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ORIGINAL ARTICLE

:
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DIAGNOSTIC ACCURACY OF ULTRASOUND O-RADS CLASSIFICATION IN DIFFERENTIATION
OF BENIGN AND MALIGNANT OVARIAN LESIONS KEEPING MRI PELVIS AS REFERENCE

STANDARD
Mehreen Khan1, Mehreen Samad2, Muneeb Ur Rehman3, Hafiza Ayesha Jawaid 4, Shnaza Ijaz5, Faryal Shah6,

Naila Tamkeen7

How to cite this article

Khan M, Samad M, Rehman MU,
Jawaid HA, Ijaz S, Shah F, et al.
Diagnostic Accuracy of Ultrasound O-
Rads Classification in Differentiation of
Benign and Malignant Ovarian Lesions
Keeping MRI Pelvis as Reference
Standard. J Gandhara Med Dent Sci.
2025;12(4):69-73.https://doi.org/10.3776

Date of Submission: 10-07-2025
Date Revised: 03-09-2025
Date Acceptance: 05-09-2025

1Trainee medical officer, Department
of Radiology, Hayatabad Medical
Complex, Peshawar

2Professor, Department of
Radiology, Hayatabad Medical
Complex, Peshawar

3Trainee medical officer, Department
of Radiology, Hayatabad Medical
Complex, Peshawar

4Trainee medical officer, Department
of Radiology, Hayatabad Medical
Complex, Peshawar

5Trainee Medical Officer,
Department of Radiology, Hayatabad
Medical Complex, Peshawar

6Specialist registrar, Department of
Radiology, Hayatabad Medical
Complex, Peshawar

Correspondence

7Naila Tamkeen, Associate professor,
Department of Radiology, Hayatabad
Medical Complex, Peshawar

+92-334-9153074
drnail814@gmail.com

ABSTRACT
OBJECTIVES
This study aimed to evaluate the diagnostic accuracy of the ultrasound O-
RADS classification for distinguishing between malignant and benign ovarian
lesions, using MRI of the pelvis as the reference standard.
METHODOLOGY
A cross-sectional study was conducted, enrolling 169 women with suspicious
adnexal masses. All participants underwent standardised ultrasound
examinations (with O-RADS scoring) and MRI of the pelvis (with O-RADS
MRI scoring). Diagnostic performance metrics, including sensitivity,
specificity, positive predictive value (PPV), negative predictive value (NPV),
overall accuracy, and the area under the receiver operating characteristic
curve (AUC), were calculated.
RESULTS
The prevalence of malignancy was 29.0%. Ultrasound O-RADS demonstrated
a sensitivity of 83.7% (95% CI: 76.2-89.5%), specificity of 85.0% (95% CI:
78.3-90.1%), PPV of 69.5%, NPV of 92.7%, and overall accuracy of 84.6%.
The AUC was 0.91 (95% CI: 0.86-0.95). Performance was superior in
postmenopausal women and for larger lesions (greater than 5 cm in
diameter). False positives occurred primarily with hemorrhagic cysts and
endometriomas.
CONCLUSION
Ultrasound O-RADS classification demonstrates high diagnostic accuracy,
particularly an excellent NPV, for evaluating adnexal masses. It serves as a
reliable first-line triage tool, potentially reducing unnecessary MRI referrals
in settings with limited resources.
KEYWORDS: Ovarian Neoplasms; Ultrasonography; Magnetic Resonance
Imaging; O-RADS; Diagnostic Accuracy; Sensitivity and Specificity

INTRODUCTION

Ovarian cancer remains the most lethal gynecologic
malignancy, accounting for the highest mortality rate
among female reproductive cancers, particularly in
postmenopausal women.1 The clinical challenge lies in
distinguishing between benign and malignant ovarian
lesions, as benign masses (64.4%) are far more
prevalent than malignant ones (29.4%).2 Accurate
preoperative characterisation is crucial to avoid
unnecessary surgical interventions in benign cases
while ensuring timely and aggressive management for
malignancies.3An essential part of the diagnosis process
for ovarian masses is imaging. Non-invasive imaging
methods such as ultrasonography and magnetic

