Objective To assess the quality of diagnostic studies on detecting the tuberculosis antibody to diagnose tuberculosis.Methods CBM (1978 to 2006) and VIP (1994 to 2006) were searched; any author-claimed diagnostic studies which used the dot immunogold filtration assay (DIGFA) to detect the tuberculosis antibody and to diagnose tuberculosis were included. The Quality Assessment of Diagnostic Accuracy Studies (QUADAS) was used to assess the quality of included diagnostic studies by two reviewers independently.Results Thirty-eight papers were included and assessed. We found that most of the quality items were not met with QUADAS. Most papers adopted the retrospective diagnostic case-control design. Thirty-one papers did not describe the selection criteria clearly, 18 did not describe whether all the included patients were verified by using a reference standard of diagnosis, 36 did not describe whether the index test results were interpreted without knowledge of the results of the reference standard, 37 did not report the uninterpretable/intermediate test results, and 34 did not report the withdrawals from the study.Conclusion There are few high quality studies on using DIGFA to detect tuberculosis antibody to diagnose tuberculosis.
Objective To evaluate the diagnostic value of antikeratin antibody (AKA) for rheumatoid arthritis (RA). Methods Systematic and comprehensive literature was searched in PubMed (1966 to June 2010), The Cochrane Library (Issue 6, 2010), CBM (1978 to June 2010), CNKI (1994 to June 2010), VIP (1989 to June 2010), and CMA Digital Periodicals (1997 to June 2010). The diagnosis studies of antikeratin antibody for rheumatoid arthritis were included. The quality assessment of diagnostic accuracy studies (QUADAS) items were used to assess the quality of the included studies. The Meta-Disc (version 1.4) software was used to analyze the data. Results A total of 69 trials involving 14 890 participants were included. The results of meta-analyses showed that compared with the RA classification criteria revised by American Rheumatism Association (ARA), the summary sensitivity, specificity, positive likelihood ratio, negative likelihood ratio, OR value, and summary receiver operating characteristic curve of antikeratin antibody were 0.41 (0.39, 0.42), 0.94 (0.94, 0.95), 9.52 (7.21, 12.57), 0.63 (0.60, 0.66), 15.24 (11.62, 19.98), and 0.613 6, respectively. Conclusion Antikeratin antibody might be one of the most effective diagnoses for rheumatoid arthritis. The clinicians should combine other autoantibodies with AKA to diagnose rheumatoid arthritis.
ObjectivesTo analyze the cooperation and basic characteristics on systematic reviews/meta-analyses (SRs/MAs) in diagnostic test registered in PROSPERO platform, in order to provide reference for registering and preparing the SRs/MAs on diagnostic test.MethodsWe searched PROSPERO platform from inception to November 12th, 2017, to identify SRs/MAs on diagnostic test. Two reviewers independently screened records and extracted data by the inclusion and exclusion criteria. The forest figure was prepared by STATA 13.0 software. The figure of network of authors, organizations and countries were prepared by NetDraw software.ResultsA total of 240 SRs/MAs in diagnostic test were included. There was a serious imbalance in the quantity of the distribution of authors (1 050), organizations (360) and countries (34). These SRs/MAs in diagnostic test were related to 21 systematic diseases, with cancer ranking the first (52, 22%). Tissue biopsy was the most used gold standard, and imaging diagnosis was the most used diagnostic test. The most commonly retrieved English databases were PubMed, EMbase The Cochrane Library, while the Chinese databases were CNKI, WanFang Data and CBM. The search strategy were reported in 105 (43.8%) SRs/MAs on diagnostic test. The QUADAS-2 was used to assess the quality of included studies in 159 (66.3%) SRs/MAs in diagnostic test, and 105 (43.8%) SRs/MAs were supported by funding.ConclusionsThe absolute quantity of SRs/MAs in diagnostic test is still minimal. There are relationships among different authors, organizations and countries. The researcher should focus on the effective sizes and statistical methods in future.
