Intraobserver Reproducibility Research Articles

Low irisin levels predict acutely decompensated heart failure in type 2 diabetes mellitus patients

Abstract Funding Acknowledgements None. Background Acutely decompensated heart failure (ADHF) continues to be associated with unacceptably increasing in-hospital mortality rates and one-year mortality rates. Distinct scenarios of the natural course of ADHF relate to clinical heterogeneity among patients admitted to hospitals, cardiac dysfunction etiology, precipitating factors contributing to heart failure (HF) decompensation including type 2 diabetes mellitus (T2DM). The aim of this study was to determine the discriminative value of irisin for ADHF in T2DM patients with hemodynamically stable chronic HF. Methods A total of 738 patients with T2DM were prescreened using the local database of "Vita Center" (Ukraine). Using criteria of inclusion (male/female with age of ≥18 years, established T2DM with hemodynamically stable chronic HF, glycosylated hemoglobin < 6.9%, informed consent to participate in the study), we enrolled 489 patients with T2DM with concomitant chronic HF I-IV New York Heart Association (NYHA) functional classes. We enrolled 480 T2DM patients with any phenotype of HF and followed them for 52 weeks. Hemodynamic performances and the serum levels of biomarkers were detected at the study entry. The primary clinical end-point was ADHF that led to urgent hospitalization. Results We found that the serum levels of N-terminal natriuretic pro-peptide (NT-proBNP) were higher (1719 [980-2457] pmol/mL vs. 1057 [570-2607] pmol/mL, respectively) and the levels of irisin were lower (4.96 [3.14-6.85] ng/mL vs. 7.95 [5.73-9.16] ng/mL) in ADHF patients than in those without ADHF. The ROC curve analysis showed that the estimated cut-off point for serum irisin levels (ADHF versus non-ADHF) was 7.85 ng/mL (area under curve [AUC] = 0.869 (95% CI = 0.800-0.937), sensitivity = 82.7%, specificity = 73.5%; p = 0.0001). The multivariate logistic regression yielded that the serum levels of irisin < 7.85 ng/mL (OR = 1.20; p = 0.001) and NT-proBNP > 1215 pmol/mL (OR = 1.18; p = 0.001) retained the predictors for ADHF. Kaplan-Meier plots (Figure) showed a significant difference of clinical end-point accumulations in patients with HF depending on irisin levels (<7.85 ng/mL versus ≥7.85 ng/mL). The intra-class correlation coefficient for inter-observer reproducibility of LV dimensions was 0.88 (95% CI = 0.83–0.92), of LVEF was 0.93 (95% CI = 0.90–0.97), of LAVI was 0.92 (95% CI = 0.89–0.94), and of E/e’ was 0.90 (95% CI = 0.87–0.94). Along with it, the intra-class correlation coefficient for the intra-observer reproducibility of LV dimensions was 0.91 (95% CI = 0.88–0.95), of LVEF was 0.94 (95% CI = 0.90–0.98), of LAVI was 0.95 (95% CI = 0.93–0.97), and of E/e’ was 0.92 (95% CI = 0.90–0.95). In conclusion, we established that decreased levels of irisin were associated with ADHF presentation in chronic HF patients with T2DM independently from NT-proBNP.Flow chart of the study designThe Kaplan–Meier analysis of ADHF

Assessing the reproducibility and predictive value of objective cough measurement for successful withdrawal of invasive ventilatory support in adult patients

BackgroundUtilizing clinical tests, such as objective cough measurement, can assist in predicting the success of the weaning process in critically ill patients.MethodsA multicenter observational analytical study was conducted within a prospective cohort of patients recruited to participate in COBRE-US. We assessed the capability of objective cough measurement to predict the success of the spontaneous breathing trial (SBT) and extubation. Intra- and inter-observer reproducibility of the cough test and was evaluated using the intraclass correlation coefficient (ICC) and Cohen’s weighted kappa. We used receiver operating characteristic curves (ROC-curve) to evaluate the predictive ability of objective cough measurement.ResultsWe recruited 367 subjects who were receiving invasive mechanical ventilation. A total of 451 objective cough measurements and 456 SBTs were conducted. A significant association was found between objective cough measurement and successful SBT (OR: 1.68; 95% CI 1.48–1.90; p = 0.001). The predictive capability of the objective cough test for SBT success had a ROC-curve of 0.58 (95% CI: 0.56–0.61). Objective cough measurement to predict successful extubation had a ROC-curve of 0.61 (95% CI: 0.56–0.66). The intraobserver reproducibility exhibited an ICC of 0.94 (95% CI: 0.89–0.96; p < 0.001), while the interobserver reproducibility demonstrated an ICC of 0.72 (95% CI: 0.51–0.85; p < 0.001). The intraobserver agreement, assessed using Cohen’s weighted kappa was 0.94 (95% CI: 0.93–0.99; p < 0.001), whereas the interobserver agreement was 0.84 (95% CI: 0.67 − 0.10; p < 0.001).ConclusionsThe objective measurement of cough using the method employed in our study demonstrates nearly perfect intra-observer reproducibility and agreement. However, its ability to predict success or failure in the weaning process is limited.