resonance imaging (MRI) are crucial for initial
assessments, although histological analysis remains the
gold standard. Due to their cost-effectiveness, ease of
application, and ability to provide real-time evaluations,
both transvaginal and transabdominal ultrasounds are
commonly employed. Nevertheless, to enhance
diagnostic reliability and risk assessment, standardised
scoring systems like the Ovarian-Adnexal Reporting
and Data System (O-RADS) have been developed in
response to the variability of subjective interpretations
and the influence of the operator‘s expertise.4 Based on
morphologic and Doppler characteristics, the O-RADS
classification system assigns ratings from 0 (incomplete
evaluation) to 5 (verysuggestive of malignancy) to
ovarian lesions. The sensitivity (84.8%) and specificity

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(81.9%) reported in studies assessing its diagnostic
ability differ, with some indicating even better
accuracy.5 These investigations, however, frequently
lack a reliable reference standard, like magnetic
resonance imaging (MRI), which provides multiplanar
imaging and improved soft-tissue contrast, making it
highly accurate in distinguishing benign from malignant
lesions.6 Previous studies validating O-RADS have
shown variable performance, with sensitivities ranging
from 84.8% to 96% and specificities from 81.9% to
93%.7 However, many studies lack a robust reference
standard, such as MRI, or are conducted in well-
resourced settings. In developing countries like
Pakistan, MRI is not readily accessible, creating a
critical need to validate highly accurate and accessible
diagnostic tools, such as ultrasound O-RADS. This
validation is essential to build clinician confidence in
using O-RADS for primary triage, thereby optimising
resource utilisation and improving patient care
pathways. Moreover, factors such as menopausal status,
CA-125 levels, and lesion characteristics may affect
diagnostic accuracy, indicating the need for further
stratification. This study aims to assess the diagnostic
accuracy of ultrasound O-RADS classification in
distinguishing between benign and malignant ovarian
lesions, with MRI of the pelvis serving as the reference
standard. In doing so, we aim to confirm the
dependability of ultrasound O-RADS within clinical
settings, especially where advanced imaging is not
readily available. The results may support the use of O-
RADS as a cost-effective initial diagnostic approach,
enhancing patient triage and minimising unwarranted
referrals for MRI.

METHODOLOGY

Study Design and Setting: This cross-sectional
validation study was conducted over six months at the
Department of Diagnostic Radiology, PGMI/Hayatabad
Medical Complex, Peshawar. The sample size was
calculated using the formula for diagnostic test
validation [8]. With an expected sensitivity of 84.8%7, a
prevalence of malignancy of 29.4%,2 a 95% confidence
level, and a desired precision (d) of 10%, the required
sample size was 169 participants. A total of 169 women
aged 18-65 years presenting with suspicious adnexal
masses on initial ultrasound were enrolled via non-
probability consecutive sampling.
Inclusion criteria were: women aged 18-65 years with
an adnexal mass deemed suspicious on referral
ultrasound. Exclusion criteria were contraindications to
MRI (e.g., metallic implants, pacemakers, severe
claustrophobia), contraindications to contrast media
(impaired renal function with serum creatinine >1.1
mg/dL or known allergy), and a history that could

confound results (prior ovarian cancer, extensive prior
pelvic surgery). All participants underwent a detailed
transabdominal and transvaginal ultrasound
examination using a Canon Aplio i800 machine with a
3.5MHz convex and a 7.5MHz endocavitary probe.
Doppler flow was assessed for colour score assignment.
A consultant radiologist with over 10 years of
experience, blinded to the MRI results, assigned an O-
RADS score based on the ACR O-RADS US lexicon.8
Subsequently, all patients underwent a 1.5T MRI of the
pelvis with intravenous contrast. A second consultant
radiologist, blinded to the US results, assigned an O-
RADS MRI score. For analysis, a score of 3 or higher
on either system was considered predictive of
malignancy. Ethical approval for this study was
obtained from the Institutional Review Board of
Hayatabad Medical Complex (approval no:1629).
Written informed consent was obtained from all
participants. Data were analysed using SPSS version
26. Continuous variables were expressed as mean ±
standard deviation, and categorical variables as
frequencies and percentages. A 2x2 contingency table
was constructed to calculate sensitivity, specificity,
PPV, NPV, and overall accuracy. A receiver operating
characteristic (ROC) curve was generated to determine
the area under the curve (AUC). A p-value of <0.05
was considered statistically significant.

