. These findings were consistent in linear mixed-effects models accounting for repeated measurements. Among the non-invasive devices evaluated, W⁺ZHF showed the closest agreement with EP measurements, although the predefined equivalence criterion was not formally met. These findings nonetheless suggest a promising role for zero-heat-flux technology in non-invasive estimation and support its further development in wearable devices.
This study aimed to evaluate the accuracy of maxillary repositioning using patient-specific implants (PSI) adapted for minimally invasive orthognathic surgery (MIOS), employing a simplified two-plate fixation protocol. Although all patients underwent bimaxillary orthognathic surgery, quantitative accuracy analysis was limited to the maxilla. This retrospective study included 20 patients treated with PSI tailored for MIOS. The surgical protocol involved limited soft tissue dissection and maxillary fixation using only two plates. Postoperative accuracy was assessed through computed tomography and voxel-based comparison with the virtual surgical plan. Discrepancies were measured in three linear axes and cant correction. Statistical analysis included Bland-Altman plots, effect sizes, and intraclass correlation coefficients (ICCs). All procedures were completed without intraoperative complications. Discrepancies between planned and postoperative positions ranged from 0.02 mm to 0.31 mm. ICCs exceeded 0.82 across all variables, with cant correction ICCs of 0.98 and 0.99. Effect sizes were negligible to small, and Bland-Altman analysis revealed no systematic bias. Customized PSI can be effectively adapted for use in MIOS protocols. Despite a reduced fixation strategy, high accuracy and reproducibility were achieved. These findings support the use of simplified PSI workflows as a precise and less invasive alternative in modern orthognathic surgery.
Hemoglobin A1c (HbA1c) level measurement using venous blood sample is essential for diabetes management. However, this method is not always readily accessible in primary health care in Indonesia. This study aimed to evaluate the comparability of venous versus capillary blood HbA1c measurement. A cross-sectional study was performed, involving subjects with and without type 2 diabetes (T2D). Venous blood samples were analyzed using a high-performance liquid chromatography (HPLC) analyzer. Simultaneously, capillary blood samples from the same subjects were analyzed using a point-of-care testing (POCT) instrument based on capillary electrophoresis (CE). Passing-Bablok regression was performed to assess constant or proportional bias between methods. Bland-Altman test was conducted to evaluate the agreement of HbA1c measurement between venous and capillary. Out of 162 subjects, 129 (79.6%) had diabetes, 9 (5.5%) had newly developed diabetes, and 24 (14.8%) did not have diabetes. Mean venous HbA1c was higher (7.79%) than capillary HbA1c (7.49%). Bland-Altman analysis showed that mean bias for all subjects was -0.30%, with 93.8% of subjects within the limit of agreement. Besides, mean bias between subjects with venous HbA1c < 6.5% and ≥ 6.5% was - 0.14% and -0.38%, respectively. Meanwhile, Passing-Bablok regression showed no constant and proportional bias in subjects with venous HbA1c < 6.5%. However, constant and proportional bias were found in all subjects and in those with venous HbA1c ≥ 6.5%. Capillary HbA1c results have a good agreement with venous HbA1c. Capillary HbA1c POCT method can be considered as an alternative for monitoring diabetes. HbA1c measurement ≥ 6.5% should be interpreted with caution. The online version contains supplementary material available at 10.1007/s13340-026-00889-3.
This study aimed to assess the diagnostic accuracy of digital intraoral photographs obtained using smartphones and a macro camera in evaluating oral health among adults. A total of 200 adult patients underwent clinical and radiographic examinations using the Decayed, Filled Teeth (DFT) Index, Caries Assessment Spectrum and Treatment (CAST) Index, Plaque Index (PI), and Modified Gingival Index (MGI). Intraoral photographs were taken using three devices: Samsung S23 Ultra, iPhone 14 Pro, and Canon EOS 400D with macro lens. Following the clinical recording of DFT, CAST, PI, and MGI scores by two calibrated examiners as the reference standard, intraoral photographs were captured by a third dentist and independently evaluated by two separate blinded examiners to compare the diagnostic accuracy of the devices against the clinical findings. Non-parametric analyses were conducted using the Friedman test with Dunn's post hoc test, Wilcoxon test and agreement between clinical and photographic methods was evaluated via the Bland-Altman method (p < 0.05). The macro camera demonstrated the highest inter-rater reliability for FT scores (ICC = 0.886), while iPhone-derived MGI scores showed the lowest reliability (ICC = 0.624). Statistically significant differences were found among all imaging devices for all indices (p < 0.001), except for MGI. Bland-Altman analysis showed that most values fell within the 95% limits of agreement, indicating good concordance with clinical data. Smartphone and macro camera photographs provided comparable diagnostic results for caries and restorations. However, limitations remain in the assessment of periodontal parameters via photographic methods. Smartphone-based intraoral photography can serve as a practical diagnostic tool in teledentistry.