Abstract PO5-14-08: External Reproducibility of PD-L1 IHC 22C3 pharmDx on Breast Cancer Specimens at CPS ≥ 1 and CPS ≥ 10 Cutoffs

Abstract Background: PD-L1 IHC 22C3 pharmDx is an approved companion diagnostic for pembrolizumab treatment in triple-negative breast cancer (TNBC). Clinical evidence for pembrolizumab approval in TNBC was demonstrated by KEYNOTE-355 (NCT02819518), which investigated the clinical validity of PD-L1 IHC 22C3 pharmDx in identifying patients with PD-L1 expressing Combined Positive Score (CPS) ≥ 10 in previously untreated locally recurrent unresectable or metastatic TNBC.1 The role of immune checkpoint inhibitors for breast cancer as a whole is not as well defined as it is for TNBC. In this study, we show evidence of the reproducibility of PD-L1 IHC 22C3 pharmDx in PD-L1 expression determination in breast cancer specimens at the CPS ≥ 1 and CPS ≥ 10 cutoffs documenting robust assay performance in breast cancer. Methods: A blinded, randomized study was conducted at three external sites using formalin-fixed, paraffin-embedded breast cancer specimens. Reproducibility of PD-L1 IHC 22C3 pharmDx was assessed at the inter-site, intra-site/inter-day, inter-observer, and intra-observer endpoints at the CPS ≥ 1 and CPS ≥ 10 cutoffs. To assess inter-site and intra-site reproducibility, five replicate sets of pre-qualified unstained specimens were stained and evaluated at each of the three external sites. To assess inter-observer and intra-observer reproducibility, one set of pre-stained specimens was evaluated three times by each of three external pathologists. Negative percent agreement (NPA), positive percent agreement (PPA), and overall percent agreement (OA), based on comparisons to consensus diagnostic outcome, were computed with corresponding two-sided 95% percentile bootstrap confidence intervals. Acceptance criteria required at least 85.0% for the lower-bound (LB) of the two-sided 95% confidence interval (CI) on NPA, PPA, and OA for all endpoints. Results: All but one endpoint in the external reproducibility study met pre-determined acceptance criteria. Both the inter- and intra-site reproducibility endpoints had 95% CI LB values of 98.8% for NPA, 95.9% for PPA, and 97.9% OA at the CPS ≥ 1 cutoff. At the CPS ≥ 10 cutoff, the inter-site reproducibility endpoint had 95% CI LB values of 88.0% for NPA, 87.1% for PPA, and 89.5% OA, and the intra-site reproducibility endpoint had 95% CI LB values of 96.7% for NPA, 92.2% for PPA, and 95.6% OA. The inter-observer reproducibility endpoint had 95% CI LB values of 95.3% for NPA, 92.3% for PPA, and 94.7% OA at the CPS ≥ 1 cutoff. At the CPS ≥ 10 cutoff, the inter-observer reproducibility endpoint had 95% CI LB values of 84.9% for NPA, 86.8% for PPA, and 87.3% OA. The intra-observer reproducibility endpoint had 95% CI LB values of 97.0% for NPA, 95.0% for PPA, and 96.6% OA at the CPS ≥ 1 cutoff. At the CPS ≥ 10 cutoff, the intra-observer reproducibility endpoint had 95% CI LB values of 92.2% for NPA, 89.2% for PPA, and 91.7% OA. Conclusions: Acceptance criteria were met for all endpoints in the breast cancer external reproducibility study of PD-L1 IHC 22C3 pharmDx at the CPS ≥ 1 and CPS ≥ 10 cutoffs, except for inter-observer at the CPS ≥ 10 cutoff, which had a 95% CI LB value of 84.9% for NPA.

Establishment and preliminary evaluation of CT-based classification for distal radius fracture

Establish a new classification system of distal radius fracture based on computed tomographic (CT), and evaluate its reliability and reproducibility preliminarily, and provide a new theoretical reference for clinicians to use the clinical classification system. The imaging data and clinical data of 204 inpatients with distal radius fracture during 6 years from January 1, 2014 to January 1, 2019 in orthopaedic department were analyzed retrospectively and classified based on CT. Three observers evaluated the image data of 48 randomly selected cases based on CT at different time nodes of T1 and T2. Cohen's kappa was used to calculate the consistency. At the last follow-up, patients' Disabilities of the Arm, Shoulder and Hand (DASH), Patient Rated Wrist Evaluation (PRWE), and VAS scores were collected. Among 204 cases, there were 12 cases of type 1, including 6 cases of type 1-D, 4 cases of type 1-V and 2 cases of type 1-R. There were 6 cases of type 2, including 2 cases of type 2-DV, 2 cases of type 2-DR and 2 cases of type 2-VR. There were 186 cases of type 3, including 32 cases of type 3–0, 127 cases of type 3–1 and 27 cases of type 3–2. There was no significant difference in DASH, PRWE and VAS scores among all types (P > 0.05). The results of interobserver reproducibility were kappa = 0.985, ICC = 0.984 in the first evaluation, kappa = 0.986, ICC = 0.986 in the second evaluation. The results of intraobserver reproducibility were O1 = 0.991, O2 = 0.991, O3 = 0.989 respectively. The new classification system of distal radius fracture based on CT has theoretical and practical significance for incision selection, fracture reduction and internal fixation. 123 classification system is clear, comprehensive, easy to understand and remember. Moreover, it has higher interobserver reliability and intraobserver reproducibility than other systems reported at present.

