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1.
Article in Chinese | WPRIM | ID: wpr-927939

ABSTRACT

Shenmai Injection is a Chinese medicinal injection prepared from Ginseng Radix et Rhizoma Rubra and Ophiopogonis Radix, which is widely used in clinical practice for the treatment and adjuvant therapy of cardiovascular diseases with significant pharmacological effects. Proton nuclear magnetic resonance spectroscopy(~1H-NMR) has the advantages of simple and nondestructive sample pretreatment, fast analysis, abundant chemical information, quantification and no need to follow the standard curve. It is widely used in the analysis and research of complex mixtures of traditional Chinese medicine, clinical blood and urine samples. In this study, the ~1H-NMR fingerprint of Shenmai Injection was established. Thirty-two chemical components were identified, including seven amino acids, eight small molecular organic acids, one alkaloid, four sugars, two nucleosides, seven saponins, and three other components. Pearson's correlation coefficient and multivariate analysis of variance(principal component analysis combined with hierarchical cluster analysis) were applied based on the ~1H-NMR fingerprint to evaluate the quality consistency. The results showed high-quality consistency of 82 batches of Shenmai Injection. This study confirms that the ~1H-NMR fingerprint has great potential in the application of quality control of Chinese medicinal injection.


Subject(s)
Chromatography, High Pressure Liquid , Drug Combinations , Drugs, Chinese Herbal/chemistry , Proton Magnetic Resonance Spectroscopy , Rhizome/chemistry
2.
International Eye Science ; (12): 741-745, 2022.
Article in Chinese | WPRIM | ID: wpr-923404

ABSTRACT

@#AIM: To investigate the feasibility of artificial intelligence(AI)in reading retinal optical coherence tomography(OCT)images of age-related macular degeneration(ARMD)in clinic. <p>METHODS: From November 2019 to November 2021, a total of 1 579 OCT images were collected in the outpatient department, and the imaging results of ophthalmologist and AI were collected. The Kappa consistency test of classification results without ARMD and with ARMD were analyzed. <p>RESULTS: The Kappa coefficients of the judgement of ophthalmologists about ARMD was 0.934. The Kappa coefficients between AI and ophthalmologists was 0.738. The sensitivity, specificity and area under curve(AUC)of AI to ARMD were 73.08%, 95.07% and 0.841 respectively. <p>CONCLUSION: AI has a high consistency with ophthalmologists in the recognition of ARMD based on OCT images, which is suitable for primary hospitals to complete the early screening and early referral of ARMD.

3.
China Pharmacy ; (12): 661-665, 2022.
Article in Chinese | WPRIM | ID: wpr-922999

ABSTRACT

OBJECTIV E To in vestigate the situation ,achievements and proble ms of consistency evaluation policy of generic medicines in China. METHODS The descriptive analysis was performed after collecting and sorting out the information of generic medicine passing consistency evaluation (GMPCE) published on the official website of the National Medical Products Administration. The basic information ,the distribution and changes of GMPCE were analyzed statistically in National Essential Medicine List (hereinafter refer to as “essential medicine list ”),Medicine List for National Basic Medical Insurance ,Industrial Injury Insurance and Maternity Insurance (hereinafter refer to as “medical insurance list ”)and the result of the successful selection of centralized medicine procurement organized by the state (hereinafter refer to as “centralized procurement list ”). RESULTS From 2017 to 2021,415 chemical generic drugs had passed consistency evaluation in China ,including 309 varieties,1 822 specifications, 6 dosage forms ,and 17 pharmacological mechanisms ,basically belonging to 30 provinces,and 492 drug manufacturers (except 12 products had not been found the manufacturers );the proportion of GMPCE in essential medicine list increased from 0.96% in 2012 edition to 25.40% in 2018 edition;that of GMPCE in medical insurance list increased f rom 2.13% in 2017 edition to 11.68% in 2021 edition;in the first 5 batches of centralized procurement list,GMPCE accounted for 81.65%,and the maximum price drop after entering the list was 97.52%. CONCLUSIONS The policy linkage has been achieved with the continual increase of the number of GMPCE and their total amount in three lists in China. The accessibility and affordability of related medicines have been improved with the apparent decrease of the price of those medicines. H owever,total number of GMPCE is a little small,with the higher repetition rate of variety and the low proportion in the three lists ;the guarantee measures of those medicine supply need to be strengthened.

