PONE-D-23-33990A Shared Decision-Making intervention for individuals living with COPD who are making Pulmonary Rehabilitation treatment options with respiratory and physiotherapy healthcare professionals: An iterative development process with qualitative methodsPLOS ONE

Dear Dr. Houchen-Wolloff,

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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Tamer I. Abo Elyazed, Ph.d

Guest Editor

PLOS ONE

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6. Please review your reference list to ensure that it is complete and correct. If you have cited papers that have been retracted, please include the rationale for doing so in the manuscript text, or remove these references and replace them with relevant current references. Any changes to the reference list should be mentioned in the rebuttal letter that accompanies your revised manuscript. If you need to cite a retracted article, indicate the article’s retracted status in the References list and also include a citation and full reference for the retraction notice.

Additional Editor Comments (if provided):

The title of the manuscript needs to be re structured to clarify the goal of the study in more simple abbreviated words; e.g I suggest [A shred decision making between health care professionals and individuals undergoing Pulmonary rehabilitation : An iterative development process with qualitative methods].

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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

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

Reviewer #1: N/A

Reviewer #2: N/A

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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

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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

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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: This article outlines the development of an intervention model for shared decision making (SDM) for individuals with Chronic Obstructive Pulmonary Disease (COPD) making decisions about Pulmonary Rehabilitation (PR). The intervention, consisting of a Patient Decision Aid (PtDA), training of healthcare professionals (HCPs) in decision coaching, and a consultation prompt, was developed over a nine-month period. The study utilized iterative development processes, including forming a steering group, defining the scope of the PtDA, data collection, prototype development, and alpha-testing with COPD individuals and PR HCPs. The PtDA was revised six times to ensure acceptability. The supporting components, decision coaching, and a consultation prompt were added to empower PR HCPs in SDM. The final intervention aims to facilitate informed and values-based decisions about PR for individuals with COPD.

This article is well-written, and the authors behind it possess solid expertise in the field. Therefore, the article has numerous strengths that enhance its academic rigor and contribute to the professional interest in this work.

These include:

1.Comprehensive Frameworks: The intervention development process utilized broad overarching frameworks, including the MRC complex intervention development and evaluation framework, the MIND-IT model, and the Ottawa Decision Support Framework. This ensured a comprehensive and methodologically sound approach.

2.Iterative Development/proto-typing: The PtDA underwent six revisions based on alpha-testing with both individuals with COPD and PR HCPs. This iterative process strengthened the intervention's clarity, comprehensibility, and usability.

3.Clear Scope: The intervention's scope was well-defined, aiming to standardize discussions between individuals and PR HCPs, facilitating information exchange, deliberation, and decision-making.

4.User-Centered Design: The PtDA development adhered to a user-centered design checklist, ensuring that the final product was tailored to the needs and preferences of the target population.

5.Integration of Supporting Components: Recognizing the need for additional support, decision coaching training for PR HCPs and a consultation prompt were integrated, addressing concerns about the time required for SDM consultations. This is extremely important, as most Shared Decision-Making (SDM) experts both know and acknowledge that Patient Decision Aids (PtDAs) cannot stand alone and are not a tick-a-box solution for SDM implementation.

6.Readability Considerations: The PtDA's readability was assessed, and modifications were made to ensure appropriateness for individuals living with COPD, contributing to improved health literacy.

However, there are also several limitations, many of which could be addressed to enhance the content, scientific rigor, and reader interest of this article. These include (read as reviewer's comments):

1.Limited Uptake Data: The intervention was completed two years ago, yet there is a lack of data on the uptake of the three interventions. While it is acknowledged that the authors might intend to publish this in a separate article, the absence of uptake data in the current study limits a comprehensive assessment of the intervention's real-world impact.

2.Small Alpha Test Sample: The alpha-testing phase involved a small number of participants, with 7 (8) healthcare professionals and 3 (4) patients. The limited size of the alpha test group raises questions about the generalizability and robustness of the intervention, particularly in capturing a diverse range of perspectives.

3.Absence of Beta Testing Data: The study lacks beta testing data conducted in real-life conditions (field tests) about feasibility.