RESULTS

This study evaluated 169 women presenting with
suspicious adnexal masses, with a mean age of 48.2
years (±12.4 SD). The cohort comprised 52
postmenopausal women (30.8%) and 117
premenopausal women (69.2%). The average lesion
size measured 6.8 cm (±3.2 SD), with 36.7% (n = 62)
of patients demonstrating elevated CA-125 levels
(greater than 35 U/mL). Using MRI pelvis as the
reference standard, 49 lesions (29.0%) were classified
as malignant (O-RADS MRI ≥3) while 120 (71.0%)
were benign (O-RADS MRI <3). Ultrasound O-RADS
classification demonstrated robust diagnostic
performance, correctly identifying 41 actual positive
malignant cases while misclassifying 18 benign lesions
as false positives. The system accurately ruled out
malignancy in 102 actual negative cases, though it
missed 8 malignant lesions (false negatives). Sensitivity
analysis revealed the method correctly detected 83.7%
of malignant cases (95% CI: 76.2-89.5%), while
specificity measurements showed 85.0% accuracy in
identifying benign lesions (95% CI: 78.3-90.1%). The
positive predictive value of 69.5% (95% CI: 61.4-
76.6%) suggests moderate confidence in positive
classifications, whereas the negative predictive value of
92.7% (95% CI: 87.5-96.0%) indicates excellent

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reliability in ruling out malignancy. The overall
diagnostic accuracy reached 84.6% (95% CI: 79.3-
88.9%). Subgroup analyses revealed important
variations in test performance. Postmenopausal women
showed higher sensitivity (88.2%) but slightly reduced
specificity (80.4%) compared to premenopausal
counterparts (80.6% sensitivity, 87.2% specificity).
Larger lesions (>5 cm) were more accurately detected
(89.1% sensitivity) than smaller lesions (76.3%
sensitivity). The combination of elevated CA-125 with
an O-RADS classification of≥4 significantly improved
the positive predictive value to 91.8%. Diagnostic
challenges were most frequently encountered with
hemorrhagic cysts (accounting for 7 of 18 false
positives), endometriomas (5 false positives), and early-
stage borderline tumours (representing 5 of 8 false
negative cases). These findings demonstrate that
ultrasound O-RADS is a clinically valuable tool, with
particular strength in ruling out malignancy, while
suggesting the need for confirmatory MRI in complex
cases or when managing premenopausal patients with
smaller lesions.

Table 1: Baseline Characteristics of Study Participants (n=169 )
Characteristic Value
Age (years), mean ± SD 48.2 ± 12.4
Menopausal status, n (%)
- Premenopausal 117 (69.2%)
- Postmenopausal 52 (30.8%)
Lesion size (cm), mean ± SD 6.8 ± 3.2
CA-125 levels, n (%)
- Elevated (>35 U/mL) 62 (36.7%)
- Normal (≤35 U/mL) 107 (63.3%)
MRI classification, n (%)
- Malignant (O-RADS MRI ≥3) 49 (29.0%)
- Benign (O-RADS MRI <3) 120 (71.0%)

Table 2: Diagnostic Performance of Ultrasound O-RADS

Classification
Parameter Value (95% CI)
Sensitivity 83.7% (76.2-89.5%)
Specificity 85.0% (78.3-90.1%)
Positive Predictive Value 69.5% (61.4-76.6%)
Negative Predictive Value 92.7% (87.5-96.0%)
Overall Accuracy 84.6% (79.3-88.9%)

Table 3: Subgroup Analysis of Diagnostic Performance

Parameter Value (95% CI)
Sensitivity 83.7% (76.2-89.5%)
Specificity 85.0% (78.3-90.1%)
Positive
Predictive Value

69.5% (61.4-76.6%)

Negative
Predictive Value

92.7% (87.5-96.0%)

Overall Accuracy

84.6% (79.3-88.9%)
Sensitivity 83.7% (76.2-89.5%)