4.
Rev. CES psicol ; 14(3): 70-93, sep.-dic. 2021. tab, graf
Article in Spanish | LILACS-Express | LILACS | ID: biblio-1376219

ABSTRACT

Resumen Introducción: El bienestar psicológico favorece el funcionamiento de la vida personal y social. Para su evaluación, es necesario contar con instrumentos válidos y confiables que permitan decidir y valorar las acciones necesarias para promoverlo. Objetivo: Evaluar las propiedades psicométricas de la Escala de Bienestar Psicológico para Adultos (BIEPS-A) en una muestra mexicana. Método: Se aplicó la escala BIEPS-A y la Escala de Autoestima de Rosenberg (EAR) a 188 estudiantes universitarios y 94 participantes de población general. Resultados: Un análisis paralelo detectó un factor único en la escala BIEPS-A, estructurado mediante análisis factorial exploratorio (componentes principales, rotación oblicua) que retuvo 9 reactivos y explicó el 54% de la varianza. La consistencia interna fue de aceptable (α de Cronbach = .78) a elevada (alfa ordinal = .90). El análisis de curva ROC identificó un punto de corte equivalente a la mediana (ABC = .72, p < .01) y otro al percentil 75 (ABC = .80, p < .01), y ser mujer, tener entre 18 y 25 años y bajo o leve nivel de autoestima como predictores de bajo nivel de bienestar psicológico. La escala BIEPS-A mostró validez concurrente (r = .57) y predictiva con la EAR (β = .63). Discusión y conclusiones: La escala BIEPS-A es un instrumento válido y confiable para evaluar el bienestar psicológico en población mexicana; sin embargo, las diferencias respecto a su estructura original indican la necesidad de una escala de bienestar psicológico diseñada específicamente para población mexicana.


Abstract Introduction: Psychological well-being favors the functioning of personal and social life. Valid and reliable instruments are necessary for its evaluation that allow deciding and assessing the actions necessary to promote it. Objective: To evaluate the psychometric properties of the Scale of Psychological Well-being for Adults (BIEPS-A) in a Mexican sample. Methods: The BIEPS-A scale and the Rosenberg Self-Esteem Scale (RSES) were administered to 188 university students and 94 participants from the general population. Results: A parallel analysis detected a single factor in the BIEPS-A scale, structured by exploratory factor analysis (main components, oblique rotation) that retained 9 items and explained 54% of the variance. Internal consistency ranged from acceptable (Cronbach's α = .78) to high (ordinal alpha = .90). ROC curve analysis identified a cut-off point equivalent to the median (AUC = .72, p <.01) and another to the 75th percentile (AUC = .80, p <.01). The latter identified as a woman, between 18 and 25 years old with a low or slight level of self-esteem as predictors of a low level of psychological well-being. The BIEPS-A scale showed concurrent (r = .57) and predictive (β = .63) validity with the EAR. Discussion and conclusions: The BIEPS-A scale is a valid and reliable instrument to assess psychological well-being in the Mexican population. However, the differences with respect to its original structure indicate the need for a psychological well-being scale designed specifically for the Mexican population.

5.
Ter. psicol ; 39(3)dic. 2021.
Article in Spanish | LILACS-Express | LILACS | ID: biblio-1390472

ABSTRACT

Resumen: Antecedentes: El Cuestionario de Imagen Corporal (BSQ, por sus siglas en inglés) se ha utilizado ampliamente en población clínica y general destacando su carácter unidimensional para la medida de la insatisfacción corporal. Diversas investigaciones han generado hasta 10 versiones cortas basadas en reducciones del BSQ-34. Sin embargo, hasta el momento ninguna de ellas ha sido sometida a pruebas de confiabilidad y validez en muestras independientes. Objetivo: Analizar la estructura interna del BSQ-8D y su relación con los tres factores del Test de Actitudes Alimentarias (EAT-26, por sus siglas en inglés), así como la fiabilidad obtenida con un diseño de consistencia interna y otro de estabilidad temporal en una muestra de mujeres universitarias. Método: Participaron 492 mujeres universitarias quienes contestaron el BSQ-8D y el EAT-26. Resultados: El análisis factorial confirmatorio corroboró la estructura unidimensional del BSQ-8D. La consistencia interna fue adecuada, con α =.91 y ω = .89, así como la confiabilidad test-retest con un CCI = .80. La correlación entre las puntuaciones obtenidas de esta versión del BSQ y el EAT-26 fue de .56 y con sus factores fue .58 para Dieta, .33 para Bulimia y Preocupación por la Comida y .26 para Control Oral. Conclusiones: Estos hallazgos aportan evidencia empírica independiente que apoya la unidimensionalidad, la confiabilidad y la relación con las actitudes hacia la comida del BSQ-8D. Para fortalecer la solidez de esta versión del BSQ-8D hace falta recolectar datos en muestra clínica y en muestras de varones con y sin trastornos alimentarios y de la ingestión de alimentos.


