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Background Immunocytochemical staining with p16/Ki67 has been suggested as a promising triage biomarker in cervical cancer screening. As dual staining is a subjective method, proper training may be required to ensure safe implementation in routine laboratories and reduce risk of misclassification. We determined concordance between novice evaluators and an expert, stratified by number of slides reviewed at three reading points. Methods The study was conducted at the Department of Pathology, Randers, Denmark. Women were eligible if they were aged ≥45, had been enrolled in one of two ongoing clinical studies, and had a dual stain slide available. Dual staining was performed using the CINtec plus assay. Slides were randomly selected from three reading points at which novice evaluators had reviewed, As training and experience in p16/Ki67 dual stain interpretation may affect concordance and possibly diagnostic accuracy of cervical precancer, it is important that future studies accurately describe any training and previous experience among evaluators to allow for a meaningful comparison of dual stain accuracy across studies. Furthermore, setting up proper dual stain training programs in routine screening laboratories is advisable to ensure sufficient interpretation skills among novice evaluators.

Although the prognostic significance of grade in endometrial cancer is well known, grade 2 cases have not been evaluated separately in most of the previous studies. In this study, we aim to investigate whether the oncologic outcomes of grade 2 endometrioid endometrial carcinomas trend towards grade 1 or 3 tumors. Patients' records and pathological reports were reviewed retrospectively and eligible patients with endometrioid endometrial carcinoma were determined and distributed into 3 groups according to their 1988 International Federation of Gynecology and Obstetrics (FIGO) grade. Groups' characteristics and oncologic outcomes were compared. Differences between grades were tested with z-test and adjusted by Bonferroni method. Kaplan-Meier method was performed for the survival analysis. In total, 776 patients of endometrioid endometrial carcinoma were included in this study. Mean follow-up time was 52 ± 14 months. Patients' mean age was 56.3 ± 10.8 years. Even though grade 2 endometrioid endometrial carcinomas were different from both grade 1 and 3 in terms of the pathological features, survival analyses demonstrated that their oncologic outcomes trended towards grade 1. The grade was determined as an independent prognostic factor for overall survival (OS). The interobserver reproducibility will be improved among pathologists by combining FIGO grade 1 and 2 endometrioid endometrial carcinomas, while prognosis prediction is not likely to be affected.

Purpose To compare the capabilities of intravoxel incoherent motion (IVIM) to those of monoexponential diffusion-weighted imaging for differentiating benign from malignant non-vascular, non-fatty soft tissue tumors (NVSFSTT). Material and methods A total of 64 patients with 64 histologically confirmed soft-tissue tumors were retrospectively included. There were 23 men and 41 women with a mean age of 52 ± 17 (SD) (range: 18–92 years). IVIM parameters, including molecular diffusion restriction coefficient (ADCtrue), perfusion fraction, and tissue perfusion related coefficient were compared to mean monoexponential ADC (ADCstd) values. Two readers calculated all parameters, which were compared to histopathological findings that were used as standard of reference. Results The overall performance of ADCtrue and ADCstd was similar for the benign-malignant differentiation of NFNVSTT with accuracies ranging from 73% to 75% for both readers (P = 0.3). Interobserver reproducibility was considered excellent for both ADCstd and all IVIM parameters (ICC = 0.81–0.96). When myxoid tumors were excluded from morphological analysis, an increase in sensitivity of 16–21% of ADCtrue was observed, with no changes in specificity values. The use of perfusion related IVIM parameters in association with ADCtrue did not improve tumor characterization. Conclusion The use of IVIM parameters does not improve the characterization of NVNFSTT by comparison with conventional monoexponential ADC calculation.

Purpose The proliferation marker Ki67 has prognostic and predictive values in breast cancer, and the cutoff of the Ki67 label index (LI) is a key index for chemotherapy. However, poor interobserver consistency in Ki67 assessment has limited the clinical use of Ki67, especially in luminal cancers. Here, we reported a modified Ki67 assessment method, size-set semiautomatic counting (SSSAC) and investigated its interobserver reproducibility. Methods One hundred invasive breast cancer tissues were set immunostained for Ki67 in one laboratory, scanned as digital slides, and sent to 41 pathologists at the laboratories of 16 hospitals for Ki67 LI assessment using size-set semiautomatic counting (SSSAC), size-set visual assessment (SSVA) and size-set digital image analysis (SSDIA) with a specific image viewing software (Aperio Image Scope, Leica, Germany). The intraclass correlation coefficient (ICC) and Bland-Altman plot were used to evaluate interobserver reproducibility. The Wilcoxon signed-rank test was used to analyze the difference in the Ki67 values assessed by SSSAC and SSDIA. Results SSSAC demonstrated better interobserver reproducibility (ICC = 0.942) than SSVA (ICC = 0.802). The interobserver reproducibility was better in Ki67 homogeneously stained slides and centralized hot-spot slides than in scattered hot-spot slides. The Ki67 value assessed with SSSAC was obviously higher than that assessed with SSDIA (negative ranks (SSDIA SSSAC): N = 17, sum of ranks = 478.50; Z = −6.837; P, Highlights • A modified method for Ki67 LI assessment based on digital image, size-set semiautomatic counting (SSSAC). • Investigated the interobserver reproducibility of SSSAC for Ki67 LI assessment of 100 cases in 41 pathologists of 16 hospitals. • SSSAC has better interobserver reproducibility than current visual assessment and was more accurate than DIA in Ki67 assessment. • SSSAC is a better choice for Ki67 LI assessment.

Background: A number of guidelines have been developed to improve standardization of the terminology and criteria for cytologic specimens obtained from the thyroid, pancreas, lung, and salivary glands. A major goal of these guidelines is to improve reproducibility and understanding of the reporting of diagnostic results among cytopathologists and between cytopathologists and clinicians. The International Academy of Cytology Yokohama System for Reporting Breast Fine-Needle Aspiration Biopsy Cytopathology (IAC YSRB) is the most recent of these guidelines. The value of this system is, in part, dependent upon interobserver reproducibility. Design: Ninety consecutive fine-needle aspiration biopsies (FNAB) of the breast, performed over a 6-year period, were independently evaluated by 4 board-certified pathologists blinded to the original diagnoses. The 5 diagnostic categories used were those of the IAC YSRB according to published criteria for these categories. Observed agreement and chance corrected agreement (Fliess κ) were calculated. Differences in κ values were evaluated using the T statistic of Gwent. Statistical calculations were performed using STATA v16.0 (STATA Corp., College Station, TX, USA). Results: Overall agreement between observers was good. Observed unweighted agreement was 69% and weighted agreement was 91%. The majority of diagnoses were concordant (68.6%). Conclusions: Interobserver agreement of 4 cytopathologists was good using the 5 categories of the IAC YRSB (69%). Agreement was greater among pathologists with more years of experience. The IAC YSRB system appears to provide greater agreement among viewers than guidelines for cytologic specimens obtained from some other body sites (salivary gland and lung). Most discrepancies were only by a single category, with only 22/113 (19%) differing by more than one category.

Distinguishing between low-grade squamous intraepithelial lesions (LSIL) and high-grade squamous intraepithelial lesions (HSIL) can be difficult on certain Papanicolaou (Pap) tests, hindering interobserver concordance. We investigated the variables influencing the interpretation of LSIL versus HSIL in Pap test slides rejected from the College of American Pathologists PAP education program.Eleven cytologists, who were unaware of the reference interpretation, examined 21 Pap slides (11 submitted as LSIL and 10 as HSIL) rejected from the PAP education program and recorded the number of LSIL cells, HSIL cells, keratinized dysplastic cells, LSIL clusters with mixed HSIL cells, atypical squamous metaplasia, atypical glandular cells, the presence of inflammation or infectious organisms, and the overall interpretation (LSIL or HSIL). We evaluated the significance of these 11 variables using a nonlinear mixed model analysis.LSIL had greater concordance (92 of 121 responses; 76.0% concordance) than HSIL (68 of 110 responses; 61.8% concordance; P0.001). The only predictors of misclassified cases were the number of atypical squamous metaplastic cells and the number of HSIL cells (P0.001). The more of these cells identified, the more likely the reviewers were to classify the slide as HSIL. The reproducibility of the diagnosis was fair (Gwet's agreement coefficient, 0.33).Interobserver reproducibility is a challenge for a subset of cases with features intermediate between LSIL and HSIL. Atypical squamous metaplasia and dysplastic nuclei with a nuclear/cytoplasmic ratio greater than one half of the cell volume (HSIL) present on a Pap test influenced the likelihood that a reviewer would interpret the case as HSIL rather than LSIL.

