Initial screening and retest mode in apheresis platelet donors: a comparative analysis / 中国输血杂志

【Objective】 To investigate the effectiveness of current indicators in initial screening and retest before donation and access the optimal testing strategies. 【Methods】 Data of initial screening (rate method for ALT, colloidal gold method for HBsAg) and retest (rate method for ALT, ELISA for HBsAg) of 18 510 platelet donors in our center from January 2019 to December 2021 were collected, and the results were retrospectively analyzed and compared in terms of different years and number of donations. 【Results】 From 2019 to 2021, data of initial screening and retest of platelet donors were as follows: 1) the deferral rate of ALT and HBsAg was 12.98% (2 403/18 510) vs 0.26%(40/15 412); 2) the deferral rate of ALT was 13.19% (712/5 398) vs 0.20%(9/4 410)in 2019, 13.33% (873/6 549) vs 0.06%(3/5 387)in 2020 and 11.05% (725/6 563) vs 0.07%(4/5 615)in 2021; for initial screening, significant difference was noticed in ALT reactivity in 2021 as in comparison to other two years(P<0.05); 3) the reactive rate of HBsAg was 0.43% (23/5 398) vs 0.18%(8/4 410)in 2019, 0.66% (43/6 549) vs 0.20%(11/5 387)in 2020 and 0.41% (27/6 563) vs 0.09%(5/5, 615) in 2021. For initial screening, HBsAg deferral in 2021 was significantly different from 2019, while similar with 2020. 4) Among ALT deferral samples in the retest, 68.75% (11/16) were ALT≥45 U/L. Among HBsAg reactive samples, 91.67% (22/24) were reactive by single reagent. 【Conclusion】 Setting the threshold value of ALT for platelet donors in initial screening as less than 45 U/L can effectively reduce the reactive rate in the retest. HBsAg screening only for first-time platelet donors can reduce the detection cost. Adding pre-donation detection indicators according to local prevalence of transfusion transmitted diseases is conductive to reduce the discarding rate of platelets.

Estudio comparativo de la concentración de la atención en boxeadores, antes y después de la intervención psicológica / Estudo comparativo da concentração de atenção em boxeadores, antes e depois da intervenção psicológica / Comparative study of the concentration of attention in boxers, before and after psychological intervention

RESUMEN Introducción: La concentración de la atención es fundamental en el boxeo, actividad donde el deportista se enfrenta a un contrario a corta distancia, en un combate que transcurre en un tiempo limitado, planteándole elevadas exigencias al proceso de atención. Objetivo: El presente trabajo tuvo como objetivo comparar la concentración de la atención en boxeadores categoría 15 - 16 años de la Eide "Mártires de Barbados" de La Habana, antes y después de la intervención psicológica del proceso. Materiales y métodos: La muestra fue de 20 deportistas de interés competitivo. La evaluación se realizó en dos momentos durante la etapa de preparación especial; el primero antes de realizar acciones de intervención psicológica del proceso y el segundo luego de ocho semanas realizándolas. Para el diagnóstico inicial se utilizaron las siguientes técnicas: Test de Anillos de Landolt, escala de autovaloración a deportistas, escala de valoración externa a entrenadores, entrevista a deportistas y observación estructurada a entrenamientos y competencias. En el retest, se repitieron las tres primeras técnicas mencionadas. Resultados: Los principales resultados arrojados inicialmente fueron una concentración evaluada de mal y de regular en el 50 % y 40 % de la muestra respectivamente, expresadas fundamentalmente en reiteración de errores ya corregidos por los entrenadores y en dificultad para mantener la focalización. Post intervención se comprobó una mejora de la concentración de la atención, al obtenerse un diagnóstico de bien, muy bien y excelente en el 35 %, 20 % y 20 % de la muestra respectivamente. Conclusiones: Se concluye que la intervención propuesta contribuyó a una mejoría en el diagnóstico del proceso.

SÍNTESE Introdução: A concentração da atenção é fundamental no boxe, uma atividade onde o atleta enfrenta um adversário a curta distância, em um combate que ocorre em um tempo limitado, colocando altas exigências no processo de atenção. Objetivo: O objetivo deste estudo foi comparar a concentração de atenção nos boxeadores da categoria "Mártires de Barbados" Eide em Havana, antes e depois da intervenção psicológica do processo. Materiais e métodos: A amostra consistiu de 20 atletas de interesse competitivo. A avaliação foi realizada em dois momentos durante a fase de preparação especial; o primeiro antes de realizar as ações de intervenção sicológica do processo e o segundo após oito semanas de realização das mesmas. Para o diagnóstico inicial, foram utilizadas as seguintes técnicas: Landolt's Ring Test, escala de auto-avaliação para atletas, escala de avaliação externa para treinadores, entrevista com atletas e observação estruturada de sessões de treinamento e competições. No novo teste, as três primeiras técnicas mencionadas acima foram repetidas. Resultados: Os principais resultados mostraram inicialmente uma concentração fraca e justa em 50% e 40% da amostra respectivamente, expressa principalmente na repetição de erros já corrigidos pelos treinadores e na dificuldade de manter o foco. Após a intervenção, verificou-se uma melhora na concentração da atenção, obtendo-se um diagnóstico de bom, muito bom e excelente em 35%, 20% e 20% da amostra, respectivamente. Conclusões: Conclui-se que a intervenção proposta contribuiu para uma melhoria no diagnóstico do processo.

