Validation of models to diagnose ovarian cancer in patients managed surgically or conservatively: multicentre cohort study
| Autor: | Ekaterini Domali, An Coosemans, Giovanni Scambia, Laure Wynants, J. Kaijser, Valentina Chiappa, Dirk Timmerman, Jolien Ceusters, Juan Luis Alcázar, Luca Savelli, Daniela Fischerova, Caroline Van Holsbeke, Elisabeth Epstein, Dorella Franchi, Povilas Sladkevicius, Nandita Deo, Ignace Vergote, Artur Czekierdowski, Tom Bourne, Maria Elisabetta Coccia, Ben Van Calster, Antonia Carla Testa, Marek Kudla, Lil Valentin, Chiara Landolfo, Ligita Jokubkiene, F. Leone, Wouter Froyman, Robert Fruscio, Stefano Guerriero, F. Buonomo |
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| Přispěvatelé: | Van Calster, B, Valentin, L, Froyman, W, Landolfo, C, Ceusters, J, Testa, A, Wynants, L, Sladkevicius, P, Van Holsbeke, C, Domali, E, Fruscio, R, Epstein, E, Franchi, D, Kudla, M, Chiappa, V, Alcazar, J, Leone, F, Buonomo, F, Coccia, M, Guerriero, S, Deo, N, Jokubkiene, L, Savelli, L, Fischerova, D, Czekierdowski, A, Kaijser, J, Coosemans, A, Scambia, G, Vergote, I, Bourne, T, Timmerman, D, Epidemiologie, RS: CAPHRI - R5 - Optimising Patient Care |
| Jazyk: | angličtina |
| Rok vydání: | 2020 |
| Předmět: |
EXTERNAL VALIDATION
RISK MODELS SURGERY PREDICTION Conservative Treatment Adnexal mass 0302 clinical medicine Prospective Studies Stage (cooking) Prospective cohort study Membrane Protein ULTRASOUND Ultrasonography Ovarian Neoplasms Aged 80 and over CALIBRATION 030219 obstetrics & reproductive medicine General Medicine Middle Aged TUMORS 030220 oncology & carcinogenesis Female Radiology Life Sciences & Biomedicine Cohort study Human Adult IOTA ADNEX MODEL medicine.medical_specialty Adolescent Ovariectomy Malignancy Risk Assessment 1117 Public Health and Health Services 03 medical and health sciences Young Adult Medicine General & Internal General & Internal Medicine medicine Fallopian Tube Neoplasms Humans Fallopian Tube Neoplasm MASSES Aged MALIGNANCY Science & Technology Receiver operating characteristic business.industry Research Ovarian Neoplasm Membrane Proteins 1103 Clinical Sciences medicine.disease Confidence interval Clinical trial Prospective Studie Logistic Models CA-125 Antigen business |
| Zdroj: | The BMJ BMJ (e), 370:2614. BMJ Publishing Group |
| ISSN: | 1756-1833 |
| Popis: | ObjectiveTo evaluate the performance of diagnostic prediction models for ovarian malignancy in all patients with an ovarian mass managed surgically or conservatively.DesignMulticentre cohort study.Setting36 oncology referral centres (tertiary centres with a specific gynaecological oncology unit) or other types of centre.ParticipantsConsecutive adult patients presenting with an adnexal mass between January 2012 and March 2015 and managed by surgery or follow-up.Main outcome measuresOverall and centre specific discrimination, calibration, and clinical utility of six prediction models for ovarian malignancy (risk of malignancy index (RMI), logistic regression model 2 (LR2), simple rules, simple rules risk model (SRRisk), assessment of different neoplasias in the adnexa (ADNEX) with or without CA125). ADNEX allows the risk of malignancy to be subdivided into risks of a borderline, stage I primary, stage II-IV primary, or secondary metastatic malignancy. The outcome was based on histology if patients underwent surgery, or on results of clinical and ultrasound follow-up at 12 (±2) months. Multiple imputation was used when outcome based on follow-up was uncertain.ResultsThe primary analysis included 17 centres that met strict quality criteria for surgical and follow-up data (5717 of all 8519 patients). 812 patients (14%) had a mass that was already in follow-up at study recruitment, therefore 4905 patients were included in the statistical analysis. The outcome was benign in 3441 (70%) patients and malignant in 978 (20%). Uncertain outcomes (486, 10%) were most often explained by limited follow-up information. The overall area under the receiver operating characteristic curve was highest for ADNEX with CA125 (0.94, 95% confidence interval 0.92 to 0.96), ADNEX without CA125 (0.94, 0.91 to 0.95) and SRRisk (0.94, 0.91 to 0.95), and lowest for RMI (0.89, 0.85 to 0.92). Calibration varied among centres for all models, however the ADNEX models and SRRisk were the best calibrated. Calibration of the estimated risks for the tumour subtypes was good for ADNEX irrespective of whether or not CA125 was included as a predictor. Overall clinical utility (net benefit) was highest for the ADNEX models and SRRisk, and lowest for RMI. For patients who received at least one follow-up scan (n=1958), overall area under the receiver operating characteristic curve ranged from 0.76 (95% confidence interval 0.66 to 0.84) for RMI to 0.89 (0.81 to 0.94) for ADNEX with CA125.ConclusionsOur study found the ADNEX models and SRRisk are the best models to distinguish between benign and malignant masses in all patients presenting with an adnexal mass, including those managed conservatively.Trial registrationClinicalTrials.gov NCT01698632. |
| Databáze: | OpenAIRE |
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