A comparison of the diagnostic performance of the O-RADS, RMI4, IOTA LR2, and IOTA SR systems by senior and junior doctors

Guo, Yuyang; Zhao, Baihua; Zhou, Shujuan; Wen, Liang; Liu, Jieyu; Fu, Yaqian; Fang, Xu; Liu, Minghui

doi:10.14366/usg.21237

Cited by 24 publications

(31 citation statements)

References 26 publications

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“…After full-text reading, three papers were excluded (no data for constructing 2 × 2 table available (n = 2), and use of MRI, instead of ultrasound (n = 1)). Eleven papers were ultimately included in the qualitative and quantitative synthesis [22][23][24][25][26][27][28][29][30][31][32]. A flowchart summarizing the literature search is shown in Figure 1.…”

Section: Search Resultsmentioning

confidence: 99%

“…The study design was retrospective in 10 studies [22][23][24][25][26][27][29][30][31][32] and prospective in just one study [28]. Eight studies were considered as having high risk regarding the patient selection domain, since inappropriate exclusions (for example, cases with poor image quality or cases with not all data available) were observed [22,23,25,[27][28][29][30][31][32], and one study was unclear since a complete description of the exclusion criteria was lacking [26].…”

Section: Methodological Quality Of Included Studiesmentioning

confidence: 99%

“…Concerning the domain "index test", all studies adequately described the method of the index text, as well as how it was performed and interpreted. Ten studies used IOTA terminology of the mass features [22,23,[25][26][27][28][29][30][31][32], while one used the ADNEX model [24]. In all retrospective studies, examiners were blinded to the reference standard result.…”

Section: Methodological Quality Of Included Studiesmentioning

confidence: 99%

“…All studies reported the mean age of patients and distribution according to menopausal status. In fact, seven studies reported the distribution of benign and malignant tumors according to menopausal status [23][24][25][27][28][29]32]. According to these studies, 402 out of 2379 (16.9%) premenopausal women had malignant lesions, whereas 474 out of 832 (56.8%) postmenopausal women had malignant lesions.…”

Section: Characteristics Of Included Studiesmentioning

confidence: 99%

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Ovarian Adnexal Reporting Data System (O-RADS) for Classifying Adnexal Masses: A Systematic Review and Meta-Analysis

Vara

Manzour

Chacón

et al. 2022

Cancers

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In this systematic review and meta-analysis, we aimed to assess the pooled diagnostic performance of the so-called Ovarian Adnexal Report Data System (O-RADS) for classifying adnexal masses using transvaginal ultrasound, a classification system that was introduced in 2020. We performed a search for studies reporting the use of the O-RADS system for classifying adnexal masses from January 2020 to April 2022 in several databases (Medline (PubMed), Google Scholar, Scopus, Cochrane, and Web of Science). We selected prospective and retrospective cohort studies using the O-RADS system for classifying adnexal masses with histologic diagnosis or conservative management demonstrating spontaneous resolution or persistence in cases of benign appearing masses after follow-up scan as the reference standard. We excluded studies not related to the topic under review, studies not addressing O-RADS classification, studies addressing MRI O-RADS classification, letters to the editor, commentaries, narrative reviews, consensus documents, and studies where data were not available for constructing a 2 × 2 table. The pooled sensitivity, specificity, positive and negative likelihood ratios, and diagnostic odds ratio (DOR) were calculated. The quality of the studies was evaluated using QUADAS-2. A total of 502 citations were identified. Ultimately, 11 studies comprising 4634 masses were included. The mean prevalence of ovarian malignancy was 32%. The risk of bias was high in eight studies for the “patient selection” domain. The risk of bias was low for the “index test” and “reference test” domains for all studies. Overall, the pooled estimated sensitivity, specificity, positive likelihood ratio, negative likelihood ratio, and DOR of the O-RADS system for classifying adnexal masses were 97% (95% confidence interval (CI) = 94%–98%), 77% (95% CI = 68%–84%), 4.2 (95% CI = 2.9–6.0), 0.04 (95% CI = 0.03–0.07), and 96 (95% CI = 50–185), respectively. Heterogeneity was moderate for sensitivity and high for specificity. In conclusion, the O-RADS system has good sensitivity and moderate specificity for classifying adnexal masses.

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Section: Search Resultsmentioning

confidence: 99%

Section: Methodological Quality Of Included Studiesmentioning

confidence: 99%

Section: Methodological Quality Of Included Studiesmentioning

confidence: 99%

Section: Characteristics Of Included Studiesmentioning

confidence: 99%

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Ovarian Adnexal Reporting Data System (O-RADS) for Classifying Adnexal Masses: A Systematic Review and Meta-Analysis

Vara

Manzour

Chacón

et al. 2022

Cancers

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“…The calculation of the sample size was performed assuming a prevalence of malignancy among women with ovarian tumors of 20% [ 18 ] and an expected sensitivity of the test of at least 85%, accepting a 95% confidence interval with a width not exceeding 0.05. The resulting sample size was of 980 patients.…”

Section: Methodsmentioning

confidence: 99%

New Analytical Approach for the Alignment of Different HE4 Automated Immunometric Systems: An Italian Multicentric Study

