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To collect reasons for selecting the methods for meta-analysis of diagnostic accuracy from authors of systematic reviews and improve guidance on recommended methods. Online survey in authors of recently published meta-analyses of diagnostic accuracy. We identified 100 eligible reviews, of which 40 had used more advanced methods of meta-analysis (hierarchical random-effects approach), 52 more traditional methods (summary receiver operating characteristic curve based on linear regression or a univariate approach), and 8 combined both. Fifty-nine authors responded to the survey; 29 (49%) authors had used advanced methods, 25 (42%) authors traditional methods, and 5 (9%) authors combined traditional and advanced methods. Most authors who had used advanced methods reported to do so because they believed that these methods are currently recommended (n = 27; 93%). Most authors who had used traditional methods also reported to do so because they believed that these methods are currently recommended (n = 18; 75%) or easy to understand (n = 18; 75%). Although more advanced methods for meta-analysis are recommended by The Cochrane Collaboration, both authors using these methods and those using more traditional methods responded that the methods they used were currently recommended. Clearer and more widespread dissemination of guidelines on recommended methods for meta-analysis of test accuracy data is needed.

The Grading of Recommendations Assessment, Development and Evaluation (GRADE) Working Group developed an approach to assess the quality of evidence of diagnostic tests. Its use in Cochrane diagnostic test accuracy reviews is new. We applied this approach to three Cochrane reviews with the aim of better understanding the application of the GRADE criteria to such reviews. We selected reviews to achieve clinical and methodological diversities. At least three assessors independently assessed each review according to the GRADE criteria of risk of bias, indirectness, imprecision, inconsistency, and publication bias. Two teleconferences were held to share experiences. For the interpretation of the GRADE criteria, it made a difference whether assessors looked at the evidence from a patient-important outcome perspective or from a test accuracy standpoint. GRADE criteria such as inconsistency, imprecision, and publication bias were challenging to apply as was the assessment of comparative test accuracy reviews. The perspective from which evidence is graded can influence judgments about quality. Guidance on application of GRADE to comparative test reviews and on the GRADE criteria of inconsistency, imprecision, and publication bias will facilitate the operationalization of GRADE for diagnostics.

Background and Objectives: This study aimed to evaluate the diagnostic roles of various immunohistochemical (IHC) markers in urothelial carcinoma in situ (uCIS) through a meta-analysis and review of diagnostic test accuracy. Materials and Methods: The IHC markers CK20, CD44, AMACR, and p53 were evaluated in the present study. We analyzed the expression rates of the IHC markers and compared their diagnostic accuracies. Results: The estimated expression rates were 0.803 (95% confidence interval [CI]: 0.726–0.862), 0.142 (95% CI: 0.033–0.449), 0.824 (95% CI: 0.720–0.895), and 0.600 (95% CI: 0.510–0.683) for CK20, CD44, AMACR, and p53, respectively. In the comparison between uCIS and reactive/normal urothelium, the expression of CK20, AMACR, and p53 in uCIS was significantly higher than in reactive/normal urothelium. CD44 showed significantly lower expression in uCIS than in the reactive/normal urothelium. Among the markers, AMACR had the highest sensitivity, specificity, and diagnostic odds ratio. The AUC on SROC was the highest for CK20. Conclusions: In conclusion, IHC markers, such as CK20, CD44, AMACR, and p53, can be useful in differentiating uCIS from reactive/normal urothelium.

