PONE-D-25-37061 What Is the Significance of A New Breast Mass in Women Aged 40 or Above? A Cross-sectional Study PLOS ONE

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Additional Editor Comments:

I believe the paper could use some refinement based on what the reviewer said. I also believe most of these issues are major in their nature.

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Reviewers' comments:

Reviewer's Responses to Questions

Comments to the Author

1. Is the manuscript technically sound, and do the data support the conclusions?

The manuscript must describe a technically sound piece of scientific research with data that supports the conclusions. Experiments must have been conducted rigorously, with appropriate controls, replication, and sample sizes. The conclusions must be drawn appropriately based on the data presented.

Reviewer #1: Yes

Reviewer #2: Yes

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2. Has the statistical analysis been performed appropriately and rigorously?

Reviewer #1: Yes

Reviewer #2: Yes

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3. Have the authors made all data underlying the findings in their manuscript fully available?

The PLOS Data policy requires authors to make all data underlying the findings described in their manuscript fully available without restriction, with rare exception (please refer to the Data Availability Statement in the manuscript PDF file). The data should be provided as part of the manuscript or its supporting information, or deposited to a public repository. For example, in addition to summary statistics, the data points behind means, medians and variance measures should be available. If there are restrictions on publicly sharing data—e.g. participant privacy or use of data from a third party—those must be specified.

Reviewer #1: Yes

Reviewer #2: Yes

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4. Is the manuscript presented in an intelligible fashion and written in standard English?

PLOS ONE does not copyedit accepted manuscripts, so the language in submitted articles must be clear, correct, and unambiguous. Any typographical or grammatical errors should be corrected at revision, so please note any specific errors here.

Reviewer #1: Yes

Reviewer #2: Yes

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5. Review Comments to the Author

Please use the space provided to explain your answers to the questions above. You may also include additional comments for the author, including concerns about dual publication, research ethics, or publication ethics. (Please upload your review as an attachment if it exceeds 20,000 characters)

Reviewer #1: This research report introduces a valuable attention to clinical factors (recency of mass) and in future this research will impact diagnostic decision-making and patient outcomes. It had its limitation which stated in discussion to be considered as well.

I only suggest revising in typos, punctuation, and double spaces as seen.

Reviewer #2: Dear authors, Thank you for this work; here are my comments for more clarity:

#Inconsistent Labeling of Protocols (P1 and P2): The methods section defines P1 as your center's protocol (considering recency) and P2 as the usual protocol (ignoring recency). However, the results, discussion, and Table 3 reverse this: Protocol 1 is labeled as "usual" (70.1% sensitivity, 95.4% specificity), and Protocol 2 as your center's (84.1% sensitivity, 40.3% specificity). This confusion could mislead readers and invalidate comparisons. Therefore, you should standardize labeling throughout. Use descriptive terms like "Recency-Inclusive Protocol" (your approach) and "Standard BI-RADS Protocol" (usual). Revise Table 3 footnotes accordingly. Recalculate if needed to confirm values—your sensitivity gain is a key selling point, so ensure accuracy.

# Methodological Clarity and Reproducibility: The "unwritten protocol" for biopsy decisions is vaguely described. For example, how was "new mass" defined (e.g., patient-reported vs. prior imaging comparison)? What thresholds were used for "suspicious clinical exam"? Abbreviations like BE (breast exam), MG (mammography), and US (ultrasound) are not defined on first use. Sample size justification is absent—was power calculated for detecting sensitivity differences? Please expand the methods to include a flow diagram of the protocol (e.g., as a supplementary figure). and define "new mass" explicitly (e.g., absent on prior imaging within 1 year). It's better to add a sample size calculation using tools like G*Power, assuming a 10-15% sensitivity difference (based on your results). If applicable report inter-rater reliability for BI-RADS assignments if multiple radiologists were involved. This will enhance reproducibility.

# Results Presentation and Interpretation: Table 1 shows gravidity differences (p<0.001), but the text misinterprets; higher gravidity (≥5) is more common in malignant cases (34.81% vs. 14.56%), yet you state "fewer pregnancies" for benign—correct this. No confidence intervals (CIs) for diagnostic metrics, limiting precision assessment. Please add 95% CIs to all metrics in Table 3 (e.g., sensitivity 84.1% [95% CI: 77.2-89.7%], calculated via binomial methods).

# References : Please update to include 2024-2025 publications

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Reviewer #1: No

Reviewer #2: No

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What Is the Significance of A New Breast Mass in Women Aged 40 or Above? A Cross-sectional Study

PONE-D-25-37061R1

Dear Dr. Amirhossein Eskandari,

We’re pleased to inform you that your manuscript has been judged scientifically suitable for publication and will be formally accepted for publication once it meets all outstanding technical requirements.

Within one week, you’ll receive an e-mail detailing the required amendments. When these have been addressed, you’ll receive a formal acceptance letter and your manuscript will be scheduled for publication.

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Kind regards,

Amirreza Khalaji

Academic Editor

PLOS One

Additional Editor Comments (optional):

Reviewers' comments:

Reviewer's Responses to Questions

Comments to the Author

1. If the authors have adequately addressed your comments raised in a previous round of review and you feel that this manuscript is now acceptable for publication, you may indicate that here to bypass the “Comments to the Author” section, enter your conflict of interest statement in the “Confidential to Editor” section, and submit your "Accept" recommendation.

Reviewer #1: All comments have been addressed

Reviewer #2: All comments have been addressed

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2. Is the manuscript technically sound, and do the data support the conclusions?

The manuscript must describe a technically sound piece of scientific research with data that supports the conclusions. Experiments must have been conducted rigorously, with appropriate controls, replication, and sample sizes. The conclusions must be drawn appropriately based on the data presented.

Reviewer #1: Yes

Reviewer #2: Yes

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3. Has the statistical analysis been performed appropriately and rigorously?

Reviewer #1: Yes

Reviewer #2: Yes

**********

4. Have the authors made all data underlying the findings in their manuscript fully available?

The PLOS Data policy requires authors to make all data underlying the findings described in their manuscript fully available without restriction, with rare exception (please refer to the Data Availability Statement in the manuscript PDF file). The data should be provided as part of the manuscript or its supporting information, or deposited to a public repository. For example, in addition to summary statistics, the data points behind means, medians and variance measures should be available. If there are restrictions on publicly sharing data—e.g. participant privacy or use of data from a third party—those must be specified.

Reviewer #1: Yes

Reviewer #2: Yes

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5. Is the manuscript presented in an intelligible fashion and written in standard English?

PLOS ONE does not copyedit accepted manuscripts, so the language in submitted articles must be clear, correct, and unambiguous. Any typographical or grammatical errors should be corrected at revision, so please note any specific errors here.

Reviewer #1: Yes

Reviewer #2: Yes

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6. Review Comments to the Author

Please use the space provided to explain your answers to the questions above. You may also include additional comments for the author, including concerns about dual publication, research ethics, or publication ethics. (Please upload your review as an attachment if it exceeds 20,000 characters)

Reviewer #1: I only suggest revising in typos, punctuation, and double spaces as seen.The manuscript now looks better for acceptance. This manuscript will definitely add valuable impact on diagnostic decision-making and future patient outcomes despite the existence of some study limitations.

Reviewer #2: (No Response)

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7. PLOS authors have the option to publish the peer review history of their article (what does this mean?). If published, this will include your full peer review and any attached files.

If you choose “no”, your identity will remain anonymous but your review may still be made public.

Do you want your identity to be public for this peer review? For information about this choice, including consent withdrawal, please see our Privacy Policy.

Reviewer #1: No

Reviewer #2: No

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