PONE-D-22-22792Decision impact studies, evidence production and clinical utility in genomic testing in cancer care: A scoping reviewPLOS ONE

Dear Dr. Parker,

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Ramon Andrade De Mello, MD, PhD, FACP

Academic Editor

PLOS ONE

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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

Reviewer #3: Yes

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

Reviewer #1: N/A

Reviewer #2: N/A

Reviewer #3: 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

Reviewer #3: 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

Reviewer #3: 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: Systematic review of a relevant and current topic. It objectively addresses the studies evaluated, including a significant number of studies published in the last decade, in the main search platforms. The results support the conclusions and favor an improvement in clinical practice. A pharmacoeconomics study would be appropriate, in order to corroborate the feasibility of using genomic tests.

Reviewer #2: Thank you for submit your article! It is interesting. I give you some comments:

TITLE: Please try to expressed in as few words as possible.

ABSTRACT: Try to synthetize the background section. Extend methods, you can briefly describe the inclusion and exclusion criteria using in the study selection and define your variables. How to categorize the types of clinical utility outcomes reported? Try to select only three or four keywords.

BACKGROUND: There are six paragraph, please try to resume in four paragraph. The first paragraph is good; in this you explain the utility of DIS. The second paragraph is regarding the use of genomic assays in cancer care. The third and the fourth paragraph could be summarize in only one paragraph. You should focus in the importance to assess clinical utility and the most accepted definition. Finally, the fifth and the sixth paragraph could be only one, try to explain the motivation for doing that research, show the knowledge gap that will lead into the importance of your study.

Study objectives: You repeat the importance of DIS. If the primary outcome is the impact of a genomic assay on treatment decisions or recommendations for a specific population of cancer patients. I am not sure if the primary objective should be only identify and characterize decision impact studies published for genomic assays in cancer care. Maybe you can change the primary objective for the second: describe the types of clinical utility outcomes reported as evidence of DIS in clinical and reimbursement decision-making.

METHODS: What type of studies were included? How many meta- analyses were conducted on that topic? Has the literature evolved significantly to justify an up- to- date meta- analysis? Are there any relevant studies missing in the already published meta- analyses?

RESULTS: The results, discussion and conclusions are good.

Reviewer #3: Decision impact studies are currently the best way to determine the most suitable treatment for each individual patient, according to their individual characteristics. A trend in oncology and precision medicine. The article was simple, easy to read and well written, it incorporated the most important studies of its category.

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Reviewer #1: No

Reviewer #2: No

Reviewer #3: No

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Decision impact studies, evidence of clinical utility for genomic assays in cancer: A scoping review

PONE-D-22-22792R1

Dear Dr. Miller,

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,

Meng Li

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 #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 #2: Yes

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

Reviewer #2: N/A

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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 #2: (No Response)

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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 #2: (No Response)

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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 #2: ABSTRACT:

Try to select only three or four keywords.

BACKGROUND

Please synthetize the last paragraph. Try to focus in the importance to assess clinical utility, resume the most relevant previous studies and show the knowledge gap that will lead into the importance of your study.

Study objectives: The first sentence is not appropriately for this section, you can include this in the last paragraph of background section. I understand that the primary outcome identify and characterize decision impact studies in genomic cancer testing.

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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 #2: Yes: Katia Roque

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