Intraobserver Agreement Research Articles

Evaluating inter- and intraobserver reliability in radiographic determination of wrist alignment following scaphoid excision and four-corner arthrodesis

BackgroundFour-corner arthrodesis is commonly performed for advanced collapse patterns of wrist arthritis. Reduction of the capitolunate (CL) angle during four-corner fusion is crucial to allow for the greatest radiocarpal joint arc of motion. Previous studies demonstrate variable inter- and intraobserver reliability of measuring the CL angle. However, in a four-corner fusion, hardware implementation and scaphoid excision can complicate carpal alignment measurements. The purpose of this study is to investigate inter- and intraobserver reliability of measuring carpal alignment parameters following scaphoid excision and four-corner arthrodesis. MethodsThree fellowship-trained orthopaedic hand surgeons evaluated 30 posteroanterior and lateral radiographs of wrists after scaphoid excision and four-corner fusion. Radiographic evaluation included analysis of the radiolunate angle (RL), CL angle, lunate posture, carpal height, carpal height ratio, hardware impingement, and arthrodesis technique. Intraclass correlation coefficients (ICCs) and kappa values were used to evaluate reliability of radiographic measurements. ResultsRL and CL angles demonstrated very good inter- (ICCs: 0.657 and 0.693, respectively) and intraobserver agreement (ICCs: 0.576 to 0.924 and 0.596 to 0.811, respectively). Hardware impingement metrics by dorsal prominence and radiocarpal prominence had excellent interobserver reliability of 0.821 and 0.803, respectively. ICC values for arthrodesis technique were equal to 1.00. The inter- and intraobserver ICC values for the number of screws/staples used were in excellent agreement ranging from 0.910 to 1.000. ConclusionsOur study demonstrated favorable intra- and interobserver reliability at assessing carpal alignment following scaphoid excision and four-corner arthrodesis and these metrics potentially could be used in future research to evaluate long-term surgical outcomes. Level of evidenceLevel III, retrospective cohort study.

The validity and reliability of CT scan based tibial plateau mapping for tibial plateau fractures

Introduction The Schatzker and computed tomography (CT)-based three-column classifications are the most used for tibial plateau fractures. The newer “10-segment classification” suggested to have better fracture identification and more accurate planning. This study aimed to assess the interobserver and intraobserver reliability of this new classification and to clarify its validity in clinical practice. Patients and methods A retrospective analysis of 30 patients with tibial plateau fractures who were admitted to a university hospital through the period between January 2020 and December 2022 was done. Patients with complete preoperative imaging, including radiographs, CT scans with three-dimensional reconstruction, and postoperative radiographs were included. Missing imaging, open fractures, pathological fractures, conservative management, or definitive fixation by circular external fixator were excluded. Data were reviewed independently by three expert trauma surgeons twice with 2-week intervals with randomization of case sequencing to evaluate their interobserver and intraobserver reliability for the Schatzker, CT-based three-column, and the new 10-segment classifications. The validity of the 10-segment classification was assessed by the agreement on the approach and implant position suggested by the observers. Results Good interobserver and intraobserver reliability was found as regards the Schatzker and CT-based three-column classifications on both intervals. Moderate and poor interobserver reliability “on both intervals respectively” and poor intraobserver reliability was found for the 10-segment classification. As regards the agreement on surgical approach on both time intervals, moderate and good interobserver agreements were found. For the implant position, poor interobserver agreement on both intervals was found. Intraobserver agreement for the surgical approach was good, while the intraobserver agreement for the implant position was moderate. Conclusion The Schatzker and CT-based three-column classifications are still more reliable than the newer 10-segment classification. This may be explained as it is still not familiar to surgeons and needs more training to be applied in clinical practice.

Digital matching of palatal rugae patterns for forensic identification in edentulous denture wearers.