ObjectivesWe aimed to determine the interobserver reproducibility in diagnosing low-grade ductal carcinoma in situ (DCIS). We also aimed to compare the interobserver variability using a proposed two-tiered grading system as opposed to the current three-tiered system.MethodsThree expert breast pathologists and one junior pathologist identified low-grade DCIS from a set of 300 DCIS slides. Months later, participants were asked to grade the 300 cases using the standard three-tiered system.ResultsUsing the two-tiered system, interobserver agreement among breast pathologists was considered moderate (κ = 0.575). The agreement was similar (κ = 0.532) with the junior pathologist included. Using the three-tiered system, pathologists’ agreement was poor (κ = 0.235).ConclusionsPathologists’ reproducibility on diagnosing low-grade DCIS showed moderate agreement. Experience does not seem to influence reproducibility. Our proposed two-tiered system of low vs nonlow grade, where the intermediate grade is grouped in the nonlow category has shown improved concordance.

OBJECTIVE. The objective of our study was to investigate the potentials of enhanced dual-source dual-energy CT (DECT) and three-planar measurements for differentiating invasive pulmonary adenocarcinomas (IPAs) from preinvasive lesions appearing as pure ground-glass nodules (pGGNs). MATERIALS AND METHODS. Thirty-nine patients with 53 pGGNs who underwent enhanced dual-source DECT were included in this retrospective study. All pGGNs were pathologically confirmed and categorized into two groups: preinvasive lesions or IPAs. The traditional CT features of the pGGNs were evaluated on unenhanced images. Quantitative parameters were measured on iodine-enhanced images of dual-source DECT in three planes, and both intra- and interobserver reproducibility analyses were performed to assess the measurement reproducibility of quantitative parameters. To identify significant factors for differentiating IPAs from preinvasive lesions, we performed logistic regression analysis and ROC curve analysis. RESULTS. For traditional CT features, only lesion size and unenhanced CT attenuation value showed significant differences between preinvasive lesions and IPAs (p < 0.05). Preinvasive lesions and IPAs exhibited significant differences in attenuation on virtual images, so-called "virtual HU" or "VHU," and the modified normalized iodine concentration (NIC) (p < 0.05), and both intra- and interobserver agreement for the quantitative measurements were excellent. Multivariate logistic regression analysis revealed that larger lesion size (adjusted odds ratio [OR], 3.65) and higher modified NIC (adjusted OR, 19.01) were significant differentiators of IPAs from preinvasive lesions (p < 0.05). ROC curve analysis revealed that modified NIC showed excellent performance (AUC, 0.924) and significantly higher performance than lesion size (AUC, 0.711) for differentiating IPAs from preinvasive lesions. CONCLUSION. In pGGNs, a lesion with a modified NIC value of more than 0.29 can be a very specific discriminator of IPAs from preinvasive lesions, and IPAs can be accurately and reliably differentiated from preinvasive lesions using enhanced dual-source DECT and three-planar measurements.

Aims: The nuclear proliferation marker Ki67 assayed by immunohistochemistry has multiple potential uses in breast cancer, but an unacceptable level of interlaboratory variability has hampered its clinical utility. The International Ki67 in Breast Cancer Working Group has undertaken a systematic programme to determine whether Ki67 measurement can be analytically validated and standardised among laboratories. This study addresses whether acceptable scoring reproducibility can be achieved on excision whole sections. Methods and results: Adjacent sections from 30 primary ER+ breast cancers were centrally stained for Ki67 and sections were circulated among 23 pathologists in 12 countries. All pathologists scored Ki67 by two methods: (i) global: four fields of 100 tumour cells each were selected to reflect observed heterogeneity in nuclear staining; (ii) hot-spot: the field with highest apparent Ki67 index was selected and up to 500 cells scored. The intraclass correlation coefficient (ICC) for the global method [confidence interval (CI) = 0.87; 95% CI = 0.799–0.93] marginally met the prespecified success criterion (lower 95% CI ≥ 0.8), while the ICC for the hot-spot method (0.83; 95% CI = 0.74–0.90) did not. Visually, interobserver concordance in location of selected hot-spots varies between cases. The median times for scoring were 9 and 6 min for global and hot-spot methods, respectively. Conclusions: The global scoring method demonstrates adequate reproducibility to warrant next steps towards evaluation for technical and clinical validity in appropriate cohorts of cases. The time taken for scoring by either method is practical using counting software we are making publicly available. Establishment of external quality assessment schemes is likely to improve the reproducibility between laboratories further.

Background Magnetic resonance enterography (MRE) is increasingly attractive as a noninvasive and radiation-free tool for assessing Crohn's disease (CD). Diffusion-weighted imaging (DWI) is recommended as an optional MRE sequence for CD by the European Society of Gastrointestinal and Abdominal Radiology, and has shown a superb potential as a quantitative modality for bowel inflammation evaluation. However, the measurement reproducibility of quantitative DWI analysis in MRE has not been ascertained so far. To facilitate the application of quantitative diffusion-weighted MRE in the clinical routine, systematic investigations of the intra and interobserver reproducibility of DWI quantitative parameters should be performed. Aim To evaluate the intra and interobserver reproducibility of quantitative analysis for diffusion-weighted MRE (DW-MRE) in ileal CD. Methods Forty-four subjects (21 with CD and 23 control subjects) who underwent ileocolonoscopy and DW-MRE (b = 800 s/mm2) within one week were included. Two radiologists independently measured apparent diffusion coefficients (ADC) of the terminal ileum and signal intensity ratio (SR) of the terminal ileum to ipsilateral psoas muscle on DWI images (b = 800 s/mm2). Between- and within-reader agreements were assessed using intraclass correlation coefficients (ICC), coefficients of variation (CoV), and 95% limits of agreement of Bland-Altman plots (BA-LA LoA). Diagnostic performances of ADC and SR for identifying inflamed terminal ileum from the normal were evaluated by receiver operating characteristic (ROC) curve analysis. Results There were no significant differences in ADC or SR values between the two sessions or between the two radiologists either in the CD or control group (paired t-test, P > 0.05). The intra and interobserver reproducibility of ADC (ICC: 0.952-0.984; CoV: 3.73-6.28%; BA-LA LoA: ±11.27% to ±15.88%) and SR (ICC: 0.969-0.989; CoV: 3.51%-4.64%; BA-LA LoA: ±10.62% to ±15.45%) was excellent for CD. Agreement of ADC measurements was slightly less in control subjects (ICC: 0.641-0.736; CoV: 10.47%-11.43%; BA-LA LoA: ± 26.59% to ± 30.83%). SR of normal terminal ileum demonstrated high intra and interobserver reproducibility (ICC: 0.944-0.974; CoV: 3.73%-6.28%; BA-LA LoA: ± 18.58% to ± 24.43%). ADC and SR of two readers had outstanding diagnostic efficiencies (area under the ROC curve: 0.923-0.988). Conclusion Quantitative parameters derived from DW-MRE have good to excellent intra and interobserver agreements with high diagnostic accuracy, and can serve as robust and efficient quantitative biomarkers for CD evaluation.

PURPOSE: In-vivo quantification of tumor uptake of 89-zirconium (89Zr)-labelled monoclonal antibodies (mAbs) with PET provides a potential tool in strategies to optimize tumor targeting and therapeutic efficacy. A specific challenge for 89Zr-immuno-PET is low tumor contrast. This is expected to result in interobserver variation in tumor delineation. Therefore, the aim of this study was to determine interobserver reproducibility of tumor uptake measures by tumor delineation on 89Zr-immuno-PET scans.METHODS: Data were obtained from previously published clinical studies performed with 89Zr-rituximab, 89Zr-cetuximab and 89Zr-trastuzumab. Tumor lesions on 89Zr-immuno-PET were identified as focal uptake exceeding local background by a nuclear medicine physician. Three observers independently manually delineated volumes of interest (VOI). Maximum, peak and mean standardized uptake values (SUVmax, SUVpeak and SUVmean) were used to quantify tumor uptake. Interobserver variability was expressed as the coefficient of variation (CoV). The performance of semi-automatic VOI delineation using 50% of background-corrected ACpeak was described.RESULTS: In total, 103 VOI were delineated (3-6 days post injection (D3-D6)). Tumor uptake (median, interquartile range) was 9.2 (5.2-12.6), 6.9 (4.0-9.6) and 5.5 (3.3-7.8) for SUVmax, SUVpeak and SUVmean. Interobserver variability was 0% (0-12), 0% (0-2) and 7% (5-14), respectively (n = 103). The success rate of the semi-automatic method was 45%. Inclusion of background was the main reason for failure of semi-automatic VOI.CONCLUSIONS: This study shows that interobserver reproducibility of tumor uptake quantification on 89Zr-immuno-PET was excellent for SUVmax and SUVpeak using a standardized manual procedure for tumor segmentation. Semi-automatic delineation was not robust due to limited tumor contrast.