Objective To introduce the multivariate random effects model (MREM) in the meta-analysis of diagnostic tests with multiple thresholds. Methods This paper expanded and extended the bivariate random effects model (BREM) to develop the MREM, and implemented it in the SAS Proc NLMIXED procedure. Results The MREM could obtain the study specific ROC curve for each study through empirical Bayes estimation, and the summary ROC curve located in between all study specific ROC curves evenly, while the BREM couldn’t obtain the study specific ROC curve. In addition, in the aspect of parameters estimation, the MREM didn’t depend on the choice of the diagnosis threshold and the type of SROC. The MREM could get only one SROC curve and its AUC was between the AUC of the 5 types of SROC from BREM, so it could avoid overestimation or underestimation. Conclusion The MREM can fully exploit the data, obtain stable and reliable results, and have a good application value in meta-analysis of diagnostic tests with multiple thresholds.
Objective To evaluate the diagnosis value of purified protein derivative (PPD) antibody tests in childhood tuberculosis. Methods We reviewed 126 cases of hospitalization children tested body fluid PPD antibody by Enzyme-Linked Immunosorbent Assay (ELISA). Twenty-two them were diagnosed with tuberculosis. We determined the sensitivity, specificity, diagnostic likelihood ratio, positive prognostic value, negative prognostic value, post-test probability, respectively. Results The following accuracy statistics for the PPD body liquid antibody tests in this study: sensitivity, 45.45%; specificity, 91.35%; diagnostic likelihood ratio positive, 5.25; diagnostic likelihood ratio negative, 0.597; positive predictive value, 52.63%; negative predictive value, 88.79% and post-test probability, 48.09% in 15% of prevalence. Conclusion This study shows that body fluid PPD tests have limited value for diagnosis of tuberculosis in pediatric tuberculosis. Clinic physicians should be wary of the positive results of body fluid PPD antibody tests. The value of diagnosis is related to prevalence of tuberculosis in the specific hospital.
Machine learning-based diagnostic tests have certain differences of measurement indicators with traditional diagnostic tests. In this paper, we elaborate the definitions, calculation methods and statistical inferences of common measurement indicators of machine learning-based diagnosis models in detail. We hope that this paper will be helpful for clinical researchers to better evaluate machine learning diagnostic models.
ObjectiveTo evaluate the performance of nuchal translucency (NT) measurement in the first trimester of pregnancy as a marker for congenital heart defects (CHD). MethodsFrom January 2010 to December 2012, middle-low risk pregnant women were prospectively evaluated at the Department of Ultrasound in West China Second Hospital of Sichuan University about Nuchal translucency and echocardiography. ResultsNT measurements was performed in 2 443 women from 2 764 pregnancy women, and a total of 2 125 case could be used in data analysis. NT measurement >2.5 mm was found in 68 fetuses, and 11 cases were diagnosed as CHD (prevalence 5.2/1 000). The sensitivity and specificity of NT measurement >2.5 mm for CHD were 45.5% and 87%, respectively. ConclusionIncreasing nuchal translucency might increase the risk of CHD in fetuses, and could be used as a method to diagnosis CHD.
