PONE-D-23-36574Asthma Care from Home: Study protocol for an effectiveness-implementation evaluation of a virtually enabled asthma care initiative in children in rural NSWPLOS ONE

Dear Dr. Mackle,

Thank you for submitting your manuscript to PLOS ONE. After careful consideration, we feel that it has merit but does not fully meet PLOS ONE’s publication criteria as it currently stands. Therefore, we invite you to submit a revised version of the manuscript that addresses the points raised during the review process.

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ACADEMIC EDITOR: The submission was reviewed by the editorial board and subjected to an external review. I believe that the authors have prepared a protocol for an important research study in the field of asthma. However, they are required to address the comments sent to us by the reviewers so that weaker sections of the manuscript can be improved.

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Bharat Bhushan Sharma, M.D.

Academic Editor

PLOS ONE

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Additional Editor Comments:

The submission was reviewed by the editorial board and subjected to an external review. We have received comments and suggestions by the reviewers Authors are required to address all the comments sent to us by the reviewers.

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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

Reviewer #2: Yes

Reviewer #3: Yes

Reviewer #4: Yes

Reviewer #5: 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: Partly

Reviewer #2: Yes

Reviewer #3: Yes

Reviewer #4: Yes

Reviewer #5: 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

Reviewer #2: Yes

Reviewer #3: Yes

Reviewer #4: Yes

Reviewer #5: 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: No

Reviewer #2: Yes

Reviewer #3: Yes

Reviewer #4: Yes

Reviewer #5: 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

Reviewer #3: Yes

Reviewer #4: Yes

Reviewer #5: 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: Study is New in its concept for the individual family and the community. But without results of data analysis how can reviewer knows the effect/impact of such community based study. Control group may be considered to observe the effect whether increasing decreasing or remaining same from the same community without home based management.

Please mention the limitation of the study

Mention the exclusion criteria

how the author has avoided the selection bias

Reviewer #2: The authors of the manuscript present here the design of a quasi-experimental pre- and post-interventional trial for an asthma care from home project. This ambitious study specifically aims to improve access to asthma care for affected children and their families in rural and remote areas in Australia.

The manuscript is written with excellent expression and spelling, making it easily understandable. The authors based their design on substantial experience in former studies. Each part of the design is explained in detail and decisions made for or against certain proceedings are discussed and made transparent. One minor point from my side is to ask the authors to shortly explain why encouragment for uptake of annual influenza vaccination is implementet in the parent letter. Despite of the that, I have no further remarks.

Reviewer #3: Comments to the Authors

I. The authors provide a detailed outline of a study designed to establish a state wide program of at home asthma management for families living in rural areas. The current manuscript has two obvious problems:

i) it is too long and, in many places, repetitive.

ii) In many places the language is verbose. A particular example comes in the second page of the discussion (page 2). To this reviewer, the sentence starting on line 14 with “Moreover it facilitates” includes a remarkable number of excessive words!

II. The map does not explain the two colors if it is just to distinguish different regions it needs to say so. To a non-Australian the map would be more useful if the towns were indicated, i.e., Sydney, Newcastle, Waga-Waga, Townsville, and Brisbane.

III. There is a mention of environmental assessment but no references to the major studies on the relevance of environment, e.g., dust mites: including studies by Ann Woolcock, Jenny Peat, Dr. Marks, and Euan Tovey. All of these worked in N.S.W.

IV. Why are truly poor patients excluded? Is there a danger that those individuals will recognize that they are being excluded? How many children will be living in a shelter? What is the justification for restricting age to 5-12 years?

