The AO classification system for tibial plateau fractures: An independent inter and intraobserver agreement study.

PURPOSE: Classifying tibial plateau fractures is paramount in determining treatment regimens and systemizing decision making. The original AO classification described by Müller in 1996 and the Schatzker classification of 1970 are the most cited classifications for tibial plateau fractures, demonstrating substantial to almost perfect agreement. The main problem with these classifications schemes is that they lack the detail required to convey the variety of fracture patterns encountered. In 2018, the AO foundation published a new classification system for proximal tibia fractures, highlighting a more complete and detailed number of categories and subcategories. We sought to independently determine inter and intraobserver agreement of the AO classification system, compared to the previous systems described by Müller and Schatzker. METHODS: One hundred seven consecutive tibial plateau fractures were screened, and a representative data set of 69 was created. Six independent evaluators (three knee surgeons, three senior orthopedic residents) classified the fractures using the original AO, the Schatzker and the new AO classifications. After six weeks, the 69 cases were randomized and reclassified by all evaluators. The Kappa coefficient (k) was calculated for inter- and intraobserver correlation and is expressed with 95% confidence intervals. RESULTS: interobserver agreement was moderate for all three classifications. k = 0.464 (0.383-0.560) for the original AO; k = 0.404 (0.337-0.489) for Schatzker; and k = 0.457 (0.371-0.545) for the base categories of the new AO classification. The inclusion of subcategories and letter modifiers to the new classification worsened agreement to k = 0.358 (0.302-0.423) and k = 0.174 (0.134-0.222), respectively. There were no significant differences between knee surgeons and residents for the new classification. Intra-observer correlation was also moderate for each of the scores: k = 0.630 (0.578-0.682) for the original AO; k = 0.623 (0.569-0.674) for Schatzker; and k = 0.621 (0.566-0.678) for the new AO base categories; without differences between knee surgeons or residents. CONCLUSIONS: This study demonstrated an adequate inter and intra-observer agreement for the new AO tibial plateau fractures classification system for its base categories, but not at the subcategory or letter modifier levels.

An independent inter- and intra-observer agreement assessment of Yeom classification for bone cement leakage following vertebroplasty/kyphoplasty.

STUDY DESIGN: An inter- and intra-observer agreement study. BACKGROUND: In recent years, vertebroplasty and kyphoplasty have been widely used in treating osteoporotic vertebral compression fractures (OVCF) though the clinical efficacy of them is still controversial. However, there are also inevitable complications, first and foremost is bone cement leakage (BCL). Yeom classification is commonly used to evaluate BCL. The objective of this study is to assess its reliability and reproducibility, and to explore its clinical application value. METHODS: All 58 patients with BCL following vertebroplasty/kyphoplasty were involved. Six spine surgeons were selected to be evaluators as they were unaware of the identity of the patients and the treatment they received. They classified BCL according to Yeom system, we used kappa (K) to assess the inter- and intra-observer agreement. After 12 weeks, we repeated the analysis. RESULTS: The inter-observer reliability of Yeom classification was substantial with K value of 0.71 (1st assessment) and 0.73 (2nd assessment). The intra-observer reproducibility of Yeom classification was near perfect with K value of 0.88. CONCLUSION: Yeom classification system has substantial inter-observer reliability and near perfect intra-observer reproducibility in BCL following vertebroplasty/kyphoplasty, which can be widely used in clinical care as an appropriate instrument for early observation, mechanism and severity cognition, and prognosis predicting of BCL. Besides, the adding of type M (the mixed type) may improve the classification.

Determining the level of cervical radiculopathy: Agreement between visual inspection of pain drawings and magnetic resonance imaging.

BACKGROUND AND AIMS: Pain drawings are commonly used in the clinical assessment of people with cervical radiculopathy. This study aimed to assess (1) the agreement of clinical interpretation of pain drawings and MRI findings in identifying the affected level of cervical radiculopathy, (2) the agreement of these predictions based on the pain drawing among four clinicians from two different professions (i.e., physiotherapy and surgery) and (3) the topographical pain distribution of people presenting with cervical radiculopathy (C4-C7). METHODS: Ninety-eight pain drawings were obtained from a baseline assessment of participants in a randomized clinical trial, in which single-level cervical radiculopathy was determined using MRI. Four experienced clinicians independently rated each pain drawing, attributing the pain distribution to a single nerve root (C4-C7). A post hoc analysis was performed to assess agreement. OUTCOME MEASURES: Percentage agreement and kappa values were used to assess the level of agreement. Topographic pain frequency maps were created for each cervical radiculopathy level as determined by MRI. RESULTS: The radiculopathy level determined from the pain drawings showed poor overall agreement with MRI (mean = 35.7%, K = -0.007 to 0.139). The inter-clinician agreement ranged from fair to moderate (K = 0.212-0.446). Topographic frequency maps revealed that pain distributions were widespread and overlapped markedly between patients presenting with different levels cervical radiculopathy. CONCLUSION: This study revealed a lack of agreement between the segmental level affected determined from the patient's pain drawing and the affected level as identified on MRI. The large overlap of pain and non-dermatomal distribution of pain reported by patients likely contributed to this result.

