药物上市前须经过人体试验，参与药物临床试验的受试者将承担不同程度的风险，我国GCP明确规定要充分保障受试者的权益，伦理委员会和知情同意书是保障受试者权益的主要措施，但在实际中仍存在不少问题。为此，如何切实保障受试者的权益，是临床试验所要解决的一个重要问题。
【摘要】 目的 应用受试者工作特征曲线（receiver operating characteristic curve，ROC曲线）探讨α-L-岩藻糖苷酶（AFU）对恶性腹水和非结核良性腹水的诊断价值。 方法 2004年7月—2008年1月对213例诊断明确的良、恶性腹水（其中良性腹水117例、恶性腹水96例）AFU活性进行检测。采用ROC曲线评价AFU的诊断灵敏度、特异度、准确性、阳性预测值、阴性预测值、阳性似然比、阴性似然比及Youden指数，评价其诊断效率。 结果 恶性腹水组AFU水平（164.96±87.72） μmol/（L•h），良性腹水组（104.02±62.07） μmol/（L•h），两者比较差异有统计学意义（Plt;0.01）。AFU诊断恶性腹水的ROC 曲线下面积为0.754±0.034，最佳分界值101.95 μmol/（L•h）。以AFU≥101.95 μmol/（L•h）来预测恶性腹水，其诊断的灵敏度为82.3%，特异度为63.2%，准确性为72.8%、阳性预测值为65.3%、阴性预测值为83.1%、阳性似然比为2.23、阴性似然比为0.28及Youden指数为0.455。 结论 腹水AFU活性检测有助于恶性腹水和非结核良性腹水的鉴别诊断，是一个比较理想的实用指标，适合于基层医院的临床应用。【Abstract】 Objective To assess the value of α-L-fucosidase (AFU) levels with receiver operating characteristic curve (ROC curve) in the diagnosis of malignant and non-tuberculous benign ascites. Methods Ascitic AFU activity was measured in 213 patients (117 with benign ascites and 96 with malignant ascites) diagnosed with benign or malignant ascites. The diagnostic sensitivity (SEN), specificity (SPE), accuracy, positive predictive value (PV+), negative predictive value (PV-), positive likelihood ratio (LR+), negative likelihood ratio (LR-) and Youden index (YI) of AFU were assessed with receiver operating characteristic curve, and the diagnostic effectiveness of AFU was evaluated. Results The average level of AFU in the malignant group [(164.96±87.72) μmol/(L•h)] was significantly higher than that in the benign group [(104.02±62.07) μmol/(L•h)] (Plt;0.01). The area under the curve (AUC) of the ROC curve of AFU was 0.754±0.034 for malignant ascites diagnosis, and the optimal cut-off value was 101.95 μmol/(L•h). When an AFU level equal to or higher than 101.95 μmol/(L•h) was used to predict malignant ascites, the diagnostic sensitivity was 82.3%, specificity was 63.2%, accuracy was 72.8%, PV+ was 65.3%, PV- was 83.1%, LR+ was 2.23, LR- was 0.28 and YI was 0.455. Conclusion Detection of AFU activity in ascites is helpful to differentiate the diagnose between malignant and non-tuberculous benign ascites, which is a relatively ideal index to fit for clinical application of local hospitals.
ObjectiveTo investigate the feasibility of quantitative detection of WBC count and bacteria count with UF-1000i urinary sediment analyzer in rapid screening for urinary tract infection by receiver operator characteristic (ROC) curve. MethodsFrom August to December 2013, we used quantitative bacterial culture and UF-1000i automatic urine sediment analyzer respectively to examine asepsis urine specimens of 218 patients with suspected urinary tract infection. Among them, there were 95 males and 123 females, with an average age of 54.7 years old. ResultsAmong the 218 urinary samples, 65 were culture positive specimens. With positive urine culture as the gold standard for making ROC curve, the area under ROC curve for WBC count and bacterial numbers by UF-1000i urine sediment analyzer were respectively 0.839 and 0.894. The cut-off values of Youden index for optimal WBC cell count and bacterial count were ≥31.0/μL and 38.8/μL, respectively. When the above numbers were used as cut-off values, the WBC count sensitivity and specificity were 78.3% and 80.4%, the positive likelihood ratio was 3.99, and the negative likelihood ratio was 1.11. And the bacterial count sensitivity and specificity were 84.3% and 80.6%, the positive likelihood ratio was 4.30, and the negative likelihood ratio was 0.80. ConclusionUsing white blood cell count ≥31/μL and bacterial count ≥38.8/μL detected by UF-1000i urine sediment analyzer as the cut off values of noninvasive screening indexes has a very important value in screening for urinary tract infection in the early stage, determining whether there is a need for urine culture, and guiding clinical rational application of antibiotics
In order to realize brain-computer interface (BCI), optimal features of single trail motor imagery electroencephalogram (EEG) were extracted and classified. Mu rhythm of EEG was obtained by preprocessing, and the features were optimized by spatial filtering, which are estimated from a set of data by method of common spatial pattern. Classification decision can be made by Fisher criterion, and classification performance can be evaluated by cross validation and receiver operating characteristic (ROC) curve. Optimal feature dimension determination projected by spatial filter was discussed deeply in cross-validation way. The experimental results show that the high discriminate accuracy can be guaranteed, meanwhile the program running speed is improved. Motor imagery intention classification based on optimized EEG feature provides difference of states and simplifies the recognition processing, which offers a new method for the research of intention recognition.