Minor comments

V. Do all subjects have to have cell phones?

VI. The abbreviation SMS appears in the abstract without introduction.

Reviewer #4: The study protocol aims to evaluate a digitally enabled asthma care initiative for children in rural NSW. The initiative builds on prior successful models, focusing on standardizing asthma discharge, coordinating care between acute and primary services, and providing home-based follow-up. The paper appears to be well-written. However, there are a few areas where slight improvements could be made for clarity or conciseness:

1. Rephrase this sentence "The initiative builds on prior successful models, focusing on standardizing asthma discharge, coordinating care between acute and primary services, and providing home-based follow-up,"

2. The phrase "particularly in areas with limited access to care" could be expanded for clarity.

3. The hypothesis is not correctly aligned with the study objectives and the title.

4. Sampling technique is not mentioned and how will you do the sampling.

5. Can it will possible to do the panel data modelling to include the effect of the study area?

Reviewer #5: The objective of this paper is to describe a planned intervention trial for children with asthma to improve access to asthma care for children in remote and rural areas. I commend the authors for this important work, as improving assess to care is a problem worldwide. I have a few comments on the methodology of the planned intervention:

1. Virtual home visits: only children with uncontrolled asthma, defined by ACT <19 will be offered the virtual home visit intervention. When will the ACT be administered to determine controlled/uncontrolled status? By definition, all kids presenting to the ED have current uncontrolled asthma and would likely have an ACT score at baseline <19. While this will likely lead to most children receiving the virtual home visit intervention, why not include all children?

2. Please define sever asthma in the methods.

3. Only those defined as having severe asthma will receive a telehealth consult to develop a shared asthma care plan. Why not include all children?

4. Since the children receive the virtual home visit and the telehealth based on their clinical asthma status, the study will be include multiple case groups (ie controlled non-severe, controlled severe, uncontrolled non-severe, uncontrolled severe). Since not all children are receiving the same intervention package, how will the efficacy of the different packages be determined?

5. The children will be their own control, and their previous 5 years of utilization will be used to determine if the intervention leads to decreased utilization for asthma. Since the inclusionary age starts at 5 and diagnosing asthma in children under 5 is problematic, how will it be determined if utilization below age 5 is due to true asthma and not transient wheeze?

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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: Yes: Dr Lina Bandyopadhyay.

Reviewer #2: No

Reviewer #3: Yes: Thomas A. Platts-Mills, FRS

Reviewer #4: No

Reviewer #5: No

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Asthma Care from Home: Study protocol for an effectiveness-implementation evaluation of a virtually enabled asthma care initiative in children in rural NSW

PONE-D-23-36574R1

Dear Dr. Mackle,

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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If your institution or institutions have a press office, please notify them about your upcoming paper to help maximize its impact. If they’ll be preparing press materials, please inform our press team as soon as possible -- no later than 48 hours after receiving the formal acceptance. Your manuscript will remain under strict press embargo until 2 pm Eastern Time on the date of publication. For more information, please contact onepress@plos.org.

Kind regards,

Bharat Bhushan Sharma, M.D.

Academic Editor

PLOS ONE

Additional Editor Comments (optional):

The changes done in the manuscript are satisfactory.

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

Reviewer #3: Yes

Reviewer #5: 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

Reviewer #3: Yes

Reviewer #5: 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

Reviewer #3: Yes

Reviewer #5: 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

Reviewer #3: Yes

Reviewer #5: 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 #3: Yes

Reviewer #5: 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: Satisfactory information being obtained as per reviewers queries .Protocol may be accepted for future activities.

Reviewer #3: The authors have responded well to our comments. In particular, the modifications to the text represent a considerable improvement. Overall, the manuscript is much improved. I have two minor comments.

i) I was disappointed that the map was removed. I understand that the editors made extensive suggestions about it. However, for a reader in the UK or the USA, it would be difficult to appreciate what was being proposed without the map. I have commented to the editor. In particular, it is difficult to appreciate the distances involved without a map.

ii) I am afraid the authors assumed I was an Australian. I suggested the Australian authors who had worked on the relevance of dust mite exposure in asthma. I am aware of the Australian work and believe there is some important work from Dr. Tovey on the effect of very high mite levels in N.S.W. (See Tovey ER, Almqvist C, Li Q, Crisafulli D, Marks GB. Nonlinear relationship of mite allergen exposure to mite sensitization and asthma in a birth cohort. J All Clin Immunol 2008; 121 :114-118)

Reviewer #5: The authors have addressed all of my concerns. I have no further comments or suggestions at this time.

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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: Yes: Dr Lina Bandyopadhyay

Reviewer #3: Yes: Thomas A. E. Platts-Mills

Reviewer #5: No

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