Identifying edentulous victims in forensic contexts poses a significant challenge. It has been reported that having a denture to reproduce and compare Palatal Rugae (PR) patterns is crucial for identifying edentulous individuals, yet there are no validated protocols for conducting this procedure. In this study, a new method was developed and validated for plaster molding of the internal surface of upper dentures, along with a protocol involving focus-stacked photographs and reference scales. Thirty-eight edentulous subjects participated in the study, obtaining plaster models of the patients (PM), and their dentures (AM) were standardized. The AM/PM model was highlighted and photographed with ten shots in different z-focuses for each model, using standard lighting and aligning the position of the PR perpendicular to the photographic axis using tubular spirit levels and modeling clay. The images were processed using the stacking technique and analyzed by three observers through the proposed protocol using Adobe® Photoshop®. The results were analyzed based on the intra-observer and inter-observer agreement levels, with a 95% confidence interval. This study demonstrated high-precision intra-observer and inter-observer agreement (k = 1) in the matching of Palatal Rugae (PR) and maxillary morphology obtained from participants and their dentures. The protocol is simple, cost-effective, and precise. It enables standardization of the technique for obtaining plaster models, and the exposure of PR and photographic protocol minimizes the presence of artifacts in the images, thereby reducing the likelihood of errors and promoting the reproducibility of both the recording technique and the comparison of the PR.

Craniocervical Morphometry in Pomeranians-Part I: Intra-Observer, Interobserver, and Intermodality (CT vs. MRI) Agreement.

Currently, there are no diagnostic imaging-based studies that have focused specifically on the craniocervical morphology of Pomeranian dogs in relation to Chiari-like malformation and syringomyelia (CM/SM). The aims of Part I of this two-part study are to assess the intra-observer, interobserver, and intermodality reliability and agreement for various aspects of the craniocervical morphology of Pomeranians with and without CM/SM. Prospectively, Pomeranians were included that underwent both CT and MRI studies of the head and cervicothoracic vertebral column. Two observers (experienced and novice) independently performed CM and SM classifications, qualitative assessments, and quantitative measurements. The experienced observer performed these assessments twice. A third observer (experienced) performed CM and SM normal or abnormal classifications. Ninety-nine (99) dogs were included. Interobserver reliability was influenced by observer experience level. For the experienced versus novice observers, substantial interobserver agreement was found for classification of SM as normal or abnormal (Cohen's kappa = 0.63), while interobserver agreement was fair for classification of SM as normal or abnormal (Cohen's kappa = 0.31). Interobserver, intra-observer, and intermodality reliability were variable for different measurements and assessments, and best overall for the CT-based measurements. Interobserver reliability and agreement results should be taken into account in the evaluation of results of future studies as well as the evaluation of imaging studies of Pomeranians presented clinically.

Evaluation of the Tibial Plateau-Patella Angle (TPPA) in Dogs.

Estimating a dog's patellar position involves various methods, which categorize it as norma, alta (high), or baja (low). However, they require various calculations. We aimed to evaluate the clinical applicability of a new method, the tibial plateau-patella angle (TPPA). This could aid in planning patella luxation surgery, estimating the patella position after TPLO and various osteotomies. We conducted a two-step study: first, on 15 stifles without pathologies from nine canine cadavers, and second, using 100 patient X-rays from the archive. Three stifle angle positions (45 ± 5°, 90 ± 5°, and 135 ± 5°) and three weight groups (S, M, and L) were evaluated in the first part of this study. Based on these results, the second part of this study was conducted using 100 pathology-free radiographs at the optimal stifle angle (90 ± 5°) from the archive. All radiographs were measured by three observers with varying levels of experience. Our results indicate that the stifle angle significantly impacted the TPPA, whereby lower values were detected with higher stifle angles, which remained consistent within the weight groups. High inter- and intra-observer agreement was achieved. The physiological TPPA values ranged from 26.7° to 48.8°, remaining consistent within the various weight groups. Observer 3 in Group S exhibited a 20% (insignificant) deviation, possibly due to challenges in determining the caudal point of the tibial plateau. In contrast with humans, TPPA values in dogs are negatively correlated with stifle angles, independent of weight. Our reliable and reproducible protocol suggests the potential benefits of training on small-breed dogs stifles.

