test validation

测试验证
  • 文章类型: Journal Article
    临床验证的人乳头瘤病毒(HPV)检测在宫颈癌筛查中至关重要。在这项研究中,我们评估了AllplexHPVHR检测试验(Seegene,韩国)根据国际标准的临床准确性和可重复性,使用实时高风险HPVm2000检测(雅培,美国)作为标准比较器。AllplexHPVHR测定对检测宫颈上皮内瘤变分级(CIN)2级或更差(CIN2)具有显着的非劣性敏感性,比率为1.00(95%CI:0.97-1.03,P=0.006),对检测CIN3+的敏感性不显著,比率为1.00(95%CI:0.88-1.13,P=0.098),和非劣等特异性排除CIN2+,与标准比较相比,比率为0.99(95%CI:0.99-1.00,P<0.001)。此外,该分析在同一实验室内[96.5%(95%CI:94.6~97.9),kappa值为0.91(95%CI:0.87~0.95)]和实验室间[96.7%(95%CI:94.8~98.0),kappa值为0.91(95%CI:0.87~0.95)]以及每个HPV类型的整体高危型HPV阳性具有优异的重现性.将我们的研究数据与另一项独立研究的数据进行汇总支持我们的发现的一致性。我们得出的结论是,检测宫颈癌前病变的临床准确性和AllplexHPVHR检测测定的可重复性均符合宫颈癌筛查中使用的国际验证标准。重要意义根据完善的国际指南对人乳头瘤病毒(HPV)测定进行临床验证对于确保仅在筛选的情况下使用经过验证的测定至关重要(Meijer等人。,IntJ癌症,2009).准则,由国际财团开发,对于宫颈上皮内瘤变(CIN)2级或更差(CIN2+)的检测,要求新的HPV检测与标准比较试验相比具有非低劣的准确性。此外,新的HPV检测应满足实验室内和实验室间可重复性的特定标准,以确保检测始终具有技术精确性和稳健性能.将我们的研究数据与另一项独立研究的数据进行汇总支持我们的发现的一致性。总之,宫颈癌前病变的临床准确性和AllplexHPVHR检测试验的可重复性均符合宫颈癌筛查的国际验证标准.
    Clinically validated human papillomavirus (HPV) assays are crucial in cervical cancer screening. In this study, we evaluated the Allplex HPV HR Detection assay (Seegene, SouthKorea) for its clinical accuracy and reproducibility according to the international criteria, using the RealTime High Risk HPV m2000 assay (Abbott, USA) as standard comparator. The Allplex HPV HR assay exhibits significant non-inferior sensitivity to detect cervical intraepithelial neoplasia grade (CIN) 2 or worse (CIN2+) with a ratio of 1.00 (95% CI: 0.97-1.03, P = 0.006), insignificant non-inferior sensitivity to detect CIN3+ with a ratio of 1.00 (95% CI: 0.88-1.13, P = 0.098), and non-inferior specificity to exclude CIN2+ with a ratio of 0.99 (95% CI: 0.99-1.00, P < 0.001) compared to the standard comparator. In addition, the assay shows an excellent reproducibility within the same laboratory [96.5% (95% CI: 94.6-97.9) with a kappa value of 0.91 (95% CI: 0.87-0.95)] and between laboratories [96.7% (95% CI: 94.8-98.0) with a kappa value of 0.91 (95% CI: 0.87-0.95)] for overall high-risk HPV positivity as well as for each individual HPV type. Pooling our study data with those of another independent study supports the consistency of our findings. We conclude that both the clinical accuracy to detect cervical precancer and the reproducibility of Allplex HPV HR Detection assay fulfill the international validation criteria of use in cervical cancer screening.IMPORTANCEThe clinical validation of human papillomavirus (HPV) assays in accordance with well-established international guidelines is crucial to ensure that only validated assays are used in the context of screening (Meijer et al., Int J Cancer, 2009). The guidelines, developed by an international consortium, require that a novel HPV assay has non-inferior accuracy against a standard comparator test for the detection of cervical intraepithelial neoplasia grade (CIN) 2 or worse (CIN2+). Additionally, a new HPV assay should meet specific criteria for both intra- and inter-laboratory reproducibility to ensure the assay consistently exhibits technical precision and robust performance. Pooling our study data with those of another independent study supports the consistency of our findings. In conclusion, both the clinical accuracy to detect cervical precancer and the reproducibility of Allplex HPV HR Detection assay fulfill the international validation criteria of use in cervical cancer screening.