ABSTRACT Introduction: The concentration of attention is essential in boxing, an activity where the athlete faces an opponent at close range, in a fight that takes place in a limited time, placing high demands on the attention process. Objective: The present study aimed to compare the concentration of attention in boxers category 15 - 16 years of the Sport Initiation School (Eide in Spanish) "Mártires de Barbados" in Havana, before and after the psychological intervention of the process. Materials and methods: The sample consisted of 20 athletes of competitive interest. The evaluation was carried out at two moments during the special preparation stage; the first before carrying out psychological intervention actions of the process and the second after eight weeks carrying them out. For the initial diagnosis, the following techniques were used: Landolt Ring Test, self-assessment scale for athletes, external assessment scale for coaches, interviews with athletes, and structured observation of training and competitions. In the retest, the first three techniques mentioned were repeated. Results: The main results initially obtained were a concentration evaluated as bad and regular in 50 % and 40 % of the sample, respectively, expressed mainly in the repetition of errors already corrected by the coaches and in difficulty in maintaining focus. Post-intervention, an improvement in attention concentration was verified, obtaining a diagnosis of good, very good and excellent in 35 %, 20 % and 20 % of the sample, respectively. Conclusions: It is concluded that the proposed intervention contributed to an improvement in the diagnosis of the process.

Application of asthenopia survey scale in patients with accommodative asthenopia / 国际眼科杂志(Guoji Yanke Zazhi)

AIM: To investigate the visual fatigue of patients with accommodative asthenopia and the difference in scores before and after treatment by using the asthenopia survey scale(ASS), and to evaluate its reliability, validity and responsiveness in this population.METHODS: A total of 112 patients with accommodative asthenopia were admitted to the department of ophthalmology, Shuguang Hospital, Shanghai University of Traditional Chinese Medicine and recruited online were investigated using the ASS questionnaire, and 48 subjects were randomly selected and retested 1wk later. A variety of reliability, validity and responsiveness indicators were used to evaluate the scale.RESULTS: The overall Cronbach's α coefficients of the scale entries was 0.91; The split-half reliability coefficients was 0.86; Repeated measurement correlation coefficient of the scale total score was 0.74, there was no significant difference before and after(P&#x003E;0.05); The results of confirmatory factor analysis showed that the absolute fit index of the three-factor structural model was χ2/df&#x003C;2.0, RMSEA=0.08; The correlation coefficients of each dimension's total score and the scale's total score were 0.92, 0.90 and 0.83 respectively; The standard association validity analysis showed statistically significant differences between groups(P&#x003C;0.01). Response analysis was statistically significant before and after treatment(P&#x003C;0.01).CONCLUSION: The ASS has high reliability, validity and responsiveness in the clinical evaluation of accommodative asthenopia, and it's an effective tool for clinical research and screening of asthenopia in this population.

Frequency-Resolved Connectome Hubs and Their Test-Retest Reliability in the Resting Human Brain / 神经科学通报·英文版

Functional hubs with disproportionately extensive connectivities play a crucial role in global information integration in human brain networks. However, most resting-state functional magnetic resonance imaging (R-fMRI) studies have identified functional hubs by examining spontaneous fluctuations of the blood oxygen level-dependent signal within a typical low-frequency band (e.g., 0.01-0.08 Hz or 0.01-0.1 Hz). Little is known about how the spatial distributions of functional hubs depend on frequency bands of interest. Here, we used repeatedly measured R-fMRI data from 53 healthy young adults and a degree centrality analysis to identify voxelwise frequency-resolved functional hubs and further examined their test-retest reliability across two sessions. We showed that a wide-range frequency band (0.01-0.24 Hz) accessible with a typical sampling rate (fsample = 0.5 Hz) could be classified into three frequency bands with distinct patterns, namely, low-frequency (LF, 0.01-0.06 Hz), middle-frequency (MF, 0.06-0.16 Hz), and high-frequency (HF, 0.16-0.24 Hz) bands. The functional hubs were mainly located in the medial and lateral frontal and parietal cortices in the LF band, and in the medial prefrontal cortex, superior temporal gyrus, parahippocampal gyrus, amygdala, and several cerebellar regions in the MF and HF bands. These hub regions exhibited fair to good test-retest reliability, regardless of the frequency band. The presence of the three frequency bands was well replicated using an independent R-fMRI dataset from 45 healthy young adults. Our findings demonstrate reliable frequency-resolved functional connectivity hubs in three categories, thus providing insights into the frequency-specific connectome organization in healthy and disordered brains.