In the PtDA development model utilized by the authors, based on Coulter et al.'s 2013 article, Coulter et al. have outlined both alpha testing, focusing on acceptability and usability, and beta testing, which includes real-world field testing for feasibility. However, the presentation lacks data or reflections on why only alpha test findings are presented, and whether the PtDA development process concluded after alpha testing without progressing to beta testing. It is possible that the authors chose to deviate from the model, adopted a different approach, or pursued an alternative path, but there is no available data or reflections on this matter. Therefore it appears, that the PtDAs appear to lack comprehensive field testing with patients or evaluation by clinicians not involved in the development process, undermining the understanding of its feasibility in practical settings.

4.Timeline Discrepancy: Reference is made to the use of the user-centered design checklist (reference 41) at the early stages of the study, during the intial phase of outlining the scope of the intervention. However, the timeline raises concerns, as reference 41 was published in October 2021, several months after the project's initiation in March 2021 (although reference 41 was online mid-June this is still several months after the start of this project)? So was this incorporated semi-retrospective?

5.Sequential Figure Reference: On page 7 of the manuscript, Figure 2 is referenced before Figure 1. Typically, figures and tables should be referenced consecutively in a scientific article. Maybe this edit will be addressed during the proofreading process to ensure consistency and compliance with common scientific standards.

6.Imbalance in Steering Group Composition: The steering group comprises 5 specialists/academics/experts and only 1 patient. This composition may not sufficiently address the inherent power imbalance, potentially limiting the representation of the patient's voice in decision-making. This should be reflected on and argued why only one patient representative was included.

7.Unclear Scope of Consultation Prompt: The manuscript lacks information about the scope, appearance, and specific content of the consultation prompt. In my view, this part of the intervention is too implicit, and it is unclear to readers what specifically it entails. A more detailed explanation is needed to understand the intervention's purpose and what exactly this is in the context of the study.

8.Limited Display of PtDA: Only the front page of the PtDA is presented in S4: “Finalised PtDA (preview; version 6). “To provide a comprehensive understanding, the entire PtDA should be showcased, as the front page alone does not convey sufficient information about its contents.

Reviewer #2: The paper describes the process of developing a shared decision making (SDM) intervention to enhance PR uptake in patients living with COPD.

It is clearly an important area, and the authors explain the purpose of the intervention well. The main suggestion I have would be to provide more information regarding the findings and details of the intervention itself within the main body of the paper instead of as supplemental materials. Readers have a tendency to focus more on the paper as opposed to accessing the supplemental materials.

I have summarised specific suggestions for further improvement to the manuscript below:

Abstract

•May have missed this, but a ‘useable leaflet’ only appears to be referenced in the abstract, with no mention of what this looks like elsewhere within the paper. It would be good to expand.

Introduction

•The authors provide a comparison of an online PR programme vs. traditional programme, but more information about what a traditional programme looks like would be beneficial. Readers of PLOS ONE typically come from different backgrounds and may not be familiar. Would be good to provide more context to the area.

•Similarly, commonly cited barriers to the uptake of traditional PR (e.g. organisational constraints) are mentioned, but an expansion and explanation of these barriers would be good.

Methods

•Step 4 describes an exercise used to support individuals identifying core values and beliefs, but a description of what this entailed would be beneficial.

•A ‘think-aloud approach’ is described in the Alpha testing section. I wonder if the authors have any quotes they could present to support their findings.

Results

•It is interesting that the HCPs seemed to identify burden as one area that required attention, but the PPI group did not. I wonder if the authors had any thoughts as to why this was the case? Would be interesting to discuss.

Discussion

•This section summarises the process of developing the SDM intervention quite nicely.

•In one area, the authors talk about limited research on the barriers of SDM, with one being insufficient knowledge of SDM amongst HCPs. The authors could explore whether gaining more knowledge always leads to taking action. In the field of behaviour change, it has been observed that knowing what to do does not always result in actual behaviour change. It would be valuable for the authors to contemplate this aspect in the context of potential future research.