An independent inter- and intra-observer agreement assessment of the AOSpine upper cervical injury classification system.

BACKGROUND CONTEXT: The complex anatomy of the upper cervical spine resulted in numerous separate classification systems of upper cervical spine trauma. The AOSpine upper cervical classification system (UCCS) was recently described; however, an independent agreement assessment has not been performed. PURPOSE: To perform an independent evaluation of the AOSpine UCCS. STUDY DESIGN: Agreement study. PATIENT SAMPLE: Eighty-four patients with upper cervical spine injuries. OUTCOME MEASURES: Inter-observer agreement; intra-observer agreement. METHODS: Complete imaging studies of 84 patients with upper cervical spine injuries, including all morphological types of injuries defined by the AOSpine UCCS were selected and classified by six evaluators (from three different countries). The 84 cases were presented to the same raters randomly after a 4-week interval for repeat evaluation. The Kappa coefficient (κ) was used to determine inter- and intra-observer agreement. RESULTS: The interobserver agreement was almost perfect when considering the fracture site (I, II or III), with κ=0.82 (0.78-0.83), but the agreement according to the site and type level was moderate, κ=0.57 (0.55-0.65). The intra-observer agreement was almost perfect considering the injury, with κ=0.83 (0.78-0.86), while according to site and type was substantial, κ=0.69 (0.67-0.71). CONCLUSIONS: We observed only a moderate inter-observer agreement using this classification. We believe our results can be explained because this classification attempted to organize many different injury types into a single scheme.

Biometry and intraocular power calculation using a swept-source optical coherence tomography: A repeatability and agreement study.

Purpose: To evaluate the repeatability of biometry and intraocular lens (IOL) power using Galilei G6 and to determine the agreement of its measurements with those of IOL Master 700 and IOL Master 500. Methods: Hundred mature cataract eyes were examined twice with Galilei G6 and the results were compared with those of other two devices. Axial length (AL), minimum (K1), maximum (K2), and mean keratometry, anterior chamber depth (ACD), white-to-white (WTW) diameter, lens thickness (LT), and the calculated IOL power were the studied parameters. The correlation coefficient, within-subject standard deviation (Sw), Bland-Altman method, and 95% limits of agreement (LoA) were used for statistical analysis. Results: The intraclass correlation coefficient (ICC) was above 0.9 for all indices, and the LoA ranged from a minimum of 0.08 mm for AL to a maximum of 0.50 D for K1. Sw also ranged between a minimum of 0.02 for AL, ACD, and WTW and a maximum of 0.13 for K1. In the Galilei G6-IOL Master 700 pair, the narrowest and widest LoA were calculated for AL (0.07 mm) and K2 (0.49 D), respectively. In the Galilei G6-IOL Master 500 pair, the narrowest and widest widths of LoA were calculated for AL (0.17 mm) and K2 (0.92 D), respectively. In the first pair, the LoA of IOL power (0.57 D) were the best for Haigis formula and in the second pair, the best agreement (LoA: 0.35 D) was observed for Holladay-1. Conclusion: Galilei G6 provided repeatable biometric measurements. The agreement between biometry and IOL power calculation was better in the Galilei G6-IOL Master 700 pair compared to the Galilei G6-IOL Master 500.

Radiotherapy Target Volume Definition in Newly Diagnosed High-Grade Glioma Using 18F-FET PET Imaging and Multiparametric MRI: An Inter Observer Agreement Study.