Purpose The purpose of this study was to measure the maximal width, middle width, and length of the cavum septi pellucidi (CSP) in normal fetuses, and compare these measurements obtained in the transthalamic (TT) plane with those obtained in the transventricular (TV) plane. Method A prospective study was conducted of normal singleton fetuses, ranging from 18 to 36 weeks in gestational age. In each case, a three-dimensional volume of the fetal head was obtained in the TT plane for further offline measurements, then the maximal width, middle width, and length of the CSP in both the TT and TV planes were measured. Intraobserver and interobserver reproducibility was assessed, and curve estimation was used to assess the possible relationship between these measurements of CSP and gestational age (GA). Results A total of 267 normal fetuses were studied. The CSP width and length in TT and TV planes as a function of GA were analyzed using a quadratic regression model. Intraobserver and interobserver agreement of the CSP measurements was excellent overall (ICCs >0.9), with intraobserver and interobserver differences of less than 4%. Conclusion Measurements of CSP in the TT and TV planes are equally reproducible.

INTRODUCTION The epinephrine challenge has been proposed to improve the diagnosis of congenital long QT syndrome (LQTS). The aim of the study was to evaluate the diagnostic reliability of the epinephrine provocative test for LQTS diagnosis, taking into consideration intra- and interobserver variability in the interpretation of the test. METHODS AND RESULTS A retrospective analysis of 79 consecutive epinephrine provocative tests was conducted. Epinephrine was administered following a standardized protocol at two doses: 0.05 and 0.10 µg kg-1 min-1 . Electrocardiograms were blindly read twice by three different operators at ≥1-week interval. QT and RR intervals were collected at rest and at each dose, as well as final operator interpretation of the test. There was a high interobserver reproducibility of corrected QT measurements with an intraclass correlation (ICC) of 0.74 (95% confidence interval, 0.66-0.80) but a low interobserver reproducibility on the final interpretation with a κ of 0.31. Intraobserver reproducibility of corrected QT was very good (ICC 0.93; 0.91-0.95), but still resulted in an only moderate intraobserver reproducibility in the final diagnosis (κ of 0.47). Perceived certainty of at least 1 reading by 2 operators (N = 62 tests) increased interobserver reproducibility compared with baseline (κ = 0.43). CONCLUSION Inter- and intraobserver agreement in the interpretation of the epinephrine provocation test for LQTS is poor to modest. Complexity in interpretation varies from one case to the next. The low reliability of this test encourages a reconsideration of its importance in the clinical management of patients with suspected LQTS.

The current World Health Organization (WHO) classification for endocervical adenocarcinoma (EA) is based on descriptive morphologic characteristics; however, it does not fully reflect our current knowledge of the diverse pathogenesis of cervical glandular neoplasia. A novel classification system, the International Endocervical Adenocarcinoma Criteria and Classification (IECC), which incorporates etiology and biological behavior into the morphologic scheme, has been recently proposed. We aimed to validate the IECC by assessing its interobserver reproducibility in comparison to the WHO system. A cohort of 75 EAs was reviewed independently by 7 gynecologic pathologists and categorized following IECC and WHO criteria based on hematoxylin and eosin material alone and after immunohistochemistry results for p16, PR, p53, Napsin-A, vimentin, CDX2, and GATA3 were provided. Human papillomavirus (HPV) in situ hybridization and polymerase chain reaction results were compared with consensus diagnoses. IECC was superior to WHO in terms of interobserver agreement with κ=0.46 versus 0.3, respectively, on hematoxylin and eosin review and κ=0.51 versus 0.33, respectively, with immunohistochemistry. Under the IECC, 73 (97%) of EAs had majority agreement (≥4 reviewers in agreement) whereas 42 (56%) had perfect agreement (7/7 reviewers in agreement). Conversely, WHO showed majority agreement in 56 (75%) and perfect agreement in only 7 (10%) EAs. Reproducibility was poor in HPV-related WHO types (usual κ=0.36, mucinous not otherwise specified κ=0.13, intestinal κ=0.31, villoglandular κ=0.21) and good in major HPV-unrelated categories (gastric type κ=0.63, clear cell κ=0.81, mesonephric κ=0.5). Classification as per the IECC had excellent correlation with HPV status (by RNA in situ hybridization or polymerase chain reaction). We have shown that the IECC has superior interobserver agreement compared with the WHO classification system, and that distinction between HPV-related and HPV-unrelated EA can be made with good reproducibility and excellent prediction of HPV status. WHO morphologic variants of HPV-related EA are poorly reproducible. Conversely, agreement is high among important high-risk HPV-unrelated subtypes. Thus, our results further support replacing the current WHO classification with the IECC.

Background: Active surveillance is recommended as an alternative to immediate surgery for low-risk papillary thyroid microcarcinoma (PTMC), and determining meaningful changes in diameter and volume...

To evaluate the reproducibility of ultrasound cervical length (CL) measurement at the second trimester.A set of 565 cervical ultrasound images were collected at 19 + 0-24 + 6 weeks' gestation. Two senior maternal-fetal specialists measured CL in each image on three occasions 2 weeks apart. In the interval between the first and following two measures, the clinicians reviewed 20 images together to agree on the criteria for measurement. Measurements were analyzed for intra- and inter-observer disagreement. The robustness of patient classification when CL measure was used with different cutoff thresholds was analyzed.Average intra-observer deviation was 2.8 mm for clinician 1 and 3.7 mm for clinician 2. Inter-observer deviation among the two clinicians was 5.2 and 3.2 mm before and after reviewing measurement criteria together. When cutoffs were used to classify as "short" cervix, disagreement ranged from 22 to 70% depending on operator and threshold used.Ultrasound CL measurements by experts showed moderate intra- and inter-observer reproducibility. The use of specific cutoffs to classify patients as high or low risk resulted in wide disagreements. The results stress the importance of training and quality assessments on considering universal screening application of CL measurement.

International audience; INTRO:Evidence of breath after birth is one of the main forensic issues in suspected neonaticide. Hydrostatic test (HT) and pathological examination are currently used to assess it, but they are not entirely reliable or immediately available.OBJECTIVE:To determine the performance of postmortem computed tomography (PMCT) to assess neonatal breath in suspected neonaticide, by comparing lung CT attenuation values between live birth and stillbirth cases, in correlation with HT and pathology.METHOD:Cases of suspected neonaticides who underwent a PMCT and complete forensic autopsy with an HT were retrospectively selected from the databases of four French Forensic Medicine Departments. The diagnosis of vitality (i.e., stillbirth or live birth) was based on the pathological examination and/or a combination of arguments, including HT result. Lung density on CT was measured in Hounsfield units (HU) by ROIs drawn in both pulmonary parenchymas.RESULTS:Eleven patients were included, six live birth and five stillbirth cases. The result of HT was concordant with pathological examination when available (seven cases). Mean lung densities in live birth cases (- 173 HU [- 255; - 91 CI 95%]) were significantly lower than in stillbirth cases (40 HU [28; 52 CI 95%]) (p

Background There is a growing need for a reproducible and effective imaging method for the quantitative differentiation of benign from malignant thyroid nodules. This study aimed to investigate the performances of intravoxel incoherent motion (IVIM) parameters and the apparent diffusion coefficient (ADC) in differentiating malignant from benign thyroid nodules derived from the most repeatable region of interest (ROI) delineation. Methods Forty-three patients with 46 pathologically confirmed thyroid nodules underwent diffusion-weighted imaging (DWI) with 8 b values. Two observers measured the intravoxel incoherent motion (IVIM) parameters (D, f and D*) and the apparent diffusion coefficient (ADC), ADC600 and ADC990 values using whole-lesion (W-L) ROI and IVIM parameters using single-section (S-S) ROI delineation. The intraclass correlation coefficients (ICCs) and Bland-Altman plots were used to evaluate the intra- and interobserver variability. The diagnostic performance of these parameters was evaluated by generating receiver operating characteristic (ROC) curves. Results The ICC values of all IVIM with W-L ROI delineation were higher than those with S-S ROI delineation, and excellent intra- and interobserver reproducibility was obtained. According to the Bland-Altman plots, the 95% limits of agreement of the IVIM parameters determined by the W-L ROIs revealed smaller absolute intra- and interobserver variability than those determined by S-S ROIs. The D and ADC600 values obtained from the W-L ROIs were the most powerful parameters in differentiating benign from the malignant nodules [area under the ROC curve = 0.962 and 0.970, P = 0.771]. Conclusions The W-L ROI of the thyroid was considered an effective method for obtaining IVIM measurements with excellent reproducibility for differentiating benign from malignant nodules.

Objective Because of the indolent nature of noninvasive follicular thyroid neoplasm with papillary-like nuclear features (NIFTP) and potential requisite for a more conservative treatment, it is crucial to identify features of this entity preoperatively. Our group recently published findings that there are several cytomorphological features that may be used as clues to distinguish NIFTP, papillary thyroid carcinoma (PTC) and follicular adenoma (FA) on fine needle aspiration. Therefore, we aimed to determine the interobserver reproducibility of these findings. Methods Presurgical fine-needle aspiration slides from NIFTP (n = 30), classic PTC (n = 30) and FA (n = 30) collected from 1/2013-8/2016 were reviewed by seven cytopathologists blindly. Presence of selected cytomorphological features was recorded and compared to determine percent agreement and inter-rater reliability among study cytopathologists using Gwet's AC1 statistics. Results For all the cytomorphological features, the overall percent agreement amongst the pathologists ranged between 65.1% and 86.8% (Gwet's AC1 0.30-0.80). There was substantial or almost perfect agreement (Gwet's AC1 > 0.60) in seven cytomorphological features in the classic PTC group, in six features in the NIFTP group and in five features in the FA group. There were no features with poor agreement (Gwet's AC1 Conclusions The current study supports the reproducibility of our previous findings. The high level of agreement amongst pathologists for these groups, and particularly the NIFTP group, supports the notion that when viewed in combination as a cytological profile, these cytomorphological features may assist the cytopathologist in raising the possibility of NIFTP preoperatively. This can potentially aid clinicians in deciding whether more conservative treatment may be appropriate.