Pulmonary Transit Time Assessment by CEUS in Healthy Rabbits: Feasibility, and the Effects of UCAs Dilution Concentration.

To evaluate the inter-observer variability and the intra-observer repeatability of pulmonary transit time (PTT) measurement using contrast-enhanced ultrasound (CEUS) in healthy rabbits, and assess the effects of dilution concentration of ultrasound contrast agents (UCAs) on PTT. Thirteen healthy rabbits were selected, and five concentrations UCAs of 1:200, 1:100, 1:50, 1:10, and 1:1 were injected into the right ear vein. Five digital loops were obtained from the apical 4-chamber view. Four sonographers obtained PTT by plotting the TIC of right atrium (RA) and left atrium (LA) at two time points (T1 and T2). The frame counts of the first appearance of UCAs in RA and LA had excellent inter-observer agreement, with intra-class correlations (ICC) of 0.996, 0.988, respectively. The agreement of PTT among four observers was all good at five different concentrations, with an ICC of 0.758-0.873. The reproducibility of PTT obtained by four observers at T1 and T2 was performed well, with ICC of 0.888-0.961. The median inter-observer variability across 13 rabbits was 6.5% and the median variability within 14 days for 4 observers was 1.9%, 1.7%, 2.2%, 1.9%, respectively; The PTT of 13 healthy rabbits is 1.01 ± 0.18 second. The difference of PTT between five concentrations is statistically significant. The PTT obtained by a concentration of 1:200 and 1:100 were higher than that of 1:1, while there were no significantly differences in PTT of a concentration of 1:1, 1:10, and 1:50. PTT measured by CEUS in rabbits is feasible, with excellent inter-observer and intra-observer reliability and reproducibility, and dilution concentration of UCAs influences PTT results.

Inter- and intra-observer variability of qualitative visual breast-composition assessment in mammography among Japanese physicians: a first multi-institutional observer performance study in Japan.

Visual assessment of mammographic breast composition remains the most common worldwide, although subjective variability limits its reproducibility. This study aimed to investigate the inter- and intra-observer variability in qualitative visual assessment of mammographic breast composition through a multi-institutional observer performance study for the first time in Japan. This study enrolled 10 Japanese physicians from five different institutions. They used the new Japanese breast-composition classification system 4th edition to subjectively evaluate the breast composition in 200 pairs of right and left normal mediolateral oblique mammograms (number determined using precise sample size calculations) twice, with a 1-month interval (median patient age: 59years [range 40-69years]). The primary endpoint of this study was the inter-observer variability using kappa (κ) value. Inter-observer variability for the four and two classes of breast-composition assessment revealed moderate agreement (Fleiss' κ: first and second reading = 0.553 and 0.587, respectively) and substantial agreement (Fleiss' κ: first and second reading = 0.689 and 0.70, respectively). Intra-observer variability for the four and two classes of breast-composition assessment demonstrated substantial agreement (Cohen's κ, median = 0.758) and almost perfect agreement (Cohen's κ, median = 0.813). Assessments of consensus between the 10 physicians and the automated software Volpara® revealed slight agreement (Cohen's κ; first and second reading: 0.104 and 0.075, respectively). Qualitative visual assessment of mammographic breast composition using the new Japanese classification revealed excellent intra-observer reproducibility. However, persistent inter-observer variability, presenting a challenge in establishing it as the gold standard in Japan.

A Novel Classification of Juvenile and Adolescent Idiopathic Scoliosis for Conservative Treatment

The operative classification of scoliosis is well-developed but inadequate for guiding conservative treatment. The current conservative classification for juvenile and adolescent idiopathic scoliosis (JAIS) exhibits noticeable deficiencies. This study aimed to establish the Peking Union Medical College Hospital (PUMCH) classification and assess its clinical value in the conservative treatment of JAIS. This study consisted of two parts. First, it involved a retrospective analysis of patients treated for JAIS in the Department of Rehabilitation Medicine, the *** Union Medical College Hospital, between January 2013 and June 2020. Second, it involved an ambispective cohort study that enrolled patients with JAIS in the above hospital between July and December 2020. A total of 989 patients with JAIS were enrolled, with 899 patients for establishing the PUMCH classification and 90 patients with JAIS for validating the PUMCH classification. The classification demonstrated an average reliability of 88.22% with a kappa coefficient of 0.862. After 1 week, the remeasured results presented a mean reproducibility of 92.78% and a kappa coefficient of 0.908. After 1-year follow-up, the Cobb angle decreased significantly from 16.61°±2.88° to 12.16°±9.97° (P=0.002) in 51 patients with PUMCH-SSE treatment, while the Cobb angle increased significantly from 15.74°±2.75° to 17.64°±5.60° (P=0.014) in 39 patients without PUMCH-SSE treatment. The PUMCH-SSE classification demonstrates good inter-observer reliability and intra-observer reproducibility. In addition, the classification may be used to guide the conservative treatment of JAIS in clinical settings.

Quantitative MRI assessment of joint effusion using T2-relaxometry at 3 Tesla: a feasibility and reproducibility study.