Background: The aim of this prospective monocentric study was to assess the inter-observer agreement for tumor volume delineations by multiparametric MRI and 18-F-FET-PET/CT in newly diagnosed, untreated high-grade glioma (HGG) patients. Methods: Thirty patients HGG underwent O-(2-[18F]-fluoroethyl)-l-tyrosine(18F-FET) positron emission tomography (PET), and multiparametric MRI with computation of rCBV map and K2 map. Three nuclear physicians and three radiologists with different levels of experience delineated the 18-F-FET-PET/CT and 6 MRI sequences, respectively. Spatial similarity (Dice and Jaccard: DSC and JSC) and overlap (Overlap: OV) coefficients were calculated between the readers for each sequence. Results: DSC, JSC, and OV were high for 18F-FET PET/CT, T1-GD, and T2-FLAIR (>0.67). The Spearman correlation coefficient between readers was ≥0.6 for these sequences. Cross-comparison of similarity and overlap parameters showed significant differences for DSC and JSC between 18F-FET PET/CT and T2-FLAIR and for JSC between 18F-FET PET/CT and T1-GD with higher values for 18F-FET PET/CT. No significant difference was found between T1-GD and T2-FLAIR. rCBV, K2, b1000, and ADC showed correlation coefficients between readers <0.6. Conclusion: The interobserver agreements for tumor volume delineations were high for 18-F-FET-PET/CT, T1-GD, and T2-FLAIR. The DWI (b1000, ADC), rCBV, and K2-based sequences, as performed, did not seem sufficiently reproducible to be used in daily practice.

Prospective Validation of a Machine Learning Model for Low-Density Lipoprotein Cholesterol Estimation.

OBJECTIVE: We aim to prospectively validate a previously developed machine learning algorithm for low-density lipoprotein cholesterol (LDL-C) estimation. METHODS: We retrospectively and prospectively evaluated a machine learning algorithm based on k-nearest neighbors (KNN) according to age, sex, healthcare setting, and triglyceridemia against a direct LDL-C assay. The agreement of low-density lipoprotein-k-nearest neighbors (LDL-KNN) with the direct measurement was assessed using intraclass correlation coefficient (ICC). RESULTS: The analysis comprised 31,853 retrospective and 6599 prospective observations, with a mean age of 54.2 ±â€…17.2 years. LDL-KNN exhibited an ICC greater than 0.9 independently of age, sex, and disease status. LDL-KNN was in satisfactory agreement with direct LDL-C in observations with normal triglyceridemia and mild hypertriglyceridemia but displayed an ICC slightly below 0.9 in severely hypertriglyceridemic patients and lower in very low LDL-C observations. CONCLUSION: LDL-KNN performs robustly across ages, genders, healthcare settings, and triglyceridemia. Further algorithm development is needed for very low LDL-C observations.

Reliability Evaluation of the New AO Spine-DGOU Classification for Osteoporotic Thoracolumbar Fractures.

OBJECTIVES: To perform an interobserver and intraobserver agreement evaluation of the new AO Spine-DGOU classification system for osteoporotic thoracolumbar fractures (OFc). METHODS: Complete imaging studies of 97 patients (radiographs, computed tomography scans, and magnetic resonance imaging) with osteoporotic thoracolumbar fractures were selected and classified using the OFc by 6 spine surgeons (3 senior surgeons with more than 15 years of experience and 3 surgeons with less than 15 years). After a 4-week interval, the same cases were presented to the same evaluators in a random sequence for a new classification assessment. The weighted kappa coefficient (wκ) was used to determine the interobserver and intraobserver agreement. RESULTS: The interobserver agreement was moderate, wκ = 0.59 (95% confidence interval 0.54-0.64). The intraobserver agreement was fair, wκ = 0.35 (95% confidence interval 0.29-0.40). Interobserver agreement slightly improved for junior staff between first and second evaluation, suggesting a learning effect. Better agreement was obtained by senior staff at the interobserver and intraobserver agreement. CONCLUSIONS: This independent assessment demonstrated that new OFc allows moderate interobserver agreement and fair intraobserver agreement. Further studies are necessary prior to its widespread adoption.

Inter- and intra-observer agreement using the new AOSpine sacral fracture classification, with a comparison between spine and pelvic trauma surgeons.

BACKGROUND: Sacral fractures treatment frequently involves both spine and pelvic trauma surgeons; therefore, a consistent communication among surgical specialists is required. We independently assessed the new AOSpine sacral fracture classification's agreement from the perspective of spine and pelvic trauma surgeons. METHODS: Complete computerized tomography (CT) scans of 80 patients with sacral fractures were selected and classified using the new AOSpine sacral classification system by six spine surgeons and three pelvic trauma surgeons. After four weeks, the 80 cases were presented and reassessed by the same raters in a new random sequence. The Kappa coefficient (κ) was used to measure the inter-and intra-observer agreement. RESULTS: The inter-observer agreement considering the fracture severity types (A, B, or C) was substantial for spine surgeons (κ= 0.68 [0.63 - 0.72]) and pelvic trauma surgeons (κ= 0.74 (0.64 - 0.84). Regarding the subtypes, both groups achieved moderate agreement with κ= 0.52 (0.49 - 0.54) for spine surgeons and κ= 0.51 (0.45 - 0.57) for pelvic trauma surgeons. The intra-observer agreement considering the fracture types was substantial for spine surgeons (κ= 0.74 [0.63 - 0.75]) and almost perfect for pelvic trauma surgeons (κ= 0.84 [0.74 - 0.93]). Concerning the subtypes, both groups achieved substantial agreement with, κ= 0.61 (0.56 - 0.67) for spine surgeons and κ= 0.68 (0.62 - 0.74) for pelvic trauma surgeons. CONCLUSION: This classification allows an adequate communication for spine surgeons and pelvic trauma surgeons at the fracture severity type, but the agreement is only moderate at the subtype level. Future prospective studies are required to evaluate whether this classification allows for treatment recommendations and establishing prognosis in patients with sacral fractures.