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  • 文章类型: Journal Article
    尽管了解印尼组织的道德气候很重要,缺乏衡量这一点的标准化量表。因此,这项研究旨在适应,验证,并确保印度尼西亚文化背景下道德气候问卷(ECQ)的一致性。
    数据来自565名18岁或以上的印度尼西亚人,使用在线调查和便利抽样。为了确保准确的测量,Beaton的指导方针得到了遵守。可靠性是用克朗巴赫的阿尔法和麦当劳的欧米茄来评估的,而效度是通过各种分析来检验的,包括内容效度指数和验证性因子分析。
    印尼版的ECQ措施利己主义者,仁慈的,和有原则的伦理气候可靠(克朗巴赫的α:利己主义=0.809,原则=0.920,仁慈=0.910)。有效性分析确认问卷的有效性。人口统计学分析显示年龄影响主要维度,而组织类型会影响所有维度。
    印尼版的ECQ表现出强大的心理测量特性和跨文化适应能力,使其成为评估18岁或以上印度尼西亚人道德气候的有价值的工具。
    UNASSIGNED: Despite the importance of understanding ethical climates in Indonesian organizations, a standardized scale for measuring this is lacking. Therefore, this study aims to adapt, validate, and ensure the consistency of the Ethical Climate Questionnaire (ECQ) within Indonesia\'s cultural context.
    UNASSIGNED: Data were collected from 565 Indonesian individuals aged 18 or older, using an online survey and convenience sampling. To ensure accurate measurements, Beaton\'s guidelines were followed. Reliability was assessed using Cronbach\'s alpha and McDonald\'s omega, while validity was examined through various analyses including content validity index and confirmatory factor analysis.
    UNASSIGNED: The Indonesian version of the ECQ measures egoist, benevolent, and principled ethical climates reliably (Cronbach\'s alpha: egoism=0.809, principle=0.920, benevolence=0.910). Validity analyses confirm the questionnaire\'s validity. Demographic analysis shows age impacts the principle dimension, while organizational type affects all dimensions.
    UNASSIGNED: The Indonesian version of the ECQ demonstrates strong psychometric properties and cross-cultural adaptability, making it a valuable tool for assessing ethical climates among Indonesian individuals aged 18 or older.
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  • 文章类型: Introductory Journal Article
    在与标准相关的验证研究中,标准识别和测量通常是事后才想到的。然而,在确定在操作环境中使用什么预测指标时至关重要。因此,本特刊讨论了解决美军入伍人员选拔和分类研究中的“标准问题”的最新进展。在这篇介绍性论文中,回顾了有关军事标准识别和测量的广泛问题以及有关该主题的先前研究,并发表了后续论文,它解决了具体的标准问题,并描述了一个前所未有的联合服务标准项目,被介绍。
    Criterion identification and measurement is often an afterthought in criterion-related validation research. Yet it is essential in determining what predictor measures to use in operational settings. Accordingly, this special issue discusses recent advances in addressing the \"criterion problem\" in U.S. military enlisted personnel selection and classification research. In this introductory paper, broad issues regarding criterion identification and measurement in the military and previous research on this topic are reviewed and subsequent papers, which address specific criterion issues and describe an unprecedented joint-service criterion project, are introduced.