T2-relaxometry could differentiate between physiological and haemorrhagic joint effusion (≥ 5% blood) in vitro. Are quantitative T2-relaxation time measurements of synovial fluid feasible and reproducible in vivo in clinically bleed-free joints of men with haemophilia? In this cross-sectional study, we measured T2-relaxation times of synovial fluid in clinically bleed-free ankles, knees or elbows of men with severe haemophilia A using a T2-mapping sequence (duration ≤ 7min) at 3 Tesla MRI. Manual and circular regions of interest (ROI) were drawn in the synovial fluid of each joint by two independent observers to measure T2-relaxation times. Measurement feasibility was expressed as the success rate of the measurements by both observers. The interobserver and intraobserver reproducibility of the measurements were evaluated by the intraclass correlation coefficient of absolute agreement (ICC) and the limits of agreement (LoA) from Bland Altman analysis. We evaluated 39 clinically bleed-free joints (11 ankles, 12 knees, 16 elbows) of 39 men (median age, 24years; range 17-33) with severe haemophilia A. The success rate of the T2-measurements was ≥ 90%. Interobserver reliability was good to excellent (manual ROI: ICC = 0.92, 95% CI 0.76-0.97; circular ROI: ICC = 0.82, 95% CI 0.66-0.91) and interobserver agreement was adequate (manual ROI: LoA = 71ms; circular ROI: LoA = 146ms). Intraobserver reliability was good to excellent (manual ROI: ICC = 0.78, 95% CI - 0.06-0.94; circular RO:ICC = 0.99, 95% CI 0.98-0.99) and intraobserver agreement was good (manual ROI: LoA = 63ms; circular ROI: LoA = 41ms). T2-relaxometry of synovial fluid in haemophilia patients is feasible with good interobserver and intraobserver reproducibility.

Prostate diffusion-weighted imaging (DWI) in MR-guided radiotherapy: Reproducibility assessment on 1.5 T MR-Linac and 1.5 T MR-simulator

PurposeDiffusion-weighted imaging (DWI) holds promise for image-guided radiotherapy (MRgRT) in prostate cancer. However, challenges persist due to image distortion, artifacts, and apparent diffusion coefficient (ADC) reproducibility issues. This study aimed to assess DWI image quality and ADC reproducibility on both a 1.5 T MR-simulator and a 1.5 T MR-Linac, employing measurements from both an ACR MRI phantom and prostate cancer patients undergoing MRgRT. MethodsDW-MRI scans were conducted on 19 patients (mean age = 69 ± 8 years, with 23 MR-visible intra-prostatic lesions) and an ACR MRI phantom using a 1.5 T MR-simulator (b-values = 0, 800, 1400s/mm2) and a 1.5 T MR-Linac (b-values = 50, 500, 800 s/mm2). ADC homogeneity in the phantom was evaluated via 1D profile flatness (FL) in three directions. Image quality was assessed through qualitative 5-point Likert scale ratings and quantitative ADC and signal-to-noise ratio (SNR) measurements. Intra-observer reproducibility of image quality scores was evaluated using ICC(1, 2). Geometric distortion was measured by comparing landmark sizes on the ACR phantom against the ground truth. Mean ADC and reproducibility were assessed using Bland-Altman plots. ResultsBoth MR-simulator and MR-Linac demonstrated high ADC homogeneity (FL > 87.5% - MR-simulator: 97.23 ± 0.62%, MR-Linac: 94.75 ± 0.62%, p < 0.05) in the phantom. Image quality scores revealed acceptable ratings (≥3) for capsule demarcation, image artifacts, and geometric distortion in patients. However, intra-prostatic lesions were barely discernible in b800 images for both MR-simulator (average score = 2.37 ± 1.33) and MR-Linac (average score = 2.16 ± 1.28). While MR-Linac DWI scans exhibited significantly more severe geometric distortion than MR-simulator scans (p < 0.01), most phantom measurements fell within the image in-plane resolution of 3 mm. Significant differences were noted in MR-simulator ADC (CTV: 1.20 ± 0.14 × 10−3 mm2/s (MR-simulator) vs 1.06 ± 0.10 × 10–3 mm2/s (MR-Linac); GTV: 1.05 ± 0.21 × 10−3 mm2/s vs 0.91 ± 0.16 × 10 mm2/s, all p < 0.05), with a small non-zero bias observed in the Bland-Altman analysis (CTV: 12.3%; GTV: 14.5%). ConclusionThe significantly larger MR-simulator ADC and the small non-zero bias hint at potential systematic differences in ADC values acquired from an MR-simulator and an MR-Linac, both at 1.5 T. Although acceptable ADC homogeneity was noted, caution is warranted in interpreting MR-Linac DWI images due to occasional severe artifacts. Further studies are essential to validate DWI and ADC as reliable imaging markers in prostate cancer MRgRT.

Age- and Sex-Specific MR-Feature Tracking Reference Values of Right Atrial Deformation in Healthy Adults.