This article systematically reviews the series of articles on randomized controlled trial (RCT) methodology guidance published in JAMA Surgery between 2022 and 2023. It focuses on providing an overview and guidance on critical aspects such as trial implementation and oversight, participant recruitment, statistical applications, and key points in manuscript publication. The aim is to offer valuable insights and references for surgeons to conduct efficient clinical trials and successfully publish their research findings.
ObjectiveTo compare the predictive value of six thrombotic risk assessment scales, including Autar, Wells, Padua, Caprini, Khorana, and COMPASS-CAT, for the deep venous thrombosis (DVT) of lower extremity in patients with gastrointestinal tumors. MethodsThe patients with gastrointestinal tumors who received surgical treatment in the General Surgery Department of Lanzhou University Second Hospital from March 2023 to October 2023 were collected. The risk of DVT on day 3 after surgery for the patient with gastrointestinal tumors was prospectively evaluated using the Autar, Wells, Padua, Caprini, Khorana, and COMPASS-CAT assessment scales. And the DVT was detected by ultrasound examination. The pionts of six thrombotic risk assessment scales were compared between the patient with DVT and without DVT based on the ultrasound examination results. The predictive value of the six thrombotic risk assessment scales for the lower extremity DVT in the patients with gastrointestinal tumors was evaluated by the area under receiver operating characteristic curve (AUC). ResultsA total of 108 patients who met the criteria, including 71 males and 37 females, were enrolled, age ranged from 18 to 85 years old, (58.3±11.2) years old. Fourty-two cases (38.9%) of DVT occurred. The age of patients with DVT was older than that of patients without DVT (P<0.05), but there were no statistical differences in the gender, body mass index, tumor location, comorbidities, and so on (P>0.05). The points of Autar, Padua, and Caprini in the patients with DVT were higher than those in the patients without DVT (P<0.05), while there were no statistical differences in the points of Wells, Khorana, and COMPASS-CAT between the two (P>0.05). The AUC for differentiating the occurrence of DVT in the patients with gastrointestinal tumors using the Autar, Wells, Padua, Caprini, Khorana, and COMPASS-CAT assessment scales were 0.907, 0.548, 0.636, 0.627, 0.589, and 0.535, respectively; The sensitivities were 97.6%, 14.3%, 52.4%, 83.3%, 47.6%, and 21.4%; The specificities were 2.4%, 85.7%, 47.6%, 16.7%, 52.4%, and 78.6%, respectively. ConclusionAccording to the abilities of Autar, Wells, Padua, Caprini, Khorana, and COMPASS-CAT to distinguish the occurrence of DVT in patients with gastrointestinal tumors after surgery, only the Autar evaluation scale is found to be more effective, while the other five evaluation scales are generally able to distinguish the occurrence of DVT.
Objective To determine the diagnostic value of fractional exhaled nitric ( FeNO)measurement in diagnosis of bronchial asthma. Methods The patients with unkown-cause respiratory symptoms including wheezing, cough, and breathlessness were enrolled from August to September in 2008.FeNO was measured by nitric oxide analyzer ( NIOX; Aerocrine AB; Solna, Sweden) . Bronchial challenge test ( BCT) or bronchodilator test was defined as golden standard for asthma diagnosis. The value of FeNO was assessed and the optimal operating point of FeNO testing was determined by the means of the receiver operating characteristic ( ROC) curves. Results A total of 101 patients were enrolled, in which 48 cases were diagnosed as asthma by positive yield in BCT ( in 38 cases) or bronchodilator test ( in 10 cases) . The severity of airway hyperresponsiveness ( AHR) judged by BCT was mild in 15 cases, moderate in 15 cases and severe in 8 cases. The levels of FeNO of asthma group were higher than those of non-asthma group [ ( 68. 19 ±43. 00) ppb vs ( 19. 52 ±10. 60) ppb, P lt; 0. 05] . A linear correlation of FeNO with lnPD20 FEV1 was revealed in the cases with AHR. Area under ROC curve was 0. 9. The optimal diagnostic cutoff point was 36. 5 ppb which was capable of differentiating asthma and non-asthma with sensitivity of 92. 7% ,specificity of 83. 3% , positive predictive value of 79. 17% , negative predictive value of 94. 34% and accuracy of 87. 13% . Conclusion FeNO test may be helpful in the diagnosis of asthma with high sensitivity and specificity.