Test-retest reliability analysis of MRI criteria in the 2019 Bosniak classification of cystic renal masses / 中华放射学杂志

Objective:To evaluate the test-retest reliability of MRI criteria in the 2019 Bosniak classification of cystic renal masses (CRMs) and to analyze the impact of lesions′ property, size and readers′ experience on the test-retest reliability.Methods:From January 2009 to June 2019, 207 patients with 207 CRMs were included in this retrospective study. All of them underwent renal MRI and surgical-pathologic examination. According to Bosniak classification, version 2019, all CRMs were independently classified twice by eight radiologists with different levels of experience. All radiologists were blinded to the pathology of the lesions. By using intraclass correlation coefficient (ICC), test-retest reliability was evaluated for all CRMs and for subgroups with different pathological properties (benign and malignant) and different sizes (≤40 mm and>40 mm). The test-retest reliability of 4 senior readers (≥10 years of experience) and 4 junior readers (<10 years of experience) were evaluated respectively. The comparison of ICC was performed using Z test. Results:The 207 CRMs included 111 benign lesions (83 benign cysts, 28 benign tumors) and 96 malignant tumors. There were 87 lesions with maximum diameter ≤40 mm and 120 with maximum diameter>40 mm. The test-retest reliability (ICC) of each reader for all lesions was 0.776-0.888, the overall ICC was 0.848 (95%CI 0.821-0.872). The ICCs of senior and junior readers were 0.853 (95%CI 0.824-0.880) and 0.843 (95%CI 0.811-0.871) respectively, without significant difference between the two groups ( Z=0.85, P=0.374). The ICC of all readers was 0.827 for benign lesions and 0.654 for malignant lesions, showing significant difference ( Z=2.80, P=0.005). The ICC was 0.770 for lesions ≤40 mm and 0.876 for lesions>40 mm, which was significantly different ( Z=-2.36, P=0.018). For CRM subgroups with different pathological properties and different sizes, there was no significant difference in test-retest reliability between senior and junior readers (all P>0.05). Conclusion:The test-retest reliability of MRI criteria in the 2019 Bosniak classification of CRMs is excellent and unaffected by readers′ experience. The reliabilities are not consistent among CRMs of different pathological properties and different sizes, but all reached the level of good and above.

Niveles de sedentarismo en población universitaria colombiana a través del cuestionario SIT-Q-7d-S / Levels of sedentary lifestyle in Colombian university population through the SIT-Q-7d-S questionnaire

Introducción. El sedentarismo es un problema de salud pública, al ser factor de riesgo para ocho de las diez primeras causas de muerte en el mundo. Evaluar los niveles de sedentarismo con instrumentos óptimos se vuelve imprescindible para su correcto diagnóstico e intervención. Objetivo. Evaluar los niveles de sedentarismo en población universitaria colombia-na a través del cuestionario Sit Q7d-S y determinar su nivel de confiabilidad. Metodología. Se condujo un estudio cuantitativo, con aplicación tipo test re-test, con una muestra de 304 personas, con un error máximo de 5% y con 95% de con-fianza. La muestra estuvo conformada por 103 hombres (33,9%) y 201 mujeres (66,1%), estudiantes de una universidad colombiana con sede en cuatro ciudades diferentes (Cali, Neiva, Popayán y Medellín). Resultados. La población evaluada es sedentaria. Tienen comportamientos que indican que pasan más de dos horas de tiempo en posiciones sedentes, aumentado el riesgo de sufrir enfermedades crónicas no transmisibles. Se obtuvo un alfa de Cron-bach 0,64 para todos los ítems del cuestionario SIT-Q-7d-S, demostrando valores moderadamente aceptables para el uso del cuestionario. Conclusión. El cuestionario SIT-Q-7d-S es un instrumento con una fiabilidad de regular a moderada para evaluar niveles de sedentarismo en población universitaria. Así mismo, se evidencia que los niveles de inactividad en la población colombiana universitaria indican que es una población sedentaria, lo que se relaciona con que pasan más de dos horas de tiempo en pantalla y pasan entre una, dos o más de tres horas sentados realizando su ocupación

Introduction. Sedentary lifestyle is a public health problem, as it is a risk factor for eight of the ten leading causes of death in the world. Assessing sedentary lifestyle levels with optimal instruments becomes essential for its correct diagnosis and intervention.Aim. To evaluate the levels of sedentary lifestyle in the Colombian university pop-ulation through the Sit Q7d-S questionnaire and to determine its level of reliability.Methodology. A quantitative study was conducted, using a test re-test type applica-tion, with a sample of 304 people with a 5% maximum error and 95% confidence. The sample size included 103 men (33.9%) and 201 women (66.1%), who are stu-dents at a Colombian university located in four different cities (Cali, Neiva, Popayan, and Medellin).Results. The evaluated population is sedentary, as they have behaviors that indicate they spend more than two hours of time in seated positions, increasing the risk of suffering from chronic non-communicable diseases. A Cronbach's alpha of 0.64 was obtained for all the items of the SIT-Q-7d-S questionnaire, showing moderately ac-ceptable values for the use of the questionnaire.Conclusion. The SIT-Q-7d-S questionnaire is an instrument with low to moderate reliability to assess levels of sedentary lifestyle in the university population. Likewise, it is evident that the levels of inactivity in the Colombian university population indi-cate that it is a sedentary population. This is related to the fact that they spend more than two hours on screen time and spend between one, two or more than three hours doing their job in a sitting position

Nuevas pruebas de validez y confiabilidad de la escala reducida del Cuestionario de Imagen Corporal (BSQ-8D) en una muestra de mujeres mexicanas / New evidence about reliability and validity of the short version of the Body Shape Questionnaire (BSQ-8D) in a Sample of Mexican Women

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.