Abstract: Background: The Body Shape Questionnaire (BSQ) has been widely used in the clinical and general population, highlighting its unidimensional nature. Research evidence has generated 10 short versions based on reductions of the BSQ-34. Hitherto, short versions have not been applied to analyze validity and reliability with independent samples. Aim: To analyze the internal structure of the BSQ-8D and its relationship with the three factors of the Eating Attitudes Test-26 (AET-26), as well as the reliability obtained with a design of internal consistency and another of temporal stability in a sample of university women. Methods: Participants were 492 undergraduate women who completed the BSQ-8D and the EAT-26. Results: Confirmatory factor analysis supported the one factor structure of the BSQ-8D. The internal consistency was adequate, α = .91 and ω = .89, as well as the test-retest reliability ICC = .80. Correlation between this BSQ-8D version and those obtained in the EAT-26 was = .56 besides the correlations with its factors .58 for Dieting, .33 for Bulimia and Food Concerns, and .26 for Oral Control. Conclusions: These findings added independent evidence about the unidimensionality of the instrument. To strengthen the robustness of this version of the BSQ-8D it is necessary to collect data in clinical and men sample with and without feeding and eating disorders.

6.
Rev. latinoam. psicol ; 53: 104-113, jul.-dic. 2021. tab, graf
Article in Spanish | LILACS-Express | LILACS | ID: biblio-1361044

ABSTRACT

Resumen Introducción: Uno de los instrumentos más usados internacionalmente para medir la conciencia plena es el Kentucky Inventory of Mindfulness Skills. Debido a que esta escala no ha sido traducida ni adaptada a la lengua española, la investigación examinó la validez del constructo, su consistencia interna y validez de criterio, en una muestra mexicana. Método: La muestra estuvo conformada por 485 participantes (145 hombres y 340 mujeres). Resultados: Los resultados revelan una buena fiabilidad de la escala general, Asimismo, confirman que las cuatro dimensiones del inventario son factores sustantivos de la conciencia plena. Un análisis factorial confirmatorio muestra que los datos se ajustan de manera adecuada al modelo de cuatro factores. Conclusiones: Se concluye que este inventario es un instrumento válido y fiable para evaluar la conciencia plena en población general mexicana.


Abstract Introduction: One of the most common instruments used in the world to measure mindfulness is the Kentucky Inventory of Mindfulness Skills. Due to this scale has not been translated and adapted to Spanish, the purpose of this research was to examine the construct validity, internal consistency, and criterion validity in a Mexican sample. Method: The sample included 485 participants (145 men and 350 women). Results: Results found in this research revealed a good reliability of the general scale It was confirmed that the four dimensions of this inventory are significant factors of indfulness. Regarding the confirmatory factor analysis, results showed that data fitted properly to the four factors model. Conclusions: Inconclusion, this inventory is a valid and reliable instrument to measure mindfulness in general Mexican population.

7.
Article in Spanish | LILACS-Express | LILACS | ID: biblio-1388661

ABSTRACT

Resumen Objetivo: Comparar el índice de consistencia cervical con la longitud cervical en la predicción de parto pretérmino inminente en pacientes sintomáticas. Método: Estudio prospectivo realizado en mujeres con embarazos únicos entre 24 y 35 semanas, con diagnóstico clínico de amenaza de parto pretérmino, que asistieron al Hospital Central Dr. Urquinaona en Maracaibo, Venezuela. Al momento del diagnóstico, las pacientes fueron evaluadas con ecografía transvaginal para establecer los valores del índice de consistencia cervical y la longitud cervical. La resultante principal fue parto inminente (en los 7 días siguientes a la evaluación). Resultados: Se incluyeron 657 pacientes, de las que 152 presentaron parto pretérmino inminente (grupo A) y 505 fueron consideradas como controles (grupo B). No se encontraron diferencias entre los grupos en cuanto a edad materna, nuliparidad, antecedente de parto pretérmino, antecedente de hábito tabáquico e índice de masa corporal. Las pacientes del grupo A presentaron valores significativamente más bajos del índice de consistencia cervical y de longitud cervical que las del grupo B (p < 0,0001). El índice de consistencia cervical mostró un valor de área bajo la curva de 0,857, mientras que para la longitud cervical este fue de 0,977. La diferencia de la capacidad de discriminación entre las áreas bajo la curva de cada prueba fue significativa (p < 0,0001). Conclusión: El índice de consistencia cervical no es superior a la longitud cervical en la predicción de parto pretérmino inminente en pacientes sintomáticas.


Abstract Objective: To compare the cervical consistency index with the cervical length in predicting imminent preterm delivery in symptomatic patients. Method: This prospective study was conducted in women with single pregnancies between 24 and 35 weeks, with a clinical diagnosis of threatened preterm delivery who attended the Central Hospital Dr. Urquinaona, in Maracaibo, Venezuela. At the time of diagnosis, the patients were evaluated using transvaginal ultrasound to establish the values of the cervical consistency index and cervical length. The main result was imminent delivery (in the 7 days following the evaluation). Results: 657 patients were included, 152 women presented imminent preterm delivery (group A) and 505 were considered as controls (group B). No differences were found between the groups concerning maternal age, nulliparity, history of preterm delivery, history of smoking, and body mass index. Group A patients presented significantly lower values of cervical consistency index and cervical length compared to group B patients (p < 0.0001). The cervical consistency index and cervical length showed an area value under the curve of 0.857 and 0.977, respectively. The difference in the ability to discriminate between the areas under the curve of each test was significant (p < 0.0001). Conclusions: The cervical consistency index is not superior to the cervical length in the prediction of imminent preterm delivery in symptomatic patients.