BACKGROUND To demonstrate whether the distance between the middle point of the patellar tendon and posterior cruciate ligament (PT-PCL) calculated on a single axial MR image could be an alternative measure to tibial tubercle-PCL (TT-PCL) distance for TT lateralization without the need of imaging processing. To show that normalization of PT-PCL (nPT-PCL) against the maximum diameter of the tibial plateau may help to identify patients with patellar instability (PI). METHODS MR scans of 30 patients (13 females, age 32 ± 13 years) with known PI and 60 patients (31 females, age 39 ± 19 years) with no history of PI were reviewed. Two operators calculated TT-PCL, and PT-PCL nPT-PCL. Intraclass correlation coefficient, Student's t-test, Receiver Operator Characteristic curves, Spearman's Rho and McNemar's test were used. RESULTS Interobserver reproducibility was 0.894 for PT-PCL for TT-PCL (95% CI = 0.839-0.930) and 0.866 for TT-PCL (95% CI = 0.796-0.912). The PT-PCL was 23.5 ± 3.8 mm in patients and 20.0 ± 2.7 mm in controls (P

Purpose To follow the evolution of intracranial hemorrhage (ICH) by using quantitative susceptibility mapping (QSM). Materials and Methods Thirty-six patients with ICH confirmed at CT were enrolled to follow ICH evolution on day 2, 7, and 30 after symptom onset between August 2013 and April 2017. QSM was reconstructed from MRI gradient-echo phase images acquired at 1.5 T or 3.0 T. ICH regions were manually drawn on two-dimensional sections of co-registered CT and MR images independently by two raters. The ICH areas and mean values were compared between CT and MRI by using Bland-Altman plots and Pearson correlation. QSM time evolution of ICH was assessed by using paired t tests and was compared with conventional T2-weighted fluid-attenuated inversion recovery, or T1-weighted or T2*-weighted magnitude intensities. Results Significant reductions in ICH susceptibility were found between day 2 and day 7 (P < .001) and between day 7 and day 30 (P = .003), corresponding to different disease stages. The ICH areas measured at CT and QSM were linearly correlated (r2 = 0.98). The mean CT attenuation and mean susceptibility of ICH were linearly correlated (r2 = 0.29). Excellent intra- and interobserver reproducibility were found for QSM (intraclass correlation coefficient, 0.987 and 0.966, respectively). Conclusion Longitudinal evolution of intracranial hemorrhage (ICH) by using quantitative susceptibility mapping (QSM) demonstrated susceptibility differences in different disease stages, which was not found at conventional MRI; therefore, QSM may assist in quantitatively following ICH iron content.

INTRODUCTION Mitral regurgitation severity assessment is usually carried out using qualitative, semiquantitative, and quantitative parameters. The mitral valve navigation (MVN) tool allows to measure the mitral effective regurgitant orifice (MERO) from 3D echo datasets. Our aim was to validate the MVN as a new tool to quantify MERO. A secondary aim was to assess the intra- and interobserver variability. METHODS This is a retrospective study in which consecutive subjects undergoing a transoesophageal echocardiogram for more than mild mitral regurgitation evaluation were included. MERO measurement obtained by means of 3D color Doppler was used as the gold standard method for comparison. In every patient, MERO was also obtained using the MVN tool. RESULTS Fifty-nine consecutive patients were analyzed (47.5% female; mean age 50.8 years). Mitral regurgitation was moderate in 23 (39%) and severe in 36 (61%) patients. Forty patients (67.8%) had a primary and 19 (32.2%) a secondary mitral regurgitation. The intraclass correlation coefficient (ICC) between 3D color Doppler and MVN was excellent (ICC: 0.95; 95% CI: 0.82 to 0.98; P

Objective To analyze the observer reproducibility of breast strain elastography in elasticity image acquisition and elasticity image interpretation. Methods This was an institutional ethics committee approved prospective study. One hundred twenty-four breast lesions in 118 women (mean age 45.39 ± 12.97 years old, range 21–77 years old) were examined with strain elastography by two blinded radiologists in turn. Three blinded observers separately reviewed and recorded the elasticity score of each lesion obtained by the two performers. The interobserver reproducibility of elasticity image acquisition between the two performers, the interobserver and intraobserver reproducibility of elasticity image interpretation among observers were evaluated. The diagnostic performance of strain elastography was compared between the two performers. Results Fifty-three lesions were malignant and 71 were benign. The interobserver kappa value was 0.438 for the elasticity score between the two performers. Between the three observers, the overall interobserver and intraobserver kappa value was 0.365 and 0.655, respectively. There was no significant difference of the area under the receiver operator characteristic curve (Az) value for the elasticity score between performer 1 and 2 (P = 0.143). Conclusions Our results suggested moderate interobserver reproducibility in breast strain elasticity image acquisition, poor interobserver and good intraobserver agreement in image interpretation.

To assess the repeatability and reproducibility of AL-Scan in agreement with those by the IOLMaster in healthy children, two skilled operators measured ocular parameters in 58 children. The parameters included keratometry (K) values, anterior chamber depth (ACD), axial length (AL), central corneal thickness (CCT), pupil diameter (PD), and corneal diameter (CD). The cohort comprised of 32 boys and 26 girls. The AL-Scan measurements showed high repeatability, as the test-retest repeatability (TRT) values of AL, CCT, ACD, Kf, Ks, Km, CD, and PD were 0.09 mm, 5.1 μm, 0.04 mm, 0.28 D, 0.24 D, 0.21 D, 0.39 mm, and 0.22 mm, respectively. The within-subject coefficient of variation (CoV) was low (0.85. The interobserver reproducibility was excellent with low values of TRT and ICC > 0.95. The CoV of AL, CCT, ACD, and K was

To evaluate several anterior chamber parameters in healthy young adults using spectral-domain optical coherence tomography and to describe the repeatability and reproducibility of this method. Prospective clinical study. Fifty-two eyes of 52 healthy volunteers were enrolled. Manual measurements of the anterior chamber angle (ACA500 and ACA750), angle opening distance (AOD500 and AOD750), angle-to-angle distance (ATA), anterior chamber width (ACW), and lens vault (LV) were obtained. The mean nasal ACA500 was 44.87 ± 12.92°; ACA750, 43.94 ± 10.41°; AOD500, 672.54 ± 270.19 µm; AOD750, 881.87 ± 290.55 µm. The mean temporal ACA500 was 41.46 ± 11.20°; ACA750, 41.27 ± 11.31°; AOD500, 603.15 ± 232.28 µm; AOD750, 823.46 ± 308.76 µm. The differences between the corresponding nasal and temporal parameters were statistically significant. The ACW was 11.97 ± 0.42 mm, the ATA was 12.10 ± 0.43 mm, and the LV was 3.71 ± 232.93 µm. The ACA was highly associated with the LV. The intraclass correlation coefficients ranged from 0.984 to 0.999 for the intraobserver repeatability and from 0.966 to 0.998 for the interobserver reproducibility. This study assessed anterior chamber parameters in healthy young adults using spectral-domain optical coherence tomography. This technique reveals the spatial relationships of the ocular structures, provides high-resolution images, and results in high degrees of intraobserver and interobserver repeatabilities.

OBJECTIVE. The objective of this study was to assess the feasibility of T2 relaxation time measurements of the sacroiliac joints. SUBJECTS AND METHODS. The sacroiliac joints of 40 patients were imaged by 3-T MRI using an oblique axial multislice multiecho spin-echo T2-weighted sequence. Manual plotting and automatic subdivision of ROIs allowed us to obtain T2 values for up to 48 different areas per patient (posterior and anterior parts, sacral, intermediate, and iliac parts). Intraand interobserver reproducibility of T2 values were calculated after independent assessment by two musculoskeletal radiologists. RESULTS. A total of 1656 measurement sites could be analyzed. Mean (± SD) T2 values were 40.6 ± 6.7 ms and 41.2 ± 6.3 ms for observer 1 and 39.9 ± 6.6 ms for observer 2. The intraobserver intraclass correlation coefficient was 0.72 (95% CI, 0.70–0.74), and the interobserver intraclass correlation coefficient was 0.71 (95% CI, 0.68–0.72). CONCLUSION. Our study shows the feasibility of T2 relaxation time...