Geração de itens e validação de conteúdo de domínios e de itens para o indivíduo com osteoartrite do joelho: um estudo de método misto / Item generation and content validation of domains with item pool for the individual with knee osteoarthritis: a mixed-method study

INTRODUÇÃO: Existem várias escalas para avaliar as percepções subjetivas e os componentes individuais em indivíduos com osteoartrite (OA) de joelho. Até o momento, não há escalas disponíveis conhecidas para medir o equilíbrio combinado entre mobilidade, AVD e QV em OA de joelho com base na Classificação Internacional de Funcionalidade, Incapacidade e Saúde (CIF). OBJETIVO: Gerar itens e domínios relacionados aos problemas enfrentados pelos indivíduos com OA de joelhos e validar o conteúdo por especialistas. MÉTODOS: Os domínios e itens foram gerados através de pesquisa bibliográfica extensa (ELS) para extrair itens relacionados a equilíbrio, mobilidade, ADL e QV em indivíduos com OA em joelhos baseados na CIF e através de entrevista aprofundada direta (EAD) em 13 pessoas com OA de joelhos e três especialistas. A validação de conteúdo dos domínios e itens gerados foi validada por 10 especialistas por meio da pesquisa Delphi online. O índice mínimo de validação de conteúdo em nível de item (I-CVI) de 0,80 foi considerado para validar os itens identificados e o índice de validação de conteúdo em nível de escala geral (S-CVI) de 0,90 foi fixado para validar os itens gerados para uso no processo de desenvolvimento da escala. RESULTADOS: Os 117 itens gerados por EAD na ELS foram inicialmente agrupados em 18 domínios. A validação de conteúdo pelo método Delphi resultou em uma diminuição para 56 itens agrupados em 14 domínios com SCVI de 0, 93. CONCLUSÃO: O conjunto abrangente de itens de deficiência, limitação de atividade e restrição de participação para indivíduos com OA de joelhos nos domínios propostos foi desenvolvido e o conteúdo validado. Esses itens são recomendados para uso no desenvolvimento de uma nova escala abrangente de índice de osteoartrite do joelho (CKOAI).

INTRODUCTION: There are several scales to evaluate subjective perceptions and individual components in individuals with knee osteoarthritis (IKOA). Till date, no scale is available to measure the combined balance, mobility, ADL and QoL in IKOA based on the International Classification of Functioning, Disability and Health (ICF). OBJECTIVE: The purpose of the study was to generate items and domains related to problems faced by IKOA and to validate the content by experts. METHODS: The domains and items were generated through extensive literature search (ELS) to extract items related to symptoms, balance, mobility, ADL and QoL in IKOA based on the International Classification of Functioning, Disability and Health (ICF) and through in-depth direct interview (IDDI) from 13 IKOA and three experts. The content validation of domains and items generated were validated by 10 experts through online Delphi survey. Minimum itemlevel content validation index (I-CVI) of 0.80 was considered to validate the identified items and the overall scale-level content validation index (S-CVI) of 0.90 was fixed to validate the generated items to use in scale development process. RESULTS: 117 items generated by IDDI and ELS were grouped under 18 domains initially. Content validation by Delphi method resulted in reduction with 56 item pool being grouped under the 14 domains with SCVI is 0.93. CONCLUSION: The comprehensive impairment, activity limitation and participation restriction item pool for IKOA under the proposed domains, have been developed and content validated. These items are recommended for their use in development of new comprehensive knee osteoarthritis index scale (CKOAI).

Analysis of influencing factors of fingertip thermotactile perception threshold in healthy young adults / 中国职业医学

OBJECTIVE: To analyze the stability of test results of fingertip thermotactile perception threshold(TPT) among healthy individuals and the influencing factors of the TPT test. METHODS: Fifty healthy young volunteers aged 20-25 were selected as the study subjects using the convenience sampling method. The HVLab thermal aesthesiometer was used to perform the fingertip TPT test under the standard condition. Right index, middle, ring, little, left index and little fingers were tested. According to the method of random number table, we selected 25 subjects to receive second test after the interval of two weeks. RESULTS: Intraclass correlation coefficient(ICC) for cold threshold of right little finger was bigger than 0.75, suggesting the test-retest reliability was excellent. The ICC for hot threshold of six test fingers, cold threshold of right and left index fingers, right middle and left little finges was in the range of 0.60-0.74, indicating the test-retest reliability was good. However, the ICC for cold threshold of right ring finger was less than 0.40, and the test-retest reliability was poor. The hot threshold of right middle, ring and little fingers, and the cold threshold of left little finger of males were higher than those of females(all P<0.05). The cold threshold of right index and little fingers were lower than those of left hand in males(all P<0.05). The cold threshold of right middle and ring fingers were lower than that of the right index finger in females(all P<0.05). The cold threshold of right little finger was lower than those of right index, middle and ring fingers in females(all P<0.05). CONCLUSION: The stability of the fingertip TPT result is good in healthy young adults aged 20-25. The fingertip TPT test could be used for occupational health surveillance of workers exposed to hand-transmitted vibration. We should take into account the influence of gender, the right or left hand and different fingers when developing TPT reference values.