8.
Article in Chinese | WPRIM | ID: wpr-908193

ABSTRACT

Objective:To explore the effect of quantifying food thickness in patients with swallowing difficulty after thyroidectomy.Methods:A total of 70 patients with swallowing difficulty after thyroidectomy in Department of Thyroid and Neck Oncology, Tianjin Medical University Cancer Institute & Hospital, during April 2019 to March 2020, randomly divided into intervention group(35cases) and control group(35cases). The patients in the control group were treated with conventional dietary nursing measures after thyroidectomy. The patients in the intervention group were treated with dietary guidance according to the results of quantifying food thickness and conventional dietary nursing. The incidence of aspiration was compared during hospitalization, the swallowing function were evaluated in the two groups pre intervention and on discharge, and relationship was evaluated between Kubota drinking test level and food consistency grade of safe eating in intervention group.Results:The incidence of aspiration in the intervention group (0) was lower than that in the control group 28.57% (10/35) and the difference was statistically significant ( χ2 value was 11.667, P<0.01). Before intervention the difference in the degrees of Kubota drinking test had no statistical significance between two groups before intervention ( Z value was -0.283, P>0.05). After interventions the degrees of Kubota drinking test was graded as gradeⅠ(1 example), gradeⅡ(4 examples), gradeⅢ(20 examples), grade Ⅳ(9 examples), gradeⅤ(1 example) respectively, meanwhile the degrees of control group was graded as gradeⅠ(0 example), gradeⅡ(1 example), gradeⅢ(16 examples), grade Ⅳ(17 examples), gradeⅤ(1 example) respectively. The difference between two groups was statistically significant ( Z value was -2.170, P<0.05). Moreover, the improvement of swallowing function in the intervention group was larger than that of the control group and the difference in the degree of the swallowing function was statistically significant between two groups ( Z value was -2.029, P<0.05). Before intervention the difference of the score of Eating Assessment Tool-10 had no statistical significance between two groups ( t value was 0.168, P>0.05). After intervention the score of Eating Assessment Tool-10 in the intervention group was 8.43±2.21, the score of Eating Assessment Tool-10 in the control group was 10.06±2.45, the difference had statistical significance between two groups( t value was -2.919, P<0.01). Conclusion:Quantification of fluid food thickness can more accurately and objectively judge the grade of food consistency that patients can eat safely, and it can effectively reduce the incidence of aspiration and contribute to improving the swallowing function in patients with swallowing difficulty after thyroidectomy and can also help them to recovery.

9.
Article in Chinese | WPRIM | ID: wpr-907872

ABSTRACT

Objective:To investigate the safety and consistency of domestic inhaled allergen extracts in the diagnosis of allergic diseases in children.Methods:Nine thousand five hundred and sixty-three children diagnosed with allergic diseases from September 2018 to June 2020 in Children′s Hospital Affiliated to Capital Institute of Pedia-trics were selected in this study, and all of them were subjected to skin prick test(SPT), and 415 of them were subjected to serum specific IgE (sIgE) test at the same time.The adverse events during SPT were recorded and the consistency of the results between SPT and sIgE test was analyzed.Results:There were 14 cases with adverse events in 9 563 patients, and the overall incidence was 0.15%.The incidence of adverse events was 0.07% (2/2 581 cases) in the 1-5 years old group, 0.19% (12/6 197 cases) in the 6-11 years old and 0 in the 12-17 years old group.The severity of all these events was grade Ⅰ.Out of the 14 cases with adverse events, only 1 case was considered to be related to allergen preparations, with the incidence being 0.01% (1/9 563 cases). The Kappa index showed that the results of dermatophagoides pteronyssinus, dermatophagoides farinae, alternaria and artemisia measured by SPT and sIgE were almost the same.There was high consistency between tree pollens and ragweed ( P<0.01), and moderate consistency between aspergillus fumigatus ( P<0.01). When the results of sIgE were used as the diagnostic criteria, the Youden index for the results of SPT ranged from 0.76 to 0.89, with aspergillus fumigatus (0.76) and tree pollens mixture (0.79) as the lowest.The positive likelihood ratio for most of the inhaled allergens was more than 10 except for tree pollens mixture (7.12) and dermatophagoides farinae (9.10). The negative likelihood ratio for most of the inhaled allergens was less than or equal to 0.1 except for aspergillus fumigatus (0.19). Conclusions:The domestic inhaled allergen extracts had high safety in the clinical application of SPT, and their results of SPT had good consistency with those of serum sIgE, which was conducive to the diagnosis and evaluation of allergic diseases in children.

