Sensitivity and specificity

灵敏度和特异性
  • 文章类型: Journal Article
    Nutritional risk screening 2002 (NRS2002) is a commonly used tool for screening the risk of malnutrition in hospitalized patients, while patient-generated subjective global assessment (PG-SGA) is a nutritional assessment tool for malignant tumor patients. However, there are still gaps in the rapid nutritional risk screening methods for cancer patients. We aimed to evaluate the value of abridged scored patient-generated subjective global assessment (abPG-SGA) for nutritional risk screening and prognosis in cancer patients. The NRS 2002 and abPG-SGA scores of 100 malignant tumor patients hospitalized in our department in December 2020 were collected. Take NRS2002 ≥ 3 as the positive standard (risk of malnutrition). Data were analyzed using Kappa test, ROC curves, cut-off values and Kaplan-Meier. In the screening of 100 patients, 25.0% of patients were at risk of malnutrition (NRS2002), abPG-SGA yielded a sensitivity and specificity of 92.0% and 72.0%, respectively (area under curve [AUC] = 0.884, cut-off value ≥ 4.5); In the screening of patients with digestive system malignancies, 22.6% of patients were at risk of malnutrition (NRS2002), and the sensitivity and specificity of abPG-SGA were 91.67% and 87.80%, respectively (AUC = 0.945, cut-off value ≥ 5.5). The results of survival analysis showed that the overall survival (OS) of patients with abPG-SGA ≥ 5 and < 5, NRS2002 ≥ 3 and abPG-SGA < 5, NRS2002 < 3 and abPG-SGA ≥ 5 were significantly different (P < .0001), the OS of patients with NRS2002 ≥ 3 and abPG-SGA ≥ 5, NRS2002 < 3 and abPG-SGA < 5 were not significantly different (P > .05). Like NRS2002, abPG-SGA can also be used for malnutrition screening and prognosis judgment in cancer patients. It can quickly screen out cancer patients who may be at risk of malnutrition and facilitate the development of nutritional assessments.
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  • 文章类型: Journal Article
    OBJECTIVE: To assess the safety and diagnostic accuracy of renal tumour biopsy (RTB) in patients with small renal masses (SRM) and to assess if RTB prevents overtreatment in patients with benign SRM.
    METHODS: In a retrospective, single-centre study from Västmanland, Sweden, 195 adult patients (69 women and 126 men) with SRM ≤ 4 cm who had undergone RTB during 2010-2023 were included. The median age was 70 years (range 23-89). The sensitivity, specificity and predictive values of RTB were calculated using the final diagnosis as the reference standard. Treatment outcomes were recorded for a median 42-month follow-up. Complications following the biopsies were assessed according to the Clavien-Dindo system.
    RESULTS: The overall sensitivity of RTB was 95% (95% confidence interval [CI] 90% - 98%) and specificity was 100% (95% CI 95% - 100%). The positive predictive value was 100% and negative predictive value was 92%. The rate of agreement between RTB and the final diagnosis measured using kappa statistics was 0.92. Of the 195 patients, 62 underwent surgery and 48 were treated with ablation. The concordance rate between the RTB histology and final histology after surgery was 89%. Treatment was withheld in 67 of 195 patients with a benign or inconclusive RTB. No patients developed renal cell carcinoma or metastasis during follow-up. Complications occurred in two patients that were classified with Clavien-Dindo grades I and IV.
    CONCLUSIONS: Percutaneous renal tumour biopsy appears to be a safe diagnostic method that provides accurate histopathological information about small renal masses and reduces overtreatment of benign SRM.
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  • 文章类型: Journal Article
    BACKGROUND: The high sensitivity of HBsAg quantitative tests has led to some challenges in the qualitative interpretation of weakly positive specimens. This study aimed to explore the clinical utility of neutralization confirma-tory testing for specimens with low positive hepatitis B surface antigen (HBsAg).
    METHODS: A retrospective analysis was conducted on outpatient and inpatient cases, from January 2021 to January 2022, at the Zhongshan City People\'s Hospital, Zhongshan. Confirmatory testing as well as enzyme-linked immunosorbent assay (ELISA) was applied to reanalyze 382 samples with low positive HBsAg detected by chemilumi-nescence microparticle immunoassay (CMIA). A retrospective analysis of hepatitis B serum markers, including e-antigen, e-antibody, and core antibody patterns, was also performed.
