Overall Percentage Of Agreement Research Articles

Clinical validation of the Lumipulse G cerebrospinal fluid assays for routine diagnosis of Alzheimer\u2019s disease

BackgroundOngoing efforts within the Alzheimer’s disease (AD) field have focused on improving the intra- and inter-laboratory variability for cerebrospinal fluid (CSF) biomarkers. Fully automated assays offer the possibility to eliminate sample manipulation steps and are expected to contribute to this improvement. Recently, fully automated chemiluminescence enzyme immunoassays for the quantification of all four AD biomarkers in CSF became available. The aims of this study were to (i) evaluate the analytical performance of the Lumipulse G β-Amyloid 1-42 (restandardized to Certified Reference Materials), β-Amyloid 1-40, total Tau, and pTau 181 assays on the fully automated LUMIPULSE G600II; (ii) compare CSF biomarker results of the Lumipulse G assays with the established manual ELISA assays (INNOTEST®) from the same company (Fujirebio); and (iii) establish cut-off values and the clinical performance of the Lumipulse G assays for AD diagnosis.MethodsIntra- and inter-assay variation was assessed in CSF samples with low, medium, and high concentrations of each parameter. Method comparison and clinical evaluation were performed on 40 neurological controls (NC) and 80 patients with a diagnosis of probable AD supported by a follow-up ≥ 3 years and/or positive amyloid PET imaging. A small validation cohort of 10 NC and 20 AD patients was also included to validate the cut-off values obtained on the training cohort.ResultsThe maximal observed intra-assay and inter-assay coefficients of variation (CVs) were 3.25% and 5.50%, respectively. Method comparisons revealed correlation coefficients ranging from 0.89 (for Aβ40) to 0.98 (for t-Tau), with those for Aβ42 (0.93) and p-Tau (0.94) in-between. ROC curve analysis showed area under the curve values consistently above 0.85 for individual biomarkers other than Aβ40, and with the Aβ42/40, Aβ42/t-Tau, and Aβ42/p-Tau ratios outperforming Aβ42. Validation of the cut-off values in the independent cohort showed a sensitivity ranging from 75 to 95% and a specificity of 100%. The overall percentage of agreement between Lumipulse and INNOTEST was very high (> 87.5%).ConclusionsThe Lumipulse G assays show a very good analytical performance that makes them well-suited for CSF clinical routine measurements. The good clinical concordance between the Lumipulse G and INNOTEST assays facilitates the implementation of the new method in routine practice.

Development of a colorimetric loop-mediated isothermal amplification assay for rapid and specific detection of Aves polyomavirus 1 from psittacine birds

A colorimetric loop-mediated isothermal amplification (LAMP) assay was developed for the rapid and specific detection of the T gene of Aves polyomavirus 1 (APyV), a causative agent of budgerigar fledgling disease (BFD) in psittacine birds. The amplification can be completed in 40 min at 60 °C, and the results can be visually detected by the naked eye using hydroxyl naphthol blue as a colorimetric indicator. The assay specifically amplified APyV DNA but not other viral and bacterial nucleic acids. The limit of detection of the assay was 5 × 102 DNA copies/reaction, which was comparable to those of previously reported conventional polymerase chain reaction assays. In the clinical evaluation, the LAMP results showed 100% concordance with those of the previously reported PCR assays with regard to specificity, sensitivity, and percentage of overall agreement, with a kappa value of 1.0. These results indicate that the developed LAMP assay will be a valuable tool for the rapid, sensitive and specific detection of APyV from BFD-suspected psittacine bird samples even in resource-limited laboratories.

Interobserver variability and accuracy of p16/Ki-67 dual immunocytochemical staining on conventional cervical smears