Test-Retest Reliability of Functional Magnetic Resonance Imaging Activation for a Vergence Eye Movement Task / 神经科学通报·英文版

Vergence eye movements are the inward and outward rotation of the eyes responsible for binocular coordination. While studies have mapped and investigated the neural substrates of vergence, it is not well understood whether vergence eye movements evoke the blood oxygen level-dependent signal reliably in separate experimental visits. The test-retest reliability of stimulus-induced vergence eye movement tasks during a functional magnetic resonance imaging (fMRI) experiment is important for future randomized clinical trials (RCTs). In this study, we established region of interest (ROI) masks for the vergence neural circuit. Twenty-seven binocularly normal young adults participated in two functional imaging sessions measured on different days on the same 3T Siemens scanner. The fMRI experiments used a block design of sustained visual fixation and rest blocks interleaved between task blocks that stimulated eight or four vergence eye movements. The test-retest reliability of task-activation was assessed using the intraclass correlation coefficient (ICC), and that of spatial extent was assessed using the Dice coefficient. Functional activation during the vergence eye movement task of eight movements compared to rest was repeatable within the primary visual cortex (ICC = 0.8), parietal eye fields (ICC = 0.6), supplementary eye field (ICC = 0.5), frontal eye fields (ICC = 0.5), and oculomotor vermis (ICC = 0.6). The results demonstrate significant test-retest reliability in the ROIs of the vergence neural substrates for functional activation magnitude and spatial extent using the stimulus protocol of a task block stimulating eight vergence eye movements compared to sustained fixation. These ROIs can be used in future longitudinal RCTs to study patient populations with vergence dysfunctions.

Comparative Analysis of Test and Retest Contents between the Management of Drug Quality Sampling and Testing and the Regulation of Drug Quality Sampling and Testing / 中国药房

OBJECTIVE：To provide re ference for the relevant personnel of drug quality sampling and testing to understand and implement the new requirements in the Management of Drug Quality Sampling and Testing . METHODS ：The test and retest requirements were compared between the Management of Drug Quality Sampling and Testing and the Regulation of Drug Quality Sampling and Testing. The revised and newly added contents were analyzed ，and the recommendations for implementation were put forward. RESULTS & CONCLUSIONS ：Referring to drug regulation need ，related requirements of test and retest in the Management of Drug Quality Sampling and Testing were modified and supplemented on the basis of the Regulation of Drug Quality Sampling and Testing . In the requirements for test ，the requirements for test items were revised ，the requirements for test time limit were confirmed ，the requirements for test report ，original record and quality management system ，the definition of “serious risk ” and its reporting requirements were added newly. The requirements for exploratory research were put forward for test institutions， as well as new requirements for test institutions and inspectors ’behaviors. In the requirements for retest ，the materials to be submitted for retest were revised ，and the identity certificate of the manager and time limit certificate were added ；the situation of no-retest were revised ，and the treatment method were added when obviously visible foreign matters were detected ；transfer requirements for retest report were added newly. It is suggested that the relevant personnel should pay more attention to the above changes，strengthen the construction of test capacity a nd the management of tes t time and quality ，attach importance to serious quality risks ，actively carry out exploratory research ，and mind their own test behaviors ；strictly review retest materials ， pay attention to the newly revised no-test and comprehensively transfer the retest report according to the requir ements and actual situation ，conduct and implement the Management of Drug Quality Sampling and Testing actively.

Repeatability of new Corvis ST parameters and influencing factors in myopia patients / 中华实验眼科杂志

Objective@#To evaluate the repeatability of corneal biomechanics parameters measured by Corneal Visualization Scheimpflug Technology (Corvis ST) and explore the factors that influence the repeatability.@*Methods@#A diagnostic test study was performed.A total of 190 eyes in 95 myopia patients (34 males and 61 females) were enrolled from September to October 2017 in Henan Eye Hospital.All the subjects underwent 5 repeated examinations with the Corvis ST.The intraclass correlation coefficient (ICC), Cronbach α coefficients and repeatability coefficient (RC) were computed to evaluate repeatability of Corvis ST parameters.The multiple linear regression analysis was used to study the factors that affect the magnitude of the test-retest variability (within subject SD) of new Corvis ST parameters.This study was approved by the Ethics Committee of Henan Eye Hospital (HNEECKY-2019[5]), and written informed consent was obtained from each subject.@*Results@#Among the 39 biomechanics parameters, The ICC and Cronbach α were greater than 0.75 for 26 parameters, within 0.60-0.75 for 4 parameters, and lower than 0.60 for deflection amplitude max time (DLAMT). The ICC and Cronbach α of DA ratio max[1 mm], DA ratio max [2 mm], max inverse radius, Ambrósio's relational thickness horizontal (ARTh), biomechanical intraocular pressure (bIOP), integrated radius, stiffness parameter applanation 1 (SPA1) and Corvis biomechanical index (CBI)were all above 0.920.The multivariate regression results indicated that the within subject SD of bIOP increased with the increase of IOP (β=0.210, P=0.010). The within subjects SD of DA Ratio Max [1 mm]decreased with the increase of central corneal thickness (CCT) (β=-0.218, P=0.008). The within subjects SD of DA Ratio Max [2 mm]decreased with the increase of CCT(β=-0.295, P<0.001). The within subject SD of CBI decreased with the increase of astigmatism, axial lengths and CCT (β=-0.190、-0.148、-0.428, all P<0.05).@*Conclusion@#The Corvis ST parameters showed favorable measurement repeatability in myopia patients, especially for the new parameters.Astigmatism, axial lengths and CCT significantly affected the repeatability of CBI.

