-->PONE-D-25-65437-->-->Family-Led post-ICU Discharge Intervention for Tracheostomised Patients in India: Feasibility and Formative Impact Evaluation.-->-->PLOS One-->-->Dear Dr. Tripathy,

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Staff Editor

PLOS One

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“National Health Mission India, Wellcome Trust.”

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“The study was funded by the National Health Mission, Odisha, and Wellcome Innovations Flagship Collaboration for Research Implementation and Training (224048/Z/21/Z). Institutional ethics committee approval was obtained, and the trial was prospectively registered (CTRI/2020/11/029443). Written informed consent was obtained from all participants.”

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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: Partly

Reviewer #3: Partly

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

Reviewer #1: Yes

Reviewer #2: N/A

Reviewer #3: No

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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: No

Reviewer #2: No

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: Dear Author,

This is a well-conducted and timely formative evaluation of a co-designed, multicomponent intervention aimed at supporting the transition of tracheostomised, functionally dependent ICU survivors to family-led home care in an LMIC setting. The study addresses an important gap in post-ICU transitional care, particularly in resource-constrained contexts. The integration of implementation science frameworks (CFIR and MRC guidance) strengthens the conceptual and methodological grounding of the work.

Overall, the manuscript is clearly written, methodologically sound, and presents meaningful findings with practical implications for scale-up. I recommend minor revision, primarily to enhance clarity, precision, and structural consistency.

My proposed revisions are as follows:

1. The manuscript reports improvements in patient and carer quality-of-life measures. Please clarify whether these improvements were: Statistically significant, clinically meaningful, or both. A brief statement on clinical relevance would strengthen interpretation.

2. While feasibility and acceptability are clearly central constructs, it would be helpful to explicitly restate the primary outcome(s) in the Discussion to reinforce alignment between study objectives and findings.

3. A few minor technical points: Ensure consistent formatting of references (e.g., spacing before citation numbers). Standardise terminology (e.g., “inner-setting” instead of “innersetting”). Correct minor punctuation inconsistencies (e.g., hyphen use in “MRC-recommended frameworks”).

4. The description of increasing clinician adoption over three years is compelling. Consider slightly strengthening the interpretive framing by explicitly linking this trajectory to known implementation theory (e.g., normalization of innovations into routine care).

5. The finding that many carers preferred WhatsApp over the purpose-built application is highly interesting. The Discussion could briefly expand on: Implications for digital health design in LMICs, whether leveraging existing communication platforms may enhance sustainability.

Reviewer #2: I enjoyed reading your paper and found it to be very interesting. In my opinion your paper handles about a very important topic with a set of interventions that is not only important to implement in MLIC, but also has a growing importance for families in high income countries. Nevertheless, the intervention under evaluation is rather complex, and clearly describing all that was undertaken is not straightforward. The authors have provided a generally clear description of the work performed, but the manuscript would benefit from additional revisions to further improve clarity and readability. I have a few comments and recommendations that you may consider that I believe will help you to clarify and strengthen your manuscript. I will try to order my comments according to the order of your manuscript.

Abstract

The abstract does not fully reflect the amount of work that has been carried out, nor the quality of the intervention the authors have developed and evaluated. With some adjustments, this can be improved. For instance, at several points it appears as though a word or part of a sentence is missing.

For example:

- ‘66% of carers completed ≥3 sessions, and 61% reached target competence after three.’ ….. After three??? Months? Sessions? Years? This is unclear.

- ‘More than half of the families? accessed equipment through the rental–retrieval bank, and 91% of eligible families received in-person follow-up.’

In addition, there are too many abbreviations in the methods section of the abstract (utilized measurement tools) that are not explained, which makes it difficult to interpret the results.

Introduction

Please describe some characteristics of the ICU where the intervention has taken place.

Methods

The bundle of interventions that the authors have implemented and evaluate in this paper is, in my view, very well designed and highly meaningful. Clear measurement methods have been used; however, I miss a description of the criteria for being selected to participate in the assessments and interviews. I understand that in implementation and developmental research it is common not to expose all participants to questionnaires, but it remains unclear why these particular participants were chosen.

Furthermore, there is no adequate description of all measurement instruments, and for some instruments no reference is provided (e.g., for the RE-AIM framework) nor is a citation included in the description of the respective instrument.

