Abstract
Background
Several diagnostic prediction models to help clinicians discriminate between benign and malignant adnexal masses are available. This study is a head-to-head comparison of the performance of the Assessment of Different NEoplasias in the adneXa (ADNEX) model with that of the Risk of Ovarian Malignancy Algorithm (ROMA).Methods
This is a retrospective study based on prospectively included consecutive women with an adnexal tumour scheduled for surgery at five oncology centres and one non-oncology centre in four countries between 2015 and 2019. The reference standard was histology. Model performance for ADNEX and ROMA was evaluated regarding discrimination, calibration, and clinical utility.Results
The primary analysis included 894 patients, of whom 434 (49%) had a malignant tumour. The area under the receiver operating characteristic curve (AUC) was 0.92 (95% CI 0.88-0.95) for ADNEX with CA125, 0.90 (0.84-0.94) for ADNEX without CA125, and 0.85 (0.80-0.89) for ROMA. ROMA, and to a lesser extent ADNEX, underestimated the risk of malignancy. Clinical utility was highest for ADNEX. ROMA had no clinical utility at decision thresholds <27%.Conclusions
ADNEX had better ability to discriminate between benign and malignant adnexal tumours and higher clinical utility than ROMA.Clinical trial registration
clinicaltrials.gov NCT01698632 and NCT02847832.References
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Clinical Trials (2)
- (1 citation) ClinicalTrials.gov - NCT01698632
- (1 citation) ClinicalTrials.gov - NCT02847832
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Funding
Funders who supported this work.
Fonds Wetenschappelijk Onderzoek (1)
Grant ID: 18B2921N
Fonds Wetenschappelijk Onderzoek (Research Foundation Flanders) (1)
Grant ID: 18B2921N
Kom Op Tegen Kanker Internal Funds
Linbury Trust Grant
National Institute for Health Research (NIHR)
Vetenskapsrådet (1)
Grant ID: K2014-99X-22475-01-3
Vetenskapsrådet (Swedish Research Council) (1)
Grant ID: K2014-99X-22475-01-3