A method for accuracy of placement analysis on radiolucent polyether-ether-keton facial implants: A case series

Facial asymmetry is defined as a bilateral difference between facial components. Correction, often desired by the patient, can be performed with the aim of bone born patient-specific solid implants designed using 3D CAD software. This treatment is embedded in the daily practice of today's healthcare. However, an analysis of the implant's accuracy of placement has not been reported. This case series describes the accuracy analysis of bone born aesthetic facial implants manufactured out of polyether-ether-ketone (PEEK). The accuracy analysis was based on postoperative (cone beam) computed tomography ((CB)CT) data and preoperative 3D planning. The analysis showed a median entry point error of 0.7 mm (min: 0.1, max: 3.3, interquartile range: 0.78). The median maximal orientation error was 5.5° (min: 0.1, max: 36.8, interquartile range: 7.13). Both parameters showed an excellent intraobserver and interobserver agreement with an ICC above 0.84. The described cases show that the analysis method is an objective approach for determining the accuracy of PSI placement and indicates that these implants can be placed accurately on the osseous face.

Total kidney volume in autosomal dominant polycystic kidney disease: intraobserver and interobserver agreement of two methods with MRI.

Total kidney volume (TKV) is a parameter used in both treatment decision and follow-up in autosomal dominant polycystic kidney disease (ADPKD) patients. The objective of this study was to evaluate intra- and interobserver agreement of the ellipsoid formula (EF) and manual boundary tracing method (MBTM) used in TKV measurement of ADPKD patients across different levels of experience radiologists. Additionally, the study aimed to evaluate the correlation between the EF and MBTM, which is considered the gold standard for TKV. A retrospective evaluation was conducted on magnetic resonance imaging (MRI) data from 55 ADPKD patients who underwent abdominal MRI between January 2017 and November 2021 to evaluate TKV. TKV measurements were performed by three independent observers (observer 1, an abdominal imaging radiologist with 5 years of experience; observer 2, a fourth-year radiology resident; observer 3, a second-year radiology resident).To assess intraobserver variability, all observers repeated the measurements at two-week intervals. The ICC was used to assess both intraobserver and interobserver variability. A comparison of the two methods was performed by linear regression for all three observers. The ICC (95% CI) indicated excellent agreement between the observers for both methods (among all observers, p < 0.001). Furthermore, excellent intraobserver agreement was found between all observer measurements either EF or MBTM based on ICC (95% CI) (p < 0.001). The results of the linear regression analysis demonstrated high correlations between the two methods in all three observers (r = 0.992, p < 0.001 for the first observer; r = 0.975, p < 0.001 for the second observer; r = 0.989, p < 0.001 for the third observer). Both the EF and MBTM methods used for the measurement of TKV provided excellent intra- and interobserver reproducibility. The EF is as accurate and precise as the MBTM. It may therefore be preferred in radiology departments with heavy workload, as it is a reliable method for rapid and easy assessment, independent of experience.

Magnetic Resonance Imaging Features of Anterolateral Ligament in Young Adults without Anterior Cruciate Ligament Injury: Preliminary Evaluation.