Background Heart failure (HF), affecting 1–4% of adults in industrialized countries, is a major public health priority. Several algorithms based on administrative health data (HAD) have been developed to detect patients with HF in a timely and inexpensive manner, in order to perform real-world studies at the population level. However, their reported diagnostic accuracy is highly variable. Objective To assess the diagnostic accuracy of validated HAD-based algorithms for detecting HF, compared to clinical diagnosis, and to investigate causes of heterogeneity. Methods We included all diagnostic accuracy studies that utilized HAD for the diagnosis of congestive HF in the general adult population, using clinical examination or chart review as the reference standard. A systematic search of MEDLINE (1946–2023) and Embase (1947–2023) was conducted, without restrictions. The QUADAS-2 tool was employed to assess the risk of bias and concerns regarding applicability. Due to low-quality issues of the primary studies, associated with both the index test and the reference standard definition and conduct, and to the high level of clinical heterogeneity, a quantitative synthesis was not performed. Measures of diagnostic accuracy of the included algorithms were summarized narratively and presented graphically, by population subgroups. Results We included 24 studies (161,524 patients) and extracted 36 algorithms. Algorithm selection was based on type of administrative data and DOR. Six studies (103,018 patients, 14 algorithms) were performed in the general outpatient population, with sensitivities ranging from 24.8 to 97.3% and specificities ranging from 35.6 to 99.5%. Eight studies (14,957 patients, 10 algorithms) included hospitalized patients with sensitivities ranging from 29.0 to 96.0% and specificities ranging from 65.8 to 99.2%. The remaining studies included subgroups of the general population or hospitalized patients with cardiologic conditions and were analyzed separately. Fourteen studies had one or more domains at high risk of bias, and there were concerns regarding applicability in 9 studies. Discussion The considerable percentage of studies with a high risk of bias, together with the high clinical heterogeneity among different studies, did not allow to generate a pooled estimate of diagnostic accuracy for HAD-based algorithms to be used in an unselected general adult population. Systematic review registration PROSPERO CRD42023487565

Background: This study aimed to compare the diagnostic accuracy of the Ki-67 labeling index (LI) between endoscopic ultrasonography-fine-needle aspiration cytology/biopsy (EUS-FNAC/FNB) and surgical specimens of pancreatic neuroendocrine neoplasms (PanNENs). Methods: Conventional meta-analysis and diagnostic test accuracy (DTA) reviews were performed on 17 eligible studies. The DTA review involved calculating the sensitivity, specificity, diagnostic odds ratio (OR), and area under the curve (AUC) of the summary receiver operating characteristic (SROC) curve. In addition, subgroup analysis was conducted based on EUS-FNAC and FNB, tumor grade, and tumor size. Results: The overall concordance rate of WHO grade based on Ki-67 LI between the EUS-FNAC/FNB and the surgical specimen was 0.767 (95% confidence interval (CI), 0.713–0.814). Concordance rates of the EUS-FNAC and EUS-FNB subgroups were 0.741 (95% CI, 0.681–0.794) and 0.839 (95% CI, 0.738–0.906), respectively. In the DTA review for grade 3, the sensitivity and specificity were calculated to be 0.786 (95% CI, 0.590–0.917) and 0.998 (95% CI, 0.987–1.000), respectively. The diagnostic OR and AUC of the SROC curve were 150.220 (95% CI, 46.145–489.000) and 0.983, respectively. The sensitivity and specificity were observed to be highest in the grade 1 and 3 subgroups, respectively. Conclusions: Higher concordance of tumor grade based on Ki-67 LI was observed between EUS-FNAC/FNB and surgical specimens, indicating the potential usefulness of Ki-67 LI in predicting PanNEN tumor grade in EUS-FNAC/FNB.