Backgroundp16/Ki-67 dual immunocytochemical staining (DS) has been proven as a sensitive and specific test for triage of HPV positive women with good reproducibility and accuracy. However, implementation of the test into an organized screening program (OSP) is not easy. The aims of this study were to compare the performance and agreement of DS results among three Slovenian cytopathological laboratories involved in the national OSP, and to define cases where staining results can be difficult to interpret.MethodsCervical smears were obtained for DS from 129 women referred to colposcopy. Smears were evaluated blindly in three laboratories by a cytotechnologist and a cytopathologist after initial training. Results were positive, suspicious, negative or inadequate. Five characteristics of DS staining were recorded. After primary evaluation, an extensive expert-led additional training was undertaken, including a discussion of difficult cases and a practical exam. Smears were re-evaluated and results compared to primary evaluation.ResultsAfter the additional training, the overall percentage of agreement among the three laboratories increased from 77.5 to 89.9% and kappa increased from 0.70 to 0.86. Sensitivity for CIN2+ increased in two laboratories, to 90.5 and 85.7%, without the loss of specificity (75.8%). In one laboratory, the sensitivity slightly decreased from 90.5 to 88.9%, but the specificity increased from 63.6 to 68.2%. Difficult cases had significantly less DS cells, weak intensity of p16 staining, suboptimal cell morphology and background staining compared to positive cases.ConclusionAdditional expert-led training and discussion of difficult cases are necessary for accurate interpretation of DS in laboratories involved in OSP. The most difficult cases were those with single stained cells and weak p16 staining. Training protocol for safe implementation of p16/Ki-67 DS in OSP is proposed.

Towards the noninvasive identification of pathologic responders to neoadjuvant pembrolizumab in muscle-invasive urothelial bladder cancer (MIBC).

4540 Background: The possibility to predict the pathologic complete response (pT0) or pT≤1 after neoadjuvant immunotherapy may deeply impact the management of MIBC and orient clinical trials. The PURE01 study ( Necchi, JCO 2018) evaluated preoperative pembrolizumab before radical cystectomy (RC) in T2-3bN0MO patients (pts). The trial was amended to increase the sample size. Methods: Pts were assessed with bladder multiparametric magnetic resonance imaging (mpMRI: T2-weighted imaging, diffusion-weighted imaging, dynamic contrast enhancement [CE]) before and after treatment (3 cycles every 3 weeks) prior to RC. All mpMRI were made with bladder catheterization. We tested the following complete response (CR) definition: any measurable residual disease (T2W, morphology), but no residual restricted diffusion and no early CE signals. Exams were independently assessed by 2 senior radiologists and tested against the pT0/pT≤1 endpoints. Logistic regression models analyzed mpMRI and biomarker data on comprehensive genomic profiling (CGP) with FoundationONE CDx assay and PD-L1 combined positive score (CPS). Results: From 02/17 to 11/18, 84 pts were assessed before and after treatment (168 total mpMRI) and had the pathological response available from RC. Baseline CR (TURB effect) was observed in 14 (16.7%) pts. The mean overall percentage of agreement (OPA) across the mpMRI data was 98.2%. The sensitivity of post-therapy (PT) CR for pT0 response was 0.80 (95%CI: 0.61-0.92); the specificity for pT≤1 response was 0.94 (95%CI: 0.80-0.99). PT-CR was associated with both pT0/pT≤1 endpoints (p < 0.001) after adjusting for clinical T-stage and histology. Baseline CPS≥10 and TMB≥20 mut/Mb were strongly associated with pT0 response (OR: 4.46 and 14.9). mpMRI CR post-pembrolizumab significantly improved the c-index of the CPS/TMB models: up to 0.81 and 0.87 for pT0/pT≤1 endpoints. Conclusions: In post-pembrolizumab MIBC, the proposed definition of radiological CR through mpMRI is endowed with limited inter-observer variability and high accuracy in predicting pT≤1. CPS/TMB-selected pts who achieve CR with mpMRI can be reliably spared any surgical treatment. Clinical trial information: NCT02736266.

Comparison of Compact and Fully Polarimetric SAR for Multitemporal Wetland Monitoring

Spaceborne Synthetic Aperture Radar (SAR) instruments are effective tools for monitoring and mapping wetlands. With the availability of SAR instruments providing various polarization options, the scope of this study is to evaluate the new compact polarization for wetland multitemporal change detection using simulated RADARSAT Constellation Mission (RCM) SAR data. A series of fully polarimetric (FP) SAR images were collected over a test site located in Ontario, Canada, and used to simulate RCM compact polarimetric (CP) data. The simulated data were evaluated for multitemporal change detection and the results were compared to those from FP SAR data. WorldView imagery and water level data were used for analysis and validation of the change detection results. The study shows potential for using the CP SAR for multitemporal change detection over three major wetland classes: shallow water, marsh, and swamp. Although FP SAR was slightly more effective in multitemporal change detection compared to CP SAR, the percentage of agreement between the change detection results of FP and CP SAR was always greater than 90% for all wetland classes. The highest overall percentage of agreement (98.4%) between the results of FP and CP SAR was observed over the shallow water, while the lowest (92.5%) was observed over swamp.

Optimization of Manufacturing Process of Traditional Algerian Jben Cheese Using Response Surface Methodology (RSM)

The Aim of this study was to develop an optimized method for manufacturing process of traditional Algerian Jben cheese, using response surface methodology (RSM). In order to develop the objective method of making this traditional cheese, several factors have been studied and a Plackett-Burman statistical design was applied. The effects of the four screened factors (enrichment with milk powder, 10 - 20 g/l; pH of milk, 5.75 - 6.75, enzymatic extract dose, 0.5 - 1.5 ml and coagulation temperature 40 - 60 °C) on the response were investigated, using a Box-Behnken statistical design. Multiple regression analysis was used so that experimental data fits to a second-order polynomial equation. This multiple analysis showed that the model explains about 90.73% of the variation. Based on statistical results, it can be noticed that enrichment with milk powder and pH of milk (Ë‚0.0001***) were highly significant factor influincing cheese yield. The optimal production parame-ters that maximized cheese product (20 g/l enrichment with milk powder, 5.75 pH of milk, 1.29 ml enzymatic extract dose and 60°C coagulation temperature) and the maximal predicted cheese yield (52.68 % ) were found out through response surface methodology. Under these conditions, a verification experiment was carried out and cheese yield was found to be 49.46 %. The overall percentage of agreement for the experimental results (more than 93 % validity) with the predicted values indicates the validation of the statistical model and the success of the optimization process.

Shoulder Instability: Interobserver and Intraobserver Agreement in the Assessment of Labral Tears.

Background:The glenohumeral joint combines large range of motion and insufficient bony stabilization, making it susceptible to instability and dislocations. Arthroscopic surgery is routinely used as a diagnostic tool and has been considered the gold standard for the diagnosis of shoulder lesions. However, several studies have demonstrated variability in intraobserver and interobserver agreement.Purpose:To evaluate interobserver and intraobserver agreement in the assessment of intra-articular lesions associated with shoulder instability among fellowship-trained shoulder surgeons.Study Design:Cohort study (diagnosis); Level of evidence, 3.Methods:A total of 24 arthroscopic videos from patients treated for recurrent shoulder instability were shown to a group of 10 fellowship-trained shoulder surgeons who are members of the Multicenter Orthopaedic Outcomes Network (MOON) Shoulder Group. They were presented to the surgeons on 2 different occasions at least 2 months apart. They were asked to classify labral tears by their position, type, extension, other intra-articular abnormality, and preferred treatment. No patient history or physical examination data were provided. The primary outcome was the median overall percentage of agreement for the surgeons performing a video review, measured for each variable evaluated. Intraclass correlation coefficients were used to evaluate continuous variables, and kappa values were used for categorical items.Results:Interobserver agreement was good for anterior labral lesions; good for Hill-Sachs lesions; and moderate for lesions of the superior labrum, posterior labrum, anterior sublabral foramen, and position and extension of the tear. Intraobserver agreement was either good or very good for all variables evaluated, except for being poor for inferior labral lesions and moderate for lesions of the meniscoid superior labrum.Conclusion:Interobserver and intraobserver reliability for the arthroscopic assessment of labral tears in patients with recurrent shoulder instability were good to moderate for the majority of anatomic structures assessed. There was relatively good agreement between shoulder instability surgeons on assessing and documenting shoulder instability–associated abnormalities. These findings are important when interpreting collaborative clinical cohort studies with numerous surgeons involved in the research.

5-year clinical and radiographic follow-up of the uncemented Symax hip stem in an international study

BackgroundThe uncemented Symax hip stem is developed through optimization of the uncemented Omnifit hip stem. The Symax stem design combines an anatomical anteverted proximal geometry with a straight distal section. The proximal part is coated with a biomimetic hydroxyapatite (HA) coating for improved osseointegration to enhance load transfer and to minimize proximal bone loss. The distal part is treated with an anodization surface treatment in order to prevent distal bone apposition, which is expected to prevent distal loading and reduce proximal stress shielding. Aim of this study is to report mid-term clinical performance and evaluate whether the radiographic features are in line with the design principles of the Symax hip.MethodsThe biomimetic hydroxyapatite-coated uncemented Symax hip stem was evaluated in 80 patients during a 5-year prospective clinical international study. Harris Hip Score (HHS), Oxford Hip Score (OHS), and Western Ontario and McMaster Universities Arthritis Index (WOMAC) were performed preoperatively and postoperatively at 6 months and 1, 2, 3 and 5 years. Anteroposterior radiographs of the pelvis and axial radiographs of the operated hips were evaluated immediately postoperative and at follow-up 6 months and 1, 2, 3, and 5 years. Wilcoxon signed-rank test was used to analyse whether clinical outcome scores changed statistically significant over time. The overall percentage of agreement between two radiology assessment teams was used to evaluate observer agreement of radiology results. The Cohen’s Kappa was evaluated as a measure of reliability to quantify the agreement between raters, corrected for chance agreement.ResultsClinical outcome scores were excellent at 5 years with mean HHS of 98.1, mean OHS of 16.2 and mean WOMAC of 6.9. Only 2.7% of the patients had pain at rest or on weight-bearing, and mid-thigh pain was reported by 1.4% of the patients after 5 years. The percentage of agreement between radiology assessment teams was 94 to 100%, except for distal line formation (48%). Radiographic evaluation showed stable stems and signs of excellent progressive proximal fixation and favourable bone remodeling.ConclusionsThe excellent mid-term clinical and radiographic performances are in line with the design principles and coating properties of this new implant and earlier published results.Trial registrationhttp://ClinicalTrials.gov, NCT03469687. Registered 19 March 2018 – Retrospectively registered.

Full Interchangeability in Regard to Immunogenicity Between the Infliximab Reference Biologic and Biosimilars CT-P13 and SB2 in Inflammatory Bowel Disease.

Infliximab (IFX) biosimilars CT-P13 and SB2 have comparable efficacy, safety, and immunogenicity to the originator Remicade (RMC). However, concerns about cross-switching patients between the 3 brands were raised in the absence of cross reactivity data between them. We aimed to determine whether antibodies to infliximab (ATI) in inflammatory bowel disease (IBD) patients cross-react with RMC, CT-P13, and SB2. Based on previous ATI status, samples from 34 patients participating in the BIOSIM01 study (13 RMC, 9 CT-P13, and 12 switchers) were selected. Patients were treated with either RMC only, or CT-P13 only, or with RMC switched to CT-P13. Additionally, 28 IFX-naïve patients were assayed as controls. In total, 180 samples were analyzed. ATI trough levels were measured in parallel with 3 different bridging Enzyme Linked Immunosorbent Assays constructed using the 3 drugs. Spearman's coefficient and percentages of agreement were used to study the correlation between each assay. In total, 76 samples out of 152 IFX-treated patient samples were ATI-positive (30 RMC, 14 CT-P13, and 32 switchers). All resulted ATI-positive when either CT-P13 or SB2 bridging assays were used. The overall percentage of agreement was 100% when compared either with CT-P13 or SB2 assays. No significant differences were found among ATI levels and coefficients (Spearman's 0.98 to 1.0, P < 0.0001). ATI of RMC-treated, CT-P13-treated or RMC to CT-P13 switched patients show full cross-reactivity with CT-P13 and SB2. Findings suggest that immunodominant epitopes in the reference and CT-P13 drugs are equally present in SB2. Data support full interchangeability between biosimilars in regard to immunogenicity.

Linking Data From Health Surveys and Electronic Health Records: A Demonstration Project in Two Chicago Health Center Clinics.

IntroductionMonitoring and understanding population health requires conducting health-related surveys and surveillance. The objective of our study was to assess whether data from self-administered surveys could be collected electronically from patients in urban, primary-care, safety-net clinics and subsequently linked and compared with the same patients’ electronic health records (EHRs).MethodsData from self-administered surveys were collected electronically from a convenience sample of 527 patients at 2 Chicago health centers from September through November, 2014. Survey data were linked to EHRs.ResultsA total of 251 (47.6%) patients who completed the survey consented to having their responses linked to their EHRs. Consenting participants were older, more likely to report fair or poor health, and took longer to complete the survey than those who did not consent. For 8 of 18 categorical variables, overall percentage of agreement between survey data and EHR data exceeded 80% (sex, race/ethnicity, pneumococcal vaccination, self-reported body mass index [BMI], diabetes, high blood pressure, medication for high blood pressure, and hyperlipidemia), and of these, the level of agreement was good or excellent (κ ≥0.64) except for pneumococcal vaccination (κ = 0.40) and hyperlipidemia (κ = 0.47). Of 7 continuous variables, agreement was substantial for age and weight (concordance coefficients ≥0.95); however, with the exception of calculated survey BMI and EHR–BMI (concordance coefficient = 0.88), all other continuous variables had poor agreement.ConclusionsSelf-administered and web-based surveys can be completed in urban, primary-care, safety-net clinics and linked to EHRs. Linking survey and EHR data can enhance public health surveillance by validating self-reported data, completing gaps in patient data, and extending sample sizes obtained through current methods. This approach will require promoting and sustaining patient involvement.

Development of an ethogram to describe facial expressions in ridden horses (FEReq)

Many horses presumed to be sound by their riders are not. Facial expression ethograms have previously been used to describe pain-related behavior in horses, but there is a need for a ridden horse facial ethogram to facilitate identification of pain in ridden horses. The objectives of this study were to develop and test an ethogram to describe facial expressions in ridden horses and to determine whether individuals could interpret and correctly apply the ethogram, with consistency among assessors. An ethogram was developed by reference to previous publications and photographs of 150 lame and nonlame ridden horses. A training manual was created. Thirteen assessors (veterinarians of variable experience, n = 4; equine technicians, n = 3; equine studies graduates, n = 2; amateur horse owners, n = 2; equine veterinary nurse, n = 1; a British Horse Society Instructor, n = 1) underwent a training session and, with reference to the training manual, evaluated still lateral photographs of 27 training heads. Features were graded as Yes, No, or “Cannot see” (when it was not possible to determine the presence or absence of a feature). The ethogram was adapted, and after further training, the assessors blindly evaluated 30 test heads from nonlame and lame horses. Intraclass correlation (ICC) and free-margin kappa tests were used to assess consensus among assessors. For the training heads, single ICC matrix among observers resulted in an overall ICC of 0.50 (95% confidence intervals, 0.40-0.62). Four assessors consistently scored differently from the others, with ranges of ICC of 0.20-0.50 (mean, 0.41). There was no difference in assessors' scoring related to their professional backgrounds. For the test heads, mean interrater agreement among assessors was 87%. Two assessors still scored consistently differently (0.28-0.50 ICC agreement; mean, 0.40) from the remaining 11 assessors (0.44-0.69 ICC agreement; mean, 0.56). The mean percentage of overall agreement was 80%, and the mean free-marginal kappa value was 0.72, standard deviation (SD) ± 0.22. The large SD was the result of inconsistency in assessments of the eyes and muzzle. It was concluded that the developed ethogram could reliably be utilized to describe facial expressions of ridden horses by people from different professional backgrounds. Future work needs to determine if nonlame and lame horses can be differentiated based on application of the ethogram.

Convergent and concurrent validity of the Frankfurt Complaint Questionnaire as a screener for psychosis risk

For the broad identification of a risk for a serious mental disorder, valid and reliable screeners are needed to detect those most likely benefitting from a time-consuming and costly in-depth clinical assessment. In the early detection of psychoses, multiple screeners for an ultra-high-risk have already been suggested. Yet, no screener explicitly targets an increased risk according to the basic symptoms (BS) criteria. We therefore explored the Frankfurt Complaint Questionnaire (FCQ) as a potential screener for BS in comparison with their gold standard clinical assessment using the Schizophrenia Proneness Instrument (SPI-A/SPI-CY) by examining its convergent (agreement between screener and gold standard, calculated by the overall percentages of agreement between FCQ and SPI-A/SPI-CY) and concurrent (degree to which a screener can identify individuals with the target condition, examined by diagnostic accuracy measures calculated using thresholds of receiver operating characteristic curves) validity. The sample consisted of 81 patients of a psychosis early detection service (41 with an at-risk mental state or psychosis, and 40 with a nonpsychotic mental disorder). Only two visual perception disturbances reached a beyond-chance level of agreement between FCQ and SPI-A/SPI-CY. For the BS criteria ‘cognitive perceptive basic symptoms’ and ‘cognitive disturbances’, only insufficient agreement between assessment techniques was detected with Cohen’s kappa being 0.228 and 0.130, respectively, with an overestimation by the FCQ. Diagnostic likelihood ratios indicated only a clinically irrelevant increase in the probability of detecting BS criteria; thus, the concurrent validity of both the total of all and of only criteria-relevant FCQ items was insufficient. Both concurrent and convergent validity of the FCQ were poor, and the FCQ dramatically overestimated clinician-assessed risk. Our results suggest that the FCQ should not be used as a screener for BS criteria and that the convergent validity is not guaranteed on the basis of face validity alone, but has to be formally assessed.

Virtual Glaucoma Clinic: Do Consultants Agree on Management Outcomes?

Objective: To evaluate inter-examiner variations in glaucoma management amongst consultants with different levels of experience in Virtual Glaucoma Clinic. Methods: Three glaucoma specialist consultants with varying years of experience (1, 5 and 15 years) independently reviewed 112 consecutive cases. The management outcomes of the three consultants were recorded for each case on a specially designed proforma. Inter-consultant agreement on recall time, review place and treatment plan was analysed using kappa coefficient. The cohort was classified into two groups for further analysis. The first group consisted of patients in whom all three consultants agreed on management outcomes. The second group consisted of patients in whom at least one consultant disagreed on management outcomes. Unpaired student-t-test was used to calculate the difference in mean values of age, visual acuity, intraocular pressure, cup-todisc ratio and visual field mean deviation between both groups for each management outcome. Results: The percentage of overall agreement on recall time (25%) and review place (45%) was fair and moderate respectively. The overall agreement on treatment plan was superior (86%). We found significant disagreement between the senior consultant and the newly appointed consultant with lowest Kappa agreement on recall time and on review place (κ 0.14 and κ 0.22 respectively). On overall, the level of complete agreement amongst ocular hypertension was best when compared to glaucoma suspect and glaucoma. Statistical analysis revealed a tendency for disagreement amongst consultants’ management outcomes on patients having more abnormal visual field and raised intraocular pressure. Conclusions: Our study demonstrates that greater difference in years of experience between consultants is associated with more disagreement in management outcomes. Discrepancies on management outcomes impact on uniformity of care and service delivery of virtual clinic. We suggest the need for implementing structured management guidance in virtual glaucoma clinic to reduce discrepancies amongst consultants.

Are radiologists superior to orthopaedic surgeons in diagnosing instability-related shoulder lesions on magnetic resonance arthrography? A multicenter reproducibility and accuracy study

We compared the diagnostic reproducibility and accuracy of musculoskeletal radiologists with orthopaedic shoulder surgeons in 2 large medical centers in assessing magnetic resonance arthrograms (MRAs) of patients with traumatic anterior shoulder instability. Forty-five surgically confirmed MRAs were assessed by 4 radiologists, 4 orthopaedic surgeons, 2 radiologic teams, and 2 orthopaedic teams. During MRA assessment and surgery, the same 7-lesion scoring form was used. κ Coefficients, sensitivity, specificity, and differences in percentage of agreement or correct diagnosis (P<.05, McNemar test) were calculated per lesion and overall per the 7 lesion types. The overall κ between the individual radiologists (κ=0.51, κ=0.46) and orthopaedic surgeons (κ=0.46, κ=0.41) was moderate. Although the overall percentage of agreement between the radiologists was slightly higher than that between the orthopaedic surgeons in both centers (80.0% vs 77.5% and 75.2% vs 73.7%), there was no significant difference. In each medical center, however, the most experienced orthopaedic surgeon was exceedingly more accurate than both radiologists per the 7 lesion types (81.9% vs 72.4%/74.6% and 76.5% vs 67.3%/73.7%). In 3 of 4 cases, this difference was significant. Overall accuracy improvement through consensus assessment was merely established for the weakest member of each team. Experienced orthopaedic surgeons are more accurate than radiologists in assessing traumatic anterior shoulder instability-related lesions on MRA. In case of diagnosis disagreement, these orthopaedic surgeons should base their treatment decision on their own MRA interpretation.

&lt;b&gt;Programa de avaliação externa das escolas em Portugal: uma análise focada na satisfação de líderes/gestores

Primary and secondary public schools in Portugal are externally evaluated under the responsibility of the General Inspection of Education and Science (IGEC), starting from 2006. Since eight years after the initial experience has passed, current paper provides the degree of satisfaction with the external evaluation program of school leaders and managers with regard to the reference used, the process followed and the report sent to the schools. Data were collected by a questionnaire survey applied to 372 leaders and school managers: top managers (23 directors, 47 members of school management) and middle managers (90 coordinators of curriculum department and 212 class directors) from 25 schools in northern Portugal. Overall, the results show a higher rate of satisfaction of top managers compared to that by middle managers. With regard to the dimensions in analysis (Reference, Process and Report), it has been observed that the overall percentage of agreement lies between 53.40% (Reference), 69.10% (Report) and 81% (Process), revealing a positive positioning of respondents regarding to the External School Evaluation Program (PAEE).