This study aimed to characterize the Magnetic Resonance Imaging (MRI) features of the Anterolateral Ligament (ALL) in young adults without Anterior Cruciate Ligament (ACL) injury and evaluate its visibility using MRI. In this retrospective analysis, MRI scans of 66 young adults without ACL injuries were assessed by two radiologists. The ALL was examined from its bone-to-bone attachment between the lateral femoral epicondyle and the lateral tibia. The visibility of the ALL was classified as normal, probably normal, abnormal, or non-visualized, based on ligament continuity and thickness relative to the Meniscotibial Ligament (MTL). A continuous structure with thickness equal to or greater than the MTL was considered normal; continuous but wavy and thin features were categorized as probably normal; discontinuity and angulation were deemed abnormal. The proximal attachment of the ALL was categorized as anterior, central, or posterior to the Fibular Collateral Ligament (FCL), while the distal attachment was noted as either at the same location or distal to the MTL. The ALL was identified in 87.9-95.5% of knees and was non-visualized in 4.5-12.1% of cases. Continuous ligamentous structures were observed in 63.7-71.2% of knees (normal in 30.3-37.9%; probably normal in 27.3-40.9%), whereas 19.7-30.3% exhibited abnormal features. Inter-observer agreement was moderate to substantial (κ = 0.66, 0.56), and intra-observer agreement was substantial to excellent (κ = 0.82, 0.66). Among the 58 visible ALLs, proximal attachments were predominantly anterior (63.8%) or central (32.8%) to the FCL, with a minority posterior (1.7%). In total, 4 of the 19 central insertions were incorporated into the FCL mid-substance, and one case was blended into the meniscofemoral ligament. Distal attachments were equally distributed between the same location (50%) and distal to the MTL (50%) (mean 3.7 mm distal). In conclusion, MRI was feasible for detecting the ALL in most young adults without ACL injury, revealing continuous ligament structures in about two-thirds of cases. Approximately 40% of cases exhibited a thickness equal to or greater than the MTL, with the majority of proximal attachments located anterior to the FCL and distal attachments evenly divided between the same insertion and distal to the MTL.

Intracapsular neck of femur fractures secondary to civilian gunshot injuries: an inter- and intra-observer agreement study on classification and treatment using the AO/OTA classification

PurposeNumerous classification systems have been developed for neck of femur fractures, but none have been tested for reliability in gunshot injuries. Our primary objective was to assess the inter-observer and intra-observer reliability of the AO/OTA classification system when applied to intracapsular neck of femur fractures secondary to low-velocity civilian gunshots wounds (GSWs). Our secondary objective was to test the reliability of the AO/OTA classification system in guiding surgeon treatment choices for these fractures.Patients and methodsEighteen reviewers (six orthopaedic traumatologists, six general orthopaedic surgeons and six junior orthopaedic fellows) were given a set of 25 plain radiographs and CT scans of femur neck fractures secondary to GSW. For each clinical case, all reviewers selected a classification as well as treatment option from a list of given options. Inter-observer reliability was measured at the initial classification. The exercise was repeated 10–12 weeks later by the same 18 reviewers to test intra-observer reliability.ResultsThe Fleiss kappa values indicate only slight agreement amongst raters, across all experience levels, for both injury classification and treatment. Intra-observer agreement was fair across all experience levels for both injury classification and treatment.ConclusionThe AO/OTA classification showed only slight reliability in classification of gunshot fractures of the femur neck. With only fair reliability, it also failed to guide surgical treatment thus rendering its routine use in daily clinical practice of questionable value.

Endoscopic scoring indices for assessing disease severity in familial adenomatous polyposis: Systematic review.

Background and study aims There is limited consensus on the optimal method for measuring disease severity in familial adenomatous polyposis (FAP). We aimed to systematically review the operating properties of existing endoscopic severity indices for FAP. Methods We searched MEDLINE, EMBASE, and the Cochrane Library from inception to February 2023 to identify randomized controlled trials (RCTs) that utilized endoscopic outcomes or studies that evaluated the operating properties of endoscopic disease severity indices in FAP. Results A total of 134 studies were included. We evaluated scoring indices and component items of scoring indices, such as polyp count, polyp size, and histology. Partial validation was observed for polyp count and size. The most commonly reported scoring index was the Spigelman classification system, which was used for assessing the severity of duodenal involvement. A single study reported almost perfect interobserver and intra-observer agreement for this system. The InSIGHT polyposis staging system, which was used for assessing colorectal polyp burden, has been partially validated. It showed substantial interobserver reliability; however, the intra-observer reliability was not assessed. Novel criteria for high-risk gastric polyps have been developed and assessed for interobserver reliability. However, these criteria showed a poor level of agreement. Other scoring indices assessing the anal transition zone, duodenal, and colorectal polyps have not undergone validation. Conclusions There are no fully validated endoscopic disease severity indices for FAP. Development and validation of a reliable and responsive endoscopic disease severity instrument will be informative for clinical care and RCTs of pharmacological therapies for FAP.

