A multisite randomized controlled trial of an early palliative care intervention in children with advanced cancer: the PediQUEST Response Study Protocol

PONE-D-22-16245

Dear Dr. Dussel,

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Kind regards,

Doris YP Leung

Academic Editor

PLOS ONE

Additional Editor Comments:

The study reports the protocol of testing an early palliative care intervention in children with advanced cancer. The topic is very important and will have great clinical implications. I agree with the reviewer that there are some minor points for clarifications. Overall, the RCT is well-designed.

Reviewers' comments:

Reviewer's Responses to Questions

Comments to the Author

1. Does the manuscript provide a valid rationale for the proposed study, with clearly identified and justified research questions?

The research question outlined is expected to address a valid academic problem or topic and contribute to the base of knowledge in the field.

Reviewer #1: Yes

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2. Is the protocol technically sound and planned in a manner that will lead to a meaningful outcome and allow testing the stated hypotheses?

The manuscript should describe the methods in sufficient detail to prevent undisclosed flexibility in the experimental procedure or analysis pipeline, including sufficient outcome-neutral conditions (e.g. necessary controls, absence of floor or ceiling effects) to test the proposed hypotheses and a statistical power analysis where applicable. As there may be aspects of the methodology and analysis which can only be refined once the work is undertaken, authors should outline potential assumptions and explicitly describe what aspects of the proposed analyses, if any, are exploratory.

Reviewer #1: Yes

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3. Is the methodology feasible and described in sufficient detail to allow the work to be replicable?

Descriptions of methods and materials in the protocol should be reported in sufficient detail for another researcher to reproduce all experiments and analyses. The protocol should describe the appropriate controls, sample size calculations, and replication needed to ensure that the data are robust and reproducible.

Reviewer #1: Yes

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4. Have the authors described where all data underlying the findings will be made available when the study is complete?

The PLOS Data policy requires authors to make all data underlying the findings described in their manuscript fully available without restriction, with rare exception, at the time of publication. 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

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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

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6. Review Comments to the Author

Please use the space provided to explain your answers to the questions above and, if applicable, provide comments about issues authors must address before this protocol can be accepted for publication. You may also include additional comments for the author, including concerns about research or publication ethics.

You may also provide optional suggestions and comments to authors that they might find helpful in planning their study.

(Please upload your review as an attachment if it exceeds 20,000 characters)

Reviewer #1: This study protocol for the PediQUEST Response Study is exemplary in its description of the study protocol. There is a clear, comprehensive, and sophisticated data analytic plan. A good rationale is provided for how to handle multiple informant information. Likewise, a reasonable discussion of contamination risk and the plan to address it.

I have only a few minor suggestions to make.

Page 8 line 161 Please name the 5 study sites.

Page 20 line 450 Mention Certificate of Confidentiality from NIH as another protection against breaches to confidentiality.

Page 23, line 526, please update manuscript in preparation if applicable.

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Reviewer #1: No

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Attachments

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Submitted filename: Plos One Review October 2022.docx