Specificity 85.0% (78.3-90.1%)
Positive
Predictive Value

69.5% (61.4-76.6%)

Parameter
Sensitivity
Specificity
Positive
Predictive Value
Negative
Predictive Value
Overall Accuracy

Sensitivity
Specificity
Positive
Predictive Value

Table 4: Analysis of Misclassified Cases

Classification
Error Type

Number of
Cases

Most Common Lesions (n)

False Positives 18 - Hemorrhagic cysts (7)
- Endometriomas (5)
- Other benign lesions (6)

False Negatives 08 - Borderline tumours (5)
- Early-stage malignancies (3)

Table 5: Receiver Operating Characteristic (ROC) Curve

Analysis of O-RADS US
Parameter Value (95% CI)
Area Under the Curve (AUC) 0.91 (0.86 - 0.95)
Standard Error 0.02
p-value <0.001

DISCUSSION

The findings of this study demonstrate that ultrasound
O-RADS classification provides clinically valuable
diagnostic performance in differentiating benign from
malignant ovarian lesions, with an overall accuracy of
84.6%. These results align with contemporary literature
while providing important insights for clinical practice
in resource-limited settings. Our observed sensitivity of
83.7% and specificity of 85.0% compare favourably
with those of previous validation studies of the O-
RADS system. A 2022 multicenter study by Guo et al.
reported similar performance characteristics (sensitivity
84.8%, specificity 81.9%) in their evaluation of 487
adnexal masses.5 The slightly higher specificity in our
study may reflect the standardised application of O-
RADS criteria by experienced radiologists in our
setting. Importantly, our findings support the growing
body of evidence that standardised ultrasound
classification systems can approach the diagnostic
accuracy of more advanced imaging modalities for
characterising ovarian masses. The excellent negative
predictive value (92.7%) we observed is particularly
clinically relevant. This finding suggests that ultrasound
O-RADS can reliably exclude malignancy when lesions
are classified as low-risk (O-RADS 1-2), potentially
reducing unnecessary MRI referrals in resource-
constrained environments. This aligns with the
conclusions of a 2021 meta-analysis by Vara et al.,
which found a pooled NPV of 94% for ultrasound-
based risk stratification systems.9 The high NPV
supports the use of O-RADS as an effective triage tool,
particularly in premenopausal women, where the
prevalence of malignancy is lower. However, our
moderate positive predictive value (69.5%) indicates
limitations in definitively diagnosing malignancy based
solely on ultrasound findings. This is consistent with
known challenges in characterising complex adnexal
masses, particularly in premenopausal women. Our
finding that 38.9% of false positives were either

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72 J Gandhara Med Dent Sci October - December 2025

hemorrhagic cysts or endometriomas echoes the results
of a 2023 study by Zhang et al., who reported similar
diagnostic pitfalls in their analysis of 632 ovarian
masses.5 These limitations underscore the importance
of correlating imaging findings with clinical and
biochemical markers, particularly in cases with
indeterminate results. The superior performance in
postmenopausal women (88.2% sensitivity) compared
to premenopausal women (80.6% sensitivity) has
important clinical implications. This difference likely
reflects both the higher prevalence of malignancy in
postmenopausal women and the greater diagnostic
challenge posed by physiologic changes in
premenopausal ovaries. A study similarly found lower
sensitivity (78.5%) in premenopausal populations.10
These results suggest that additional caution should be
exercised when interpreting O-RADS classifications in
premenopausal patients, with consideration given to
serial follow-up or MRI confirmation for cases that are
indeterminate. Our findings regarding lesion size are
particularly noteworthy. The significantly higher
sensitivity for lesions greater than 5 cm (89.1% vs
76.3% for lesions ≤5 cm) supports existing evidence
that smaller lesions pose greater diagnostic challenges.
This finding is consistent with a 2022 study by Hack et
al., which reported a decrease in diagnostic accuracy
with smaller lesion sizes in their evaluation of 354
adnexal masses.10 This size-dependent performance
should be considered when making clinical
management decisions, particularly for small complex
lesions where the risk of missing early-stage
malignancies may be higher. The combination of CA-
125 with O-RADS classification significantly improved
PPV to 91.8% in our study. This finding supports the
growing trend toward multimodal risk assessment in the
evaluation of ovarian masses. A study found that
combining IOTA simple rules with CA-125 improved
specificity from 82% to 91% without compromising
sensitivity.11 Our results suggest that such combined
approaches may be particularly valuable in settings
where MRI availability is limited. The ultrasound O-
RADS system demonstrated strong clinical utility with
84.6% overall accuracy and excellent negative
predictive value (92.7%), supporting its role in initial
triage of adnexal masses.12 However, reduced
sensitivity in premenopausal women (80.6%) and for
small lesions (76.3%) highlights important diagnostic
limitations, particularly for borderline tumours.13 The
significant improvement in positive predictive value to
91.8% when combining O-RADS with CA-125
underscores the value of multimodal assessment.14
These findings suggest O-RADS serves best as part of
an integrated diagnostic approach, particularly in
resource-limited settings where MRI availability is
constrained.15 The diagnostic challenges we identified