Verifying a novel bile cytology scoring system.

The scoring system for bile cytology (SSBC) aims to improve bile cytology diagnostic accuracy. Here, the practicality of SSBC was verified by multiple cytotechnologists. Bile cytological specimens were evaluated by 24 cytotechnologists using SSBC. The samples were assessed before using the SSBC (first-time assessment) according to three categories: benign, indeterminate, and malignant. A first scoring evaluation (FSE) was then performed using SSBC; each item in the scoring system was classified as present or absent. After distributing an instruction sheet with diagnostic criteria, a second scoring evaluation (SSE) was performed using SSBC. Each method was evaluated using diagnostic accuracy and interobserver and intraobserver agreement. Several samples were assessed as indeterminate in the first-time assessment. Although the specificity of the SSE improved, the sensitivity and accuracy decreased compared with those of the FSE. The overall interobserver agreement was fair for all parameters, including abnormal chromatin, irregular internuclear distances, irregularly overlapped nuclei, irregular cluster margins, and final evaluation in the FSE and SSE. The final evaluation by histological type exhibited slight agreement for well-differentiated tubular adenocarcinoma and almost perfect agreement for poorly differentiated tubular adenocarcinoma in the FSE and SSE. For moderately differentiated tubular adenocarcinoma, agreement was moderate in the FSE and fair in the SSE. For cholangitis, a slight agreement was observed in the FSE, which improved to fair in the SSE. Although the SSBC is expected to improve specificity, there exists ambiguity regarding SSBC criteria and interindividual assessment differences. Therefore, the objective assessment method should be revised.

The TACOs (time-based assessment computerized strategy) approach to evaluating occupational working postures.

Many investigations of biomechanical overload concentrate on upper limbs and manual handling: certain jobs require an evaluation on spinal and lower limb postures. While existing methodologies adequately describe postures, they often poorly consider the organisation. This shortcoming prompted the development of TACOs for spinal and lower limb postures, using organisational factors to adjust the risk indexes. The TACOs is set out in steps: task identification, posture assessment, duration, and a final evaluation also for complex cycles. Given the complexity, tools have been devised, free downloadable, to facilitate evaluation. Studies on the TACOs reliability indicate excellent intra-observer and moderate interobserver agreement. TACOs, defining the task as a measurement unit, offers the advantage of assessing postures more easily and, considering duration, provides precise evaluation of the final risk. While the method does not demonstrate predictive validity regarding related diseases, it nonetheless enables the classification of exposure levels, even in complex multitask scenarios.

Amniotic sac reference interval in early pregnancy between 7 and 10 weeks' gestation.

To establish a normal reference interval for amniotic sac measurements between 7 and 10 weeks of gestation and its relative size in relation to the gestational sac and the embryo. This was a prospective, cross-sectional study of consecutive women presenting to UCLH Early Pregnancy Unit between August 2022 to June 2023. We included live, normally sited, singleton pregnancies with a normal 20-week anomaly scan. We collected 120 cases per gestational week totaling 360 cases. We performed an inter and intra-observer variability assessment in the measurement of mean ASD in 30 patients. Regression analyses were used to establish reference intervals for GSD to CRL, ASD to CRL, GSD to ASD and GSD:ASD ratio to CRL. The fitted regression line was calculated, along with a 90% prediction interval and the R2 value. There was good interobserver agreement (difference 0.007mm ± 1.105 (95%CI -2.160 to 2.174)) and good intra-observer agreement between Observer A (0.007 ± 1.105 (-2.160 to 2.174)) and Observer B (-0.014 ± 0.919 (-1.814 to 1.786)) in the measurement of mean ASD in 30 patients. Regression analyses showed a highly statistically significant association between each pair of values (all p-values <0.001). There were significant quadratic associations between mean GSD and CRL (R2 = 56%) and mean GSD and ASD (R2 = 60), significant cubic association between ASD and CRL (R2 = 90%) and significant quadratic association between GSD to ASD ratio and CRL (R2 = 68%). The regression equations were used to quantify the values of ASD and GSD to ASD ratios for a range of CRL values and gestational age in days. Our study has produced comprehensive reference intervals for amniotic sac size in early pregnancy which could be used in routine clinical practice. This article is protected by copyright. All rights reserved.