Background: The present study aims to evaluate the diagnostic roles of various immunohistochemical (IHC) markers in thymic tumors, including thymic carcinoma (TC) and thymoma (TM). Methods: Eligible studies were obtained by searching the PubMed databases and screening the searched articles. Thirty-eight articles were used in the present meta-analysis and included 636 TCs and 1861 TMs. Besides, for IHC markers with statistical significance, a diagnostic test accuracy review was performed. Results: The comparison of various IHC expressions between TC and TM was performed for 32 IHC markers. Among these IHC markers, there were significant differences between TC and TM for beta-5t, B-cell lymphoma 2 (Bcl-2), calretinin, CD1a, CD5, carcinoembryonic antigen (CEA), cytokeratin19 (CK19), CD117, glucose transporter 1 (Glut-1), insulin-like growth factor 1 receptor (IGF-1R), mesothelin, MOC31, mucin1 (MUC1), p21, and terminal deoxynucleotidyl transferase (TdT). Markers with higher expressions in TCs were Bcl-2, calretinin, CD5, CEA, CD117, Glut-1, IGF-1R, mesothelin, MOC31, MUC1, and p21. Among these markers, there were no significant differences between TC and TM type B3 in immunohistochemistries for Bcl-2 and CK19. On the other hand, β-catenin and CD205 showed a considerable difference in IHC expressions between TC and TM type B3, but not between TC and overall TM. In diagnostic test accuracy review, MUC1 and beta-5t were the most useful markers for TC and TM, respectively. Conclusions: Taken together, our results showed that the expression rates for various IHC markers significantly differed between TC and TM. The IHC panel can be useful for differentiation from limited biopsied specimens in daily practice.

Background: The present study aims to evaluate the diagnostic accuracy between ultrasonography-guided fine-needle aspiration cytology (US-FNAC) and core needle biopsy (CNB) of axillary lymph nodes (ALNs) in patients with breast cancer through a meta-analysis and a diagnostic test accuracy (DTA) review. Methods: The present meta-analysis and DTA review included 67 eligible studies. The diagnostic accuracy of various preoperative assessments, including US-FNAC and CNB, was evaluated for ALNs assessments in patients with breast cancer. In addition, a subgroup analysis based on methods of cytologic preparation was performed. In the DTA review, the sensitivity, specificity, diagnostic odds ratio (OR) and area under the curve (AUC) on the summary receiver operating characteristic (SROC) curve were calculated. Results: The diagnostic accuracy of the preoperative assessments of ALNs was 0.850 (95% confidence interval (CI) 0.833–0.866) for patients with breast cancer. The diagnostic accuracy of CNB was significantly higher than that of US-FNAC (0.896, 95% CI 0.844–0.932 vs. 0.844, 95% CI 0.825–0.862; p = 0.044 in a meta-regression test). In the subgroup analysis based on cytologic preparation, the diagnosis accuracies were 0.860, 0.861 and 0.859 for the methods of conventional smear, liquid-based preparation and cell block, respectively. In the DTA review, CNB showed higher sensitivity than US-FNAC (0.849 vs. 0.760). However, there was no difference in specificity between US-FNAC and CNB (0.997 vs. 1.000). US-FNAC with liquid-based preparation and CNB showed the highest diagnostic OR and AUC on the SROC, respectively. Conclusion: Both US-FNAC and CNB are useful in preoperative assessments of ALNs in patients with breast cancer. Although the most sensitive test was found to be CNB in this study, there was no difference in specificity between various preoperative evaluations and the application of US-FNAC or CNB may be impacted by various factors.

Purpose: The aim of this study was to investigate the rate of ROS1 rearrangement and concordance between ROS1 immunohistochemistry (IHC) and molecular tests in non-small cell lung cancer (NSCLC). Methods: The study included 10,898 NSCLC cases from 21 eligible studies. ROS1 rearrangement rates were evaluated in NSCLC by a meta-analysis, including subgroup analyses. In addition, we performed a concordance analysis and a diagnostic test accuracy review of ROS1 IHC in NSCLC. Results: The estimated overall rate of ROS1 rearrangement and IHC positivity was 2.4% (95% confidence interval (CI) 1.5, 3.7). In the subgroup analysis, which was based on tumor subtype, the rate of ROS1 rearrangement and IHC positivity was 2.9% (95% CI 1.9, 4.5) and 0.6% (95% CI 0.3, 1.2) in adenocarcinoma and non-adenocarcinoma, respectively. The overall concordance rate between ROS1 IHC and molecular tests was 93.4% (95% CI 78.3, 98.2). In ROS1 IHC positive and negative cases, the concordance rates were 79.0% (95% CI 43.3, 94.9) and 97.0% (95% CI 83.3, 99.5), respectively. The pooled sensitivity and the specificity of ROS1 IHC were 0.90 (95% CI 0.70, 0.99) and 0.82 (95% CI 0.79, 0.84), respectively. The diagnostic odds ratio and the area under the curve of the summary receiver operating characteristic curve were 118.01 (95% CI 11.81, 1179.67) and 0.9417, respectively. Conclusion: The rates of ROS1 rearrangement differed by tumor histologic subtype in NSCLC. ROS1 IHC may be useful for the detection of ROS1 rearrangement in NSCLC. Detailed criteria for evaluating ROS1 IHC are needed before it can be applied in daily practice.