Angeloni

Vito

Farina

et al. 2022

JCM

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Human epididymal secretory protein 4 (HE4) elevation has been studied as a crucial biomarker for malignant gynecological cancer, such us ovarian cancer (OC). However, there are conflicting reports regarding the optimal HE4 cut-off. Thus, the goal of this study was to develop an analytical approach to harmonize HE4 values obtained with different laboratory resources. To this regard, six highly qualified Italian laboratories, using different analytical platforms (Abbott Alinity I, Fujirebio Lumipulse G1200 and G600, Roche Cobas 601 and Abbott Architett), have joined this project. In the first step of our study, a common reference calibration curve (designed through progressive HE4 dilutions) was tested by all members attending the workshop. This first evaluation underlined the presence of analytical bias in different devices. Next, following bias correction, we started to analyze biomarkers values collected in a common database (1509 patients). A two-sided p-value < 0.05 was considered statistically significant. In post-menopausal women stratified between those with malignant gynecological diseases vs. non-malignant gynecological diseases and healthy women, dichotomous HE4 showed a significantly better accuracy than dichotomous Ca125 (AUC 0.81 vs. 0.74, p = 0.001 for age ≤ 60; AUC 0.78 vs. 0.72, p = 0.024 for age > 60). Still, in post-menopausal status, similar results were confirmed in patients with malignant gynecological diseases vs. patients with benign gynecological diseases, both under and over 60 years (AUC 0.79 vs. 0.73, p = 0.006; AUC 0.76 vs. 0.71, p = 0.036, respectively). Interestingly, in pre-menopausal status women over 40 years, HE4 showed a higher accuracy than Ca125 (AUC 0.73 vs. 0.66, p = 0.027), thus opening new perspective for the clinical management of fertile patients with malignant neoplasms, such as ovarian cancer. In summary, this model hinted at a new approach for identifying the optimal cut-off to align data detected with different HE4 diagnostic tools.

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Diagnostic Performance of Ultrasonography-Based Risk Models in Differentiating Between Benign and Malignant Ovarian Tumors in a US Cohort

et al. 2023

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ImportanceUltrasonography-based risk models can help nonexpert clinicians evaluate adnexal lesions and reduce surgical interventions for benign tumors. Yet, these models have limited uptake in the US, and studies comparing their diagnostic accuracy are lacking.ObjectiveTo evaluate, in a US cohort, the diagnostic performance of 3 ultrasonography-based risk models for differentiating between benign and malignant adnexal lesions: International Ovarian Tumor Analysis (IOTA) Simple Rules with inconclusive cases reclassified as malignant or reevaluated by an expert, IOTA Assessment of Different Neoplasias in the Adnexa (ADNEX), and Ovarian-Adnexal Reporting and Data System (O-RADS).Design, Setting, and ParticipantsThis retrospective diagnostic study was conducted at a single US academic medical center and included consecutive patients aged 18 to 89 years with adnexal masses that were managed surgically or conservatively between January 2017 and October 2022.ExposureEvaluation of adnexal lesions using the Simple Rules, ADNEX, and O-RADS.Main Outcomes and MeasuresThe main outcome was diagnostic performance, including area under the receiver operating characteristic (ROC) curve (AUC), sensitivity, specificity, positive and negative predictive values, and positive and negative likelihood ratios. Surgery or follow-up were reference standards. Secondary analyses evaluated the models’ performances stratified by menopause status and race.ResultsThe cohort included 511 female patients with a 15.9% malignant tumor prevalence (81 patients). Mean (SD) ages of patients with benign and malignant adnexal lesions were 44.1 (14.4) and 52.5 (15.2) years, respectively, and 200 (39.1%) were postmenopausal. In the ROC analysis, the AUCs for discriminative performance of the ADNEX and O-RADS models were 0.96 (95% CI, 0.93-0.98) and 0.92 (95% CI, 0.90-0.95), respectively. After converting the ADNEX continuous individualized risk into the discrete ordinal categories of O-RADS, the ADNEX performance was reduced to an AUC of 0.93 (95% CI, 0.90-0.96), which was similar to that for O-RADS. The Simple Rules combined with expert reevaluation had 93.8% sensitivity (95% CI, 86.2%-98.0%) and 91.9% specificity (95% CI, 88.9%-94.3%), and the Simple Rules combined with malignant classification had 93.8% sensitivity (95% CI, 86.2%-98.0%) and 88.1% specificity (95% CI, 84.7%-91.0%). At a 10% risk threshold, ADNEX had 91.4% sensitivity (95% CI, 83.0%-96.5%) and 86.3% specificity (95% CI, 82.7%-89.4%) and O-RADS had 98.8% sensitivity (95% CI, 93.3%-100%) and 74.4% specificity (95% CI, 70.0%-78.5%). The specificities of all models were significantly lower in the postmenopausal group. Subgroup analysis revealed high performances independent of race.Conclusions and RelevanceIn this diagnostic study of a US cohort, the Simple Rules, ADNEX, and O-RADS models performed well in differentiating between benign and malignant adnexal lesions; this outcome has been previously reported primarily in European populations. Risk stratification models can lead to more accurate and consistent evaluations of adnexal masses, especially when used by nonexpert clinicians, and may reduce unnecessary surgeries.

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A comparison of the diagnostic performance of the O-RADS, RMI4, IOTA LR2, and IOTA SR systems by senior and junior doctors

Cited by 24 publications

References 26 publications

Ovarian Adnexal Reporting Data System (O-RADS) for Classifying Adnexal Masses: A Systematic Review and Meta-Analysis

Ovarian Adnexal Reporting Data System (O-RADS) for Classifying Adnexal Masses: A Systematic Review and Meta-Analysis

New Analytical Approach for the Alignment of Different HE4 Automated Immunometric Systems: An Italian Multicentric Study

Diagnostic Performance of Ultrasonography-Based Risk Models in Differentiating Between Benign and Malignant Ovarian Tumors in a US Cohort

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