ObjectivesTo explore the characteristics of Chinese methodological studies on patient compliance in clinical trials so as to provide reference for clinical trial of patient compliance in future.MethodsCNKI, VIP, CBM and WanFang Data databases were electronically searched to collect methodological studies on patient compliance in clinical trials published in Chinese language from January 2000 to December 2018. Two reviewers independently screened literature, extracted data and then, qualitative analysis of document characteristics was then performed.ResultsA total of 84 articles were included, in which 68 were studies on Western medicine and 16 were studies on traditional Chinese medicine (TCM). The results showed that: the quantity of studies on patient compliance increased along with time. However, those in TCM field did not increase. All included studies summarized their strategies to improve patient compliance, however key information for quality evaluation were missing.ConclusionsThere is still a lack of research on how to improve patients’ compliance in clinical trials to ensure the reliability of the results. Existing studies have not systematically and comprehensively explored the influencing factors of patients’ compliance. Clinical trials researchers in China have not focused sufficiently to patients’ compliance and lack the proper methodology to frame studies.
Objective To explore the diagnostic value of a disintegrin-like and metalloproteinase with thrombospondin type 1 motifs (ADAMTS)-9 in acute aortic dissection (AAD). Methods A total of 328 patients with acute onset of chest pain within 24 hours were enrolled in West China Hospital from January 2015 to June 2016 and according to the results of computed tomography angiography they were divided into an AAD group (n=172, 107 males, 65 females, mean age of 50.4±13.1 years) and a control group (n=156, 89 males, 67 females, mean age of 54.9±14.7 years). The enzyme-linked immunosorbent assay (ELISA) test was used to measure the level of ADAMTS-9. Results Patients in two groups had no significant difference in age, gender, smoke history, hypertension history, total cholesterol, triacylglyceride and hemoglobin (P>0.05). But systolic and diastolic blood pressures were significantly higher in the AAD group than those in the control group (P<0.05, respectively). The level of ADAMTS-9 was significantly higher in the AAD group than that in the control group (249.4±186.8 ng/mlvs. 78.2±48.6 ng/ml,t=11.107, P<0.001). Receiver operating characteristic curve analysis showed that ADAMTS-9 (156.7 ng/ml) was predictive in the diagnosis of AAD with sensitivity of 0.942 and specificity of 0.628. Conclusion ADAMTS-9 might be an effective and important biomarker in diagnosis of AAD.
Objective To evaluate the diagnostic value of creatinine, as an indicator of glomerular filtration function injury. Methods MEDLINE, EMBASE and CBM-disc were searched from 1993 to 2003. Thirty four articles that described biomedical markers to indicate glomerular filtration function injury were selected according to specified inclusion criteria. These articles were evaluated systematically using SPSS, EXCEL, and RevMan software. Results The odds ratios of creatinine was 24.23. Areas under summarized receiver operator characteristic curve were 0.871. Selected articles were divided to groups for analysis according to diagnostic standards, such as inulin, iohexol, 125I-iothalamate, 51Cr-EDTA, 99mTc-DTPA and sodium thiosulfate. Inter-group analysis of creatinine was not statistically different (P=0.32). Intra-group analysis of inulin, 51Cr-EDTA, 99mTc-DTPA, and iohexol was not statistically different, P value were 0.61, 0.50, 0.36, 0.32, respectively. Intra-group analysis of 125I-iothalamate was statistically different (P=0.02). Selected articles were sub-grouped according to different analytic techniques of creatinine. Intra-group analysis by the Jaffe method was statistically different (P=0.03), intra-group analysis of enzymatic method was not statistically different (P=0.22). Conclusion The diagnostic value of creatinine was not qualified enough to indicate glomerular filtration function injury. Enzymatic methods are recommended to measure creatinine. Inulin or 51Cr-EDTA is suggusted to measure glomerular filtration rate in investigation of creatinine，and feedforward cohort is recommended to apply.