An inter- and intra-rater agreement assessment of a novel classification of pyogenic spinal infections.

PURPOSE: Pola et al. described a clinical-radiological classification of pyogenic spinal infections (PSI) based on magnetic resonance imaging (MRI) features including vertebral destruction, soft tissue involvement, and epidural abscess, along with the neurological status. We performed an inter- and intra-observer agreement evaluation of this classification. METHODS: Complete MRI studies of 80 patients with PSI were selected and classified using the scheme described by Pola et al. by seven evaluators. After a four-week interval, all cases were presented to the same assessors in a random sequence for repeat assessment. We used the weighted kappa statistics (wκ) to establish the inter- and intra-observer agreement. RESULTS: The inter-observer agreement was substantial considering the main categories (wκ = 0.77; 0.71-0.82), but moderate considering the subtypes (wκ = 0.51; 0.45-0.58). The intra-observer agreement was substantial considering the main types (wκ = 0.65; 0.59-0.71), and moderate considering the subtypes (wκ = 0.58; 0.54-0.63). CONCLUSION: The agreement at the main type level indicates that this classification allows adequate communication and may be used in clinical practice; at the subtypes level, the agreement is only moderate.

An independent inter- and intra-observer agreement assessment of the Eno classification of sacroiliac joint degeneration.

BACKGROUND: Recently, a scoring system to grade sacroiliac joint (SIJ) degeneration using computed tomography (CT) scans was described. No independent evaluation has determined the inter- and intra-observer agreement using this scheme. PURPOSE: To perform an independent inter- and intra-observer agreement assessment using the Eno classification and determining gas in the SIJ. MATERIAL AND METHODS: We studied 64 patients aged ≥60 years who were evaluated with abdominal and pelvic computed tomography scans. Six physicians (three orthopaedic spine surgeons and three musculoskeletal radiologists) assessed axial images to grade SIJ degeneration into grade 0 (normal), grade 1 (mild degeneration), grade 2 (significant degeneration), and grade 3 (ankylosis). We also evaluated the agreement assessing the presence of gas in the SIJ. After a four-week interval, all cases were presented in a random sequence for repeat assessment. We determined the agreement using the kappa (κ) or weighted kappa coefficient (wκ). RESULTS: The inter-observer agreement was moderate (wκ = 0.50 [0.44-0.56]), without differences among surgeons (wκ = 0.53 [0.45-0.61]) and radiologists (wκ = 0.49 [0.42-0.57]). The agreement evaluating the presence of gas was also moderate (κ = 0.45 [0.35-0.54]), but radiologists obtained better agreement (κ = 0.61 [0.48-0.72]) than surgeons (κ = 0.29 [0.18-0.39]). The intra-observer agreement using the classification was substantial (wκ = 0.79 [0.76-0.82]), without differences comparing surgeons (wκ = 0.75 [0.70-0.80]) and radiologists (wκ = 0.83 [0.79-0.87]). The intra-rater agreement evaluating gas was substantial (κ = 0.77 [0.72-0.82]), without differences between surgeons (κ = 0.71 [0.63-0.78]) and radiologists (κ = 0.84 [0.78-0.90]). CONCLUSION: Given the only moderate agreement obtained using the Eno classification, it does not seem adequate to be used in clinical practice or in research.

Agreement in the CARTaGENE cohort between self-reported medication use and claim data.