10.
Article in Chinese | WPRIM | ID: wpr-906315

ABSTRACT

With the publication of Registration and Classification of Traditional Chinese Medicine (TCM) and Application Data Requirements, the related management and technical documents of TCM with the same name and prescription need to be further studied and formulated. In this paper, the management mode and technical evaluation of TCM with the same name and prescription are discussed to provide reference for the formulation of management and technical documents of TCM with the same name and prescription. The issues to be discussed include which management mode to adopt, how to select the control drugs with the same name and prescription, whether the indication risk level should be divided, whether the indication should be limited to medium and low risk, and how to carry out the technical evaluation of similarity/consistency. From the perspective of technical document research and formulation, this paper mainly focuses on the technical level. However, there are still other theoretical possibilities in the management mode and technical evaluation of TCM with the same name and prescription. Therefore, this paper, as a preliminary summary of the management and technical evaluation of TCM with the same name and prescription, needs more scholars and industry experts to pay attention to and participate in this work.

11.
Article in Chinese | WPRIM | ID: wpr-921703

ABSTRACT

The present study determined five saponins in Xuesaitong Dropping Pills(XDP) by micellar electrokinetic chromatography(MEKC), and evaluated between-batch consistency by MEKC fingerprints and similarity analysis. A background buffer was composed of 20 mmol·L~(-1) sodium tetraborate-20 mmol·L~(-1) boric acid solution(pH 8.5), 55 mmol·L~(-1) sodium dodecyl sulfate(SDS), 23 mmol·L~(-1) β-cyclodextrin, and 13% isopropyl alcohol. All separations were performed at 25 ℃,20 kV and the detection wavelength was set at 203 nm. The separation channel was a fused silica capillary with a dimension of 75 μm I.D. and a total length of 50.2 cm(effective length of 40.0 cm). The contents of notoginsenoside R_1, and ginsenosides Rg_1, Re, Rb_1, Rd were determined with their quality control ranges set. The fingerprints of XDP were established and the between-batch consistency was evaluated by similarity analysis. The contents of five saponins from the 19 batches of XDP were stable in the fixed ranges. Statistical analysis was carried out on the results of multiple batches of samples, and the specific quality control ranges were recommended as follows: notoginsenoside R_1 21.92-34.16 mg·g~(-1), ginsenosides Rg_1 83.54-131.78 mg·g~(-1), ginsenosides Re 13.58-19.82 mg·g~(-1), ginsenosides Rb_1 89.40-129.90 mg·g~(-1), and ginsenosides Rd 22.34-35.67 mg·g~(-1). Eleven characteristic peaks were identified in the fingerprints. Five peaks, notoginsenoside R_1 and ginsenosides Rg_1, Re, Rb_1, Rd, were identified with reference standards. The similarities of the 19 batches of samples were all above 0.988, indicating good between-batch consistency. This method is green and simple, and can be used for the quantitative determination and quality evaluation of XDP. It can also provide references for the quality control of other Chinese medicinal dripping pills.


Subject(s)
Chromatography, Micellar Electrokinetic Capillary , Drugs, Chinese Herbal , Micelles , Quality Control , Saponins
12.
Article in Chinese | WPRIM | ID: wpr-912134

ABSTRACT

Objective:To study the intestinal mucosal state of ulcerative colitis (UC) through UC endoscopic scores and to investigate the correlation between the endoscopic scores and clinical activity and histological scores.Methods:A retrospective analysis was performed on data of 152 patients who underwent colonoscopy or sigmoidoscopy in Nanjing Drum Tower Hospital from January 2014 to September 2019. The results were graded with 7 endoscopic scores, namely, Mayo endoscopic score(MES), modified Baron score(MBS), endoscopic activity index(EAI) , Sutherland index(DAI or UCDAI) , Rachmilewitz endoscopic index(REI), Lemann endoscopic index (LEI), and ulcerative colitis endoscopic index of severity(UCEIS). Spearman correlation coefficients between endoscopic score and partial Mayo scores, Truelove-Witts disease severity score and Nancy index (NI), Robarts index (RHI) and Geboes score (GS) were calculated respectively. Consistency of each endoscopic score among different observers was analyzed.Results:Except for the weak correlation between DAI and Truelove - Witts classification ( r= 0.469, P < 0.001), all other endoscopic scores were moderately positively correlated with clinical activity scores with significance( all P<0.001). However, the correlation between 7 endoscopic scores and histological scores was weak ( P<0.001). Except that the consistency of MBS among observers was medium, those of MES, DAI and LEI among observers were poor, and those of UCEIS, EAI and REI among observers were worse ( P<0.001). Conclusion:Endoscopic scores were moderately correlated with clinical activity indexes and weakly correlated with histological scores. However, patients with endoscopic remission may have histologic inflammatory activity, so attention should be paid to histological mucosal healing after endoscopic remission. The consistency of all 7 endoscopic scoring stystems among observers was low, and the repeatability was poor.