Objective To systematically review the diagnostic accuracy of 18F-FDG PET dual time point scan in identifying benign and malignant lung lesions, in order to necessity and clinical value of dual time point scan. Methods We electronically searched PubMed, EMbase, The Cochrane Library, WanFang Data, CNKI and CBM for diagnostic tests on 18F-FDG PET dual time point scan vs. surgery or needle biopsy (gold standard) from January 1990 to November 2013. Two reviewers independently screened literature according to the inclusion and exclusion criteria, extracted data, and assessed the methodological quality of included studies. Then statistical analysis was performed to calculate pooled effect sizes of sensitivity (SEN) and specificity (SPE), and area under the curve (AUC) of summary receiver operating characteristics (SROC), followed by sensitive analysis and subgroup analysis. Results A total of 19 domestic and foreign studies were totally included, involving 1 225 lesions. The results of meta-analysis showed SEN 0.82 (95%CI 0.79 to 0.85) and SPE 0.74 (95%CI 0.71 to 0.78) regarding 18F-FDG PET dual time point scan in identifying benign and malignant lung lesions. The results of sensitive analysis showed that: a) after eliminating studies in which tuberculosis in the benign lesions accounted for more than 50%, it showed pooled SEN 0.81 (95%CI 0.77 to 0.84), pooled SPE 0.76 (95%CI 0.72 to 0.80), and AUC 0.850 3; b) after eliminating studies in which sample size was less than 50 cases, it showed pooled SEN 0.78 (95%CI 0.74 to 0.82), pooled SPE 0.78 (95%CI 0.74 to 0.82), and AUC 0.814 1; and c) after eliminating studies in which iSUV was more than 2.5, it showed pooled SEN 0.67 (95%CI 0.55 to 0.78), pooled SPE 0.66 (95%CI 0.54 to 0.77), and AUC 0.779 8. Conclusion 18F-FDG PET dual time point scan has intermediate value in identifying benign and malignant lung lesions, which is almost as good as single time point scan, so it’s unnecessary to apply it as a clinical routine test.
ObjectivesTo evaluate the accuracy of liver cancer screening techniques to inform screening intervention and early diagnosis.MethodsWe searched PubMed, The Cochrane Library, EMbase, Web of Science, CNKI, WanFang Data, CBM, VIP databases to collect relevant diagnostic accuracy studies of screening technologies for liver cancer from January 1980 to December 2017. Two reviewers independently screened the literature, extracted the data and assessed the risk of bias of included studies. Then meta-analysis was performed by using Meta-Disc 1.4 software.ResultsA total of 54 publications with 47 728 individuals were included. In terms of pooled sensitivity from the meta-analysis, it was estimated as 0.71 (95%CI 0.70 to 0.72), 0.57 (95%CI 0.56 to 0.59) and 0.43 (95%CI 0.41 to 0.45); the pooled specificity was estimated as 0.92 (95%CI 0.92 to 0.93), 0.95 (95%CI 0.94 to 0.96) and 0.95 (95%CI 0.94 to 0.96); the pooled positive likelihood ratio was 5.65 (95%CI 4.37 to 7.30), 13.24(95%CI 4.25 to 41.22) and 11.39 (95%CI 4.01 to 32.35); the pooled negative likelihood ratio was 0.35 (95%CI 0.31 to 0.39), 0.38 (95%CI 0.29 to 0.52) and 0.49 (95%CI 0.39 to 0.62); the diagnosis odds ratio was 17.23 (95%CI 12.26 to 24.20), 33.79 (95%CI 12.65 to 90.24) and 24.41(95%CI 9.23 to 64.53) for AFP alone with cut-off of 20, 200 and 400 ng/mL, respectively. The pooled sensitivity, specificity, positive likelihood ratio, negative likelihood ratio and diagnosis odds ratio were 0.65 (95%CI 0.62 to 0.69), 0.97 (95%CI 0.97 to 0.97), 16.48 (95%CI 9.55 to 28.42), 0.27 (95%CI 0.18 to 0.42) and 64.54 (95%CI 30.16 to 138.11) for ultrasound examination alone. The pooled sensitivity, specificity, positive likelihood ratio, negative likelihood ratio and diagnosis odds ratio were 0.96 (95%CI 0.94 to 0.98), 0.96 (95%CI 0.96 to 0.96), 10.76 (95%CI 2.62 to 44.27), 0.07 (95%CI 0.02 to 0.22) and 160.59 (95%CI 31.61 to 816.03) for the combined strategy.ConclusionFor liver cancer screening technologies, the overall accuracy of serum AFP test alone is the optimum at cut-off of 20 ng/mL, and the sensitivity increased substantially when combined with ultrasound examination.