A Proposal of a New Tool for the Assessment of Damage in Behçet Syndrome Uveitis: Cerrahpasa Ocular Damage Grading System

ABSTRACT Introduction/Objective There is currently no tool available to assess the severity of damage in uveitis due to Behçet’s syndrome (BS). In this preliminary study, we developed a new grading system to evaluate ocular damage and assessed it in a prospective cohort. Methods A specialist in BS uveitis (YO) developed a grading system for ocular damage with five grades based on the extent of damage in the posterior segment. YO trained a senior and general ophthalmologist with sample fundus images. BS patients who had undergone color fundus photography during their routine visits in attack-free periods were included in the study. The color fundus photos of this prospective cohort were evaluated blindly by YO and his trainees using the new grading tool. Inter and intra-observer agreement between the graders were assessed by Cohen’s kappa analysis. The evaluation of YO was considered as the gold standard. Results One hundred eighty-five eyes of 108 (29 F/79 M) patients with BS uveitis were graded for damage by two investigators. Their mean age was 38,58 years and their median ocular disease duration was 13 years. The gold standard and the two investigators exhibited substantial concordance with the ocular damage grading system. The inter- and intra-observer agreement were also almost perfect. Conclusion The newly developed ocular damage grading system enables the standardization of damage severity in BS uveitis. It is imperative to conduct internal and external validations across diverse cohorts. Furthermore, future studies should investigate its correlation with other multimodal imaging methods such as fluorescein angiography and optical coherence tomography.

Validation of computer-based analysis of static ultrasound images of patellar and Achilles tendon enthesis territories

Aim: The aim of the present study is to conduct interobserver and intra-observer validation of computer analysis of static ultrasound images of entheseal territories of the Achilles and distal patellar tendons. Methods: Three rheumatologists with varying levels of experience underwent training in the use of ImageJ software for the analysis of 384 pairs of ultrasound images (long and short axis) from recorded studies of the Achilles and patellar tendons of both spondyloarthritis (SpA) patients and controls. Intra-observer and interobserver tests were conducted by calculating the differences in measurements of the same image at two different times by the same observer and by two different observers assessing the same image. The measurements included the area of analysis, the mean grayscale intensity, and the dispersion of grayscale intensity. Results: In the intra-observer test, no measurement showed a difference greater than 15%, ranging from 4.10% to 14.14%. In the interobserver test, no measurement exhibited a difference greater than 16%, ranging from 7.96% to 15.87%. The differences detected were evenly distributed among observers in both the intra-observer and inter-observer tests. Higher differences were detected in the analysis of images obtained from patient studies compared to control studies in almost all measurements. Conclusions: Whether analyzing control or patient ultrasound images of Achilles and patellar tendons, the intra-observer and interobserver agreement of computer-based analysis of static ultrasound images is more than acceptable and predominantly excellent.

Validation of the Behçet's Syndrome Overall Damage Index (BODI) for Retrospective Studies and a Proposal for Modification.