Distinguishing hyalinized stroma from osteoid production by a heterologous osteosarcomatous component can be challenging in gynecologic tract carcinosarcomas. As heterologous components in a carcinosarcoma may have prognostic and therapeutic implications, it is important that these are recognized. This study examines interobserver reproducibility among gynecologic pathologists in the diagnosis of osteosarcomatous components, and its correlation with expression of the novel antibody SATB2 (marker of osteoblastic differentiation) in these osteosarcomatous foci. Digital HE images from 20 gynecologic tract carcinosarcomas were reviewed by 22 gynecologic pathologists with a request to determine the presence or absence of an osteosarcomatous component. The 20 preselected cases included areas of classic heterologous osteosarcoma (malignant cells producing osteoid; n=10) and osteosarcoma mimics (malignant cells with admixed nonosteoid matrix; n=10). Interobserver agreement was evaluated and SATB2 scored on all 20 cases and compared with the original diagnoses. Moderate agreement (Fleiss' κ=0.483) was identified for the 22 raters scoring the 20 cases with a median sensitivity of 7/10 and a median specificity of 9/10 for the diagnosis of osteosarcoma. SATB2 showed 100% sensitivity (10/10) and 60% (6/10) specificity in discriminating classic osteosarcoma from osteosarcoma mimics. Utilizing negative SATB2 as a surrogate marker to exclude osteosarcoma, 73% (16/22) of the reviewers would have downgraded at least 1 case to not contain an osteosarcomatous component (range, 1-6 cases, median 1 case). Gynecologic pathologists demonstrate only a moderate level of agreement in the diagnosis of heterologous osteosarcoma based on morphologic grounds. In such instances, a negative SATB2 staining may assist in increasing accuracy in the diagnosis of an osteosarcomatous component.

Aim To evaluate the intraobserver and interobserver reproducibility of the HER2 in-situ hybridization (ISH) test in breast cancer by measuring the impact of counting different numbers of invasive cancer cells. Methods and results A cohort of 101 primary invasive breast cancer cases were evaluated for HER2 gene amplification by silver ISH, and the concordance among four observers with different levels of experience, counting different numbers of invasive cancer cells, was determined. The evaluation of the samples included scoring 20 nuclei, in three different areas. The cases were scored twice, with a washout interval of at least 2 weeks. We observed an increase in the intraobserver concordance rate between the first and second evaluations with an increase in cell count. A count of 60 invasive cells was needed to obtain a concordance rate near 95% and an agreement rate greater than 0.80 by all observers. The interobserver concordance rate of the HER2 test also increased with the increase in cell count, reaching at least a 90% concordance rate with a count of 60 invasive cells. The median variability of both the HER2/CEP17 ratio and the average HER2 copy number between different evaluations decreased with the increase in cell count, being statistically higher in HER2-positive cases. Conclusions The minimal cell number recommended in current guidelines should be raised to at least 40, and preferably 60, invasive cells. Moreover, cases with amplification levels close to the threshold should be subjected to a dual count from an experienced observer.

Objective The aim of this study was to estimate interobserver reproducibility of Tc-99m mercaptoacetyltriglycine renography in children and adults by assessing the parameters of the International Atomic Energy Agency (IAEA) software for the analysis of dynamic renal studies. Methods The renograms of 65 children and 65 adults covered a wide age range, different quality of drainage, overall function and differential renal function (DRF). Three observers were processing parameters of the IAEA software. Normalized residual activity at 20 min (NORA20), NORA on the postmicturition acquisition (NORApm), PM to maximum renal count ratio (PM/max), output efficiency at 20 min (OE20), OE 20 min after diuretic stimulation (OEF + 20), whole kidney mean transit time (MTT) and DRF by integral and Rutland-Patlak were calculated by observers. Results The overall agreement between three observers was almost perfect [the average intraclass correlation coefficient (ICC) above 0.99] in children and adults, with no significant difference between the parameters of renal drainage, transit and DRF. ICCs for all parameters were higher than 0.980 in children under 12 months, even slightly greater for PM/max and OEF+20. In children with poor/incomplete drainage and DRF below 40%, ICCs were above 0.98. In the subgroup of adults with impaired overall tubular extraction rate, level of reproducibility was almost perfect. Slightly lower but still insignificant values of ICC were presented in adults with poor/incomplete drainage. Conclusion Our results indicate an excellent interobserver reproducibility for all quantitative parameters of IAEA software in both pediatric and adult patients.

PURPOSE: We aimed to compare the size-specific dose estimates (SSDE), computed tomography (CT) dose indices and image quality parameters of the chest CTs obtained with fast kilovoltage-switching (FKS) dual-energy (DE) CT versus those with single-energy (SE) CT. METHODS: Patients who had chest SECT within the last 6 months were prospectively scanned with chest FKS-DECT. Quantitative comparison was made by calculating the mean SSDE, CTDI(vol), contrast, noise, contrast-to-noise ratio (CNR), and signal-to-noise ratio (SNR) for both acquisitions. Two radiologists evaluated the chest SECT and DECT images qualitatively blinded to the technique used. The paired Student’s t test was utilized for comparing the quantitative and qualitative data. Inter- and intraobserver agreement were also assessed. RESULTS: A total of 42 patients were included. The mean SSDE, CTDI(vol), contrast, noise, CNR, and SNR for SECT versus DECT were 12.7±2.2 mGy vs. 9.3±1.2 mGy (P = 0.001), 10.9±2.4 mGy vs. 8±1.2 mGy (P < 0.001), 211.9±44.7 vs. 216.3±59 (P = 0.350), 12.9±2.4 vs. 13.9±3.7 (P = 0.086), 13.5±5.2 vs. 13.3±8.4 (P = 0.548) and 12±3.5 vs. 11.5±3.4 (P = 0.774), respectively. Interobserver reproducibility was high for contrast, noise, CNR, and SNR (ICC = 0.89, 0.85, 0.93, and 0.82, respectively; all P < 0.05). Intraobserver reproducibility was high for contrast, noise, CNR, and SNR (ICC = 0.80, 0.77, 0.85, and 0.88, respectively; all P < 0.05). CONCLUSION: The mean SSDE of the chest CTs obtained with FKS-DECT were 26.8% lower than those with SECT with significant difference for the objective assessment and there was no significant difference for the subjective assessment of the image qualities, in this series.

OBJECTIVES: To compare the performance of ultrasound measurements and subjective ultrasound assessment (SA) in detecting deep myometrial invasion (MI) and cervical stromal invasion (CSI) in women with endometrial cancer, overall and according to whether they had low- or high-grade disease separately, and to validate published measurement cut-offs and prediction models to identify MI, CSI and high-risk disease (Grade-3 endometrioid or non-endometrioid cancer and/or deep MI and/or CSI). METHODS: The study comprised 1538 patients with endometrial cancer from the International Endometrial Tumor Analysis (IETA)-4 prospective multicenter study, who underwent standardized expert transvaginal ultrasound examination. SA and ultrasound measurements were used to predict deep MI and CSI. We assessed the diagnostic accuracy of the tumor/uterine anteroposterior (AP) diameter ratio for detecting deep MI and that of the distance from the lower margin of the tumor to the outer cervical os (Dist-OCO) for detecting CSI. We also validated two two-step strategies for the prediction of high-risk cancer; in the first step, biopsy-confirmed Grade-3 endometrioid or mucinous or non-endometrioid cancers were classified as high-risk cancer, while the second step encompassed the application of a mathematical model to classify the remaining tumors. The 'subjective prediction model' included biopsy grade (Grade 1 vs Grade 2) and subjective assessment of deep MI or CSI (presence or absence) as variables, while the 'objective prediction model' included biopsy grade (Grade 1 vs Grade 2) and minimal tumor-free margin. The predictive performance of the two two-step strategies was compared with that of simply classifying patients as high risk if either deep MI or CSI was suspected based on SA or if biopsy showed Grade-3 endometrioid or mucinous or non-endometrioid histotype (i.e. combining SA with biopsy grade). Histological assessment from hysterectomy was considered the reference standard. RESULTS: In 1275 patients with measurable lesions, the sensitivity and specificity of SA for detecting deep MI was 70% and 80%, respectively, in patients with a Grade-1 or -2 endometrioid or mucinous tumor vs 76% and 64% in patients with a Grade-3 endometrioid or mucinous or a non-endometrioid tumor. The corresponding values for the detection of CSI were 51% and 94% vs 50% and 91%. Tumor AP diameter and tumor/uterine AP diameter ratio showed the best performance for predicting deep MI (area under the receiver-operating characteristics curve (AUC) of 0.76 and 0.77, respectively), and Dist-OCO had the best performance for predicting CSI (AUC, 0.72). The proportion of patients classified correctly as having high-risk cancer was 80% when simply combining SA with biopsy grade vs 80% and 74% when using the subjective and objective two-step strategies, respectively. The subjective and objective models had an AUC of 0.76 and 0.75, respectively, when applied to Grade-1 and -2 endometrioid tumors. CONCLUSIONS: In the hands of experienced ultrasound examiners, SA was superior to ultrasound measurements for the prediction of deep MI and CSI of endometrial cancer, especially in patients with a Grade-1 or -2 tumor. The mathematical models for the prediction of high-risk cancer performed as expected. The best strategies for predicting high-risk endometrial cancer were combining SA with biopsy grade and the subjective two-step strategy, both having an accuracy of 80%. Copyright © 2019 ISUOG. Published by John Wiley & Sons Ltd. ispartof: ULTRASOUND IN OBSTETRICS & GYNECOLOGY vol:55 issue:1 pages:115-124 ispartof: location:England status: published