OBJECTIVES: To describe the agreement of self-reported medication use with claim prescription records and to ascertain factors associated with agreement between the two data sources. METHODS: Baseline data on self-reported medication use was extracted from CARTaGENE, a cohort study in Quebec, Canada, and from the provincial health insurance records (dispensation database) of the same individuals. Kappa statistics were used to estimate concordance beyond chance between the two data sources. Logistic regression models were adjusted to estimate the association between agreement and selected individual's characteristics (sex, age, education, region, income, utilization of health care system, and comorbidities). RESULTS: Agreement between self-reported medication use and administrative data varied considerably across medication classes (kappa 0.54 for respiratory system and 0.91 for systemic hormonal preparations). Overall, agreement improved when a fixed time window of 90 days was used for exposure measurement. Sex, education level, frequency of health care use and the number of reported medications were associated with agreement. DISCUSSION: Overall, there was a reasonable agreement between the two data sources, but important variations were found for the different drug classes. These results could be used by researchers to more accurately assess drug exposures using real-world data, which are increasingly important to regulators.

Reliability of the sperm chromatin dispersion assay to evaluate sperm deoxyribonucleic acid damage in men with infertility.

OBJECTIVE: To investigate the intraindividual agreement of the sperm chromatin dispersion (SCD) assay results to assess sperm DNA fragmentation (SDF) in men with infertility. DESIGN: Diagnostic test reliability study. SETTING: Andrology laboratories. PATIENT(S): A total of 219 men with infertility. INTERVENTION(S): Sperm DNA fragmentation assessment in two ejaculates of the same subjects within a 3-month interval, using the SCD assay performed and analyzed by the same observers under similar testing conditions. MAIN OUTCOME MEASURE(S): Cohen's κ statistics to assess the degree of agreement between the pairs of results after converting the nominal SCD values into categorical data, that is, normal (<20%), intermediate (21%-29%), and high (≥30%) SDF rates. We also assessed the pairs of results using reliability measures for numerical variables (intraclass correlation coefficient for consistency using the two-way mixed-effects model and Bland-Altman plots). RESULT(S): The degree of agreement in classifying patients according to normal and pathological SDF classes was overall substantial (κ = 0.632; 95% confidence interval [CI], 0.546-0.718). A total of 76.7% of individuals were classified under the same class using paired ejaculates. The agreement rate was highest (approximately 80%) in ejaculates initially classified as either normal or high and lowest (approximately 60%) among those with intermediate SDF levels. The frequency of intermediate SDF ejaculates downgraded to normal or upgrade to high SDF classes in the second test was similar (approximately 20%). The intraclass correlation coefficient was 0.856 (95% CI, 0.812-0.887), and the mean difference between the pairs of observations was 0.80% (95% CI, -0.72 to 2.23), indicating no systematic difference between paired observations. CONCLUSION(S): Our study indicates a substantial intraindividual agreement of paired SCD assay results to classify men with infertility into three SDF categories: normal, intermediate, and high. The reliability of the SCD assay was adequate and exceeded 0.80 using two ejaculates analyzed within a 3-month interval under similar conditions. Although this evidence overall supports a single SCD test for patient classification using predefined SDF thresholds, particularly when the first test shows normal or high SDF levels, one in four men will have discordant values in paired ejaculates. Clinicians should be judicious when using SDF test results in decision-making.

Comparison of SDSG and CARDS classifications for L5/S1 lumbar degenerative spondylolisthesis: an independent inter- and intra-observer agreement study.

BACKGROUND: Lumbar degenerative spondylolisthesis (DS) has been a common disease that makes increasing patients to suffer from different degrees of low back pain and radicular symptoms. The Spinal Deformity Study Group (SDSG) and the Clinical and Radiographic Degenerative Spondylolisthesis (CARDS) systems are commonly used to classify the disease, and help to make a more detailed treatment plan. The objective of this study is to compare the reliability and reproducibility of SDSG and CARDS classifications, and to explore their clinical application value. METHODS/DESIGN: All 117 patients with L5/S1 lumbar DS were enrolled. Five experienced spine surgeons were selected to assess DS with SDSG and CARDS systems. Kappa (K) value was used to check the coefficient consistency for multi-factor and assess the inter- and intra-observer agreement. After 12 weeks, the analysis was repeated. RESULTS: The inter-observer reliability and intra-observer reproducibility of SDSG system were substantial with K values of 0.704 and 0.861, while those of CARDS system were substantial with values of 0.620 and 0.878. CONCLUSION: SDSG system had better inter-observer reliability in comparison with CARDS system, and though CARDS system is more intuitive and simpler, it is more likely to produce deviations when using it. Both SDSG and CARDS systems show substantial agreement and have great significance in surgical strategy of L5/S1 lumbar DS, they can be widely used in clinical practice.

Is Machine Learning-derived Low-Density Lipoprotein Cholesterol estimation more reliable than standard closed form equations? Insights from a laboratory database by comparison with a direct homogeneous assay.