I also miss an example of the interview guide as well as information about the characteristics of the interviewers, the healthcare workers who delivered the training and the researchers. Such details are important for assessing the credibility and transferability of the qualitative findings. Especially because the authors describe that reflexive practice, including regular team meetings conducted with experienced qualitative researchers, ensured analytic credibility. Please elaborate about that expertise.

Results

The results are well described and clearly illustrate the barriers and facilitators to scaling up this intervention more broadly. The authors have also used illustrative and meaningful quotes.

Figures and tables

Regarding the TREND Statement Checklist: I could not find page numbers in the manuscript, which makes it difficult to locate where the listed items are addressed. I would recommend adding these page numbers.

Regarding the protocol that was added as a supplement, I would recommend adding the flowchart that outlines the entire project to the main manuscript, but in a much more readable format. This would greatly help the reader to understand the timelines of the interventions and the corresponding measurement points.

I personally find the flowcharts somewhat less elegantly presented, although they are clear in terms of content. The language used could be more consistent as well (e.g., using either “expired” or “deceased,” rather than switching between the two).

I wish the authors much success with revising the manuscript and with the further implementation of the intervention.

Reviewer #3: Greater clarity in reporting the assessment/evaluation time points would strengthen the manuscript. The statistical analysis approach is not clearly outlined, and incorporating inferential statistical analyses where appropriate could enhance the findings. Attention to consistent formatting and thorough proofreading would further improve the presentation of the manuscript.

Abstract: Abbreviations to be spelled out first, prior to usage.

At least 1 decimal place is required for the percentage figure. This includes the figures in the text, tables, etc.

Exclusion criteria are to be stated.

The sampling strategy for participant recruitment is unclear, particularly given the use of a convenience sampling approach. More details are to be provided.

Dyads are to be defined.

Page 19: The statement, ‘By year three, nearly all referrals were made directly by treating teams or families (64/65, 98.5%),’ lacks clarity. Please clarify how this figure was derived, including the definitions of the numerator and denominator.

Page 19: Supplementary table *? Supplementary Table 1 was not found in the manuscript.

Page 20: took ~1 hour (symbol ~ is to be replaced with approximately)

Page 20: For ‘Median time to discharge was 10 (SD 3.5)’, IQR is to be displayed rather than SD.

Page 20 & 21: Some words appear excessively spaced or stretched to accommodate page alignment and should be adjusted to ensure proper formatting and readability.

In Table 1, the decimal places for percentages (%) are to be standardised throughout. Female should be presented together with male under the same variable category. The table requires minor formatting adjustments for improved presentation. A separating row is to be included between variables to enhance clarity. Additionally, bold formatting should be avoided for subcategories/stems to ensure consistency.

In Table 2, the ‘definitions’ of “Range” and “IQR” are be clearly denoted in the table footnote. The font size is to be standardised throughout the table. For the healthcare workers’ data, the IQR value is to be clearly separated/spaced out from the Range value to improve readability.

It would strengthen the manuscript if the flow chart incorporated the assessment/evaluation time points.

While multiple time points were used to assess the outcome variables, these were not clearly presented, and inferential statistical analyses were not reported. Including a table summarising the assessment time points for each outcome variable would enhance clarity. Statistical analyses are to be aligned with the specified assessment time points where appropriate, and effect sizes with 95% confidence intervals could be presented where applicable.

Further details regarding the qualitative analysis process, including the analytical approach and software used, would also enhance transparency.

Description on missing data and method handling is to be provided (if any).

References did not conform to the journal format.

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Reviewer #1: No

Reviewer #2: No

Reviewer #3: No

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<p>Family-Led post-ICU Discharge Intervention for Tracheostomised Patients in India: Feasibility and Formative Impact Evaluation.

PONE-D-25-65437R1

Dear Dr. Tripathy,

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,

Marianne Clemence

Staff 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 #3: 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 #3: (No Response)

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

Reviewer #1: Yes

Reviewer #3: (No Response)

**********

-->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 #3: (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 #1: Yes

Reviewer #3: (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 #1: The authors have made the corrections I suggested. Therefore, my decision will be to accept the article.

Reviewer #3: (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 #3: No

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