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  • 文章类型: Journal Article
    UNASSIGNED:该研究旨在适应和验证最初由Herscovitch和Meyer开发的印尼版本的变更规模承诺。
    UNASSIGNED:数据是通过几所大学的教师在线申请收集的,这些大学经历了印尼政府关于研究相关问题的政策变化。共获得204个响应。使用内容有效性指数(CVI)验证数据,验证性因子分析(CFA),收敛和判别相关性以及Cronbachα。
    未经评估:结果表明,对变化的承诺可以通过三个情感维度来表示,对变革的持续和规范承诺,虽然有一项必须调整。量表内容效度指数(S-CVI)的结果表明,承诺变化量表具有出色的内容效度(S-CVI/Ave=0.97)。CFA结果显示,Cronbach的α与ACTC(α=0.71)获得了良好的结果;CCTC(α=0.83);NCTC(α=0.77)和构造可靠性(CR)值也很好,ACTC=0.85;CCTC=0.86;NCTC=0.86。从收敛性和判别有效性检验的结果来看,研究发现,改变的情感承诺与工作满意度呈正相关,与工作压力呈负相关。然而,对变化规模的连续性和规范性承诺都与这两个变量不相关。
    UNASSIGNED:印尼语版本的承诺变化量表显示出良好的心理测量特性,并且已被证明可以有效地提供对变化的承诺的度量,特别是对印度尼西亚的教职员工来说。
    UNASSIGNED: The study aims to adapt and validate the Indonesian version of the commitment to change scale that was initially developed by Herscovitch and Meyer.
    UNASSIGNED: Data were collected using an online application among faculty members of several universities who have experienced policy changes from the Indonesian government regarding research-related issues. A total of 204 responses were obtained. The data was validated using the Content Validity Index (CVI), the Confirmatory Factor Analysis (CFA), the Convergent and Discriminant correlations as well as the Cronbach\'s alpha.
    UNASSIGNED: The results demonstrated that commitment to change could be represented by three dimensions of affective, continuance and normative commitment to change, although there is one item that must be adjusted. The results of the Scale-Content Validity Index (S-CVI) show that the commitment to change scale has excellent content validity (S-CVI/Ave = 0.97). CFA results show a good fit, Cronbach\'s alpha obtains good results with ACTC (α = 0.71); CCTC (α = 0.83); NCTC (α = 0.77) and Construct Reliability (CR) values obtained are also quite good with ACTC = 0.85; CCTC = 0.86; NCTC = 0.86. From the results of the convergent and discriminant validity tests, it was found that the affective commitment to change positively correlates with job satisfaction and negatively correlates with job stress. However, both continuance and normative commitment to change scale does not correlate with the two variables.
    UNASSIGNED: The Indonesian version of the commitment to change scale shows good psychometric properties and has proven valid to provide the measurement of commitment to change, especially for the faculty members in Indonesia.
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  • 文章类型: Journal Article
    目的:宫颈癌筛查中使用的人乳头瘤病毒(HPV)检测应根据国际标准进行临床验证。OncoPredictHPV®筛选(SCR)是针对13个高风险(hr)HPV的E6/E7基因的部分基因分型多重实时PCR测定。OncoPredictHPV®SCR(指数测定)分别鉴定HPV-16和HPV-18,总共有11个其他hrHPV,包括样品充分性的质量控制,DNA提取效率和PCR抑制。
    方法:1,300份VALGENT-2研究样本(来自参加苏格兰宫颈癌筛查计划的20-60岁女性)用指数测定法和GP5+/6+PCR酶免疫测定(标准比较测定法)进行了测试。与比较指标相比,检测2级或更差(CIN2)的宫颈上皮内瘤变的准确性不低。通过总体一致性和Cohen'skappa评估指标的实验室内和实验室间可重复性,使用亚群体(n=526)。
    结果:该指数对CIN2+的相对灵敏度和特异度与比较为1.01(95CI:0.99-1.03)和1.02(95CI:1.0-1.04),分别。非劣效性p值均≤0.05,但≥30岁患者的CIN3+除外。表现出优异的实验室内和实验室间可重复性,一致性>98%,kappas>0.95。
    结论:OncoPredictHPV®SCR符合宫颈癌筛查中hrHPVDNA检测的三个国际验证标准。本文受版权保护。保留所有权利。