Background Assessment of interobserver reproducibility and interocular symmetry using optical coherence tomography (OCT)–based measurements of the macular ganglion cell complex (GCC) in healthy children facilitates interpretation of OCT data. We assessed the interobserver reproducibility and interocular symmetry of GCC and evaluated candidate determinants. Methods This was a cross-sectional study performed in a primary and tertiary health-care setting. A total of 126 healthy participants aged 5 to 18 years were eligible. GCC scans were performed by 4 operators using the Topcon 3D OCT-2000 device. Intraclass correlation coefficients (ICCs) were used to estimate reproducibility and symmetry. Cut-off points for symmetry were defined as the 95th percentile of the absolute interocular difference for 6 GCC parameters. Percentile distributions of interocular difference were generated based on age and difference in absolute interocular spherical equivalent (SE). Results The reproducibility ICC ranged from 0.96 to 0.98 for all 6 GCC parameters. Cut-off points for interocular symmetry of the superior and inferior quadrants and total macular retinal nerve fibre layer thickness (mRNFL) and macular ganglion cell layer-inner plexiform layer thickness were 3.5, 4.5, 3.0, 3.0, 2.5, and 2.5 μm respectively. A positive association was observed between the absolute interocular difference of SE and superior and total mRNFL symmetry values (p = 0.047 and p = 0.040, respectively). Conclusions OCT measurements of GCC in healthy children show excellent reproducibility. Interocular differences in SE should be assessed when mRNFL differences exceed the 95% cut-off. These findings can contribute to establish reference values for interocular symmetry in paediatric GCC parameters.

Dermoscopic studies about cutaneous metastases of malignant melanoma (CMMM) are few. Our objective was to analyze the dermoscopic features of CMMM and propose a new dermoscopic pattern classification based on color pigmentation and some specific dermoscopic features. A retrospective evaluation of 150 dermoscopic images of CMMM taken from 40 patients was performed. One hundred CMMM images were individually evaluated by six dermatologists in order to classify them according to four dermoscopic patterns: (i) blue pattern; (ii) pink pattern; (iii) brown pattern; and (iv) mixed pattern. One hundred and fifty dermoscopic images including 50 CMMM and 100 benign lesions were evaluated by five dermatologists to calculate the accuracy of these patterns in the recognition of CMMM. An intra- and interobserver reproducibility agreement study between all different dermoscopic pattern classifications was performed. Seventy-five percent of our cases of CMMM showed a monochromatic pattern. Light brown pigmented halo, peripheral gray spots and polymorphic atypical vessels were the most significant focal dermoscopic structures. The reproducibility of the color-based dermoscopic pattern classification was superior to previous dermoscopic pattern classification. In summary, a dermoscopic pattern classification based on color pigmentation and some specific dermoscopic features may be useful in recognizing early cutaneous melanoma metastasis. Multicentric studies are recommended in order to lower the impact of interobserver variability.

Aim To determine the interobserver reproducibility of measuring cervical lymph nodes at computed tomography (CT) in patients with head and neck squamous cell carcinoma (HNSCC) and to investigate the influence of finding extracapsular spread (ECS) at CT on measurement reliability. Materials and methods The institutional review board approved the study protocol, and informed consent was obtained. A total of 146 patients with 224 suspicious lymph nodes underwent CT before treatment. Two observers independently measured the diameters (minimal axial, maximum axial, and maximum longitudinal diameter) and assessed the ECS using CT. The greatest diameter was defined as the largest among the three measured diameters. Interobserver variability was determined by the within-subject coefficient of variation, and interobserver agreement was determined by the intraclass correlation coefficient (ICC). Results The within-subject coefficients of variation were 7.8%, 7.6%, and 11.4% for the minimal axial, maximum axial, and greatest diameters, respectively. The ICC values for interobserver agreement were excellent for all diameter measurements (i.e., ICC >0.9). Minimum and maximum axial diameter measurements were statistically more reliable than the greatest diameter measurement (p=0.008 and p=0.0001, respectively). The presence of ECS on CT does not significantly affect the reliability of lymph node diameter measurements (p>0.05). Conclusion Lymph node diameter measurement on CT is a highly reproducible and robust method. Additionally, imaging features of ECS do not affect reliability. Therefore, the measurement of lymph node diameter can be confidently performed in daily clinical practice or clinical trials.

PURPOSE To evaluate the applicability of the fourth-generation OCULUS keratograph in measuring lower tear meniscus height. METHODS Seventy cases (140 eyes) with dry eye disease and 37 controls (74 eyes) were enrolled. Tear breakup time (TBUT), Schirmer test I, and corneal fluorescein staining were examined. The images of lower tear meniscus were obtained by OCULUS keratograph. The tear meniscus height was measured and its correlation with traditional tear film diagnostic tests were analyzed. RESULTS Using the hyper-reflective lines, the height of the tear meniscus was measured using the images of the OCULUS keratograph. For the inter-individual variation, the intraclass correlation coefficients and coefficient of variation values were 0.914 and 16.4%, respectively. For the intra-individual variation, the intraclass correlation coefficients and coefficient of variation values were 0.939 and 15.9%, respectively. The interobserver reproducibility and the intraobserver repeatability were for the control only. The average tear meniscus height value in dry eye disease group was 0.22 (0.19-0.24) mm, being significantly lower compared with 0.29 (0.26-0.34) mm in the control group (p

Objective The aim of this study was to assess intra and interobserver reproducibility of placental volume and vascularization during the first trimester of pregnancy studied by three dimensional ultrasonography and angio power Doppler. Study design This is a prospective study in 69 singleton pregnancies. Once the bi-dimensional protocol study was carried out, we performed a 3D-US (three-dimensional ultrasonography) of the placenta by abdominal ultrasonography. The Virtual Organ Computer-Aided Analysis program was used to evaluate the placental volume (PV), the placental quotient (PQ: placental volume/crown-rump length) and the vascular indices (vascularization index VI, flow index FI and vascularization-flow index VFI). The intraobserver and interobserver variability were respectively expressed as an intraclass correlation coefficient (Intra-CC) and interclass correlation coefficient (inter-CC). Results Intraobserver correlation for PV was excellent with an Intra-CC of 0.97 while an Inter-CC of 0.71 demonstrated less agreement between observers. In the same way, PQ showed better intraobserver than interobserver correlation, with an Intra-CC of 0.97 and an inter-CC of 0.67. The analyzed vascular indices had both excellent intraobserver and interobserver correlation coefficients, with values of 0.98 and 0.96 for VI, 0.93 and 0.89 for FI and 0.97 and 0.95 for VFI, respectively. Conclusion Our study demonstrate an excellent intra and inter-observer reproducibility for vascular indices and a good reproducibility of the evaluated Doppler indices with intra-CC higher than 0.90. PV and PQ were also reproducible most of all within the same observer. As a conclusion, first trimester tridimensional sonography is a reproducible tool for the systematic study of placental vascularization.

Purpose To determine the intravisit and interobserver reproducibility of subfoveal choroidal thickness (SFCT) measurements in patients with noninfectious uveitis. Design Reliability analysis. Methods Two consecutive enhanced depth imaging optical coherence tomography (EDI-OCT) scans were obtained at a single clinic visit for 97 uveitic eyes from patients ≥16 years of age with noninfectious anterior (n = 10), intermediate (n = 11), posterior (n = 26), and panuveitis (n = 13) at the National Eye Institute. SFCT was manually measured by 2 ophthalmologists using manufacturer's software. Intravisit and interobserver reproducibility of SFCT measurements were assessed by using the Bland-Altman method to determine the estimate of bias (mean difference in SFCT measurements), 95% limits of agreement, and coefficients of repeatability. The reproducibility of these measurements was also compared between groups by anatomic location and clinical activity. Results Of 97 eyes, 65 (67.0%) were clinically quiet, 18 (18.6%) were minimally active, and 14 (14.4%) were active at the time the scans were obtained. Manual SFCT measurements were reproducible within 32.4 ± 3.8 μm between sessions for the same observer and 51.4 ± 8.5 μm between observers for the same session. Coefficients of repeatability did not differ significantly by anatomic location or disease activity. Conclusions Manual SFCT measurements obtained by EDI-OCT are reproducible in uveitis patients, with coefficients of repeatability that are nearly comparable to those published for normal eyes. This study provides guidance for using manual SFCT measurements in clinical practice, but further studies are still needed to determine their utility in clinical trials.