13.
Article in Chinese | WPRIM | ID: wpr-910836

ABSTRACT

Objective:To investigate the consistency and diagnostic efficiency of Chinese Thyroid Imaging Reporting and Date System (C-TIRADS) in thyroid nodule evaluation by different seniority sonographers.Methods:The preoperative ultrasonographic datum of 134 thyroid nodules in 112 patients from January to November 2020 were independently analyzed by sonographers with different seniority. According to the C-TIRADS guidelines, the C-TIRADS ultrasonographic indicators of each nodule were recorded and C-TIRADS classification was performed. Cohen′s Kappa (K) statistical method was used to analyze the consistency of ultrasonic indicators evaluated by different seniority sonographers. Using postoperative pathological results as the gold standard, the diagnostic efficacy of C-TIRADS classification for differentiating benign and malignant thyroid nodules by junior and senior sonographers was calculated respectively, and the Receiver Operating Characteristic (ROC) curves were drawn respectively.Results:The solid structure and vertical orientation of thyroid nodule judged by different seniority sonographers were very consistent ( K=0.84, 0.81). The consistencies of very hypoechoic and microcalcifications were substantial agreement ( K=0.80, 0.61), and moderate ( K=0.531) for the margin of the nodules. The sensitivity, specificity, accuracy, positive predictive value and negative predictive value of distinguishing benign and malignant thyroid nodules by junior and senior sonographers were 91.8%, 65.8%, 77.6%, 69.1%, 90.6% and 96.7%, 67.1%, 80.6%, 71.1%, 96.1%, respectively. The corresponding area under the ROC curves were 0.788 and 0.819, respectively ( Z=1.369, P=0.171). Conclusion:Ultrasonologists with different experience have good consistency in evaluating the C-TIRADS ultrasonic indicators of thyroid nodule, and the diagnostic efficacy of C-TIRADS classification in differentiating benign and malignant thyroid nodule was similar.

14.
Acta Pharmaceutica Sinica ; (12): 1739-1744, 2021.
Article in Chinese | WPRIM | ID: wpr-881561

ABSTRACT

Based on the "requirements on the submitted documents for consistency evaluation of generic oral solid dosage forms of chemical drugs" and relevant guidance, this article summarized and formulated the decision tree of in vitro consistency evaluation of oral solid generic drugs, discussed the differences and common problems of in vitro evaluation research projects under different conditions, selective analyzed the technical requirements and concern problems of unconventional research projects, and proposed corresponding recommendations for concern problems, in order to provide more references for the follow-up study on consistency evaluation of oral solid generic drugs.

15.
Article in Chinese | WPRIM | ID: wpr-909231

ABSTRACT

Objective:To investigate the application value of multi-slice spiral CT (MSCT) in Borrmann classification of advanced gastric cancer.Methods:The clinical data of 80 patients with advanced gastric cancer who received treatment in Cixi Integrated Traditional Chinese and Western Medicine and Health Group from January 2016 to January 2020 were analyzed. Clinical results were compared with MSCT imaging findings.Results:Postoperative specimens of 80 patients with gastric cancer showed that a single cancer occurred in cardiac fundus of 13 (16.25%) patients, in gastric body of 21 (26.25%) patients, in gastric antrum of 46 (57.50%) patients. Advanced gastric cancer involved gastric fundus and gastric body in 21(26.25%) patients, gastric antrum and gastric body in 34 (42.50%) patients, and gastric fundus, gastric body and gastric antrum in 13 (16.25%) patients. Pathological results of gastric cancer showed Borrmann type I in 12 (15.00%) patients, Borrmann type II in 28 (35.00%) patients, Borrmann type III in 27 (33.75%) patients and Borrmann type IV in 13 (16.25%) patients. The accuracy rate of preoperative MSCT in the identification of Borrmann type I, II, III and IV gastric cancer was 83.33%, 78.57%, 77.78%, and 84.62%, respectively, with the total preoperative MSCT accuracy rate of 80.00%. Preoperative MSCT has good intra-observer consistency and inter-observer consistency in the Borrmann classification of advanced gastric cancer, with the kappa values of 0.883 and 0.853, respectively ( P < 0.001). Conclusion:MSCT has a high accuracy rate and good repeatability in Borrmann typing of advanced gastric cancer.