    Human papillomavirus (HPV) assays used in cervical cancer screening should be clinically validated according to international criteria. OncoPredict HPV® Screening (SCR) is a partial genotyping multiplex real-time PCR assay targeting E6/E7 genes of 13 high-risk (hr) HPVs. OncoPredict HPV® SCR (index assay) identifies HPV-16 and HPV-18 separately, 11 other hrHPV in aggregate and includes quality controls for sample adequacy, DNA extraction efficiency and PCR inhibition. 1300 VALGENT-2 study samples (from women aged 20-60 attending the Scottish cervical cancer screening program) were tested with the index assay and the GP5+/6+ PCR enzyme immunoassay (standard comparator assay). Non-inferior accuracy detecting cervical intraepithelial neoplasia of grade 2 or worse (CIN2+) of the index versus comparator was verified. Intra- and interlaboratory reproducibility of the index was evaluated by overall concordance and Cohen\'s kappa, using a sub-population (n = 526). Relative sensitivity and specificity for CIN2+ of the index versus comparator were 1.01 (95% confidence interval [CI]: 0.99-1.03) and 1.02 (95% CI: 1.0-1.04), respectively. Noninferiority p values were all ≤0.05, except for CIN3+ in patients ≥30 years. Excellent intra- and interlaboratory reproducibility was shown with concordance >98% and kappas >0.95. OncoPredict HPV® SCR fulfills the three international validation criteria for hrHPV DNA tests in cervical cancer screening.
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  • 文章类型: Journal Article
    性别微侵害,特别是其微妙的形式,微损伤和微无效根据定义很难辨别。我们的目标是构建和验证反映微侵略分类法两个方面的量表:对工作场所女性的微侮辱和微无效,MIMI-16进行了两项研究(N1=500,N2=612)。使用遗传算法,我们制定了16项量表,并通过验证性因素分析(CFA)在3个独立的验证样本中进行了验证.进行了与组织结果测量的相关分析。MIMI-16在所有验证样品中表现出良好的模型拟合(CFI=0.936-0.960,TLI=0.926-0.954,RMSEA=0.046-0.062,SRMR=0.042-0.049)。Multigroup-CFA建议所有验证样本之间具有严格的测量不变性。相关性符合预期,表明内部和外部有效性。关于性别微侵略的学者大多采用定性研究。借助新开发的MIMI-16,我们提供了一种可靠有效的定量工具来测量工作场所的性别微侵害。
    Gender microaggressions, especially its subtler forms microinsults and microinvalidations are by definition hard to discern. We aim to construct and validate a scale reflecting two facets of the microaggression taxonomy: microinsults and microinvalidations toward women in the workplace, the MIMI-16. Two studies were conducted (N1 = 500, N2 = 612). Using a genetic algorithm, a 16-item scale was developed and consequently validated via confirmatory factor analyses (CFA) in three separate validation samples. Correlational analyses with organizational outcome measures were performed. The MIMI-16 exhibits good model fit in all validation samples (CFI = 0.936-0.960, TLI = 0.926-0.954, RMSEA = 0.046-0.062, SRMR = 0.042-0.049). Multigroup-CFA suggested strict measurement invariance between all validation samples. Correlations were as expected and indicate internal and external validity. Scholars on gender microaggressions have mostly used qualitative research. With the newly developed MIMI-16 we provide a reliable and valid quantitative instrument to measure gender microaggressions in the workplace.
