-->PONE-D-25-47949-->-->Feasibility assessment of double-blind, crossover, random controlled trial protocol comparing two oxygen-supplemented pulmonary rehabilitation for patients with chronic obstructive pulmonary disease: A pilot study-->-->PLOS One

Dear Dr. Akihiro Ito,

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PLOS One

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Reviewers' comments:

Reviewer's Responses to Questions

-->Comments to the Author

1. Does the manuscript report a protocol which is of utility to the research community and adds value to the published literature?-->

Reviewer #1: No

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-->2. Has the protocol been described in sufficient detail?

To answer this question, please click the link to protocols.io in the Materials and Methods section of the manuscript (if a link has been provided) or consult the step-by-step protocol in the Supporting Information files.

The step-by-step protocol should contain sufficient detail for another researcher to be able to reproduce all experiments and analyses.-->

Reviewer #1: Partly

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-->3. Does the protocol describe a validated method?

The manuscript must demonstrate that the protocol achieves its intended purpose: either by containing appropriate validation data, or referencing at least one original research article in which the protocol was used to generate data.-->

Reviewer #1: No

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-->4. If the manuscript contains new data, have the authors made this data 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

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-->5. Is the article 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 highlight any specific errors that need correcting in the box below. -->

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. 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: The following comments aim to provide constructive feedback on the scientific content, methodological rigor, and clarity of presentation.

Abstract:

Lines 51–52: One month of regular PR followed by two months of oxygen-supplemented PR does not clearly reflect a crossover design, which typically includes randomized order and washout periods.

Lines 50–52: The inclusion of “physical measurements” is too generic, Abstracts should specify key secondary outcomes, especially in feasibility studies.

Introduction:

Lines 65–67: The statement that COPD has a “global prevalence of more than 10%” is potentially misleading, GOLD reports prevalence varying widely by region, age, and diagnostic criteria.

Lines 68–69: COPD is described as being caused by smoking and air pollution only, Other risk factors (e.g., biomass exposure, occupational dusts) are omitted.

Lines 75–76: Describing PR as strictly a “4- to 12-week supervised exercise program” may be overly narrow, PR includes education, behavioral change, and long-term maintenance strategies.

Lines 94–95: The hypothesis that “both methods would be valid” is methodologically vague, Validity is not a measurable endpoint.

Lines 96–98: Claims about establishing a “new standard of care” are not appropriate for a feasibility pilot study.

Method:

Lines 111–113: “Six participants were consecutively recruited” conflicts with the earlier statement implying 108 patients.

Lines 115–117: “random controlled trial” should be randomized controlled trial.

Lines 118–120: Randomization “by their physicians” raises allocation bias risk.

Only the physical therapist appears to be blinded, this does not constitute double blinding, Participant blinding to FiO₂ levels is not explained.

Lines 126–131: The sequence described does not clearly reflect a balanced crossover design, both groups appear to receive “regular PR” first, Period effects and order randomization are unclear. A washout of “>3 months” is unusually long and not justified with references.

Lines 132–136: A total of six assessments” are claimed, but only four time points are listed.

Lines 161–166: The rationale for including trunk ROM as an outcome is not justified in the context of COPD PR.

Line 172: Once-weekly PR is below standard PR frequency.

Line 204: Too low carbon dioxide” should be replaced with hypocapnia.

Lines 211–222: Power-based sample size calculation is not standard for feasibility studies.

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Reviewer #1: No

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Feasibility assessment of double-blind, crossover, randomized controlled trial protocol comparing two oxygen-supplemented pulmonary rehabilitation for patients with chronic obstructive pulmonary disease: A pilot study

PONE-D-25-47949R1

Dear Dr. Ito,

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,

Jamal Akhtar

Academic Editor

PLOS One

Additional Editor Comments (optional):

Reviewers' comments:

Reviewer's Responses to Questions

-->Comments to the Author

1. Does the manuscript report a protocol which is of utility to the research community and adds value to the published literature?-->

Reviewer #1: Yes

**********

-->2. Has the protocol been described in sufficient detail?

To answer this question, please click the link to protocols.io in the Materials and Methods section of the manuscript (if a link has been provided) or consult the step-by-step protocol in the Supporting Information files.

The step-by-step protocol should contain sufficient detail for another researcher to be able to reproduce all experiments and analyses.-->

Reviewer #1: Yes

**********

-->3. Does the protocol describe a validated method?

The manuscript must demonstrate that the protocol achieves its intended purpose: either by containing appropriate validation data, or referencing at least one original research article in which the protocol was used to generate data.-->

Reviewer #1: Yes

**********

-->4. If the manuscript contains new data, have the authors made this data 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

**********

-->5. Is the article 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 highlight any specific errors that need correcting in the box below. -->

Reviewer #1: Yes

**********

-->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: All the questions in the previous version of the manuscript have been addressed by the authors and so it seems now the manuscript is realy to be accepted.

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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

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