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Reviewer #1: No

Reviewer #2: Yes: Louisa Lawrie

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PONE-D-23-33990R1A shared decision-making intervention between health care professionals and individuals undergoing Pulmonary rehabilitation: An iterative development process with qualitative methodsPLOS ONE

Dear Dr. Houchen-Wolloff,

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. Please submit your revised manuscript by Aug 19 2024 11:59PM. If you will need more time than this to complete your revisions, please reply to this message or contact the journal office at plosone@plos.org. When you're ready to submit your revision, log on to https://www.editorialmanager.com/pone/ and select the 'Submissions Needing Revision' folder to locate your manuscript file.

Please include the following items when submitting your revised manuscript:

• A rebuttal letter that responds to each point raised by the academic editor and reviewer(s). You should upload this letter as a separate file labeled 'Response to Reviewers'.
• A marked-up copy of your manuscript that highlights changes made to the original version. You should upload this as a separate file labeled 'Revised Manuscript with Track Changes'.
• An unmarked version of your revised paper without tracked changes. You should upload this as a separate file labeled 'Manuscript'.

If you would like to make changes to your financial disclosure, please include your updated statement in your cover letter. Guidelines for resubmitting your figure files are available below the reviewer comments at the end of this letter.

If applicable, we recommend that you deposit your laboratory protocols in protocols.io to enhance the reproducibility of your results. Protocols.io assigns your protocol its own identifier (DOI) so that it can be cited independently in the future. For instructions see: https://journals.plos.org/plosone/s/submission-guidelines#loc-laboratory-protocols. Additionally, PLOS ONE offers an option for publishing peer-reviewed Lab Protocol articles, which describe protocols hosted on protocols.io. Read more information on sharing protocols at https://plos.org/protocols?utm_medium=editorial-email&utm_source=authorletters&utm_campaign=protocols.

We look forward to receiving your revised manuscript.

Kind regards,

Tamer I. Abo Elyazed, Ph.d

Guest Editor

PLOS ONE

Journal Requirements:

Please review your reference list to ensure that it is complete and correct. If you have cited papers that have been retracted, please include the rationale for doing so in the manuscript text, or remove these references and replace them with relevant current references. Any changes to the reference list should be mentioned in the rebuttal letter that accompanies your revised manuscript. If you need to cite a retracted article, indicate the article’s retracted status in the References list and also include a citation and full reference for the retraction notice.

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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: (No Response)

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 #1: Yes

Reviewer #2: Yes

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

Reviewer #1: N/A

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 #1: Yes

Reviewer #2: 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

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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: Thank you for the sufficient response to the raised criticism. I believe the article is ready for publication. However, I don't think it is clear to the reader when reading the figure legends for supplementary figure 4 that it is only a small excerpt of figure 4 that is presented in the supplementary material. I find it unfortunate that they do not display the entire PtDA in supplementary figure 4. However, if the authors are concerned due to copyright issues, it must be taken into account. Nevertheless, they should explain to the reader that only a small excerpt is shown in the supplementary material, for example, that it is page 1, x, and x out of a total of xx pages of the paper-based (?) PtDA.

Reviewer #2: (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 #2: Yes: Louisa Lawrie

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[NOTE: If reviewer comments were submitted as an attachment file, they will be attached to this email and accessible via the submission site. Please log into your account, locate the manuscript record, and check for the action link "View Attachments". If this link does not appear, there are no attachment files.]

While revising your submission, please upload your figure files to the Preflight Analysis and Conversion Engine (PACE) digital diagnostic tool, https://pacev2.apexcovantage.com/. PACE helps ensure that figures meet PLOS requirements. To use PACE, you must first register as a user. Registration is free. Then, login and navigate to the UPLOAD tab, where you will find detailed instructions on how to use the tool. If you encounter any issues or have any questions when using PACE, please email PLOS at figures@plos.org. Please note that Supporting Information files do not need this step.

A shared decision-making intervention between health care professionals and individuals undergoing Pulmonary rehabilitation: An iterative development process with qualitative methods

PONE-D-23-33990R2

Dear Dr. Houchen-Wolloff,

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,

Tamer I. Abo Elyazed, Ph.d

Guest Editor

PLOS ONE

Additional Editor Comments (optional):

Reviewers' comments: