Cohortes de premedicación en endoscopia alta con simeticona, N-acetilcisteína, Hedera helix y validación de la escala visual / Cohorts of premedication for endoscopy of the upper gastrointestinal tract with simethicone, N-acetylcysteine, Hedera helix and visual scale validation

Resumen Los parámetros de calidad para endoscopia digestiva alta han introducido indicadores intraprocedimiento, dentro de los cuales la adecuada visibilidad de la mucosa, libre de saliva, moco o burbujas, puede aumentar la posibilidad de detección de lesiones en fase temprana. Sin embargo, el uso de mucolíticos y antiburbujas ha mostrado gran variabilidad de eficiencia según las soluciones, concentraciones, tiempos de exposición y escala de visibilidad aplicados. Objetivos: determinar la efectividad de diferentes soluciones de premedicación para la limpieza de la mucosa digestiva; validar, mediante una prueba de concordancia interobservador, una nueva escala de adecuada visualización de la mucosa (TVMS) para el esófago, estómago y duodeno; y reportar eventos adversos o complicaciones relacionadas con las soluciones utilizadas y los procedimientos realizados. Material y métodos: estudio de cohortes prospectivas comparativas. Se incluyeron 412 pacientes adultos, ASA I y ASA II, para endoscopia diagnóstica bajo sedación consciente, distribuidos en 6 cohortes similares, divididas en dos grupos: no premedicación, 2 cohortes C1 (ayuno de 6 a 8 horas)y C2 (agua 100 mL); premedicación, 4 cohortes C3 a C6 (C3: agua 100 m L + simeticona 1000 mg; C4: agua 100 mL + simeticona 200 mg + N-acetilcisteína 600 mg; C5: agua 100 mL + simeticona 200 mg + N-acetilcisteína 1000 mg; C6: agua 100 mL + simeticona 200 mg + Hedera helix 70 mg). Se ingirió la solución 15 a 30 minutos antes del paso por cricofaríngeo. Se realizó la prueba de Kappa para medir la concordancia interobservador de la escala TVMS. Resultados: De 412 pacientes, 58% fueron de sexo femenino; 23% (136) fue de cohortes C1 y C2 y 67% (276) fue de cohortes C3 a C6. El tiempo medio de exposición a cada solución fue de 24,4 minutos. El volumen de lavado para lograr una adecuada visualización fue significativamente diferente entre ambos grupos: en los pacientes con premedicación se utilizaron 75,6 mL, mientras que en los pacientes sin premedicación se utilizaron 124 mL (p = 0,000), con una calidad de TVMS excelente de 88,7% frente al 41,4%, respectivamente. La cohorte C4 (agua 100 mL + simeticona 200 mg + N-acetilcisteína 600 mg) mostró ser la más efectiva con una diferencia significativa (p = 0,001) frente a C1 (ayuno) y C2 (placebo con agua 100 mL), y también tuvo una eficiencia superior frente a C3, C5 y C6 en su orden. No se presentaron eventos adversos o complicaciones en relación con la endoscopia, la sedación y los productos usados en la premedicación. Conclusiones: la solución más efectiva como premedicación para lograr una excelente visibilidad de la mucosa digestiva correspondió a la cohorte C4 (SIM 200 + NAC 600 + H2O 100 mL). La escala TVMS propuesta es una herramienta muy completa y fácil de aplicar por más de un observador. La premedicación ingerida, con antiburbuja, mucolítico y agua hasta 100 mL, entre 15 y 30 minutos previos a endoscopia, es segura en las condiciones descritas en este estudio.

Abstract Quality parameters for upper gastrointestinal endoscopy have introduced intraprocedural indicators, including adequate mucosal visualization free of saliva, mucus, or bubbles, which may increase the possibility of early-stage injury detection. The use of mucolytics and anti-foaming agents has shown great efficiency variability depending on the type of solution, concentrations, exposure times and visibility scale applied. Objectives: To determine the effectiveness of different premedication solutions for cleaning the digestive mucosa; to validate, by means of an interobserver concordance test, a new scale for the adequate visualization of the mucosa (TVMS) for the esophagus, stomach, and duodenum; and to report adverse events or complications associated with the solutions used and the procedures performed. Material and methods: Prospective, comparative cohort study. 412 adult patients, ASA I and ASA II, were included for diagnostic endoscopy under conscious sedation. They were distributed in 6 similar cohorts and divided into two groups: non-premedication, 2 in C1 (fasting 6 to 8 hours) and C2 (water 100 mL) cohorts; premedication, 4 C3 to C6 cohorts (C3: water 100 mL + simethicone 1000 mg; C4: water 100 ml + simethicone 200 mg + N-acetylcysteine 600 mg; C5: water 100 ml + simethicone 200 mg + N-acetylcysteine 1000 mg; C6: water 100 ml + simethicone 200 mg + Hedera helix 70 mg). The solution was swallowed 15 to 30 minutes passing through the cricopharyngeus muscle. The Kappa test was performed to measure interobserver concordance of the TVMS scale. Results: Of 412 patients, 58% were female; 23% (136) were included in the C1 and C2 cohorts; and 67% (276) were in the C3 to C6 cohorts. The average exposure time to each solution was 24.4 minutes. The wash volume for proper visualization was significantly different between the two groups. In premedicated patients, 75.6 mL of solution were used, while in patients without premedication, 124 mL were used (p = 0.000), with an excellent quality of TVMS of 88.7% versus 41.4%, respectively. The C4 cohort (water 100 mL + simethicone 200 mg + N-acetylcysteine 600 mg) was the most effective with a significant difference (p= 0.001) compared with the C1 (fasting) and C2 (placebo with water 100 mL) cohorts. It also had better efficiency compared to the C3, C5 and C6 cohorts in that order. There were no adverse events or complications associated with endoscopy, sedation, or premedication products. Conclusions: The most effective solution as a premedication to achieve excellent visibility of the digestive mucosa was that used in the C4 cohort (SIM 200 + NAC 600 + H2OR 100 mL). The proposed TVMS scale is a very complete and easy tool to apply by more than one observer. Premedication ingested, with anti-foam, mucolytic and water up to 100 mL, between 15 and 30 minutes before endoscopy, is safe under the conditions described in this study.

Validación de recursos humanos pre-profesionales para la detección de biofilm en niños en edad escolar / Validation of preprofessional resources for detecting biofilm in schoolchildren

Objetivo: Estimar la concordancia para la detección de biofilm dental entre recursos humanos que participan de programas de educación para la salud con diferente nivel de formación profesional. Métodos: Se seleccionó en forma intencionada un grupo deestudiantes de los primeros años de la carrera de odontología que participan como ayudantes en el curso Educación para la Salud (n= 8) (Grupo A). Los examinadores de referencia fueron odontólogos/docentes universitarios que desarrollan acciones sistemáticas de educación para la salud en escuelas públicas de Ciudad Autónoma de Buenos Aires (C.A.B.A.) (n= 2) (Grupo B). Se examinaron 67 escolares (edades 7 a 9 años) previo consentimiento informado de los responsables legales y el asentimiento de los niños/as. Los diagnósticos se realizaron bajo condiciones estandarizadas en la sede escolar. Los pares de examinadores determinaron en cada escolar la presencia de biofilm dental, primero a simple vista y luego con solución reveladora (Índice de O`Leary, 1970). La concordancia se valoró utilizando el coeficiente de correlación intraclase para valores absolutos. La fuerza del grado de acuerdo se valoró según Landis y Koch, 1977. Resultados: El coeficiente de correlación intraclase fue: 1) para el índice de placa visible: medidas individuales = 0,71 IC95 por ciento [0,56-0,81]; promedios = 0,83 IC95 por ciento [0,71-0,90] b) para el índice de O´Leary: medidas individuales = 0,62 IC95 por ciento [0,44-0,75]; promedios = 0,77 IC95 por ciento [0,61-0,86]. Conclusión: los examinadores del Grupo A (recursos humanos pre-reprofesionales) respecto del Grupo B (recursos humanos profesionales) alcanzaron un grado considerable de concordancia para la detección de placa a simple vista y un grado moderado de concordancia para la detección de placa con solución reveladora.

Objective: The aim of this study was to measure inter-observer agreement in the assessment of dental biofilm between subjectsparticipating in health education programs with different levels of professional training. METHODS: In order to perform thisvalidation procedure, a group of undergraduate students in the initial years of the career of dentistry engaged as teaching assistants for aHealth Education Course (n=8) was intentionally recruited (GROUP A). Freshmen dental graduates / teaching assistants whodevelop systematic health educational activities in public schools (n=2). 67 children (ages 7 to 9) were considered reference examiners(GROUP B). Clinical examinations were performed among 67 schoolchildren (ages 7 to 9 years old). Informed consent of children´slegal guardians and assent of children themselves as for participation in the study were obtained. At first, examiners set into pairs,assessed dental biofilm presence/absence in each child visually (Visual Plaque Index). The same procedure was repeated after applyingdisclosing solution (O´Leary Index). The intraclass correlation index (ICI) was used to establish interobserver agreement whereas theLandis-Koch criteria was used to interpret the results. RESULTS: The intraclass correlation index was 1) Visual Plaque Index:individual measures = 0,71 IC95% [0,56-0,81]; average measures = 0,83 IC95% [0,71-0,90] b) O´Leary Index: individualmeasures = 0,62 IC95% [0,44-0,75]; average measures = 0,77 IC95% [0,61-0,86]. CONCLUSION: examiners fromGROUP A (undergraduate students) respect to those from GROUP B (graduates) reached a substantial agreement in the assessment ofdental biofilm visually and a moderate degree of agreement in the assessment of dental biofilm using disclosing solution.

Interobserver Agreement on Pathologic Features of Liver Biopsy Tissue in Patients with Nonalcoholic Fatty Liver Disease

BACKGROUND: The histomorphologic criteria for the pathological features of liver tissue from patients with non-alcoholic fatty liver disease (NAFLD) remain subjective, causing confusion among pathologists and clinicians. In this report, we studied interobserver agreement of NAFLD pathologic features and analyzed causes of disagreement. METHODS: Thirty-one cases of clinicopathologically diagnosed NAFLD from 10 hospitals were selected. One hematoxylin and eosin and one Masson's trichrome-stained virtual slide from each case were blindly reviewed with regard to 12 histological parameters by 13 pathologists in a gastrointestinal study group of the Korean Society of Pathologists. After the first review, we analyzed the causes of disagreement and defined detailed morphological criteria. The glass slides from each case were reviewed a second time after a consensus meeting. The degree of interobserver agreement was determined by multi-rater kappa statistics. RESULTS: Kappa values of the first review ranged from 0.0091-0.7618. Acidophilic bodies (k = 0.7618) and portal inflammation (k = 0.5914) showed high levels of agreement, whereas microgranuloma (k = 0.0984) and microvesicular fatty change (k = 0.0091) showed low levels of agreement. After the second review, the kappa values of the four major pathological features increased from 0.3830 to 0.5638 for steatosis grade, from 0.1398 to 0.2815 for lobular inflammation, from 0.1923 to 0.3362 for ballooning degeneration, and from 0.3303 to 0.4664 for fibrosis. CONCLUSIONS: More detailed histomorphological criteria must be defined for correct diagnosis and high interobserver agreement of NAFLD.

Interobserver and Intraobserver Reliability of Sub-Axial Injury Classification and Severity Scale between Radiologist, Resident and Spine Surgeon

OBJECTIVE: The sub-axial injury classification (SLIC) and severity scale was developed to decide whether to operate the cervical injured patient or not, but the reliability of SLIC and severity scale among the different physicians was not well known. Therefore, we evaluated the reliability of SLIC among a spine surgeon, a resident of neurosurgery and a neuro-radiologist. METHODS: In retrograde review in single hospital from 2002 to 2009 years, 75 cases of sub-axial spine injured patients underwent operation. Each case was blindly reviewed for the SLIC and severity scale by 3 different observers by two times with 4 weeks interval with randomly allocated. The compared axis was the injury morphology score, the disco-ligamentous complex score, the neurological status score and total SLIC score; the neurological status score was derived from the review of medical record. The kappa value was used for the statistical analysis. RESULTS: Interobserver agreement of SLIC and severity scale was substantial agreement in the score of injury morphology [intraclass correlation (ICC)=0.603] and total SLIC and severity sacle (ICC value=0.775), but was fair agreement in the disco-ligamentous complex score (ICC value=0.304). Intraobserver agreements were almost perfect agreement in whole scales with ICC of 0.974 in a spine surgeon, 0.948 in a resident of neurosurgery, and 0.963 in a neuro-radiologist. CONCLUSION: The SLIC and severity scale is comprehensive and easily applicable tool in spine injured patient. Moreover, it is very useful tool to communicate among spine surgeons, residents of neurosurgery and neuro-radiologists with sufficient reproducibility.

Accuracy and Safety in Pedicle Screw Placement in the Thoracic and Lumbar Spines : Comparison Study between Conventional C-Arm Fluoroscopy and Navigation Coupled with O-Arm(R) Guided Methods

OBJECTIVE: The authors performed a retrospective study to assess the accuracy and clinical benefits of a navigation coupled with O-arm(R) system guided method in the thoracic and lumbar spines by comparing with a C-arm fluoroscopy-guided method. METHODS: Under the navigation guidance, 106 pedicle screws inserted from T7 to S1 in 24 patients, and using the fluoroscopy guidance, 204 pedicle screws from T5 to S1 in 45 patients. The position of screws within the pedicle was classified into four groups, from grade 0 (no violation cortex) to 3 (more than 4 mm violation). The location of violated pedicle cortex was also assessed. Intra-operative parameters including time required for preparation of screwing procedure, times for screwing and the number of X-ray shot were assessed in each group. RESULTS: Grade 0 was observed in 186 (91.2%) screws of the fluoroscopy-guided group, and 99 (93.4%) of the navigation-guided group. Mean time required for inserting a screw was 3.8 minutes in the fluoroscopy-guided group, and 4.5 minutes in the navigation-guided group. Mean time required for preparation of screw placement was 4 minutes in the fluoroscopy-guided group, and 19 minutes in the navigation-guided group. The fluoroscopy-guided group required mean 8.9 times of X-ray shot for each screw placement. CONCLUSION: The screw placement under the navigation-guidance coupled with O-arm(R) system appears to be more accurate and safer than that under the fluoroscopy guidance, although the preparation and screwing time for the navigation-guided surgery is longer than that for the fluoroscopy-guided surgery.

Concordância interobservador na interpretação imuno-histoquímica da superexpressão do Her2 detectada por cinco diferentes anticorpos em array de carcinomas mamários / Interobserver agreement in scoring immunohistochemical overexpression of Her2 detected by five different antibodies on tissue microarrays of breast carcinomas

OBJETIVO: Estudar a concordância interobservador na interpretação da superexpressão imuno-histoquímica para a proteína Her2 empregando diferentes anticorpos em array de carcinomas mamários. MATERIAL E MÉTODO: Foi construído um array contendo dois cilindros (2 mm de diâmetro cada) de 25 carcinomas mamários. Cortes histológicos seriados do array foram submetidos à imuno-histoquímica utilizando-se cinco anticorpos anti-Her2: SP3 (NeoMarkers), HercepTest e A0485 (Dako), CB11 (Novocastra) e 4D5 (Genentech). Uma lâmina corada por cada anticorpo (total = cinco lâminas) foi submetida à avaliação individual por cinco observadores seguindo-se o sistema de escore proposto no HercepTestTM. Para a avaliação interobservador os resultados foram interpretados em três diferentes análises: I (0; 1+; 2+; 3+); II (0 e 1+; 2+ e 3+) e III (0 e 1+; 2+; 3+) e aplicado o teste estatístico de kappa. RESULTADOS: A concordância interobservador foi boa quando os casos foram avaliados em quatro categorias (0; 1+; 2+; 3+). Quando avaliados em duas categorias (0 e 1+; 2+ e 3+), a concordância interobservador foi boa para os casos corados por SP3 e CB11 e muito boa para os corados por A0485, HercepTest e 4D5. Na análise III (0 e 1+; 2+; 3+), a concordância interobservador foi considerada moderada para os casos corados por CB11 e boa para os corados pelos outros anticorpos. CONCLUSÃO: A concordância interobservador foi considerada entre moderada e muito boa na avaliação dos cinco anticorpos. A menor concordância interobservador ocorreu nos casos com marcações fraca (1+) e moderada (2+). A experiência dos observadores influenciou as taxas de concordância.

AIM: To examine interobserver agreement in immunohistochemical evaluation of Her2 overexpression using five different antibodies on breast cancer array. MATERIAL AND METHOD: Material and method: One array was built with two cores (2 mm diameter each) from 25 breast carcinomas. Serial sections from the array were submitted to immunohistochemistry using five anti-Her2 antibodies: SP3 (NeoMarkers), HercepTest and A0485 (Dako), CB11 (Novocastra), and 4D5 (Genentech). One slide immunostained for each antibody (total = five slides) were independently scored by five observers following HercepTestTM scoring system. Interobserver agreement was evaluated in three different analysis: I (0; 1+; 2+; 3+); II (0 and 1+; 2+ and 3+) and III (0 and 1+; 2+; 3+), and the kappa statistics was applied. RESULTS: There was a good rate of interobserver agreement when the four scores were considered (0; 1+; 2+; 3+). When the scores were considered in two categories (0 and 1+; 2+ and 3+) the interobserver agreement rate was considered substantial for cases stained for SP3 and CB11, and almost perfect for cases stained for A0485, HercepTest and 4D5. For analysis III (0 and 1+; 2+; 3+), a moderate rate of interobserver agreement was considered for cases stained for CB11, and a substantial rate for other antibodies. CONCLUSION: The overall interobserver agreement was considered moderate to substantial in the evaluation of cases stained for the five antibodies. The lowest rate of agreement was obtained in the evaluation of the cases scored as weak (1+) and moderate (2+). The observers experience altered the concordance rates.

Interobserver Agreement among Experts in Determining the Depth of Invasion of Early Colorectal Carcinoma / 대한소화기내시경학회지

BACKGROUND/AIMS: Discrimination between mucosal and submucosal colorectal cancer is important because of different therapeutic plan. Although many characteristic endoscopic findings suggesting submucosal cancer were demonstrated, there are few reports about diagnostic accuracy and interobserver agreement among experienced endoscopists. So we studied about diagnostic accuracy and interobserver agreement about the diagnosis of submucosal invasive colorectal carcinoma by endoscopic findings. METHODS: Fifty patients (58% male, mean age 64 years) diagnosed pathologically as early colorectal carcinoma after polypectomy and operation were randomly selected. Fifteen cases were submucosal invasive colorectal carcinoma. Three experienced endoscopists (A, B and C) blinded to the patient's data reviewed photographs. RESULTS: Diagnostic accuracy of submucosal cancer by A, B and C were 82%, 74% and 78%, respectively. A to B and A to C showed moderate agreement in the diagnosis of submucosal invasion (kappa=0.504 and kappa=0.649). However, agreement power between B and C was somewhat weak (kappa=0.298). Among endoscopic findings, three experts strongly agreed on the features of white spots, hemorrhage and exudate (kappa=0;73, kappa=0.649 and kappa=0.641, respectively). CONCLUSIONS: Interobserver agreement in the diagnosis of submucosal colorectal carcinoma was moderate among three experts. More meticulous effort to improve interobserver agreement and accuracy in the diag- nosis of submucosal invasive colorectal carcinoma is mandatory.

Interobserver Agreement in Gastric Lesions by Magnifying Endoscopy / 대한소화기내시경학회지

BACKGROUND/AIMS: Various magnifying endoscopic classifications have been introduced in esophageal and gastric lesions. However, studies on an agreement between observers according to the form classification of magnifiying endoscopic findings have not been performed yet. The aim of this study was to determine the interobserver agreement for magnifying endoscopic classifications. METHODS: The patients were divided into 3 groups. The first group of patients had post-EMR ulcer scar (50 cases), the second group, elevated gastric lesion (38 cases), and the third group, gastritis (43 cases). Two mucosal patterns were used in the post-EMR ulcer scar group, 6 mucosal patterns in the elevated gastric lesion group, and 3 patterns of the collecting venule in the gastritis group. Three experienced observers (A, B, C) blinded to the patients' data participated in this study. The agreement between observers was evaluated by calculated kappa. The kappa value of 0.75 or greater was rated excellent, 0.4~0.74, fair to good, and 0.4 or less, poor. RESULTS: Regarding 2 mucosal pattern in post-EMR ulcer scar, agreements between A and B, A and C, and B and C were 0.896, 0.793, and 0.901, respectively (p<0.01). Regarding 6 mucosal patterns in elevated gastric lesion, agreements between A and B, A and C, and B and C were 0.607, 0.458, and 0.557, respectively (p<0.01). Regarding 3 collecting venule pattern in gastritis, agreements between A and B, A and C, and B and C were 0.822, 0.823, and 0.751, respectively (p<0.01). CONCLUSIONS: Interobserver agreement is good to excellent in mucosal pattern and collecting venule by magnifying endoscopy. However magnifying endoscopic classification needs to be refinded in order to improve an agreement between observers.