BACKGROUND AND AIMS The hepatic venous pressure gradient (HVPG) plays an important role in the diagnosis, prognosis and therapy of patients with cirrhosis and portal hypertension. One barrier to its widespread use is the potential for a low reproducibility. We aimed to evaluate the interobserver agreement in the interpretation of optimally acquired HVPG tracings from patients with cirrhosis and different degrees of portal hypertension. METHODS Two hundred and fifteen tracings obtained from 51 patients with cirrhosis in a single centre were interpreted independently by two hepatologists: one experienced observer and one inexperienced observer. Correlation was performed by Pearson linear regression and the intraclass correlation coefficient (ICC). A Bland-Altman plot was constructed to visualize how the differences between observers compared across the range of measurements. Logistic regression was used to identify predictors of ≥10% variation between observers' readings. RESULTS There was a significant linear relationship between observers' readings r = 0.98 (P = 0.001). The ICC between observers (interobserver agreement) was also excellent at 0.991 (P = 0.001). Using the Bland-Altman technique, the mean difference between the observers' readings was 0.2 mmHg (95% CI: -1.2 mmHg to 1.6 mmHg). Thirteen per cent of all readings and 9% of readings with an HVPG of ≥10 mmHg differed by ≥10%. As expected, a lower baseline HVPG was a predictor of this variability. CONCLUSIONS Interobserver reproducibility in the assessment of optimally acquired HVPG tracings is excellent without differences related to experience. The data provide further support that the HVPG can be used accurately in clinical and research settings.

AimsTo evaluate and compare the prognostic value and reproducibility of different methods of pattern of invasion scoring in oral squamous cell carcinomas. The additional prognostic value to established histopathological prognostic factors was also analysed.Methods and resultsThe study group was confined to 211 previously untreated patients who underwent surgery for low-stage oral squamous cell carcinoma between 1997 and 2008. Median follow-up was 64months (range 0-193months). Pattern of invasion was scored using five previously described methods, at random and independently, by two observers. Pattern of invasion scoring showed moderate interobserver reproducibility (Cohen's =0.52-0.58). The predominant pattern of invasion and the summed predominant and worst pattern of invasion were independent prognosticators for locoregional recurrence-free survival (LRRFS) [hazard ratio (HR): 2.1, P=0.033 and HR 2.2, P=0.024, respectively] and disease-specific survival (DSS) (HR 2.3, P=0.032 and HR 2.1, P=0.044, respectively) in multivariate Cox regression analyses. The Harrell's C index for proven prognostic histopathological factors was 0.66 for LRRFS and 0.67 for DSS. This improved to 0.69 and 0.73 with the addition of pattern of invasion.ConclusionsPattern of invasion is an independent prognostic factor in low-stage oral squamous cell carcinoma. However, it has a moderate reproducibility, and the contributory value next to other prognostic histopathological factors is minimal.

Our purpose was to evaluate the safety and efficacy of (68)Ga-DOTATATE PET/CT compared with (111)In-pentetreotide imaging for diagnosis, staging, and restaging of pulmonary and gastroenteropancreatic neuroendocrine tumors.(68)Ga-DOTATATE PET/CT and (111)In-pentetreotide scans were obtained for 78 of 97 consecutively enrolled patients with known or suspected pulmonary or gastroenteropancreatic neuroendocrine tumors. Safety and toxicity were measured by comparing vital signs, serum chemistry values, or acquisition-related medical complications before and after (68)Ga-DOTATATE injection. Added value was determined by changes in treatment plan when (68)Ga-DOTATATE PET/CT results were added to all prior imaging, including (111)In-pentetreotide. Interobserver reproducibility of (68)Ga-DOTATATE PET/CT scan interpretation was measured between blinded and nonblinded interpreters.(68)Ga-DOTATATE PET/CT and (111)In-pentetreotide scans were significantly different in impact on treatment (P0.001). (68)Ga-DOTATATE PET/CT combined with CT or liver MRI changed care in 28 of 78 (36%) patients. Interobserver agreement between blinded and nonblinded interpreters was high. No participant had a trial-related event requiring treatment. Mild, transient events were tachycardia in 1, alanine transaminase elevation in 1, and hyperglycemia in 2 participants. No clinically significant arrhythmias occurred. (68)Ga-DOTATATE PET/CT correctly identified 3 patients for peptide-receptor radiotherapy incorrectly classified by (111)In-pentetreotide.(68)Ga-DOTATATE PET/CT was equivalent or superior to (111)In-pentetreotide imaging in all 78 patients. No adverse events requiring treatment were observed. (68)Ga-DOTATATE PET/CT changed treatment in 36% of participants. Given the lack of significant toxicity, lower radiation exposure, and improved accuracy compared with (111)In-pentetreotide, (68)Ga-DOTATATE imaging should be used instead of (111)In-pentetreotide imaging where available.

Purpose To evaluate the feasibility and reproducibility of artificial intelligence software (Smartplanes®) to automatically identify the transthalamic plane from 3D ultrasound volumes and to measure the biparietal diameter (BPD) and head circumference (HC) in fetus. Material and methods Thirty fetuses were evaluated at 17–30 weeks’ gestation. For each fetus two three-dimensional (3D) volumes of the fetal head along with one conventional two-dimensional (2D) image of the transthalamic plane were prospectively acquired. The Smartplanes® software identified the transthalamic plane from the 3D volumes and performed BPD and HC measurements automatically (3D auto). Two experienced sonographers also measured BPD and HC from 2D images and from the 3D volumes. Measurements were compared using Bland-Altman plots. Interclass correlation coefficient (ICC) was used to evaluate intra- and interobserver reproducibility. Results For each series of measurements, intra- and interobserver reproducibility rates were high with ICC values > 0.98. The 95% confidence intervals between the BPD measurements were 2 mm (3D versus 2D) and 4 mm (3D auto versus 2D) and the HC measurements were 7.5 mm (3D versus 2D) and 11 mm (3D auto versus 2D). Conclusion Fetal head measurements obtained automatically by Smartplanes® software from 3D volumes show good agreement with those obtained by two experienced sonographers from conventional 2D images and 3D volumes. The reproducibility of these measurements is similar to that observed by experienced sonographers.

Background To assess the precision and agreement of measurements of higher order aberrations (HOAs) obtained with a ray tracing aberrometer (iTrace) and a Hartmann-Shack aberrometer (Topcon KR-1 W). Methods Prospective evaluation of the diagnostic test. Data from the right eyes of 92 normal subjects obtained using the two devices were included in this study. Two observers performed 3 consecutive scans to determine the intraobserver repeatability and interobserver reproducibility. About one week later, one observer performed an additional 3 consecutive scans to obtain the intersession reproducibility. The within-subject standard deviation (Sw), test-retest repeatability (TRT) and intraclass correlation coefficient (ICC) were used to assess the precision, while Bland-Altman plots were performed to assess the agreement. Results For intraobserver repeatability of the ocular, corneal and internal HOAs, Topcon KR-1 W showed a 2.77Sw of 0.079 μm or less and ICCs of 0.761 or more; and iTrace showed a 2.77Sw of 0.105 μm or less and ICCs of 0.805 or more. The ICCs of the internal HOAs of interobserver reproducibility were less than 0.75 except for spherical aberration (SA) (0.862), and interobserver reproducibility of the counterpart showed similar but lower results. For the ocular, corneal and internal HOA measurements, statistically significant differences existed between the Topcon KR-1 W and iTrace (all P

Objectives: To assess the feasibility and reliability of an automated technique for the assessment of the angle of progression (AoP) in labor by using three-dimensional (3D) ultrasound. Methods: AoP was assessed by using 3D transperineal ultrasound by two operators in 52 women in active labor to evaluate intra- and interobserver reproducibility. Furthermore, intermethod agreement between automated and manual techniques on 3D images, and between automated technique on 3D vs 2D images were evaluated. Results: Automated measurements were feasible in all cases. Automated measurements were considered acceptable in 141 (90.4%) out of the 156 on the first assessments and in all 156 after repeating measurements for unacceptable evaluations. The automated technique on 3D images demonstrated good intra- and interobserver reproducibility. The 3D-automated technique showed a very good agreement with the 3D manual technique. Notably, AoP calculated with the 3D automated technique were significantly wider in comparison with those measured manually on 3D images (133 ± 17° vs 118 ± 21°, p = 0.013). Conclusions: The assessment of the angle of progression through 3D ultrasound is highly reproducible. However, automated software leads to a systematic overestimation of AoP in comparison with the standard manual technique thus hindering its use in clinical practice in its present form.