Although right atrial (RA) myocardial deformation has important implications for patient diagnosis, prognosis, and risk stratification, its implementation in clinical practice has been hampered by limited normal reference values, especially in Asian populations. To establish age- and sex-specific reference values for RA strain, strain rate (SR), and displacement based on a large sample of healthy Chinese adults using MR-feature tracking (MR-FT). Retrospective. 524 healthy Chinese adults (287 male; mean age 43.7 ± 11.9 years). 1.5T/balanced steady-state free precession. RA deformation parameters, including reservoir, conduit, and booster strain (εs, εe, and εa), peak positive, early negative, and late negative SR (SRs, SRe, and SRa), and total, passive, and active displacement (Ds, De, and Da), were assessed using MR-FT. Student's t-test, one-way ANOVA, coefficients of determination (r2 ), intraclass correlation coefficients (ICC), and Bland-Altman plots. A P value <0.05 was considered significant. Women demonstrated significantly greater magnitudes of RA deformation parameters than men: εs (57.4% ± 15.1% vs. 44.3% ± 12.6%), εe (37.5% ± 13.4% vs. 27.4% ± 10.9%), εa (19.9% ± 5.7% vs. 16.9% ± 5.0%), SRs (2.62 ± 0.88 sec-1 vs. 2.00 ± 0.63 sec-1 ), SRe (-2.98 ± 1.26 sec-1 vs. -2.16 ± 0.92 sec-1 ), SRa (-2.28 ± 0.75 sec-1 vs. -1.84 ± 0.62 sec-1 ), Ds (-7.80 ± 1.90 mm vs. -7.46 ± 1.70 mm), and De (-4.84 ± 1.31 mm vs. -4.49 ± 1.21 mm). For both sexes, aging was significantly associated with decreased RA reservoir and conduit function (εs, SRs, Ds, εe, SRe, and De), and with increased εa and Da. RA deformation measurements had good to excellent intraobserver and interobserver reproducibility, with ICCs ranging from to 0.790 to 0.972. This study provides age- and sex-specific reference values of RA strain, SR, and displacement based on a large cohort of healthy Chinese adults using MR-FT. 3 TECHNICAL EFFICACY: Stage 2.

Feasibility and reproducibility of new technique for measurement of transverse diameter of levator ani muscle hiatus using two-dimensional transperineal ultrasound in nulliparous women at term.

The aim of the present study was twofold; firstly to develop and describe the technique for measurement of the transverse diameter of the levator ani muscle hiatus (TD) in the coronal view using 2D transperineal ultrasound (TPUS) in nulliparous women at term of pregnancy. Secondly, we aimed to assess the feasibility and reproducibility of 2D TPUS assessment of TD, in addition to the inter-method agreement between 2D TPUS and the 3D measurement of TD on the axial plane, the latter considered as the gold standard in nulliparous women at term of pregnancy. For the aim of the study, we recruited a group of nulliparous women at term of pregnancy before the onset of labor. The study was conducted in two phases: phase 1 involved developing and describing the 2D TPUS technique for measuring TD, while phase 2 focused on assessing the technique's feasibility, reproducibility, and inter-method agreement. In phase 1, we enrolled 30 women. Each woman underwent the acquisition of a 3D TPUS volume, which was analyzed using the multiplanar mode to identify the appearance of the lateral borders of the levator ani muscle at the level of the plane of minimal hiatal dimensions in the coronal plane. These borders were used as landmarks for TD measurement. Additionally, we measured the distance between the line indicating TD and the center of the urethra in the axial view. Phase 2 involved recruiting 100 women. Each woman underwent the acquisition of three 2D TPUS clips in the coronal plane, each encompassing a sweep of the entire levator hiatus, and a 3D volume, all obtained during rest. On the 2D clips, TD was measured twice by one operator and once by another operator. TD was measured once in the 3D volume in the axial plane, considered the gold standard. Each operator was blinded to all other measurements during their assessments. We analyzed intraobserver, interobserver, and intermethod (2D vs. 3D) reproducibility. Bland-Altman analysis was conducted, and Levene's W0 and Student t-tests were performed to explore clinical factors that might contribute to systematic differences. In phase 1, we successfully identified the landmarks denoting the lateral borders of TD in the coronal view. These appeared as two symmetrical hypoechoic indentations located at the inner border of the hyperechoic structure of the levator ani muscle, at the point of maximum distance between the two sides of the levator ani muscle. Additionally, the distance between the urethra and the plane where TD was measured using 3D TPUS in the axial plane had a median of 4 mm and varied from 0 to 9 mm. This enabled us to describe the method for assessing TD in the coronal plane through the use of 2D TPUS. In phase 2, TD was successfully measured in all 2D and 3D acquisitions from the entire group of 100 women. The analyses for intraobserver, interobserver reproducibility, and intermethod comparison (2D vs. 3D) revealed almost perfect agreement in TD measurements using 2D TPUS, with Intraclass Correlation Coefficients (ICCs) of 0.95 (95% CI, 0.92 to 0.96), 0.87 (95% CI, 0.78 to 0.92), and 0.85 (95% CI, 0.78 to 0.90), respectively. The average differences between measurements were 0.1 mm for intraobserver, 1.0 mm for interobserver, and 0.2 mm for intermethod repeatability. No systematic differences were observed in any of the measurement sets, except in the inter-operator analysis, although the difference was clinically insignificant (38.2 vs. 37.1 mm, P= 0.01). None of the examined clinical factors (maternal body mass index and maternal age) exhibited a statistically significant impact on intraobserver, interobserver, or intermethod reliability. Utilizing our described technique to measure the transverse diameter of the levator hiatus in the coronal view using 2D TPUS is not only feasible but also highly reproducible and accurate in nulliparous women at term of pregnancy. Moreover, it yields measurements that are comparable to those obtained in the reconstructed axial plane generated by 3D TPUS. This article is protected by copyright. All rights reserved.