The present study aimed to compare the diagnostic accuracy between conventional smear (CS) and liquid-based preparation (LBP) in endoscopic ultrasonography-fine needle aspiration cytology (EUS-FNAC) of pancreatic lesions. Using 31 eligible studies, the diagnostic accuracy of cytologic examination in CS and LBP was evaluated through a conventional meta-analysis and diagnostic test accuracy review. Overall concordance rates were 82.8% (95% confidence interval [CI], 79.8–85.5%) and 94.0% (95% CI, 84.4–97.8%) in CS and LBP, respectively. CS with rapid on-site evaluation (ROSE) showed a higher concordance rate than CS without ROSE. In CS, the pooled sensitivity and specificity were 89.8% (95% CI, 85.2–93.1%) and 95.0% (95% CI, 90.0–97.6%), respectively. The diagnostic odds ratio (OR) and area under curve (AUC) of the summary receiver operating characteristic (SROC) curve were 90.32 (95% CI, 43.85–147.11) and 0.945, respectively. In LBP, the pooled sensitivity and specificity were 80.9% (95% CI, 69.7–88.7%) and 99.9% (95% CI, 1.5–100.0%), respectively. The diagnostic OR and AUC of the SROC curve were 57.21 (95% CI, 23.61–138.64) and 0.939, respectively. Higher concordance rates were found in CS with ROSE and LBP in EUS-FNAC of pancreatic lesions. Regardless of the cytologic preparation method, EUS-FNAC is a useful and accurate diagnostic tool for pancreatic lesions.

Introduction The aim of this study was to elucidate the clinicopathological significance of HER2 expression and the diagnostic accuracy of HER2 immunohistochemistry (IHC) in colorectal cancer (CRC). A total of 2,573 CRC cases from 13 eligible studies were included. Methods We performed a meta-analysis to examine the correlations between HER2 expression and clinicopathological characteristics in CRC. Concordance analysis between HER2 IHC and in situ hybridization (ISH) and diagnostic test accuracy review was conducted. Results The estimated rate of HER2 IHC overexpression was 0.162 (95% confidence interval [CI] 0.106-0.240). HER2 IHC overexpression was significantly correlated with lymph node metastasis and distant metastasis but not tumor depth. HER2 IHC overexpression was not correlated with overall survival. The concordance rates between IHC and ISH were 0.968 (95% CI 0.881-0.992), 0.377 (95% CI 0.225-0.557) and 0.780 (95% CI 0.390-0.952) for HER2 IHC scores of 0/1+, 2+ and 3+, respectively. The diagnostic test accuracy review of HER2 IHC revealed that the pooled sensitivity and specificity were 0.71 (95% CI 0.58-0.82) and 0.96 (95% CI 0.94-0.97), respectively. The diagnostic odds ratio and area under the summary receiver operating characteristic curve were 51.34 (95% CI 3.82-690.54) and 0.9704, respectively. Conclusions HER2 IHC overexpression was significantly correlated with lymph node metastasis and distant metastasis. CRC cases with HER2 IHC scores of 0/1+ exhibited good agreement with the ISH data. However, additional ISH analysis is needed to confirm HER2 status in cases with IHC scores of 2+ or 3+.