    RESULTS: When the HBsAg value ranged from 0.05 - 0.09 IU/mL, the positivity rate of the confirmatory testing was 34.5%. The HBsAg true positivity levels were all between 0.07 and 0.09. In the range of 0.10 - 0.49, the positivity rate of confirmatory testing was 96.1%. The three methods exhibited a high consistency, when testing samples with relatively high HBsAg values. A receiver operating characteristic (ROC) analysis showed that the optimal sensitivity and specificity were achieved at 0.14 IU/mL. For the HBV e-antigen-positive and negative groups, the positivity rate of confirmatory testing was 100% and 93.8%, with no statistical difference between them.
    CONCLUSIONS: For specimens with weakly positive, low-value HBsAg, particularly when the hepatitis B surface an-tigen level is less than 0.14 IU/mL, neutralization confirmatory testing can serve as a means for further confirmation.
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  • 文章类型: Journal Article
    BACKGROUND: This study aimed to establish a method for the rapid detection of highly virulent Klebsiella pneumoniae (hvKP) by using multienzyme isothermal rapid amplification (MIRA) technology. The laboratory can quickly, accurately, and conveniently diagnose highly virulent Klebsiella pneumoniae infection.
    METHODS: For this study, 7 laboratory standard strains and 184 clinical isolates (including 70 strains of Klebsiella pneumoniae) were collected and screened for highly virulent Klebsiella pneumoniae based on its colony morphology, wire drawing test, and next-generation sequencing (NGS) results. Based on the nucleic acid sequence of the peg344 gene of highly virulent Klebsiella pneumoniae on GenBank (no. AP006726.1), specific conserved regions were selected to design MIRA and real-time fluorescence quantitative PCR (qPCR) specific primers and probes. The MIRA and qPCR methods were used to detect the tested strain, and the specificity, sensitivity, and clinical performance of the MIRA method for detecting hvKP were evaluated.
    RESULTS: In total, 21 cases of hvKP were screened from clinical isolates. The MIRA detection method utilizes specific primers and probes to transmit significant fluorescence signals at 39°C, and the detection process takes 30 minutes. The specificity test results showed that only hvKP had a specific amplification curve, while the rest of non-highly virulent Klebsiella pneumoniae (non-hvKP) had no specific amplification curve. The sensitivity test results showed that the sensitivity of MIRA for detecting hvKP is 7 × 102 CFU/mL, which is consistent with the sensitivity of the real-time fluorescence qPCR method. A simultaneous detection of 184 clinical isolates was accomplished by using MIRA and qPCR methods. Twenty-one strains of hvKP have specific amplification curves, while the remaining 163 strains of non-hvKP have no specific amplification curves. The accuracy of both methods for detecting hvKP is 100%.
    CONCLUSIONS: The established multienzyme isothermal rapid amplification (MIRA) has the following characteristics: a short detection time, high sensitivity, and a strong specificity, and it can be used as a powerful tool for an early diagnosis and epidemiological monitoring of hvKp.
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  • 文章类型: Journal Article
    BACKGROUND: Ancillary immunohistochemistry testing for p16 loss has been proposed as a diagnostic tool for melanoma, but its accuracy remains uncertain.
    METHODS: A systematic review and meta-analysis were conducted on 26 studies involving 979 melanomas and 974 nevi.
    RESULTS: Through bivariate analysis of data across all cut-off values, the sensitivity and specificity were calculated to be 0.55 (95% confidence interval [CI]: 0.38, 0.70) and 0.85 (95% CI: 0.70, 0.94), respectively. Summary estimates of diagnostic accuracy fell below recommended thresholds for effective tests, but subgroup analysis suggested that p16 loss could aid in diagnosing ambiguous lesions as melanoma in certain scenarios. However, the presence of p16 expression in these contexts does not definitively rule out melanoma. The findings were limited by underpowered exploratory study designs at risk for bias in patient selection and test interpretation.
    CONCLUSIONS: While the use of p16 immunohistochemistry for detecting melanoma is not universally reliable, it may serve as a confirmatory test in differential diagnoses involving common, congenital, acral, Spitz, and deep penetrating nevi. Nevertheless, further studies are needed to validate its utility. Until then, the application of p16 immunohistochemistry in melanoma diagnosis should be regarded as experimental.