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  • 文章类型: Journal Article
    这项研究的主要目标是检查巴勒斯坦背景下COVID压力量表(CSS)的心理测量特性以及仪器的阶乘结构。CSS,一项新出现的与接触或感染COVID-19相关的国际标准化压力衡量标准,已针对巴勒斯坦背景进行了翻译和验证,以确保它可用于衡量COVID-19压力。该研究的样本包括居住在巴勒斯坦西岸的860名巴勒斯坦成年人。受试者年龄20~48岁(M=34.7,SD=13.46)。他们都是从网络广告中招募的,电子邮件活动,博客,社交媒体,和短信活动。CSS在巴勒斯坦上下文中被发现在阿拉伯语中是有效的。验证性因素分析产生了六个因素:(1)对COVID-19危险性的恐惧,(2)对个人社会的恐惧,以及COVID-19的经济后果,对供应链中断的担忧,害怕抢劫或骚乱,(3)COVID-19-仇外心理,担心外国人是COVID-19的来源,(4)担心COVID-19相关污染源,(5)与COVID-19相关的创伤应激症状;(6)与COVID-19相关的检查,由序数结构量表组成。CSS在巴勒斯坦环境中表现出很高的有效性和可靠性,因此随着COVID-19大流行的持续存在,可以考虑用于未来的研究。使用阿拉伯语CSS进行的进一步调查可能对在个人和社会层面测量和应对COVID-19在个人和社会层面上的压力具有深远的影响,例如在巴勒斯坦被占领土上。
    The main goal of this study was to examine the psychometric properties of the COVID Stress Scales (CSS) in the Palestinian context and the factorial structure of the instrument. The CSS, a newly emerging internationally standardized measure of stress related to being exposed to or contracting COVID-19, was translated and validated for a Palestinian context to ensure that it can be used to measure COVID-19 stress. The sample of the study consisted of 860 Palestinian adults living in the West Bank of Palestine. Participants\' age ranged from 20 to 48 years old (M = 34.7, SD =13.46). They were all recruited from online advertisements, e-mail campaigns, blogs, social media, and SMS campaigns. The CSS was found to be valid in the Arabic language within a Palestinian context. The confirmatory factor analysis yielded six factors: (1) Fears about the dangerousness of COVID-19, (2) fears about the personal social, and economic consequences of COVID-19, fears of disruption in the supply chain, fears of looting or rioting, (3) COVID-19-xenophobia, fears that foreigners are sources of COVID-19, (4) fears about sources of COVID-19-related contamination,(5) traumatic stress symptoms related to COVID-19, and (6) COVID-19-related checking which is consisting with the ordinal structure the scale. The CSS demonstrated a high level of validity and reliability in a Palestinian context and therefore can be considered for future studies as the COVID-19 pandemic persists. Further investigations using the Arabic Language of CSS may have far-reaching implications for measuring and combating the stress of COVID-19 at a personal and societal level for uniquely at-risk populations such as in the occupied territories of Palestine.
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  • 文章类型: Journal Article
    Only clinically validated human papillomavirus (HPV) tests should be used in cervical cancer screening. VALGENT provides a framework to validate new HPV tests. In the VALGENT-3 study, the clinical accuracy of the recently launched Abbott Alinity m HR HPV assay (Alinity m) to detect cervical precancerous lesions was assessed against the standard comparator test (Hybrid Capture 2; HC2) and against two previously validated alternative comparator tests (Abbott RealTime HR HPV and Roche cobas 4800 assays). Validation was conducted using 1,300 consecutive cervical samples from women attending an organized population-based cervical screening program enriched with 300 cytologically abnormal samples. Overall high-risk HPV test concordance was assessed by kappa values; the concordance for HPV-16 and HPV-18 was assessed for Alinity m, RealTime, and cobas, and the Linear Array (Roche) was used for more detailed genotyping concordance. In the total study population, the relative sensitivity and specificity for cervical intraepithelial neoplasia grade 2 or worse (CIN2+) and CIN3+ of Alinity m compared to HC2 was 1.02 (95% confidence interval [CI], 0.99 to 1.06) and 1.03 (95% CI, 0.99 to 1.06), respectively. The relative specificity for nondiseased subjects (≤CIN1) was 1.01 (95% CI, 1.00 to 1.02) (all p non-inferiority ≤ 0.001). Alinity m showed noninferior clinical accuracy among women 30 years or older when cobas or RealTime was used as a comparator. HPV genotype-specific concordance between Alinity m and the three comparator tests showed excellent agreement, with kappa values ranging from 0.82 to 1.00. In conclusion, Alinity m fulfills the international accuracy requirements for use in cervical cancer screening and shows excellent HPV genotype-specific concordance with three clinically validated HPV tests.