with specific lesion types (hemorrhagic cysts,
endometriomas, and borderline tumours) have been
consistently reported in the literature. A 2022 study by
Van Calster et al. specifically highlighted these lesion
types as familiar sources of misclassification in
ultrasound-based systems.16 These limitations
underscore the importance of: 1) correlating imaging
findings with clinical context, 2) considering follow-up
imaging for potentially physiologic lesions, and 3)
maintaining a low threshold for MRI referral in cases
with discordant findings. The performance
characteristics we observed compare favorably with
MRI-based characterisation in several respects. While
MRI generally offers higher specificity (typically 90 -
95% in recent studies), our results suggest ultrasound
O-RADS may be sufficient for initial triage in many
cases.17 This is particularly relevant for low-resource
settings where MRI availability is limited. A cost-
effectiveness analysis by Chacon et al.,in 2023
concluded that ultrasound-based triage followed by
selective MRI was the most efficient strategy for
evaluating ovarian masses in resource-limited
environments.18

LIMITATIONS

The single-centre design may limit generalizability;
although our sample size was adequate, it was smaller
than that of some recent multicenter studies.
Additionally, we did not evaluate inter-observer
variability in O-RADS application, which has been
shown to impact diagnostic performance in other
studies.20 Future research should address these
limitations through multicenter collaborations with
standardised imaging protocols.

CONCLUSIONS

The ultrasound O-RADS classification is a highly
accurate and validated tool for the preoperative
assessment of adnexal masses. Its high NPV makes it
an effective first -line triage tool to rule out malignancy.
In resource-constrained environments, adopting O-
RADS can optimise resource utilisation by confidently
stratifying patients, reserving advanced imaging, such
as MRI, for indeterminate or positive cases, ultimately
streamlining patient care.

CONFLICT OF INTEREST: None
FUNDING SOURCES: None

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Mehreen Khan - Concept & Design; Data Acquisition; Data
Analysis/Interpretation;Drafting Manuscript; Critical Revision;
Final Approval
Mehreen Samad - Concept & Design; Data Acquisition;
Drafting Manuscript; Critical Revision; Final Approval
Muneeb Ur Rehman – Concept & Design; Data Acquisition;
Data Analysis/Interpretation; Drafting Manuscript; Final
Approval
Hafiza Ayesha Jawaid -Concept & Design; Data Acquisition;
Data Analysis/Interpretation; Drafting Manuscript; Critical
Revision; Final Approval
Shnaza Ijaz - Concept & Design; Data Acquisition; Data
Analysis/Interpretation; Drafting Manuscript; Final Approval
Faryal Shah - Concept & Design; Data Acquisition; Drafting
Manuscript; Critical Revision; Supervision; Final Approval
Naila Tamkeen - Concept & Design; Data Acquisition;
Drafting Manuscript; Critical Revision; Supervision; Final
Approval

AUTHORS CONTRIBUTION

The authors accept responsibility for all aspects of the work
and will ensure that any concerns regarding the accuracy or
integrity of any part are properly investigated and resolved.

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Diagnostic Accuracy of Ultrasound O-Rads Classification