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  • 文章类型: Journal Article
    Objective: The National Institute of Neurological Disorders and Stroke (NINDS) recently revised criteria for Traumatic Encephalopathy Syndrome (TES) (Katz et al.), aiming to improve the specificity of former TES criteria (Montenigro et al.) and adding methods to gauge certainty of underlying Chronic Traumatic Encephalopathy (CTE). This study examined base rates of Montenigro et al. and Katz et al. TES criteria in healthy community-dwelling adults. Method: Participants consisted of healthy adults (n = 835; M = 48.1 ± 18.2 years-old, range = 18-85; 37.1% male; 64.1% White) without known history of neurotrauma or psychiatric or neurological conditions. The former and current TES criteria were operationalized using the NIH Toolbox Cognition, Motor, and Emotion batteries and PROMIS-29. Results: Per Katz et al. criteria, 36.9% had symptoms Suggestive of CTE (i.e. either cognitive impairment or neurobehavioral dysregulation), 4.1% had Possible CTE (i.e. requiring cognitive impairment and two additional criteria), and 0.8% had Probable CTE (i.e. requiring cognitive impairment and three additional criteria). The requirement of cognitive impairment for Possible CTE certainty decreased the base rate of Possible CTE tenfold from Montenigro et al. criteria (40.1%). Conclusion: The Katz et al. criteria were met less frequently by healthy adults than the Montenigro et al. criteria. Requiring cognitive impairment and more supportive TES features when gauging CTE certainty may reduce false-positive diagnoses. This finding supports the role of neuropsychologists in the diagnosis and monitoring of patients in TES research studies. To assess specificity, future research should examine base rates of Katz et al. criteria in other psychiatric and neurological conditions.
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  • 文章类型: Journal Article
    BACKGROUND: Reactive case detection (RCD) aims to reduce malaria transmission stemming from asymptomatic carriers. Symptomatic individuals diagnosed with malaria at a health centre are followed to their households, where members of the index case and neighbouring households are tested and treated for malaria. An RCD programme was tested in the Ashanti region of Ghana in order to study diagnostic accuracy in the hospital and household settings, assess the prevalence of subclinical infections and possible clustering in index case households, and identify operational challenges for future RCD programmes. Currently, transmission in this region is high, but reactive interventions might become an option once transmission is reduced.
    METHODS: 264 febrile individuals were enrolled at the Mankranso Government Hospital and tested for malaria using rapid diagnostic tests (RDT). From the pool of RDT-positive febrile index cases, 14 successful RCD follow-ups were conducted, and 233 individuals were enrolled from the index case, neighbour, and control households. The sensitivity of diagnostic tools for clinical and subclinical cases was compared, including RDT, expert microscopy by World Health Organization-certified microscopists, field microscopy, and qPCR.
    RESULTS: Poor diagnosis and low receptivity to RCD-style follow-ups were major limitations to a successful and effective RCD programme. Field microscopy detected only 49% of clinical infections compared to RDT. 54% of individuals did not agree to a follow-up, and 66% of attempted follow-ups failed. The system effectiveness of RCD, calculated as the product of correctly diagnosed index cases, successful follow-ups, and proportion of asymptomatic infections detected by RDT, was very low at 4.0%.
    CONCLUSIONS: Due to low system effectiveness and the endemic nature of the disease setting in which asymptomatic prevalence is high and infections are not clustered around index case households, RCD is currently not a feasible option for malaria control in this region. The operational challenges identified through this study may help inform future reactive intervention programme designs once transmission is reduced.
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  • 文章类型: Journal Article
    BACKGROUND: Symptoms of obstructive sleep apnoea (OSA) overlap significantly with those of psychiatric disorders, making accurate diagnosis of OSA challenging within psychiatric settings. Diagnosing OSA in psychiatric patients is crucial because untreated OSA can exacerbate psychiatric symptoms, reduce treatment efficacy, and impair overall quality of life. This study aimed to determine the diagnostic accuracy of a readily accessible procedure for psychiatric patients in a real-world clinical setting by comparing the Somnocheck micro CARDIO® (SCm) portable cardiorespiratory polygraphy device with the gold standard polysomnography (PSG).
    METHODS: This observational cohort study included consecutive psychiatric patients at intermediate to high risk for OSA based on screening with the STOP-Bang questionnaire, admitted to a single tertiary care centre between June 1, 2016 and December 31, 2022. The Apnoea-Hypopnoea-Index (AHI), Apnoea-Index (AI), Oxygen-Desaturation-Index (ODI), and minimum oxygen saturation were measured sequentially by SCm and PSG.