Evaluation of Observable Items of Gait Abnormality in Patients with Knee Osteoarthritis：Criterion-related Validity Using Three-dimensional Gait Analysis and Test-retest Reliability / The Japanese Journal of Rehabilitation Medicine

Objective：We aimed to examine the criterion-related validity of observable items of gait abnormality in patients with knee osteoarthritis (OA) using three-dimensional gait analysis and to assess the test-retest reliability.Methods：The items of gait abnormality were pooled from a prior study and rated using a 3-point scale. Content validity was examined by four experts in knee OA research and accepted when there was an agreement among at least three experts. Correlation between abnormality rating and three-dimensional gait analysis data was examined. The test-retest reliability of the agreement rate was then assessed in the same subject twice.Results：Eleven items were pooled, and all met the criterion of content validity. Eight items showed adequate correlation with the three-dimensional gait analysis data and had test-retest reliability exceeding 0.61.Conclusion：In patients with knee OA, observable items of gait abnormality had good test-retest reliability and criterion-related validity according to the three-dimensional gait analysis data.

Evaluation of Observable Items of Gait Abnormality in Patients with Knee Osteoarthritis：Criterion-related Validity Using Three-dimensional Gait Analysis and Test-retest Reliability / The Japanese Journal of Rehabilitation Medicine

Objective：We aimed to examine the criterion-related validity of observable items of gait abnormality in patients with knee osteoarthritis (OA) using three-dimensional gait analysis and to assess the test-retest reliability.Methods：The items of gait abnormality were pooled from a prior study and rated using a 3-point scale. Content validity was examined by four experts in knee OA research and accepted when there was an agreement among at least three experts. Correlation between abnormality rating and three-dimensional gait analysis data was examined. The test-retest reliability of the agreement rate was then assessed in the same subject twice.Results：Eleven items were pooled, and all met the criterion of content validity. Eight items showed adequate correlation with the three-dimensional gait analysis data and had test-retest reliability exceeding 0.61.Conclusion：In patients with knee OA, observable items of gait abnormality had good test-retest reliability and criterion-related validity according to the three-dimensional gait analysis data.

Reliabitily study (test-retest) of the Scale for Conception of Disability (SCD) / Estudo de confiabilidade (teste-reteste) da Escala Concepções de Deficiência (ECD) / Estudio de confiabilidad (test-retest) de la Escala Concepciones de Discapacidad (ECD)

This article describes the reliability of the test-retest of the Scale for Conception of Disability (SCD), which comprehends four dimensions ­ biological, social, metaphysical and historical cultural ­ through the analysis of its temporal stability. In this study, a sample of 52 students from a public university of the State of São Paulo completed the same instrument with 30-day-interval between one another. For rating the stability, the Pearson correlation coefficient was used. In terms of total sample, the results of the SCD, as a whole, presented a correlation of strong magnitude (r=0,77) between test and retest. According to the results, the reliability of the scale was considered appropriate, recommending its use in studies that aim to find out how social groups conceive the disability, understanding that such conception guides the attitudes of society towards people in this condition.

Este artigo traça uma síntese sobre concepções de deficiência circulantes nos discursos sociais e descreve a confiabilidade testereteste da Escala Concepções de Deficiência (EDC), que abrange quatro dimensões ­ biológica, social, metafísica e histórico cultural ­, pela análise de sua estabilidade temporal. No estudo, uma amostra de 52 estudantes de uma universidade pública do Estado de São Paulo preencheu o mesmo instrumento, em duas oportunidades, com intervalo de trinta dias. Como medida de estabilidade, foi usado o teste de correlação de Pearson. Em termos da amostra total, os resultados da ECD, em sua totalidade, apresentaram correlação de magnitude forte (r=0,77) entre o teste e o reteste. De acordo com os resultados, a confiabilidade da escala foi considerada adequada, indicando sua utilização em estudos que procurem conhecer como grupos sociais concebem a deficiência, entendendo que tal concepção norteia as atitudes da sociedade diante das pessoas que se encontram nessa condição.

Este artículo describe el estudio de confiabilidad test-retest de la Escala de Concepciones de Discapacidad (ECD) que presenta cuatro dimensiones ­ biológica, social, metafísica e histórica cultural ­ por medio del análisis de su estabilidad temporal. En este estudio fue utilizada una muestra de 52 estudiantes de una universidad pública del estado de San Pablo, que completaron el mismo instrumento con un intervalo de 30 días entre ellos. Para clasificar la estabilidad temporal fue utilizado el coheficiente de correlación de Pearson. Sobre la muestra total, el resultado de la ECD presentó correlación de magnitud fuerte (.77) entre el test y el retest. De acuerdo con los resultados, la confiabilidad de la escala fue considerada adecuada, recomendando su utilización en estudios que quieran descubrir como los grupos sociales entienden la discapacidad, siendo que esa concepción nortea las actitudes de la sociedad en relación a las personas con esas condiciones.