Assessment of fetal cardiac function in early fetal life: feasibility, reproducibility, and early fetal nomograms

BackgroundFetal cardiology has shown a rapid development in the last decades. Fetal echocardiography is not only used for the detection of structural anomalies but also to assess fetal cardiac function. Assessment of the fetal cardiac function is performed mostly at second and third trimester. The study of fetal cardiac function at the end of first timester has not been properly investigated and there is a lack of reference values at early gestational weeks. ObjectiveTo assess whether the measurement of time related parameters of cardiac function in the left ventricle of the fetal heart is feasible and reproducible at the end of the first trimester. If possible, we provide nomograms of these parameters from 11 to 13.6 gestational weeks. Study designWe conducted a prospective observational study from March to September 2022. The study was carried out in two hospitals (Hospital Universitari Dexeus, Barcelona and Hospital VITAHS 9 Octubre, Valencia). The scans were performed by 3 specialists in fetal medicine. Exclusion criteria were: fetal cardiac rhythm abnormalities, abnormal nuchal translucency, abnormal ductus venosus, fetal malformations, stillbirth, estimated fetal weight< 10 centile, diabetes and gestational hypertensive disorders. The cardiac function parameters studied in the left ventricle were: isovolumetric contraction time, isovolumetric relaxation time, ejection time, filling time, cycle time, myocardial performance index, ejection time fraction and filling time fraction. We study the feasibility and intra- and inter-observer reproducibility of this parameters using the interclass correlation coefficient (ICC). Nomograms were made and the percentiles of the values of the different parameters were calculated. Results409 cases were recruited but only 296 could be included in the statistical analysis once exclusion criteria were applied. The intra-observer reproducibility study was excellent (ICC>0.900) and the inter-observer reproducibility study was good (ICC>0.700). Data regression analysis showed that cycle time, filling time, isovolumetric contraction time and filling time fraction increased with gestational age, whereas ejection time fraction decreased with gestational age and myocardial performance index (mean 0.43±0.08), isovolumetric relaxation time (mean 0.04±0.01) and ejection time (mean 0.16±0.01) remained constant from 11 to 13 weeks. ConclusionsThe study of fetal cardiac function is feasible and reproducible at 11 to 13+6 gestational weeks. Nomograms of the studied parameters are provided.

Inter- and intra-rater reproducibility of quantitative T1 measurement using semiautomatic region of interest placement in myometrium.

This study aimed to investigate the inter- and intraobserver reproducibility of quantitative T1 (qT1) measurements using manual and semiautomatic region of interest (ROI) placements. We hypothesized the usefulness of the semiautomatic method, which utilizes a three-dimensional (3D) anatomical relationship between the myometrium and other tissues, for minimizing ROI placement variation, thereby improving qT1 reproducibility compared to the manual approach. The semiautomatic approach, which considered anatomical relationships, was expected to enhance reproducibility by reducing ROI placement variabilities. This study recruited 23 healthy female volunteers. Data with variable flip angle (VFA) and inversion recovery were acquired using 3D-spoiled gradient echo and spin echo sequences, respectively. T1 maps were generated with VFA. Manual and semiautomatic ROI placements were independently conducted. Mean qT1 values were calculated from the T1 maps using the corresponding pixel values of the myometrial ROI. Inter- and intraobserver reproducibility of qT1 values was investigated. The inter- and intraobserver reproducibility of qT1 values was evaluated by calculating the coefficient of variation (CoV). Further, reproducibility was evaluated with inter- and intraobserver errors and intraclass correlation coefficients (ICCs). Bland-Altman analysis was utilized to compare the results, estimate bias, and determine the limits of agreement. The mean inter- and intraobserver CoV of the qT1 values for semiautomatic ROI placement was significantly lower than those for manual ROI placement (p < 0.05 and p < 0.01, respectively). ICCs for semiautomatic ROI placement were greater than those for manual ROI placement. Further, the mean inter- and intraobserver errors for semiautomatic ROI placement were significantly lower than those for manual ROI placement (p < 0.05 and p < 0.01, respectively). Semiautomatic ROI placement demonstrated high reproducibility of qT1 measurements compared with manual methods. Semiautomatic ROI placement may be useful for evaluating uterine qT1 with high reproducibility.

Classification of intraarticular calcaneal fractures: comparison of two classification systems

PurposeAccurately classifying displaced intraarticular calcaneal fractures (DIACFs) is essential for orthopedic surgeons to choose optimal treatment methods and provide results evaluation and communication. Many authors studying used Sanders classification reported moderate intra- and interobserver reliability. Taking the software opportunity of 3D virtual exarticulation, Goldzak updated French tri-dimensional Utheza classification, providing an alternative framework for classifying DIACFs. The aim of this study was to compare the intra- and interobserver reliability of Sanders versus Goldzak classification systems.MethodsThe CT scans of 30 patients with displaced intraarticular calcaneal fractures, treated in the same trauma center between 2014–2018, were analyzed by 16 medical doctors (specialists and residents in orthopedic surgery, specialists and residents in radiology), and classified according to Sanders and Goldzak classifications. The same images were sent on two separate sessions, in a randomized order. Interobserver reliability and intraobserver reproducibility were assessed using Kappa statistics and Gwet’s AC1 coefficient.ResultsInterobserver reliability using Gwet reported a value of 0.36 for Goldzak classification and 0.30 for Sanders classification (corresponding to “fair assessment” in both cases). In absence of subclasses, “substantial assessment” was reported for Goldzak classification (Gwet of 0.61) and “moderate assessment” for Sanders classification (Gwet of 0.46). Goldzak system had a greater interobserver reliability in the group of radiology residents. Intraobserver reliability coefficient was 0.60 for Goldzak classification and 0.69 for Sanders classification, indicating a substantial agreement for both classifications.ConclusionDespite the better view of the fracture lines provided by 3D reconstructions, this study failed to prove the superiority of Goldzak classification compared to Sanders classification for DIACFs.