To assess the agreement between transthoracic echocardiography (TTE) and computed tomography coronary angiography (CT-CAG) for measurement of the left ventricular outflow tract diameter (LVOTd) in the parasternal long-axis orientation, and to explore anthropometric predictors of LVOTd in stable Indian adults. In this prospective, single-centre study, hemodynamically stable adults in sinus rhythm undergoing outpatient CT-CAG were enrolled (October-December 2024). LVOTd was measured by TTE (parasternal long-axis view, mid-systole) and by CT in a matched long-axis orientation (anteroposterior diameter at the same anatomical level) by separate blinded readers. Agreement was assessed using intraclass correlation coefficients (ICC) and Bland-Altman analysis. Of 100 screened subjects, 91 were analysed (mean age 53.9 ± 8.7 years; 72.5% male; 84.6% health screening). Mean LVOTd was 1.94 ± 0.24 cm (CT-CAG) versus 1.88 ± 0.18 cm (TTE). The two modalities demonstrated good agreement for LVOTd (ICC 0.85; 95% CI 0.77-0.89). Bland-Altman analysis revealed a bias of 0.05 cm (limits of agreement 0.25 to 0.34 cm), with CT-CAG yielding larger values. Agreement diminished for derived parameters, being moderate for LVOT area (ICC 0.74) and modest for cardiac output (CO) (ICC 0.57; bias 0.5 L/min), indicating non-interchangeability for hemodynamic calculations. Body weight was the sole significant predictor of LVOTd (β = 0.004 cm/kg; R2 = 0.29; p = 0.04). In stable Indian adults, TTE and CT-CAG show good agreement for LVOTd measured in a comparable anatomical plane. Agreement diminishes for derived area and CO estimates. The weight-based model requires validation in larger, more diverse cohorts.
The arithmetic hip-knee-ankle angle (aHKAA) has been proposed as a bony geometry-based parameter reflecting constitutional coronal alignment. However, normative values of aHKAA in individuals with normal mechanical alignment remain insufficiently defined. This study aimed to determine the distribution of aHKAA in individuals with normal hip-knee-ankle angle (HKA) and joint-line convergence angle (JLCA), and to evaluate its relationship with mechanical alignment parameters. In this retrospective radiographic reference study, 649 knees with normal HKA (1° valgus to 3.2° varus) and JLCA (0-2°) were included. mMPTA, LDFA, HKA, and JLCA were measured. aHKAA was calculated as mMPTA - mLDFA, and mechanical HKA (mHKA) was derived as 180° + aHKAA - JLCA. Normative reference intervals were defined using non-parametric methods. Correlations were assessed using Spearman analysis and agreement using Bland-Altman analysis. Mean aHKAA was 1.14 ± 1.85°, with higher values in females than males (1.56 ± 1.81° vs 0.50 ± 1.74°, p < 0.001). Mechanical parameters showed narrow distributions (HKAA: 0.46 ± 1.18°; mHKA: 179.62 ± 1.53°). mHKA strongly correlated with HKAA (ρ = -0.756, p < 0.001) and with aHKAA (ρ = 0.719, p < 0.001). Bland-Altman analysis demonstrated a mean difference of -0.68° (95% limits -4.19° to 2.83°). Despite normal mechanical alignment, aHKAA demonstrates inter-individual variability and sex-related differences. Mechanical neutrality does not necessarily reflect geometric neutrality.