16.
Article in Chinese | WPRIM | ID: wpr-908540

ABSTRACT

Objective:To investigate if the dynamic optotype is comparable with conventional logarithm of the minimum angle of resolution (LogMAR) optotype.Methods:This is a cross-sectional study investigating visual acuity measurement with two methods.The study lasted for 6 months from May to November 2017.One hundred and fifty subjects (150 right eyes) with age (58.7±14.3) years were recruited in the Optometry Clinics of the School of Optometry, The Hong Kong Polytechnic University.Habitual distance visual acuity of each eye was measured with a 3-meter LogMAR E chart and a Dyop ? acuity chart displayed on a monitor placed at 6 meters, respectively.Subjects were asked to comment on the Dyop ? system regarding the overall speed and ease of understanding the test using a 5-point Likert scale.The agreement between the two charts was assessed.This study was approved by an Ethics Committee of The Hong Kong Polytechnic University (No.HSEARS20170215006) in accordance with the Declaration of Helsinki, and written information consent was obtained from all the subjects prior to any ocular examination. Results:The mean difference between the LogMAR E chart and Dyop ? system was (0.05±0.07) LogMAR units, and the 95% limits of agreement was -0.09 to 0.19.The intra-class correlation coefficient of the two methods was 0.957.In general, 70% (105/150) of the subjects considered the Dyop ? system fast and 81% (121/150) easy to understand. Conclusions:Visual acuity measured by the Dyop ? system is comparable to the traditional LogMAR E chart.

17.
Article in English | WPRIM | ID: wpr-922400

ABSTRACT

OBJECTIVES@#To study the consistency between nasopharyngeal aspirates (NPA) and bronchoalveolar lavage fluid (BALF) in pathogen detection in children with pneumonia@*METHODS@#A retrospective analysis was performed on the data of pathogens detected in 533 children with pneumonia from February 2017 to March 2020. The paired McNemar's test was used to compare the difference in pathogen detection between NPA and BALF groups. The @*RESULTS@#NPA had a sensitivity of 28%, a specificity of 74%, a positive predictive value of 14%, and a negative predictive value of 91% in detecting bacteria, and a @*CONCLUSIONS@#There is poor consistency between NPA and BALF in the detection of bacteria and viruses, and clinicians should be cautious in diagnosing lower respiratory tract infection based on bacteria or viruses detected in NPA. There is moderate consistency between NPA and BALF in the detection of


Subject(s)
Bronchoalveolar Lavage Fluid , Child , Humans , Mycoplasma pneumoniae , Pneumonia , Pneumonia, Mycoplasma , Respiratory Tract Infections , Retrospective Studies
18.
Rev. bras. educ. espec ; 27: e0208, 2021. tab
Article in Portuguese | LILACS-Express | LILACS | ID: biblio-1288268

ABSTRACT

RESUMO: Um mesmo instrumento pode ser adequado para distintas realidades, mas, para ele que avalie de fato concepções atreladas a um contexto cultural particular, é preciso compreender o fenômeno sob as lentes desse cenário. O objetivo deste artigo foi apresentar os resultados preliminares de validação e de confiabilidade da Escala Intercultural de Concepções de Deficiência (EICD) para a realidade brasileira. A EICD é um instrumento elaborado por uma equipe de distintos países (Brasil, Espanha e Portugal) e voltado para a avaliação de concepções de deficiência. Contou-se com a validação qualitativa (com base no conteúdo), por meio dos juízes nacionais e internacionais, e por verificação de componentes principais realizada por análise fatorial exploratória dos dados coletados com um grupo amostral brasileiro. A versão final contou com tradução e retradução para quatro diferentes línguas: espanhol (Cuba), catalão (Barcelona), castelhano (Sevilha) e português (Portugal). No que tange ao estudo fatorial para a realidade brasileira, a EICD ficou composta por 43 itens, distribuídos em três dimensões (Concepção Biológica, Concepção Social e Concepção Metafísica (Religiosa)). Estudos futuros serão necessários para o aprimoramento psicométrico do instrumento, tanto no contexto nacional quanto no internacional.


ABSTRACT: The same instrument may be suitable for different realities, but in order to actually assess conceptions linked to a particular cultural context, it is necessary to understand the phenomenon under the lens of this scenario. The objective of this paper was to present preliminary results of validation and reliability of the Escala Intercultural de Concepções de Deficiência - EICD (Intercultural Scale of Conceptions of Disability) for the Brazilian reality. EICD is an instrument developed by a team from different countries (Brazil, Spain and Portugal) and aimed at assessing concepts of disability. Qualitative validation (based on content) was carried out, by means of national and international judges, and by verification of main components carried out by exploratory factor analysis of the data collected with a Brazilian sample group. The final version included translation and backtranslation into four different languages: Spanish (Cuba), Catalan (Barcelona), Castilian (Seville) and Portuguese (Portugal). Regarding the factorial study for the Brazilian reality, the EICD was composed of 43 items, distributed in three dimensions (Biological Conception, Social Conception and Metaphysical (Religious) Conception). Future studies will be necessary for the psychometric improvement of the instrument, both in the national and international context.