Impact of heart rate on reproducibility of heart rate variability analysis in the supine and standing positions in healthy men

OBJECTIVE: The reliability of heart rate variability (HRV) analysis is not yet fully understood, especially considering different body positions and the mathematical influence of heart rate. The aim of this study was to evaluate the reliability of HRV in supine and standing positions, with and without mathematical adjustment of HRV by the average R-R interval (iRR). METHODS: We evaluated 37 young males (23.1±4 years; 25.1±3 kg/m2). A 5-min segment of the iRR was collected in the supine and standing positions on three occasions separated by 48-hour intervals. Absolute and relative reliability of temporal and spectral indices were assessed by the coefficient of variation (CV) and the intraclass correlation coefficient (ICC), respectively. RESULTS: We did not observe differences in HRV indices in the three occasions in the supine or standing position (p>0.05). Moderate to good reproducibility was observed for temporal and spectral indices of HRV in the supine position (ICC: 0.65-0.89; CV: 0.9-19.8). In the orthostatic position, low to good reproducibility was observed (ICC: 0.35-0.89; CV: 1.1-34.8), with higher ICCs for temporal indices. After mathematical adjustment, only a small modification in HRV reliability was observed in both positions. CONCLUSIONS: In young adult males, the mathematical adjustment of HRV by the average iRR led to a nonsignificant effect on HRV reliability. Additionally, HRV reliability is dependent on body position and the index analyzed. Promising measures in both supine and standing positions include r-MSSD and the HF band (parasympathetic indices).

Linguistic validity and reliability of cariogenic food frequency and oral health knowledge, attitude and practice questionnaires for parents of 6-11 years old children in Kota Bharu, Kelantan

@# Introduction: Cariogenic food intake and oral health knowledge, attitude and practices (KAP) of parents are contributing factors that influence the oral health status of children. As there is lack of a validated questionnaire in Bahasa Melayu (the Malay language) to measure the factors, this cross-sectional study was carried out to establish a linguistically valid and reliable cariogenic food frequency questionnaire (M-CFFQ) and oral health kap questionnaire (M-OHKAPQ) in Bahasa Melayu, for parents of children aged 6-11 years in Kota Bharu, Kelantan. Methods: Relevant questionnaires in English were selected and translated to Malay language. This process included forward translation, synthesis, backward translation and consolidation to produce the preliminary drafts of M-CFFQ and M-OHKAPQ. Pretesting was conducted on ten parents of children from a primary school in Kota Bharu by face-to-face interview. The findings were reviewed to produce the final versions of M-CFFQ and M-OHKAPQ. A test-retest reliability study was undertaken involving 49 parents. The participants were asked to answer the final M-CFFQ and M-OHKAPQ versions twice, within a 7-14 days interval. Data collected were entered into IBM SPPS version 22 software and analysed using the Intraclass Correlation Coefficient (ICC) test. Results: Semantic, idiomatic, experiential, conceptual as well as content and face validity issues were successfully resolved. Fifteen categories of food/drinks for M-CFFQ and 26 items/questions M-OHKAPQ were produced. The total ICC values achieved for M-CFFQ and M-OHKAPQ were 0.887 and 0.807, respectively. Conclusion: The M-CFFQ and M-OHKAPQ appeared to be linguistically valid and reliable with excellent test-retest reliability (ICC>0.80).

Validity and reliability of the Neurobehavioral Evaluation of Infant Development (VANEDELA). Screening Instrument from one to 24 months in primary health care in Mexico / Validez y confiabilidad del instrumento de tamizaje Valoración Neuroconductual del Desarrollo del Lactante (VANEDELA) de uno a 24 meses en el primer nivel de atención en México

Abstract: Introduction: Early identification of developmental delays or disabilities in children is a challenge and a global concern. In Mexico, the prevalence of childhood disability is 6%, and it is estimated that 25% of the unattended delays will have consequences on their potential. VANEDELA is a rapid screening test to detect and prevent developmental disorders in primary health care. Objective: To determine the external validity and test-retest reliability of the behavioral (DB) and reflex (DR) developmental formats of the VANEDELA screening test, compared with the diagnostic test of Gesell's Developmental Schedule Test. Method: Descriptive, transversal, and prospective study in 379 infants aged one to 24 months attending the Neurodevelopment Monitoring Laboratory / INP and the ISSSTE Tlalpan Family Medicine Clinic from 2011 to 2014. Measurements: A set of four aspects was evaluated including validity by external criteria: sensitivity, specificity, positive-negative predictive criteria, and test-retest reliability. Results: In the DB format, we found a 79% - 89% sensitivity (S) and a 83% - 95% specificity (Sp). In the DR format, a 18% - 35% sensitivity and a 81% - 96% specificity were found. Using both DB-DR formats, we found a 82% - 89% sensitivity and 72% to 91% specificity, and a test-retest reliability .62-1. Discussion and conclusion: The VANEDELA increased its validity parameters with respect to the previous assessment with adequate stability. The DB formats and the DB-DR combination of VANEDELA have an adequate validity based on external criteria, making them suitable for use in primary health care.