    RESULTS: A total of 57 patients were analysed (median age 62.0 [Interquartile Range (IQR), 51.5-72.5] years; 34 [59.6%] men). Regarding AHI, no significant differences (AHI measured by PSG, median, 16.6 [IQR, 6.2-26.7] vs. AHI measured by SCm, median, 14.9 [IQR, 10.0-22.8]; p = 0.812; r = 0.71) were found between SCm and PSG. AI, ODI and minimum oxygen saturation differed significantly between SCm and PSG. Using optimised cut-off values (any OSA: AHISCm ≥ 9.25), SCm showed high sensitivity (0.894) and high specificity (0.800) for the diagnosis of OSA, with an area under the receiver operating characteristic curve of 0.877.
    CONCLUSIONS: This study found that the SCm portable device was accurate in identifying psychiatric patients with OSA. AHI measurement by SCm provided reliable diagnostic performance in comparison with the gold standard polysomnography. These findings support the integration of polygraphic measurements into the routine sleep assessment of psychiatric patients. Early and accurate diagnosis of OSA in this population can significantly improve the management of both sleep disorders and psychiatric conditions, potentially enhancing overall treatment outcomes and quality of life for these patients.
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  • 文章类型: Journal Article
    背景美国是临床建立的乳房成像,但它的诊断性能取决于操作者的经验。计算机辅助(实时)图像分析可以帮助克服这种限制。目的通过结合经典的影像组学和基于自动定位病变的基于自动编码器的特征,开发基于US的精确实时分类。资料与方法回顾性分析2018年4月至2024年1月期间1619例乳腺肿瘤的B型超声影像资料。nnU-Net被训练用于病变分割。从肿瘤节段中提取特征,边界框,和整个图像使用经典的影像组学,自动编码器,或者两者兼而有之。进行特征选择以生成放射组学签名,用于训练用于肿瘤分类的机器学习算法。使用接受者工作特征曲线下面积(AUC)评估模型,灵敏度,和特异性,并与组织病理学或随访证实的诊断进行统计学比较。结果模型建立于1191(平均年龄,61岁±14[SD])女性患者,50岁(平均年龄,55年±15])。发育数据集分为两部分:测试和训练病变分割(419和179检查)和病变分类(503和90检查)。nnU-Net在数据集1的测试集中证明了病变分割的准确性和可重复性(中值Dice评分[DS]:0.90[IQR,0.84-0.93];P=0.01)和数据集2(中位数DS:0.89[IQR,0.80-0.92];P=.001)。最好的模型,用来自肿瘤边界框的23个混合特征进行训练,AUC为0.90(95%CI:0.83,0.97),灵敏度为81%(57人中的46人;95%CI:70,91),特异性为87%(45人中的39人;95%CI:77,87)。在模型和人类读者之间没有发现差异的证据(AUC=0.90[95%CI:0.83,0.97]vs0.83[95%CI:0.76,0.90];P=.55和0.90vs0.82[95%CI:0.75,0.90];P=.45)在肿瘤分类中或在模型和组织病理学或随访确认的诊断之间;(AUC=0.90,[95%CI:0.00结论通过混合经典的影像组学和来自肿瘤边界框的基于自动编码器的特征来开发精确的基于US的实时乳腺肿瘤分类。ClinicalTrials.gov标识符:NCT04976257在CCBY4.0许可证下发布。本文提供补充材料。另见本期Bahl的社论。
    Background US is clinically established for breast imaging, but its diagnostic performance depends on operator experience. Computer-assisted (real-time) image analysis may help in overcoming this limitation. Purpose To develop precise real-time-capable US-based breast tumor categorization by combining classic radiomics and autoencoder-based features from automatically localized lesions. Materials and Methods A total of 1619 B-mode US images of breast tumors were retrospectively analyzed between April 2018 and January 2024. nnU-Net was trained for lesion segmentation. Features were extracted from tumor segments, bounding boxes, and whole images using either classic radiomics, autoencoder, or both. Feature selection was performed to generate radiomics signatures, which were used to train machine learning algorithms for tumor categorization. Models were evaluated using the area under the receiver operating characteristic curve (AUC), sensitivity, and specificity and were statistically compared with histopathologically or follow-up-confirmed diagnosis. Results The model was developed on 1191 (mean age, 61 years ± 14 [SD]) female patients and externally validated on 50 (mean age, 55 years ± 15]). The development data set was divided into two parts: testing and training lesion segmentation (419 and 179 examinations) and lesion categorization (503 and 90 examinations). nnU-Net demonstrated precision and reproducibility in lesion segmentation in test set of data set 1 (median Dice score [DS]: 0.90 [IQR, 0.84-0.93]; P = .01) and data set 2 (median DS: 0.89 [IQR, 0.80-0.92]; P = .001). The best model, trained with 23 mixed features from tumor bounding boxes, achieved an AUC of 0.90 (95% CI: 0.83, 0.97), sensitivity of 81% (46 of 57; 95% CI: 70, 91), and specificity of 87% (39 of 45; 95% CI: 77, 87). No evidence of difference was found between model and human readers (AUC = 0.90 [95% CI: 0.83, 0.97] vs 0.83 [95% CI: 0.76, 0.90]; P = .55 and 0.90 vs 0.82 [95% CI: 0.75, 0.90]; P = .45) in tumor classification or between model and histopathologically or follow-up-confirmed diagnosis (AUC = 0.90 [95% CI: 0.83, 0.97] vs 1.00 [95% CI: 1.00,1.00]; P = .10). Conclusion Precise real-time US-based breast tumor categorization was developed by mixing classic radiomics and autoencoder-based features from tumor bounding boxes. ClinicalTrials.gov identifier: NCT04976257 Published under a CC BY 4.0 license. Supplemental material is available for this article. See also the editorial by Bahl in this issue.