Assessment of damage accrual over time is important for evaluating and comparing long-term results of treatment modalities and strategies. Retrospective studies may be useful for assessing long-term damage, especially in rare diseases. We aimed to validate Behçet's Syndrome Overall Damage Index (BODI) for use in retrospective studies by evaluating its construct validity, reliability, and feasibility in retrospectively collected data. Additionally, we aimed to determine missing items by evaluating Behçet's syndrome patients with different types of organ involvement and long-term follow-up. We included 300 patients who had at least 2 clinic visits at 1-year intervals. The construct validity for use in retrospective trials was assessed by comparing BODI scores calculated from patient charts and during face-to-face visits. BODI was additionally scored using retrospective chart data by 2 different observers and by the same observer six months apart, in a blinded manner. The time for filling BODI was evaluated to assess feasibility. Additionally, damaged items that were missing from BODI were identified. There was a good correlation between the retrospective and face-to-face evaluation of BODI (ICC 0.99; %95 CI 0.99-0.99). Inter-observer and intra-observer agreement were good (ICC 0.96 and 1, respectively). The main damage items that BODI did not capture were hypertension, liver failure, lung parenchymal involvement, glaucoma, and lymphedema. BODI seems to be a reliable and feasible instrument for assessing damage in retrospective studies. Modifying BODI using the additional damage items identified in this study may make it an even better scale.

Assessment of inter- and intraobserver agreement for META score in distinguishing osteoporotic from multiple myeloma vertebral fractures.

To conduct an independent assessment of inter- and intraobserver agreement for the META score as a tool for differentiating osteoporotic vertebral fractures and multiple myeloma vertebral fractures. This is a retrospective observational study. The magnetic resonance imaging analysis was made by two independent spinal surgeons. We designated a Subjective assessment, in which the surgeon should establish a diagnostic classification for each vertebral fracture based on personal experience: secondary to osteoporosis, categorized as a benign vertebral fracture (BVF), or attributed to multiple myeloma, categorized a malign vertebral fracture (MVF). After a 90-day interval, both surgeons repeated the evaluations. For the next step, the observers should establish a diagnosis between BVF and MVF according to the META score system, and both observers repeated the evaluations after a 90-day interval. The intra and interobserver reliability of the Subjective evaluation was studied using the kappa (κ) test. Then, the META evaluations were paralleled using the intraclass correlation coefficient (ICC). A total of 220 patients who had the potential to participate in the study were initially enrolled, but after applying the exclusion criteria, 44 patients were included. Thirty-three patients had BVF, and 12 patients presented MVF. Interobserver agreement for both Subjective evaluations moments (initial and 90-days interval) found a slight agreement for both moments (0.35 and 0.40 respectively). Kappa test for both META evaluations moments (initial and 90-days interval) found a moderate interobserver agreement for both moments (0.54 and 0.48 respectively). It was observed that the ICC calculated for the Initial evaluation using META score was 0.680 and that in the 90-days interval was 0.726, indicating regular to good agreement. Kappa test for intraobserver agreements for the Subjective evaluation presented moderate agreement for both Surgeons. On the other side, Kappa test for intraobserver agreements for the META evaluation presented substantial agreement for both Surgeons. The Intraclass Correlation Coefficient of the META score found presented an almost perfect agreement for both Surgeons. Intra and interobserver agreement for both surgeons were unsatisfactory. The lack of consistent reproducibility by the same observer discourages and disfavors the routine use of the META score in clinical decision making, when potentially cases of multiple myeloma may be present.

Influence of intercostal muscles contraction on sonographic evaluation of lung sliding: a physiological study on healthy subjects

ObjectivesTo investigate the following: (a) effects of intercostal muscle contraction on sonographic assessment of lung sliding and (b) inter-rater and intra-observer agreement on sonographic detection of lung sliding and lung pulse.MethodsWe used Valsalva and Muller maneuvers as experimental models in which closed glottis and clipped nose prevent air from entering the lungs, despite sustained intercostal muscles contraction. Twenty-one healthy volunteers underwent bilateral lung ultrasound during tidal breathing, apnea, hyperventilation, and Muller and Valsalva maneuvers. The same expert recorded 420 B-mode clips and 420 M-mode images, independently evaluated for the presence or absence of lung sliding and lung pulse by three raters unaware of the respiratory activity corresponding to each imaging.ResultsDuring Muller and Valsalva maneuvers, lung sliding was certainly recognized in up to 73.0% and up to 68.7% of imaging, respectively, with a slight to fair inter-rater agreement for Muller maneuver and slight to moderate for Valsalva. Lung sliding was unrecognized in up to 42.0% of tidal breathing imaging, and up to 12.5% of hyperventilation imaging, with a slight to fair inter-rater agreement for both. During apnea, interpretation errors for sliding were irrelevant and inter-rater agreement moderate to perfect. Even if intra-observer agreement varied among raters and throughout respiratory patterns, we found it to be higher than inter-rater reliability.ConclusionsIntercostal muscles contraction produces sonographic artifacts that may simulate lung sliding. Clinical studies are needed to confirm this hypothesis. We found slight to moderate inter-rater agreement and globally moderate to almost perfect intra-observer agreement for lung sliding and lung pulse.Trial registrationClinicalTrials.gov registration number.NCT 02386696.