BACKGROUND: There is no consensus on the best method to estimate Low Density Lipoprotein-Cholesterol (LDL-C) in routine laboratories. METHODS: We conducted a retrospective study to compare the performances of a Machine Learning (ML) algorithm using the K-Nearest Neighbors (LDL-KNN) method with that of the Friedewald formula (LDL-F), the Martin-Hopkins equation (LDL-NF), the de Cordova equation (LDL-CO) and the Sampson equation (LDL-SA) against direct homogeneous LDL-C assay (LDL-D) in patients who presented to the Laboratories of Hôtel Dieu de France university hospital in Beirut, Lebanon, from September 2017 to July 2020. Agreements between methods were analyzed using Intraclass Correlation Coefficients (ICC) and the Bland-Altman method of agreement. RESULTS: 31,922 observations from 19,279 subjects were included, with a mean age of 52 ± 18 years and 10,075 (52.3%) females. All methods except LDL-F and LDL-CO exhibited an overall ICC beyond the 0.9 cut-off. LDL-SA, LDL-NF and LDL-KNN were less susceptible to triglyceridemia than LDL-F and LDL-CO, with LDL-KNN resulting in the lesser fraction of points beyond the Bland-Altman limits of agreement. CONCLUSION: An ML algorithm using LDL-KNN is promising for the estimation of LDL-C as it agrees better with LDL-D than closed form equations, especially in mild and severe hypertriglyceridemia.

Do age-adjusted sex-specific cut-off values improve the agreement between high sensitivity cardiac troponins I and T? A retrospective study.

BACKGROUND: Many reports noted a disagreement between High sensitivity cardiac Troponin (hs-cTn) assays on the diagnosis of Acute Coronary Syndrome (ACS). METHODS: We conducted a retrospective study aiming to assess the agreement between hs-cTn T (Roche) and hs-cTn I (Abbott) in patients presenting with a suspected ACS to the emergency department at Hotel-Dieu hospital between September 2017 and October 2019 using overall, sex-specific, and age-adjusted sex-specific cut-off values. This was measured using Cohen's Kappa. We explored whether renal function, circadian rhythm, age and sex influenced the discordance. And we analyzed the trend of agreement between baseline and repeated measurements. RESULTS: 4856 patients who had simultaneous hs-cTn I and T values were retained for the analysis. 53.5% had a hs-cTn T above the overall 99th percentile, compared to 19.9% for hs-cTn I. The numbers were significantly reduced when applying age-adjusted sex-specific 99th percentile. A disagreement was seen in 34% of cases using overall 99th percentile. Using sex-specific cut off values did not impact this discordance; however, age-adjusted sex-specific cut-off values reduced the percentage of discrepancies to 15.8%. The decreased renal function had a negative effect on the agreement while the circadian rhythm had minimal effect. This initial discordance was carried forward into repeated measurements. CONCLUSION: The disagreement between hs-cTn T and I assays could be imputed to the choice of cut-off values. The use of age-adjusted sex specific 99th percentile reduced majorly these discordances. Further studies are needed in order to evaluate their clinical utility in patients presenting with ACS.

Antral follicle count and anti-Müllerian hormone to classify low-prognosis women under the POSEIDON criteria: a classification agreement study of over 9000 patients.