ArUco-based stylus reliability for reproductible 3D digitalisation of shoulder cartilage contours.

Imaging techniques in anatomy have developed rapidly over the last decades through the emergence of various 3D scanning systems. Depending on the dissection level, non-contact or tactile contact methods can be applied on the targeted structure. The aim of this study was to assess the inter and intra-observer reproducibility of an ArUco-based localisation stylus, that is, a manual technique on a hand-held stylus. Ten fresh-frozen, unembalmed adult arms were used to digitalise the glenoid cartilage related to the glenohumeral joint and the contour of the clavicle cartilage related to the acromioclavicular joint. Three operators performed consecutive digitalisations of each cartilage contour using an ArUco-based localisation stylus recorded by a single monocular camera. The shape of each cartilage was defined by nine shape parameters. Intra-observer repeatability and inter-observer reproducibility were computed using an intra-class correlation (ICC) for each of these parameters. Overall, 35.2 ± 2.4 s and 26.6 ± 10.2 s were required by each examiner to digitalise the contour of a glenoid and acromioclavicular cartilage, respectively. For most parameters, good-to-excellent agreements were observed concerning intra-observer (ICC ranging between 0.81 and 1.00) and inter-observer (ICC ranging between 0.75 and 0.99) reproducibility. To conclude, through a fast and versatile process, the use of an ArUco-based localisation stylus can be a reliable low-cost alternative to conventional imaging methods to digitalise shoulder cartilage contours.

Reprodutibilidade de instrumento para avaliação motora de jovens com autismo

Abstract Introduction Individuals with autistic spectrum disorder (ASD) have motor impairments that precede communi-cation and socialization disorders. Evaluative instruments compatible with the real possibilities and specificities of patients with ASD, and who quantitatively and qualitatively translate the data in which is wished to intervene with therapeutic actions, are important both in the scope of research and in the clinical evaluation of physiotherapists. Objective To test the interobserver and intraobserver reproducibility of the instrument “Gross Motor Assessment of Children and Adolescents with Autism Spectrum Disorder” (GMA-AUT checklist). Methods The sample consisted of 34 individuals with ASD, aged between 6 and 18 years. The interobserver reproducibility was performed in a blinded manner by two physiotherapists experts in the ASD area of treatment. Intraobserver reproducibility was performed by one of the evaluators on two different days, with a gap of seven days and without access to data from the first evaluation. To verify the reproducibility, percentage of agreement and kappa statistics (k) were used, with the weighted kappa and, for the instrument scores, the intraclass correlation coefficient (ICC). Results The GMA-AUT checklist showed excellent intraobserver agreement, with k ≥ 0.75 and ICC &gt; 0.75. Interobserver reproducibility ranged from good to sufficient agreement with k between 0.40 and 0.75 and ICC &gt; 0.75 for the most part. Conclusion The GMA-AUT checklist had excellent intraobserver reproducibility and, therefore, can be reliably used for assessments of individuals aged between 6 and 18 years with ASD.

Healthy Adult Left and Right Ventricular Torsion and Torsion Rates With MR-Feature Tracking.

The clinical value of myocardial torsion quantification in prognostic assessment and risk stratification of various cardiovascular diseases is gradually being recognized. However, normal values of left and right ventricular (LV and RV) torsion and torsion rates (TRs) have not been fully determined, and their correlation with age and gender has not been well studied. To establish normal ranges of biventricular torsion, peak systolic and diastolic TRs using magnetic resonance feature tracking (MR-FT) technique based on a large sample of healthy adults, and further investigate their relationship with age and gender. Retrospective. 566 Healthy adults (312 males, aged 43 ± 10 years; 254 females, aged 43 ± 11 years). 1.5T/gradient echo. Biventricular torsion, peak systolic, and diastolic TRs. Shapiro-Wilk test, Student's t-test, Mann-Whitney-U test, linear regression, intraclass correlation coefficient, Bland-Altman analysis. Differences were regarded as statistically significant at P < 0.05. Women demonstrated greater magnitudes of left ventricle (LV) torsion (1.23 ± 0.44 vs. 1.00 ± 0.42°/cm), peak systolic TR (9.69 ± 3.70 vs. 8.27 ± 3.73°/cm*sec), peak diastolic TR (-7.78 ± 2.82 vs. -6.06 ± 2.44°/cm*sec), and RV torsion (2.20 ± 1.23 vs. 1.65 ± 1.11°/cm*sec), peak systolic TR (16.07 ± 8.18 vs. 12.62 ± 7.08°/cm*sec), peak diastolic TR (-15.39 ± 6.53 vs. -11.70 ± 6.03°/cm*sec). For both genders, the magnitudes of LV and RV torsion, peak systolic, and diastolic TRs increased linearly with age. All the measurements of biventricular torsion, peak systolic and diastolic TRs achieved good to excellent intraobserver and interobserver reproducibility, with all intraclass correlation coefficients >0.70. The present study systematically provided age- and sex-stratified reference values for LV and RV torsion and TRs using MR-FT technique. Women and aging are associated with greater magnitudes of biventricular torsion, peak systolic, and diastolic TRs. 3 TECHNICAL EFFICACY: Stage 2.