Background: In this study, it was aimed to compare transrectal ultrasound (TRUS)- and magnetic resonance imaging (MRI)-derived prostate-specific antigen density (PSAD) in patients with gray-zone PSA levels (4-10 ng/mL), evaluate their diagnostic performance for clinically significant prostate cancer (csPCa), and assess the clinical implications of reclassification across commonly used thresholds. Methods: We retrospectively analyzed 202 men who underwent both TRUS and multiparametric MRI between January 2020 and June 2025. Prostate volume was measured using the ellipsoid formula for TRUS and contour-based planimetry for MRI. PSA density (PSAD) was calculated as total PSA (tPSA, ng/mL) divided by prostate volume (mL) for each modality: TRUS-PSAD and MRI-PSAD. Agreement between modalities was evaluated using Bland-Altman plots and correlation analyses. Reclassification at PSAD thresholds of 0.15, 0.20, and 0.30 ng/mL/mL was assessed using Cohen's κ and net reclassification improvement (NRI). Diagnostic performance for csPCa (ISUP grade group ≥ 2) was evaluated with ROC analysis and the DeLong test. Inter- and intra-observer reproducibility was determined using intraclass correlation coefficients (ICC) and Cohen's κ. Clinical utility was assessed by decision curve analysis (DCA). Results: MRI-derived prostate volumes were significantly lower than TRUS-derived volumes (median 47.0 vs. 52.5 mL, p < 0.001), resulting in higher MRI-PSAD values (median 0.14 vs. 0.12 ng/mL/mL, p < 0.001). Bland-Altman analysis demonstrated a negative bias for prostate volume (-3.2 mL) and a positive bias for PSAD (+0.03). Strong correlations were observed between TRUS and MRI measurements (r = 0.96 for volume and r = 0.94 for PSAD). MRI-PSAD frequently reclassified patients into higher risk categories, yielding positive net reclassification improvement for cancer cases across all thresholds, while introducing some negative reclassification among non-cancer cases. ROC analysis showed comparable overall diagnostic performance between TRUS-PSAD and MRI-PSAD (AUC 0.681 vs. 0.679, p = 0.91). However, MRI-PSAD demonstrated higher sensitivity at predefined thresholds at the expense of reduced specificity, reflecting a threshold-dependent shift rather than improved discrimination. Reproducibility was higher for MRI-derived measurements (ICC = 0.94; κ = 0.83) compared with TRUS (ICC = 0.86; κ = 0.71). Decision curve analysis indicated that MRI-PSAD, particularly when combined with PI-RADS ≥ 3, provided the greatest net clinical benefit at lower threshold probabilities (5-15%). Conclusions: MRI-derived PSA density produces systematically higher values than TRUS-based measurements due to inherent differences in prostate volume estimation. While this results in increased sensitivity at standard thresholds, overall discrimination remains unchanged. These findings support the use of modality-specific PSAD thresholds rather than uniform cutoffs across imaging techniques. In clinical practice, MRI-PSAD may provide additional value when interpreted in conjunction with PI-RADS, primarily through improved threshold calibration rather than enhanced diagnostic accuracy.
Functional Threshold Power (FTP) is widely used for performance evaluation and training prescription in endurance sports. Although FTP is strongly associated with power at the Respiratory Compensation Point (RCP), its interchangeability remains debated. This study examined the relationship and agreement between FTP and RCP in amateur triathletes and tested whether sex influences this relationship. Forty-nine amateur triathletes (male and female) participated. Each athlete completed a maximal cardiorespiratory cycling test and an FTP test, separated by at least 72 h. Linear regression models were used to test the association between FTP and RCP. A regression model including the interaction term (FTP × sex), equivalent to an ANCOVA framework, was applied to assess sex effects on the FTP-RCP relationship. Agreement between methods was assessed using Bland-Altman analysis. Two-way analysis of variance (ANOVA) was performed to examine the effects of sex, test type, and their interaction on absolute power (W), power relative to total body mass, and power relative to lean mass. FTP and RCP were strongly correlated (r = 0.916; p < 0.001). The interaction term FTP × sex was not significant (β = -0.135, p = 0.524), indicating that the regression slopes do not differ between males and females. Thus, the relationship between FTP and RCP was statistically similar across sexes. However, Bland-Altman analysis revealed wide limits of agreement, indicating poor interchangeability between FTP and RCP at the individual level. FTP is strongly associated with RCP, and the relationship is independent of sex. Despite this association, FTP and RCP are not interchangeable measures. Caution is warranted when using FTP as a direct surrogate for RCP in training prescription and performance assessment.