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  • Van Calster, BenCatholic University of Leuven,Leiden University Medical Centre (author)

Validation of models to diagnose ovarian cancer in patients managed surgically or conservatively : multicentre cohort study

  • Article/chapterEnglish2020

Publisher, publication year, extent ...

  • 2020-07-30
  • BMJ,2020

Numbers

  • LIBRIS-ID:oai:lup.lub.lu.se:41d5e198-bd41-4ba9-80e0-8cde03d4d644
  • https://lup.lub.lu.se/record/41d5e198-bd41-4ba9-80e0-8cde03d4d644URI
  • https://doi.org/10.1136/bmj.m2614DOI
  • http://kipublications.ki.se/Default.aspx?queryparsed=id:144342206URI

Supplementary language notes

  • Language:English
  • Summary in:English

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  • Subject category:art swepub-publicationtype
  • Subject category:ref swepub-contenttype

Notes

  • OBJECTIVE: To evaluate the performance of diagnostic prediction models for ovarian malignancy in all patients with an ovarian mass managed surgically or conservatively. DESIGN: Multicentre cohort study. SETTING: 36 oncology referral centres (tertiary centres with a specific gynaecological oncology unit) or other types of centre. PARTICIPANTS: Consecutive adult patients presenting with an adnexal mass between January 2012 and March 2015 and managed by surgery or follow-up. MAIN OUTCOME MEASURES: Overall 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. RESULTS: The 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. CONCLUSIONS: Our 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 REGISTRATION: ClinicalTrials.gov NCT01698632.

Subject headings and genre

Added entries (persons, corporate bodies, meetings, titles ...)

  • Valentin, LilLund University,Lunds universitet,Obstetrisk, gynekologisk och prenatal ultraljudsdiagnostik,Forskargrupper vid Lunds universitet,Obstetric, Gynaecological and Prenatal Ultrasound Research,Lund University Research Groups,Skåne University Hospital(Swepub:lu)obst-lva (author)
  • Froyman, WouterCatholic University of Leuven,University Hospitals Leuven (author)
  • Landolfo, ChiaraCatholic University of Leuven,Queen Charlotte's and Chelsea Hospital (author)
  • Ceusters, JolienCatholic University of Leuven (author)
  • Testa, Antonia C.Catholic University of the Sacred Heart, Rome,Policlinico Universitario Agostino Gemelli (author)
  • Wynants, LaureMaastricht University,Catholic University of Leuven (author)
  • Sladkevicius, PovilasLund University,Lunds universitet,Obstetrisk, gynekologisk och prenatal ultraljudsdiagnostik,Forskargrupper vid Lunds universitet,Obstetric, Gynaecological and Prenatal Ultrasound Research,Lund University Research Groups,Skåne University Hospital(Swepub:lu)obst-psl (author)
  • Van Holsbeke, CarolineHospital Oost-Limburg (author)
  • Domali, EkateriniNational and Kapodistrian University of Athens (author)
  • Fruscio, RobertUniversity of Milano-Bicocca (author)
  • Epstein, ElisabethKarolinska Institutet,Karolinska Institute(Swepub:lu)obst-eep (author)
  • Franchi, DorellaEuropean Institute of Oncology (author)
  • Kudla, Marek J.Medical University of Silesia (author)
  • Chiappa, ValentinaIstituto Nazionale dei Tumori (author)
  • Alcazar, Juan L.University of Navarra (author)
  • Leone, Francesco P.G.Luigi Sacco University Hospital (author)
  • Buonomo, FrancescaBurlo Garofolo Pediatric Institute (author)
  • Coccia, Maria ElisabettaUniversity of Florence (author)
  • Guerriero, StefanoUniversity of Cagliari (author)
  • Deo, NanditaWhipps Cross University Hospital (author)
  • Jokubkiene, LigitaLund University,Lunds universitet,Urogynekologi och reproduktionsfarmakologi,Forskargrupper vid Lunds universitet,Urogynaecology and Reproductive Pharmacology,Lund University Research Groups,Skåne University Hospital(Swepub:lu)obst-ljo (author)
  • Savelli, LucaUniversity of Bologna (author)
  • Fischerová, DanielaGeneral University Hospital in Prague (author)
  • Czekierdowski, ArturMedical University of Lublin (author)
  • Kaijser, JeroenIkazia Hospital (author)
  • Coosemans, AnCatholic University of Leuven,University Hospitals Leuven (author)
  • Scambia, GiovanniCatholic University of the Sacred Heart, Rome,Policlinico Universitario Agostino Gemelli (author)
  • Vergote, IgnaceUniversity Hospitals Leuven,Catholic University of Leuven (author)
  • Bourne, TomUniversity Hospitals Leuven,Queen Charlotte's and Chelsea Hospital,Catholic University of Leuven (author)
  • Timmerman, DirkUniversity Hospitals Leuven,Catholic University of Leuven (author)
  • Catholic University of LeuvenLeiden University Medical Centre (creator_code:org_t)

Related titles

  • In:BMJ (Clinical research ed.): BMJ3701756-1833

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