STUDY QUESTION: What is the agreement between antral follicle count (AFC) and anti-Müllerian hormone (AMH) levels when used to patient classification according to the Patient-Oriented Strategies Encompassing IndividualizeD Oocyte Number (POSEIDON) criteria? SUMMARY ANSWER: Our study indicates a strong agreement between the AFC and the AMH levels in classifying POSEIDON patients; thus, either can be used for this purpose, although one in four women will have discordant values when both biomarkers are used. WHAT IS KNOWN ALREADY: According to the POSEIDON criteria, both AFC and AMH may be used to classify low-prognosis patients. Proposed AFC and AMH thresholds of 5 and 1.2 ng/ml, respectively, have their basis in published literature; however, no study has yet determined the reproducibility of patient classification in comparing one biomarker with the other, nor have their thresholds ever been validated within this patient population. STUDY DESIGN, SIZE, DURATION: A population-based cohort study involving 9484 consecutive patients treated in three fertility clinics in Brazil, Turkey and Vietnam between 2015 and 2017. PARTICIPANTS/MATERIALS, SETTING, METHODS: Participants were infertile women between 22 and 46 years old in their first in vitro fertilization/intracytoplasmic sperm injection cycle of standard ovarian stimulation with exogenous gonadotropins whose baseline ovarian reserves had been assessed by both AFC and AMH. Details of pre- and post-treatment findings were input into a coded research file. Two indicators of interest were created to classify patients according to the POSEIDON criteria based upon AFC and AMH values. Patients who did not fit any of the four POSEIDON groups were classified as non-POSEIDON. AFC was determined in the early follicular phase using two-dimensional (2D) transvaginal ultrasonography, whereas AMH values were based on the modified Beckman Coulter generation II enzyme-linked immunosorbent assay. Agreement rates were computed between AFC and AMH to classify patients using Cohen's kappa statistics. Logistic regression analyzes were carried out to examine the association between ovarian markers and low (<4) and suboptimal (4-9) oocyte yield. MAIN RESULTS AND THE ROLE OF CHANCE: The degree of agreement in classifying patients according to POSEIDON groups was strong overall (kappa = 0.802; 95% CI: 0.792-0.811). A total of 73.8% of individuals were classified under the same group using both biomarkers. The disagreement rates were ∼26% and did not diverge when AFC or AMH was used as the primary biomarker criterion. Significant regression equations were found between ovarian markers and oocyte yield (P < 0.0001). For low oocyte yield, the optimal AFC and AMH cutoff values were 5 and 1.27 ng/ml with sensitivities of 0.61 and 0.66, specificities of 0.81 and 0.72, and AUC receiver operating characteristics of 0.791 and 0.751, respectively. For suboptimal oocyte yield respective AFC and AMH cutoffs were 12 and 2.97 ng/ml with sensitivities of 0.74 and 0.69, specificities of 0.76 and 0.66 and AUCs of 0.81 and 0.80. LIMITATIONS, REASONS FOR CAUTION: Our study relied on 2D transvaginal sonography to quantify the AFC and manual Gen II assay for AMH determination and classification of patients. AMH data must be interpreted in an assay-specific manner. Treatment protocols varied across centers potentially affecting patient classification. WIDER IMPLICATIONS OF THE FINDINGS: Three of four patients will be classified the same using either AFC or AMH values. Both biomarkers provide acceptable and equivalent accuracy in predicting oocyte yield further supporting their use and proposed thresholds in daily clinical practice for patient classification according to the POSEIDON criteria. However, the sensitivity of POSEIDON thresholds in predicting low oocyte yield is low. Clinicians should adopt the biomarker that may best reflect their clinical setting. STUDY FUNDING/COMPETING INTEREST(S): Unrestricted investigator-sponsored study grant (MS200059_0013) from Merck KGaA, Darmstadt, Germany. The funder had no role in study design, data collection, analysis, decision to publish or manuscript preparation. S.C.E. declares receipt of unrestricted research grants from Merck and lecture fees from Merck and Med.E.A. H.Y. declares receipt of payment for lectures from Merck and Ferring. L.N.V. receives speaker fees and conferences from Merck, Merck Sharp and Dohme (MSD) and Ferring and research grants from MSD and Ferring. T.M.H. received speaker fees and conferences from Merck, MSD and Ferring. The remaining authors have nothing to disclose. TRIAL REGISTRATION NUMBER: not applicable.

A pilot agreement study of a new classification system for Peri-implant femoral fractures.

BACKGROUND: Peri-implant fractures occur in association with an implant, used to treat a previous injury that is still attached to the bone. We recently published a proposal for a classification system for peri-implant femoral fractures [Videla-Cés, Injury,2019]. AIM: To assess the agreement of our classification system for peri-implant femoral fractures among a group of future users of said classification system. METHODS: A prospective, multicentre, international agreement pilot study was conducted among a group of independent traumatologists/orthopaedic surgeons (evaluators): senior (a minimum of 10 years' experience) and junior (in fourth or fifth training year). A set of 30 radiographs of peri-implant femoral fractures were selected (stratified into 3 levels of difficulty: low, medium and high). Each evaluator interpreted the radiographs on 2 different occasions separated by a period of one month and in a different order each time. The level of difficulty was masked from the evaluators and they had one week to classify the radiographs each time. Logistic regression and Cohen's kappa coefficient (κ) and its 95% confidence interval (95%CI) were used to assess the accuracy and agreement, both intra- and inter-evaluator. Between senior and junior surgeons was performed an exploratory analysis. RESULTS: 35 traumatologists/orthopaedic surgeons (17 senior and 18 junior) from 16 tertiary hospitals from 4 countries acted as evaluators. The accuracy, percentage of correct classifications (2 digits and 3 letters), in the first and second evaluation was: 56% (95%CI: 53-59%) and 55% (95%CI: 51-57%), respectively. (insert space) Negligible differences were found between junior and senior evaluators (first evaluation, OR: 1.46, 95%CI: 0.82-2.61, p-value: 0.199; second evaluation, OR: 1.06, 95%CI: 0.56-2.00, p-value: 0.860). (insert space) Both medium and low radiograph difficulty were associated with a lower probability of an incorrect classification compared with those of high difficulty (first evaluation, OR: 7.60, 95%CI: 5.24-11.05, p-value: <0.001; OR: 14.15, 95%CI: 9.12-21.96, p-value: <0.001, respectively; second evaluation, OR: 7.11, 95%CI: 4.88-10.38, p-value: <0.001, OR: 15.28, 95%CI: 9.77-23.89, p-value: <0.001). (insert space) The kappa for intra-observer agreement between the first and second evaluation was: 0.66, 95%CI: 0.63, 0.69. The kappa for inter-observer agreement considering all 30 radiographs was: 0.40, 95%CI: 0.40, 0.41 in the first evaluation and 0.39, 95%CI: 0.39, 0.40 in the second evaluation. CONCLUSION: The proposed classification for peri-implant femoral fractures may be useful and user-friendly. Future studies are needed to assess the how clinically useful this classification system may be (the third phase in the validation process).