Resumen: Introducción: La identificación temprana de retrasos o discapacidades del desarrollo en los niños es un reto y una preocupación mundial. En México, la prevalencia de discapacidad infantil es del 6% y se estima que un 25% de los retrasos no atendidos tendrán consecuencias en su potencial alcanzado. El VANEDELA es una prueba de tamizaje rápido para detectar y prevenir alteraciones del desarrollo en el primer nivel de atención. Objetivo: Determinar la validez (criterio externo) y confiabilidad (test-retest) de los formatos de conductas (CD) y reacciones del desarrollo (RD) de la prueba de tamizaje VANEDELA, contrastado con la Prueba Diagnóstica de Desarrollo de Gesell. Método: Estudio descriptivo, transversal y prospectivo en 379 lactantes de uno a 24 meses que asistieron al Laboratorio de Seguimiento del Neurodesarrollo del INP y la Clínica de Medicina Familiar Tlalpan del ISSSTE de 2011 a 2012. Mediciones: Validez por criterio externo, sensibilidad y especificidad, validez predictiva positiva y negativa; confiabilidad test-retest (intervalo de siete días). Resultados: En el formato CD, se encontró sensibilidad (S) de 79% a 89% y especificidad (E) de 83% a 95%. Utilizando ambos formatos CD-RD, se encontraron una sensibilidad de 82% a 89% y una especificidad de 72% a 91%. Test-retest .62-1. Discusión y conclusión: El VANEDELA aumentó sus parámetros de validez con respecto a la valoración anterior, estabilidad adecuada. Los formatos CD y la combinación CD-RD del VANEDELA poseen una adecuada validez por criterio externo y estabilidad test-retest, para ser utilizada en el primer nivel de atención.

Validation Study of a Korean Version of the Abbreviated University of California, Los Angeles, PTSD Reaction Index (Abb-UCLA-PTSD RI) for Adolescents

BACKGROUND: We aimed to verify a Korean version of the Abbreviated University of California, Los Angeles, Post-Traumatic Stress Disorder Reaction Index (Abb-UCLA-PTSD RI-Korean version) among Korean adolescents to assess post-traumatic stress in this population. METHODS: We recruited 1,254 adolescents who completed the Abb-UCLA-PTSD RI-Korean version scale, the Child Report of Post-Traumatic Symptoms (CROPS), the Lifetime Incidence of Traumatic Events (LITE), and the Children's Depression Inventory (CDI). Test-retest reliability was computed for a randomly selected 314 participants. Among all the students, 765 were included in the analysis because 143 students were classified in the normative group (LITE 1) and 622 were in the traumatized group (LITE 4). RESULTS: The internal consistencies of the nine-item and eight-item versions of the Abb-UCLA PTSD RI-Korean version were found to be high (Cronbach's α = 0.843 and 0.842, respectively). The criterion-related validity was based on comparison of the Abb-UCLA PTSD RI total scores between the normative and trauma groups. For the eight-item version, the normative group (4.6 ± 4.6) and the traumatized group (8.8 ± 6.0) demonstrated better criterion-related validity than those in the nine-item version (4.5 ± 4.3 and 8.5 ± 5.0, respectively). The test-retest reliability of the eight-item version was better than the nine-item version (r = 0.85 vs. 0.77). A two-factor model with eight items (two items regarding sleep, and the other six items made up the second factor) showed the best fit. CONCLUSION: Our results indicate that the eight-item Abb-UCLA PTSD RI-Korean version is a useful screening tool for post-traumatic stress in Korean adolescents.

Short Term Test-Retest Reliability of Contralateral Inhibition of Distortion Product Otoacoustic Emissions

BACKGROUND AND OBJECTIVES: Strength of medial olivocochlear reflex can be measured reliably using contralateral inhibition of distortion product otoacoustic emissions (DPOAEs) when its fine structure is considered. However, measurement of fine structure of DPOAE is difficult with clinical equipment. Thus, this study investigated the clinically relevant test-retest reliability of contralateral inhibition of DPOAEs. SUBJECTS AND METHODS: Twenty-six young adults with normal hearing sensitivity participated. DPOAEs were recorded at 27 discrete f2 frequencies between 800 Hz and 8,000 Hz at frequency resolution of 8 points per octave with and without contralateral white noise presented at 50 dB SPL. To check for short term inter-session reliability, contralateral inhibition of DPOAEs were recorded in three sessions, two recording sessions on first day separated by 30 minutes and third time after one week of the first session. Within each session, DPOAEs were recorded twice in single probe-fit condition to test for intra-session reliability. RESULTS: Cronbach’s alpha was calculated having poor reliability (α≤ 0.7) of contralateral inhibition of DPOAEs in both intra-session and inter-session conditions for most of the tested frequencies. 95% confidence intervals of contralateral inhibition magnitude also showed large variability. CONCLUSIONS: The current results showed that though DPOAE amplitudes were highly reliable across sessions, amount of inhibition of DPOAEs was not reliable when DPOAEs were measured at discrete frequencies. These findings are concurrent with the literature.