Robustness of Quantitative Diffusion Metrics from Four Models: A Prospective Study on the Influence of Scan-Rescans, Voxel Size, Coils, and Observers.

Quantitative diffusion metrics provide additional microstructural information of diseases. The robustness of quantitative diffusion metrics should be established before clinical application. To evaluate the variability and reproducibility of quantitative diffusion MRI metrics. Prospective. 14 volunteers (7 men; median age, range, 28, 26-59 years). 3.0-T/Diffusion spectrum imaging. Brain MRI studies were performed four times per subject: involving different combinations of coil types and voxel sizes. Regions of interest of 13 brain anatomical sites were drawn by one observer twice and another observer once to allow interobserver and intraobserver reproducibility assessment. Twenty-five quantitative metrics were calculated using four diffusion models. The variability was evaluated with coefficients of variation (CV), and quartile coefficient of dispersion (QCD). The reproducibility was assessed with intraclass correlation coefficient (ICC), and concordance correlation coefficient (CCC). Wilcoxon signed rank test was used to compare the influence of factors on robustness of quantitative diffusion metrics. A two-tailed P < 0.05 was considered statistically significant. The variability of quantitative diffusion metrics showed CV of 2.4%-68.2%, and QCD of 0.6%-48.2%, respectively. The reproducibility of scans using 20-channel coils with voxels of 2 × 2 × 2 mm3 and 3 × 3 × 3 mm3 , respectively (ICC 0.03-0.84, CCC 0.03-0.84) was significantly worse than that of repeated scans using a 20-channel coil with a voxel size of 2 × 2 × 2 mm3 (ICC of 0.74-0.97, CCC 0.74-0.97) and that of scans using 20- and 64-channel coils, respectively, with a voxel size of 2 × 2 × 2 mm3 (ICC 0.59-0.95, CCC 0.59-0.95). The intraobserver reproducibility (ICC 0.49-0.94, CCC 0.49-0.94) was significantly better than the interobserver reproducibility (ICC 0.28-0.91, CCC 0.28-0.91). Our study indicated that the voxel size has a greater influence on the reproducibility of quantitative diffusion metrics than scan-rescans and coils. The reproducibility within one observer was higher than that between two observers. 2 TECHNICAL EFFICACY: Stage 1.

A comparison of 3-D CT and 2-D plain radiograph measurements of the wrist in extra-articular malunited fractures of the distal radius.

Two-dimensional (2-D) plain radiographs may be insufficient for the evaluation of distal radial malunion, as it is a three-dimensional (3-D) deformity. This study introduced a 3-D measuring method that outputs radial inclination, ulnar variance, palmar tilt and axial rotation. To this end, a standardized and clearly defined coordinate system was constructed that allowed 3-D measurements closely resembling the conventional 2-D method in 35 patients. Mean differences between 3-D and 2-D measurements in affected wrists were 1.8° for radial inclination, 0.8 mm for ulnar variance and 3.7° for palmar tilt. In addition, inter- and intra-observer reproducibility of all 3-D and 2-D measurements were good or excellent (intraclass correlation coefficient >0.75), with 3-D reproducibility always better than 2-D. Axial rotation was present in all patients with a mean of 7.9° (SD 6.9). Although the differences between 2-D and 3-D measurements were small, 3-D evaluation enables the assessment of axial rotation and brings us closer to a routine 3-D evaluation of malunion.Level of evidence: III.

Validation of an automated software (Smartpelvic™) in assessing hiatal area from three dimensional transperineal pelvic volumes of pregnant women: comparison with manual analysis.

The aim of this investigation was to evaluate the agreement between a manual and an automatic technique in assessing levator hiatus area (LHA) during pregnancy from three-dimensional (3D) pelvic floor volumes obtained by trans-perineal ultrasound (TPUS). 3D volumes were acquired during rest, maximum pelvic floor contraction and Valsalva maneuver from 66 pregnant women. Manual selection of LHA and automatic software (Smart Pelvic™) were applied on TPUS volume starting from a C-plane view. To evaluate intra- and inter-observer variability measurements of LHA were performed twice by the same operator and once by a second sonographer. Reference hiatal contours obtained manually by the first operator were compared with the automated ones. Reproducibility was evaluated by intraclass correlation coefficients (ICC) and Bland-Altman plots. LHA measurement, using automatic software, achieved excellent intra-observer and inter-observer reproducibility in pregnant women both at rest and after dynamic analysis (ICC>0.9). Further, an excellent agreement resulted between manual selection of the LHA and automatic imaging (ICC>0.9). The average time taken to obtain LHA manually was significantly longer when compared to the automatic analysis (p≤0.0001). Smart pelvic software resulted from a reliable method for automatically measuring the LHA, showing high reproducibility and accuracy.