Intra- and interobserver concordance of a new classification system for myopic maculopathy.

BACKGROUND: Myopic maculopathy (MM) is one of the major causes of visual impairment and irreversible blindness in eyes with pathologic myopia (PM). However, the classification of each type of lesion associated with MM has not been determined. Recently, a new MM classification system, known as the ATN grading and classification system, was proposed; it is based on the fundus photographs and optical coherence tomography (OCT) images and includes three variable components: atrophy (A), traction (T), and neovascularization (N). This study aimed to perform an independent evaluation of interobserver and intraobserver agreement for the recently developed ATN grading system for MM. METHODS: This was a retrospective study. Fundus photographs and OCT images of 125 patients (226 eyes) with various MMs were evaluated and classified using the ATN grading of the new MM classification system by four blinded and independent evaluators (2 attending ophthalmologists and 2 ophthalmic residents). All cases were randomly re-evaluated by the same observers after an interval of 6 weeks. The kappa coefficient (κ) and 95% confidence interval (CI) were used to determine the interobserver and intraobserver agreement. RESULTS: The interobserver agreement was substantial when considering the maculopathy type (A, T, and N). The weighted Fleiss κ values for each MM type (A, T, and N) were 0.651 (95% CI: 0.602-0.700), 0.734 (95% CI: 0.689-0.779), and 0.702 (95% CI: 0.649-0.755), respectively. The interobserver agreement when considering the subtypes was good or excellent, except for stages A1, A2, and N1, in which the weighted κ value was less than 0.6, with moderate agreement. The intraobserver agreement of types and subtypes was excellent, with κ > 0.8. No significant differences were observed between the attending ophthalmologists and residents for interobserver reliability or intraobserver reproducibility. CONCLUSIONS: The ATN classification allows an adequate agreement among ophthalmologists with different qualifications and by the same observer on separate occasions. Future prospective studies should further evaluate whether this classification can be better implemented in clinical decision-making and disease progression assessments.

An independent inter- and intraobserver agreement assessment of the AOSpine sacral fracture classification system.

BACKGROUND CONTEXT: The AOSpine sacral classification scheme was recently described. It demonstrated substantial interobserver and excellent intraobserver agreement in the study describing it; however, an independent assessment has not been performed. PURPOSE: To perform an independent inter- and intraobserver agreement evaluation of the AOSpine sacral fracture classification system. STUDY DESIGN: Agreement study. METHODS: Complete computerized tomography (CT) scans, including axial images, with coronal and sagittal reconstructions of 80 patients with sacral fractures were selected and classified using the morphologic grading of the AOSpine sacral classification system by six evaluators (from three different countries). Neurological modifiers and case-specific modifiers were not assessed. After a four-week interval, the 80 cases were presented to the same raters in a random sequence for repeat assessment. We used the Kappa coefficient (κ) to establish the inter- and intraobserver agreement. RESULTS: The interobserver agreement was substantial when considering the fracture severity types (A, B, or C), with κ=0.68 (0.63-0.72), but moderate when considering the subtypes: κ=0.52 (0.49-0.54). The intraobserver agreement was substantial considering the fracture types, with κ=0.69 (0.63-0.75), and considering subtypes, κ=0.61 (0.56-0.67). CONCLUSION: The sacral classification system allows adequate interobserver agreement at the type level, but only moderate at the subtypes level. Future prospective studies should evaluate whether this classification system allows surgeons to decide the best treatment and to establish prognosis in patients with sacral fractures.