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  • 文章类型: Journal Article
    本研究的目的是开发一种评估工具,以衡量继续教育干预对药剂师3个领域的影响,为跨性别患者提供药学服务所需的知识:(1)性别确认护理的基础,(2)健康差异和跨性别患者的特定需求,和(3)跨性别患者的激素治疗。多项选择题被开发出来,起草了47个项目的初始项目库。项目库修订由内容事项专家进行,同时提供了来自8位执业药师的反馈,以了解面部有效性和进一步的见解。初步测试,在3小时的继续教育干预之前和之后,对64名药剂师进行了包含42个项目的研究.Cronbach的α系数作为前测的值为0.65,作为后测的值为0.77。在接受了三个小时的继续教育后,参与者的回答难度较小,在测试后的仪器管理中表现出更好的区分度,以及在将参与者的总分表现与项目级表现进行比较时更好的相关性。心理测量证据支持进一步的仪器检查,这可以改进这一工具来衡量与跨性别患者护理相关的药剂师知识的收益。
    The objective of this study was to develop an assessment instrument to measure the effects of a continuing education intervention on 3 domains in pharmacists\' knowledge needed to provide pharmaceutical care for transgender patients: (1) foundations of gender-affirming care, (2) health disparities and the specific needs of transgender patients, and (3) hormone treatments for transgender patients. Multiple-choice questions were developed, and an initial item bank of 47 items was drafted. Item bank revision was conducted by content matter experts, while feedback from 8 practicing pharmacists was provided for face validity and further insights. A preliminary test, containing 42 items was administered to 64 pharmacists before and after a three-hour continuing education intervention. Cronbach\'s alpha coefficient yielded a value of 0.65 as a pre-test and 0.77 as a post-test. Items were less difficult to answer by participants after taking the three-hour continuing education, showing better discrimination among high and low performers in the instrument administration as post-test, as well as better correlation when comparing participants\' performance in the overall score against item-level performance. Psychometric evidence supports further instrument examination, which can improve this tool to measure gains in pharmacists\' knowledge related to the care of transgender patients.
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  • 文章类型: Journal Article
    Evaluating general cognitive ability (i.e., intelligence) is common in neuropsychological practice, and identifying abbreviated assessments of intelligence is often advantageous. Despite the Wechsler Intelligence Scale for Children, Fifth Edition\'s (WISC-V) widespread contemporary use, limited research has identified clinically useful short form (SF) full scale IQ (FSIQ) estimations in clinical samples. This study sought to address this gap in the literature. Two hundred sixty-eight pediatric participants (M age = 9.79; 69% male; 88% Caucasian/White) who underwent psychological/neuropsychological evaluation were included. Mean scores for WISC-V scores fell in the low average-to-average ranges, consistent with the clinical nature of this sample (e.g., M FSIQ = 85.3). Ten unique SF combinations with five (pentad) and four (tetrad) subtests, each intentionally selected to represent a breadth of domains subsumed by WISC-V FSIQ, were described by summing subtest age-corrected scaled scores. Regression-based and prorated FSIQ estimates were calculated, and mean differences suggested some prorated estimates should be arithmetically adjusted. Both regression-based and prorated/adjusted methods provided FSIQ estimates that were accurate within five Standard Score points of true FSIQ for approximately 81-92% (pentad) and 65-76% (tetrads) of participants. Prorated/adjusted estimates appeared to provide somewhat better accuracy than regression-based estimates. Relationships between SFs and true FSIQ did not appear to be moderated by participant age, gender, nor how many WISC-V subtests were administered to participants within this archival sample (i.e., 7 vs. 10). Implications of these findings, including benefits, detriments, and other considerations of each SF combination, in addition to limitations of this study, are discussed in detail.
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