title: Strategies to diagnose ovarian cancer: new evidence from phase 3 of the multicentre international IOTA study.
abstract: BACKGROUND
  To compare different ultrasound-based international ovarian tumour analysis (IOTA) strategies and risk of malignancy index (RMI) for ovarian cancer diagnosis using a meta-analysis approach of centre-specific data from IOTA3.
  
  
  METHODS
  This prospective multicentre diagnostic accuracy study included 2403 patients with 1423 benign and 980 malignant adnexal masses from 2009 until 2012. All patients underwent standardised transvaginal ultrasonography. Test performance of RMI, subjective assessment (SA) of ultrasound findings, two IOTA risk models (LR1 and LR2), and strategies involving combinations of IOTA simple rules (SRs), simple descriptors (SDs) and LR2 with and without SA was estimated using a meta-analysis approach. Reference standard was histology after surgery.
  
  
  RESULTS
  The areas under the receiver operator characteristic curves of LR1, LR2, SA and RMI were 0.930 (0.917-0.942), 0.918 (0.905-0.930), 0.914 (0.886-0.936) and 0.875 (0.853-0.894). Diagnostic one-step and two-step strategies using LR1, LR2, SR and SD achieved summary estimates for sensitivity 90-96%, specificity 74-79% and diagnostic odds ratio (DOR) 32.8-50.5. Adding SA when IOTA methods yielded equivocal results improved performance (DOR 57.6-75.7). Risk of Malignancy Index had sensitivity 67%, specificity 91% and DOR 17.5.
  
  
  CONCLUSIONS
  This study shows all IOTA strategies had excellent diagnostic performance in comparison with RMI. The IOTA strategy chosen may be determined by clinical preference.
authors.affiliation: Department of Gynaecologic Oncology, Catholic University of the Sacred Heart, Largo Francesco Vito 8, Rome 00165, Italy.
authors.forename: A
authors.initials: A
authors.lastname: Testa
authors.affiliation: 1] KU Leuven Department of Development and Regeneration, Herestraat 49 Box 7003, 3000 Leuven, Belgium [2] Department of Obstetrics and Gynaecology and Leuven Cancer Institute, University Hospitals Leuven, Herestraat 49 Box 7003, 3000 Leuven, Belgium.
authors.forename: J
authors.initials: J
authors.lastname: Kaijser
authors.affiliation: 1] KU Leuven Department of Electrical Engineering (ESAT-STADIUS), Kasteelpark Arenberg 10, 3001 Leuven, Belgium [2] iMinds Future Health Department, KU Leuven, Kasteelpark Arenberg 10, 3001 Leuven, Belgium.
authors.forename: L
authors.initials: L
authors.lastname: Wynants
authors.affiliation: Department of Obstetrics and Gynaecology, Gynaecological Oncology Center, Charles University, Apolinarska 18, 12000 Prague, Czech Republic.
authors.forename: D
authors.initials: D
authors.lastname: Fischerova
authors.affiliation: Department of Obstetrics and Gynaecology, Ziekenhuis Oost Limburg, Schiepse Bos 6, 3600 Genk, Belgium.
authors.forename: C
authors.initials: C
authors.lastname: Van Holsbeke
authors.affiliation: Preventive Gynaecology Unit, Division of Gynaecology, European Institute of Oncology, Via Ripamonti 435, Milan 20141, Italy.
authors.forename: D
authors.initials: D
authors.lastname: Franchi
authors.affiliation: Gynaecology and Reproductive Medicine Unit, S. Orsola-Malpighi Hospital, University of Bologna, Via Albertoni 15, Bologna 40138, Italy.
authors.forename: L
authors.initials: L
authors.lastname: Savelli
authors.affiliation: Department of Obstetrics and Gynaecology, Karolinska University Hospital, Solna, SE-17176 Stockholm, Sweden.
authors.forename: E
authors.initials: E
authors.lastname: Epstein
authors.affiliation: First Department of Gynecologic Oncology and Gynecology, Medical University of Lublin, ul. Staszica 16, 20-081 Lublin, Poland.
authors.forename: A
authors.initials: A
authors.lastname: Czekierdowski
authors.affiliation: Department of Obstetrics and Gynaecology, Azienda Ospedaliero Universitaria di Cagliari, Strada Statale 554 Monserrato, Cagliari 09045, Italy.
authors.forename: S
authors.initials: S
authors.lastname: Guerriero
authors.affiliation: Department of Obstetrics and Gynaecology, San Gerardo Hospital, University of Milan-Bicocca, Via Pergolesi, 33, 20052 Monza, Italy.
authors.forename: R
authors.initials: R
authors.lastname: Fruscio
authors.affiliation: Department of Obstetrics and Gynecology, Clinical Sciences Institute L. Sacco, University of Milan, Via G.B. Grassi 74, 20157 Milan, Italy.
authors.forename: F P G
authors.initials: FP
authors.lastname: Leone
authors.affiliation: Department of Obstetrics and Gynaecology and Leuven Cancer Institute, University Hospitals Leuven, Herestraat 49 Box 7003, 3000 Leuven, Belgium.
authors.forename: I
authors.initials: I
authors.lastname: Vergote
authors.affiliation: 1] KU Leuven Department of Development and Regeneration, Herestraat 49 Box 7003, 3000 Leuven, Belgium [2] Department of Obstetrics and Gynaecology and Leuven Cancer Institute, University Hospitals Leuven, Herestraat 49 Box 7003, 3000 Leuven, Belgium [3] Department of Obstetrics and Gynaecology, Queen Charlotte's and Chelsea Hospital, Imperial College, Du Cane Road, London W12 0HS, UK.
authors.forename: T
authors.initials: T
authors.lastname: Bourne
authors.affiliation: Department of Obstetrics and Gynaecology, Skåne University Hospital Malmö, Lund University, Södra Förstadsgatan, 20502 Malmö, Sweden.
authors.forename: L
authors.initials: L
authors.lastname: Valentin
authors.affiliation: KU Leuven Department of Development and Regeneration, Herestraat 49 Box 7003, 3000 Leuven, Belgium.
authors.forename: B
authors.initials: B
authors.lastname: Van Calster
authors.affiliation: 1] KU Leuven Department of Development and Regeneration, Herestraat 49 Box 7003, 3000 Leuven, Belgium [2] Department of Obstetrics and Gynaecology and Leuven Cancer Institute, University Hospitals Leuven, Herestraat 49 Box 7003, 3000 Leuven, Belgium.
authors.forename: D
authors.initials: D
authors.lastname: Timmerman
mesh_terms: D018293:Cystadenoma, Serous / Q000000981:diagnostic imaging*; D004715:Endometriosis / Q000000981:diagnostic imaging*; D005260:Female; D006801:Humans; D015337:Multicenter Studies as Topic; D010051:Ovarian Neoplasms / Q000000981:diagnostic imaging*; D016016:Proportional Hazards Models; D011446:Prospective Studies; D012372:ROC Curve; D014463:Ultrasonography