Patient perspectives in adverse event reporting after vaginal apical prolapse surgery

BackgroundMany clinical trials use systematic methodology to monitor adverse events (AE) and determine grade (severity), expectedness, and relatedness to treatments as determined by clinicians. However, patient perspective in the process remains lacking. ObjectivesTo compare clinician versus patient grading of AE severity in a urogynecologic surgical trial. Secondary objectives were to estimate the association between patient grading of AEs with decision-making and quality of life outcomes and to determine if patient perspective changes over time. Study DesignThis was a planned supplementary study, “Patient-Perspectives in Adverse Event Reporting” (PPAR), to a randomized trial comparing 3 surgical approaches to vaginal apical prolapse. In the parent trial, AEs experienced by patients were collected per a standardized protocol every 6 months where clinicians graded AE severity (mild, moderate, severe/life threatening). In this sub-study, we obtained additional longitudinal patient perspectives for 19 predetermined “PPAR AEs”. Patients provided their own severity grading (mild, moderate, severe/very severe/ life threatening) at initial assessment and at 12 and 36 months postoperatively. Clinicians and patients were masked to each other’s reporting. The primary outcome was the interrater agreement (kappa statistic, κ) for AE severity between the initial clinician and patient assessment, combining patient grades of mild and moderate. Association between AE severity and the Decision-Regret Scale (DRS), Satisfaction with Decision Scale (SDS), the Short-Form Health Survey-12 (SF-12), and Patient-Global Impression of Improvement (PGI-I) scores were assessed utilizing Spearman’s correlation coefficient (ρ) for continuous scales, Mantel-Haenszel chi-squared test for PGI-I, and T-tests or chi-squared tests comparing assessments of severe vs other grades. To describe patient perspective changes over time, the intra-observer agreement was estimated for AE severity grade over time using weighted kappa-coefficients. ResultsOf 360 patients randomized, 219 (61%) experienced a total of 527 PPAR AEs (91% moderate and 9% severe/life threatening by clinician grading). Mean patient age was 67 years, 87% were White, and 12% Hispanic. Of patients reporting any PPAR event, the most common were urinary tract infection (61%), de novo urgency urinary incontinence (35%), stress urinary incontinence (22%), and fecal incontinence (13%).Overall agreement between clinician and participant grading of severity was poor (κ=0.24 (95%CI 0.14, 0.34). Of 414 AEs clinicians graded as moderate, patients graded 120 (29%) mild, and 80 (19%) severe. Of 39 AEs graded severe by clinicians, patients graded 15 (38%) mild or moderate. Initial patient grading of the most severe reported AE was mildly correlated with worse DRS (ρ=0.2, p=0.01), SF-12 (ρ=-0.24, p<0.01) and PGI-I (p<0.01). There was no association between AE severity and SDS. Patients with an initial grading of “severe” had more regret, lower quality of life, and poorer global impressions of health than those whose worst severity grade was mild (p<0.05). Agreement between the patients’ initial severity and later timepoints was fair at 12 months (κ=0.48 (95% CI 0.39, 0.58)) and 36 months (κ=0.45 (95% CI 0.37, 0.53)). ConclusionsClinician and patient perceptions of AE severity are discordant. Worse severity from the patient perspective was associated with patient-centered outcomes. Including the patient perspective provides additional information for evaluating surgical procedures.

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

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