Quantitative assessment of thyroid-to-background ratio improves the interobserver reliability of technetium-99m sestamibi thyroid scintigraphy for investigation of amiodarone-induced thyrotoxicosis

Amiodarone-induced thyrotoxicosis (AIT) is caused by excessive hormone synthesis and release (AIT I), a destructive thyroiditis (AIT II), or a combination of both (AIT Ind). Although no gold-standard diagnostic test is available, technetium-99m sestamibi thyroid scintigraphy (99mTc-STS) has been previously reported to be an accurate tool for differentiating subtypes with important therapeutic implications. However, the information to guide reporting of 99mTc-STS is qualitative and highly subjective. This study aims to compare the interobserver reliability of 99mTc-STS before and after the use of quantitative thyroid-to-background ratios (TBRs) displayed on a time-activity curve for differentiation of AIT subtypes. A retrospective audit of Nuclear Medicine Departments at Royal Melbourne Hospital (Parkville, Victoria, Australia) and Cabrini Hospital (Malvern, Victoria, Australia) identified 15 consecutive 99mTc-STS studies performed for AIT. Four nuclear medicine physicians reported the studies according to previously established criteria (series 1). Quantitative TBR and estimated 'normal' range TBR were subsequently provided before the studies were reordered and reported again (series 2). Interobserver reliability was calculated using Fleiss' κ statistic for each assessment. The overall percentage of agreement (PoA) and κ statistics for use of conventional 99mTc-STS for diagnosis of AIT improved from 47 to 80% and from 0.30 to 0.67 following the use of quantitative TBR displayed on a time-activity curve with reference to a normal population. Interobserver reliability improved substantially under all diagnostic comparisons, particularly for differentiation of either AIT I (PoA 80% to 94%, κ: 0.48 to 0.84) or AIT Ind (PoA 47% to 82%, κ: -0.05 to 0.51) from other types of AIT. Use of quantitative TBR improves the interobserver reliability of reporting 99mTc-STS for investigation of different types of AIT. There is 'almost perfect' agreement upon differentiation of AIT I from AIT II and AIT Ind, with important implications for rationalizing the use of corticosteroid therapy. Prospective identification of AIT Ind is improved from 'poor' to a 'moderate' level of agreement to facilitate rational use of combination therapy at diagnosis.

Improving diagnostic accuracy in assessing pulmonary edema on bedside chest radiographs using a standardized scoring approach.

BackgroundTo assess the value of a score-based system which allows standardized evaluation of pulmonary edema on bedside chest radiographs (CXRs) under routine clinical conditions.MethodsSeven experienced readers assessed bedside CXRs of ten patients with an extravascular lung water (EVLW)-value of ≤ 8 mL/kg (range: 4–8 mL/kg; indicates no pulmonary edema) and a series of ten patients with an EVLW-value of ≥ 15 mL/kg (range: 15–21 mL/kg; = indicates a pulmonary edema) with and without customized software which would permit a standardized assessment of the various indications of pulmonary edema. The software provides a score that identifies patients with and without pulmonary edema. EVLW-values were measured instantly after bedside CXR imaging using a pulse contour cardiac output (PiCCO) system and served as a reference standard. The patients were non-traumatic and not treated with diuretics or dobutamine during bedside CXR imaging and the PiCCO measurements. Mean sensitivity, specificity, positive and negative predictive value, the percentage of overall agreement and the free-marginal multirater kappa value was calculated for both the standard and the standardized score-based approach. The net reclassification index was calculated for each reader as well as for all readers.ResultsEvaluation of bedside CXRs by means of the score-based approach took longer (23 ± 12 seconds versus 7 ± 3 seconds without the use of the software) but improved radiologists’ sensitivity (from 57 to 77%), specificity (from 90 to 100%) and the free-marginal multirater kappa value (from 0.34 to 0.68). The positive predictive value was raised from 85 to 100% and the negative predictive value from 68 to 81%. A net reclassification index of 0.3 (all readers) demonstrates an improvement in prediction performance gained by the score-based approach. The percentage of overall agreement was 67% with the standard approach and 84% with the software-based approach.ConclusionsThe diagnostic accuracy of bedside CXRs to discriminate patients with elevated EVLW-values from those with a normal value can be improved with the use of a standardized score-based approach. The investigated system is freely available as a web-based application (accessible via: http://www.radiologie.uk-erlangen.de/aerzte-und-zuweiser/edema).