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  • 文章类型: Journal Article
    确定患有进行性圆锥角膜的眼睛中圆锥角膜百分比(KISA%)指数功效的误分类率。
    这是一项回顾性病例对照研究,对确诊为进行性圆锥角膜的连续患者和同期正常对照组的屈光度为1.00或更高的规律性散光进行研究。对所有患者进行Scheimpflug成像(PentacamHR)。KISA%指数和下-上(IS)值是从Pentacam局部测量/圆锥角膜分期图获得的。产生接收器工作特性曲线以确定接收器工作特性曲线下的面积(AUROC),灵敏度,和特异性值。
    对160名患者的160只眼进行了评估,包括80例进行性圆锥角膜患者的80只眼和80例对照患者的80只眼。有20只眼睛(25%)进行性圆锥角膜被KISA%指数错误分类,进行性圆锥角膜队列中有16只眼(20%)被分类为正常(即,KISA%<60)。有4只眼睛(5%)患有进行性圆锥角膜,使用已发布的非常不对称扩张的标准将其归类为“正常地形”,其中KISA%小于60,IS值小于1.45。所有对照的KISA%指数值均小于15。区分队列的最佳临界值为15.31(AUROC=0.972,93.75%灵敏度)。60和100的KISA%指数值实现了低灵敏度(80%和73.75%,分别)。
    KISA%指数将大部分进行性圆锥角膜眼错误分类为正常。尽管对临床圆锥角膜具有高度特异性,KISA%指数缺乏敏感性,不能有效区分正常和异常地形,因此不应在大数据分析或基于人工智能的建模中使用。[JRefractSurg.2024;40(9):e614-e624。].
    UNASSIGNED: To determine the misclassification rate of the keratoconus percentage (KISA%) index efficacy in eyes with progressive keratoconus.
    UNASSIGNED: This was a retrospective case-control study of consecutive patients with confirmed progressive keratoconus and a contemporaneous normal control group with 1.00 diopters or greater regular astigmatism. Scheimpflug imaging (Pentacam HR) was obtained for all patients. KISA% index and inferior-superior (IS) values were obtained from the Pentacam topometric/keratoconus staging map. Receiver operating characteristic curves were generated to determine the area under the receiver operating characteristic curve (AUROC), sensitivity, and specificity values.
    UNASSIGNED: There were 160 eyes from 160 patients evaluated, including 80 eyes from 80 patients with progressive keratoconus and 80 eyes from 80 control patients. There were 20 eyes (25%) with progressive keratoconus misclassified by the KISA% index, with 16 eyes (20%) of the progressive keratoconus cohort classified as normal (ie, KISA% < 60). There were 4 eyes (5%) with progressive keratoconus that would classify as having \"normal topography\" using the published criteria for very asymmetric ectasia with normal topography of KISA% less than 60 and IS value less than 1.45. All controls had a KISA% index value of less than 15. The optimal cut-off value to distinguish cohorts was 15.31 (AUROC = 0.972, 93.75% sensitivity). KISA% index values of 60 and 100 achieved low sensitivity (80% and 73.75%, respectively).
    UNASSIGNED: The KISA% index misclassified a significant proportion of eyes with progressive keratoconus as normal. Although highly specific for clinical keratoconus, the KISA% index lacks sensitivity, does not effectively discriminate between normal and abnormal topography, and thus should not be used in large data analysis or artificial intelligence-based modeling. [J Refract Surg. 2024;40(9):e614-e624.].
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