Objective To study the interobserver reproducibility of our new ultrasonographic mapping system to define the type and extension of uterine adenomyosis. Design Interobserver study involving two observers with different medical backgrounds and gynecological ultrasound experience. Setting University hospital. Patients Seventy consecutive women who underwent transvaginal ultrasound for suspected endometriosis, pelvic pain, heavy menstrual bleeding, and infertility. Intervention Two operators (observers A and B), who were blinded, independently reviewed the ultrasound videos offline, assessing the type of adenomyosis and the severity of the disease. Diagnosis of adenomyosis was made when typical ultrasonographic features of the disease were observed at the examination. Adenomyosis was defined as diffuse, focal, and adenomyoma according to the ultrasonographic characteristics. The severity of adenomyosis was described using a new schematic scoring system that describes the extension of the disease considering all possible ultrasound adenomyosis features. Main Outcome Measures Reproducibility of the new mapping system for adenomyosis and rate agreement between two operators. Results Multiple rate agreements to classify the different features and the score of adenomyosis (diffuse, focal adenomyoma, and focal or diffuse alteration of junctional zone) ranged from substantial to almost perfect (Cohen κ = 0.658 – 1) except for adenomyoma score 4 (one or more adenomyomas with the largest diameter >40 mm) in which interobserver agreement was moderate (κ = 0.479). Conclusion Our new scoring system for uterine adenomyosis is reproducible and could be useful in clinical practice. The standardization of the transvaginal approach and of the sonographer training represent a crucial point for a correct diagnosis of myometrial disease.

Background Mitral annular plane systolic excursion (MAPSE) is an increasingly used echocardiography technique to assess left ventricular (LV) function. However, reproducibility and dependence on echocardiographic image quality for MAPSE in pediatric patients have not been studied to date. Methods We analyzed 284 transthoracic echocardiograms performed on consecutive normotensive children without structural heart disease (mean age 12.6±3.1 years, 50.4% female). B-mode and M-mode derived MAPSE measurements were performed and analyzed regarding inter- and intraobserver reliability and the influence of echocardiographic image quality. Results Overall, MAPSE measurements were highly reproducible with only minor bias. Both inter- and intraobserver reliability were significantly better for M-mode derived MAPSE (p0.235). In contrast, B-mode lateral MAPSE was significantly better reproducible in optimal image quality (-0.07±1.04) when compared to suboptimal echocardiographic images (0.42±1.59, p

Graft versus host disease (GvHD) is a clinically important complication after allogeneic hematopoietic stem cell transplantation (HSCT). Its diagnosis relies on clinical and histopathological findings. In order to evaluate and improve inter-institutional diagnostic agreement on histological diagnosis and grading of acute gastrointestinal GvHD, we conducted a round robin test, which included 33 biopsies from 23 patients after HSCT. Five pathologists from different institutions independently evaluated the original sections from the biopsies submitted for diagnosis. Based on their results, consensus qualitative criteria for the assessment of typical histological features of GvHD (e.g., apoptosis, crypt destruction, mucosa denudation) were proposed, including detailed descriptions as well as histological images. In a second round robin test with involvement of the same pathologists, the reproducibility of both diagnosis and grading had improved. Remaining differences were mostly related to differential diagnostic considerations, including viral infection or toxic side effects of medication, which should be resolved by integrating histopathological findings with proper clinical information.

Objective To evaluate the influence of papillary muscles and trabeculae on left ventricular (LV) cardiovascular magnetic resonance (CMR) analysis using three methods of cavity delineation (classic or modified inclusion methods, and the exclusion method) in patients with hypertrophic cardiomyopathy (HCM). Materials and Methods This retrospective study included 20 consecutive HCM patients who underwent 1.5-T CMR imaging with short-axis cine stacks of the entire LV. LV measurements were performed using three different methods of manual cavity delineation of the endocardial and epicardial contours: method A, presumed endocardial boundary as seen on short-axis cine images; method B, including solely the cavity and closely adjacent trabeculae; or method C, excluding papillary muscles and trabeculae. Ascending aorta forward flow was measured as reference for LV-stroke volume (SV). Interobserver reproducibility was assessed using intraclass correlation coefficients. Results Method A showed larger end-diastole and end-systole volumes (largest percentage differences of 25% and 68%, respectively, p < 0.05), compared with method C. The ejection fraction was 55.7 ± 6.9% for method A, 68.6 ± 8.4% for B, and 71.7 ± 7.0% for C (p < 0.001). Mean mass was also significantly different: 164.6 ± 47.4 g for A, 176.5 ± 50.5 g for B, and 199.6 ± 53.2 g for C (p < 0.001). LV-SV error was largest with method B (p < 0.001). No difference in interobserver agreement was observed (p > 0.05). Conclusion In HCM patients, LV measurements are strikingly different dependent on whether papillary muscles and trabeculae are included or excluded. Therefore, a consistent method of LV cavity delineation may be crucial during longitudinal follow-up to avoid misinterpretation and erroneous clinical decision-making.

Purpose The progressive loss of skeletal muscle and function (known as sarcopenia) has been shown to be associated with various adverse outcome measures. Sophisticated measurements of body composition are increasingly being incorporated into research studies to stratify patients into those with or without sarcopenia, monitor treatment effects, and predict complications. A typical approach is to select axial image(s) at the mid-lumbar level and use semi-automated software to identify and quantify the skeletal muscle area. This area is then used to estimate whole-body parameters. This approach is somewhat subjective, and in this study we investigate its reproducibility, both within and between observers. Materials and methods Repeated muscle measurements were performed on a cohort of 29 patients by 3 radiologists, to examine their intra- and interobserver reproducibility. Results and discussion Mean muscle area for the cohort was 156 cm2, with a wide range (98 – 261 cm2). There was good intraobserver agreement between measurements, with a mean absolute difference between repeated measurements on the same patient of 0.98 cm2, and a measurement variability of 2.92 cm2. Much of the variability was shown to be due to the choice of a different slice when performing the repeated measurement. Averaging two slices provided a small but non-significant improvement in comparison to the single slice approach. Interobserver results showed good agreement, though there was a small bias for one observer, who measured slightly larger volumes compared to the other two. We conclude that the approach described provides reproducible skeletal muscle area measurements, and offer three specific recommendations to minimise variability.

To determine if the capitohamate (CH) planimetry could be a reliable indicator of bone age, and to compare it with Greulich-Pyle (GP) method. This retrospective study included 391 children (age, 1–180 months). Two reviewers manually measured the areas of the capitate and hamate on plain radiographs. CH planimetry was defined as the measurement of the sum of areas of the capitate and hamate. Two reviewers independently applied the CH planimetry and GP methods in 109 children whose heights were at the 50th percentile of the growth chart. There was a strong positive correlation between chronological age and CH planimetry measurement (right, r = 0.9702; left, r = 0.9709). There was no significant difference in accuracy between CH planimetry (84.39–84.46 %) and the GP method (85.15–87.66 %) (p ≥ 0.0867). The interobserver reproducibility of CH planimetry (precision, 4.42 %; 95 % limits of agreement [LOA], −10.5 to 13.4 months) was greater than that of the GP method (precision, 8.45 %; LOA, −29.5 to 21.1 months). CH planimetry may be a reliable method for bone age assessment. • Bone age assessment is important in the work-up of paediatric endocrine disorders. • Radiography of the left hand is widely used to estimate bone age. • Capitatohamate planimetry is a reliable and reproducible method for assessing bone age.

To evaluate the value of analyzing the anterior talofibular ligament (ATFL) on preoperative MRI as a decision-making tool to determine the surgical technique in patients undergoing surgery for chronic lateral ankle instability.A retrospective study of prospective data was performed. All patients who underwent surgery between 2013 and 2016 for arthroscopic stabilization of the ankle were included. The ATFL was evaluated on preoperative MRI including axial T2-weighted images by two readers who were blinded to arthroscopic results. The arthroscopic evaluation, which was considered to be the reference examination, was performed by one senior surgeon. The main judgment criteria were two features of the ATFL: (1) absent or thin ( 1 mm thick) and (2) detached or thickened ( 3.2 mm in diameter) with or without a high intensity intraligamentous signal. Inter- and intraobserver reproducibility was evaluated by the kappa coefficient (k), and parameters of the diagnostic accuracy of preoperative MRI were analyzed.Twenty-two patients were included, 15 men/7 women mean age 30.3 ± 9.5 years. Fourteen patients (63.6%) underwent arthroscopic repair of the ATFL (Broström-Gould technique) and 8 patients (36.4%) an arthroscopic anatomical reconstruction of the ATFL. Intraobserver reproducibility of MRI findings was substantial (k = 0.68) and interobserver reproducibility moderate (k = 0.55) to nearly perfect (k = 0.87). Agreement between MRI and arthroscopic findings was substantial (k = 0.70). Diagnostic parameters of preoperative MRI were good for both observers: Se = 85.7-87.5%, Sp = 86.7-92.9%, PPV = 75-87.5%, NPV = 92.9%, and classification of patients was good = 86.4-90.9%.Preoperative MRI of the ATFL is a reliable and valid decisional tool to choose the surgical technique for stabilization of chronic lateral ankle instability.Level II; Diagnostic study-development of diagnostic criteria on the basis of consecutive patients.