19.
Acta colomb. psicol ; 23(2): 339-348, jul.-dic. 2020. tab, graf
Article in English | LILACS-Express | LILACS | ID: biblio-1124049

ABSTRACT

Abstract The study is aimed at analyzing psychometric features of the local version of the Honey-Alonso Learning Styles Questionnaire. First, the inner structure of the scale is examined by means of a confirmatory factor analysis and an analysis of factorial invariance, splitting the sample by faculty. Second, internal consistency coefficients of the dimensions are analyzed and compared to previous results. Third, external convergent validity evidences are considered, regarding scores obtained from a learning approach scale which was used as an external criterion. Findings show an adequate model fit, even employing different estimation methods. Furthermore, the factorial invariance analysis verifies the metrical equivalence of the model. The internal consistency study finds acceptable values. The dimensions' stability reliability indices do not verify significant differences between test and retest. Finally, the convergent validity evidences analyses show positive associations between learning styles and the Deep learning approach on the one hand, and negative associations between the Surface approach and learning styles on the other, as reported in previous studies. Results are discussed on the grounds of the theoretical and empirical background.


Resumen En el presente trabajo se examinan las propiedades psicométricas de la versión argentina del Cuestionario Honey-Alonso de Estilos de Aprendizaje (CHAEA). Primero se analiza la estructura interna de la escala mediante un análisis factorial confirmatorio y de invarianza factorial, segmentando la muestra según facultad; luego se estudia la consistencia interna de las dimensiones confirmadas y se comparan los resultados con los obtenidos en estudios previos; posteriormente se examina la estabilidad temporal de las puntuaciones de cada dimensión; y, por último, se estudian las evidencias de validez concurrente con otra escala que evalúa enfoques de aprendizaje. Los resultados del análisis factorial confirmatorio muestran un adecuado ajuste del modelo testeado a partir de distintos métodos de estimación, mientras que con el análisis de invarianza factorial se comprueba la equivalencia métrica del modelo. Asimismo, los índices de consistencia interna son aceptables, aunque el análisis de estabilidad temporal de las dimensiones no comprueba diferencias significativas entre la primera y segunda administración del instrumento. Finalmente, en consonancia con hallazgos previos, las evidencias de validez concurrente exhiben asociaciones positivas entre los estilos de aprendizaje y el enfoque profundo, así como asociaciones negativas entre los estilos y el enfoque superficial. Al final se discuten los resultados a partir de antecedentes teóricos y empíricos.

20.
Rev. bras. educ. espec ; 26(4): 657-672, out.-dez. 2020. tab
Article in Portuguese | LILACS-Express | LILACS | ID: biblio-1144043

ABSTRACT

RESUMO: Nos últimos anos, tem havido na literatura uma larga estimativa de prevalência de desordens do processamento sensorial. A avaliação dessas dificuldades deve fazer parte da competência dos profissionais que desenvolvem o seu trabalho com crianças que as apresentam por meio de instrumentos validados. Este estudo examina a consistência interna e homogeneidade dos itens da versão portuguesa do Sensory Processing Measure-Preschool (SPM-P). Foi aplicado o SPM-P a cem crianças entre os 2 e os 5 anos de idade que frequentavam a creche e o jardim de infância com o objetivo de determinar a sua fiabilidade e a validade. A análise da correlação de Pearson (homogeneidade dos itens) e do alfa de Cronbach (consistência interna) determinou a exclusão de quatro itens. Os valores de alfa de Cronbach para as várias dimensões ("Participação Social", "Visão", "Audição", "Toque", "Consciência Corporal", "Equilíbrio", "Planeamento Motor e Ideias") oscilou entre ‹=0.742 ("Visão" e "Toque") e ‹=0.908 ("Consciência Corporal"). Os resultados deste estudo mostram que o SPM-P é um instrumento de rastreio válido e fiável para despistar as dificuldades de processamento sensorial das crianças Portuguesas com idades compreendidas entre os 2 e os 5 anos integradas em contexto escolar.


ABSTRACT: Over the past several years, a wide range of estimates of the prevalence of sensory processing disorders has emerged in the literature. The assessment of these difficulties should be part of the competence of professionals working with children with these kinds of needs through validated instruments. This study examined the internal consistency and items homogeneity of a Portuguese language version of the Sensory Processing Measure-Preschool (SPM-P). One hundred typically developing children aged between 2 and 5 years were recruited at Nursery Schools and assessed using the SPM-P to determine its reliability and validity. Pearson correlation (item homogeneity) and Cronbach's alpha (internal consistency) determined the exclusion of 4 items. Cronbach's alpha values for the different dimensions ("Social Participation", "Vision", "Hearing", "Touch", "Body Awareness", "Balance and Motion", "Planning and Ideas") ranged from 0.742 ("Vision" and "Touch") and 0.908 ("Body Awareness"). The findings of this study showed that the SPM-P is a valid and reliable tool in screening for sensory processing difficulties in Portuguese preschool children aged between 2 and 5 years in a nursery school setting.

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