Evidence map›Paper›PMID 42036775›Full record

ArticleBJOG : an international journal of obstetrics and gynaecology2026

Evaluation of the IOTA ADNEX Model, Two-Step Strategy and RMI in Routine Gynaecologic Care in Denmark and Implications for Implementation: A Prospective Multicenter Cohort Study.

Nikoline Schou Karlsen, Eva Dreisler, Claus Kim Høgdall, Estrid Solyom Høgdall, Mona Aarenstrup Karlsen, Thomas Alexander Gerds, Guðbjörg Andrésdóttir, Lea Langhoff-Thuesen, Malene Merete Forstholm, Abelone Elisabeth Sakse

Registry-linked trialAbstract readMulticenter StudyEvaluation Study
In one paragraph

Article in BJOG : an international journal of obstetrics and gynaecology, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04188652 (Diagnosing Ovarian Cysts - the DOC Study), which is not on this map. Not yet cited in PubMed.

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1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT04188652 completednot on this map

Diagnosing Ovarian Cysts - the DOC Study

Typeobservational_patient_registrySponsorRigshospitalet, DenmarkRan2020 to 2024Enrolled1,123ConditionsOvarian Cysts, Ovarian Cancer, Ovarian Neoplasms, Ovarian Cancer StageArmsDetailed symptomregistration
3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

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4 · The record

Corrections and comments

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5 · Who and what money

Authors and funding

10 authors.

Nikoline Schou KarlsenDepartment of Obstetrics and Gynecology, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark.ORCID https://orcid.org/0000-0003-3782-7178
Eva DreislerDepartment of Obstetrics and Gynecology, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark.
Claus Kim HøgdallDepartment of Obstetrics and Gynecology, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark.
Estrid Solyom HøgdallMolecular Unit, Department of Pathology, Herlev & Gentofte University Hospital, Herlev, Denmark.
Mona Aarenstrup KarlsenDepartment of Obstetrics and Gynecology, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark.
Thomas Alexander GerdsDepartment of Public Health, Section of Biostatistics, University of Copenhagen, Copenhagen, Denmark.
Guðbjörg AndrésdóttirDepartment of Obstetrics and Gynecology, North Zealand University Hospital, Hillerød, Denmark.
Lea Langhoff-ThuesenInstitute of Clinical Medicine, University of Copenhagen Faculty of Health and Medical Sciences, Copenhagen, Denmark.
Malene Merete ForstholmDepartment of Obstetrics and Gynecology, Herlev & Gentofte University Hospital, Herlev, Denmark.
Abelone Elisabeth SakseDepartment of Obstetrics and Gynecology, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark.

Funding

Kræftens BekæmpelseNEYE Foundation
6 · The paper itself

Abstract

objectiveTo evaluate whether the IOTA ADNEX model and the Two-Step Strategy improve triage and referral of adnexal masses in routine gynaecologic care compared with the RMI and to identify an appropriate malignancy-risk threshold.

designProspective multicenter cohort study.

settingThirteen non-tertiary hospitals and clinics and one tertiary referral hospital in Denmark. SAMPLE: A complete-case cohort of 966 patients with adnexal masses.

methodsMalignancy risk was estimated using prospectively collected clinical data, ultrasound findings, and CA125 levels. Reference standard was histopathology or ≥ 12 months of clinical follow-up. Performance was evaluated across predefined thresholds (1%-30% for ADNEX/Two-Step Strategy (modified benign descriptors + ADNEX); ≥ 200 for RMI), stratified by centre type. OUTCOME MEASURES: Negative and positive predictive values (NPV, PPV), sensitivity, referral rates to assess correct and incorrect referrals.

resultsIn non-tertiary centres, NPVs were ≥ 96% for IOTA models versus 95% for RMI; corresponding values in the tertiary centre were 82%-100% versus 78%. PPVs increased with higher thresholds and approached RMI at 20% threshold. In non-tertiary centres, where referral decisions are made, a 15% threshold provided the most favourable balance between sensitivity (~63%) and referral rate (~14%). At thresholds ≥ 25%, referral rates were similar to RMI (~8%), with only marginal gains in sensitivity (~50% vs. 39%). Most additionally detected tumours were stage I ovarian cancers or borderline tumours. For masses classified as benign by modified benign descriptors, ADNEX showed high NPVs but low PPVs and negligible net benefit, providing limited additional diagnostic value over the Two-Step Strategy.

conclusionsIOTA-based models improve early detection but increase referral rates. A 15% risk threshold appears to offer a clinically reasonable balance between early detection of malignancy and referral burden, based on observed trade-offs between detection and referral rates.

trial registrationClinicalTrials.gov identifier: NCT04188652.

Indexed as

Adnexal DiseasesAdultAgedCA-125 AntigenDenmarkFemaleHumansMiddle AgedOvarian NeoplasmsPredictive Value of TestsProspective StudiesReferral and ConsultationRisk AssessmentSensitivity and SpecificityTriageUltrasonographyCA-125 Antigenadnexal massesdiagnostic modelsIOTA ADNEX modelovarian cancerreferral thresholdsrisk of malignancy index

Identifiers

PMID42036775
PMCPMC13571888

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