Analysis of 3 Algorithms for Syphilis Serodiagnosis and Implications for Clinical Management

Algorithms for the diagnosis of syphilis continue to be a source of great controversy, and numerous test interpretations have perplexed many clinicians. We conducted a cross-sectional study of 24 124 subjects to analyze 3 syphilis testing algorithms: traditional algorithm, reverse algorithm, and the European Centre for Disease Prevention and Control (ECDC) algorithm. Every serum sample was simultaneously evaluated using the rapid plasma reagin, Treponema pallidum particle agglutination, and chemiluminescence immunoassay tests. With the results of clinical diagnoses of syphilis as a gold standard, we evaluated the diagnostic accuracy of the 3 syphilis testing algorithms. The κ coefficient was used to compare the concordance between the reverse algorithm and the ECDC algorithm. Overall, 2749 patients in our cohort were diagnosed with syphilis. The traditional algorithm had the highest negative likelihood ratio (0.24), a missed diagnosis rate of 24.2%, and only 75.81% sensitivity. However, both the reverse and ECDC algorithms had higher diagnostic efficacy than the traditional algorithm. Their sensitivity, specificity, and accuracy were 99.38%-99.85%, 99.98%-100.00%, and 99.93%-99.96%, respectively. Moreover, the overall percentage of agreement and κ value between the reverse and the ECDC algorithms were 99.9% and 0.996, respectively. Our research supported use of the ECDC algorithm, in which syphilis screening begins with a treponemal immunoassay that is followed by a second, different treponemal assay as a confirmatory test in high-prevalence populations. In addition, our results indicated that nontreponemal assay is unnecessary for syphilis diagnosis but can be recommended for determining serological activity and the effect of syphilis treatment.

Usefulness of pan-fungal NASBA test for surveillance of environmental fungal contamination in a protected hematology unit

A pan-fungal nucleic acid sequence based applification (NASBA) test was adapted and used for the first time to detect and quantify the level of filamentous fungi in environmental samples. Surface samples (n = 356) collected in a controlled air flow hematology ward were tested by mycological culture and the pan-fungal NASBA test. The overall percentage of agreement between culture and NASBA was 88%, the Kappa coefficient was equal to 0.61 (95%CI = [0.51; 0.72]). This pan-fungal NASBA test could be a promising tool to rapidly monitor the absence of molds in controlled environments.

Do Oblique Views Add Value in the Diagnosis of Spondylolysis in Adolescents?

Anteroposterior, lateral, and right and left oblique lumbar spine radiographs are often a standard part of the evaluation of children who are clinically suspected of having spondylolysis. Recent concerns regarding radiation exposure and costs have brought the value of oblique radiographs into question. The purpose of the present study was to determine the diagnostic value of oblique views in the diagnosis of spondylolysis. Radiographs of fifty adolescents with L5 spondylolysis without spondylolisthesis and fifty controls were retrospectively reviewed. All controls were confirmed not to have spondylolysis on the basis of computed tomographic scanning, magnetic resonance imaging, or bone scanning. Anteroposterior, lateral, and right and left oblique radiographs of the lumbar spine were arranged into two sets of slides: one showing four views (anteroposterior, lateral, right oblique, and left oblique) and one showing two views (anteroposterior and lateral only). The slides were randomly presented to four pediatric spine surgeons for diagnosis, with four-view slides being presented first, followed by two-view slides. The slides for twenty random patients were later reanalyzed in order to calculate of intra-rater agreement. A power analysis demonstrated that this study was adequately powered. Inter-rater and intra-rater agreement were assessed on the basis of the percentage of overall agreement and intraclass correlation coefficients (ICCs). PCXMC software was used to generate effective radiation doses. Study charges were determined from radiology billing data. There was no significant difference in sensitivity and specificity between four-view and two-view radiographs in the diagnosis of spondylolysis. The sensitivity was 0.59 for two-view studies and 0.53 for four-view studies (p = 0.33). The specificity was 0.96 for two-view studies and 0.94 for four-view studies (p = 0.60). Inter-rater agreement, intra-rater agreement, and agreement with gold-standard ICC values were in the moderate range and also demonstrated no significant differences. Percent overall agreement was 78% for four-view studies and 82% for two-view studies. The radiation effective dose was 1.26 mSv for four-view studies and 0.72 mSv for two-view studies (difference, 0.54 mSv). The charge for four-view studies was $145 more than that for two-view studies. There is no difference in sensitivity and specificity between four-view and two-view studies. Although oblique views have long been considered standard practice by some, our data could not identify a diagnostic benefit that might outweigh the additional cost and radiation exposure.