PONE-D-20-04939

Protocol for evaluating stakeholder engagement in the design, evaluation, and dissemination of the Informed Health Choices resources for helping secondary school students learn to think critically about health claims and choices

PLOS ONE

Dear Dr. Oxman,

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 note that both reviewers have very substantial comments and the expected revision is significant both from a conceptual and methodological description level. Should you decide to revise and resubmit the paper, it will be re-reviewed.

Please submit your revised manuscript by Aug 16 2020 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: http://journals.plos.org/plosone/s/submission-guidelines#loc-laboratory-protocols

We look forward to receiving your revised manuscript.

Kind regards,

Sara Rubinelli

Academic Editor

PLOS ONE

Journal requirements:

When submitting your revision, we need you to address these additional requirements.

1. Please ensure that your manuscript meets PLOS ONE's style requirements, including those for file naming. The PLOS ONE style templates can be found at

https://journals.plos.org/plosone/s/file?id=wjVg/PLOSOne_formatting_sample_main_body.pdf and

https://journals.plos.org/plosone/s/file?id=ba62/PLOSOne_formatting_sample_title_authors_affiliations.pdf

2. Thank you for including your ethics statement: 

"We will seek ethics approval from local institutional review boards and national research governing councils in each country. We will obtain informed consent for all interviews. Data from questionnaires, interviews, photos, videos and notes from discussions will be anonymised.

Teachers, students and policymakers who are invited to participate in one of the six networks will be informed of the purpose of their participation before written permission is sought. The students who participate on the networks and user-testing will be given information about the project to take to their parents, where written permission will be obtained both from the parents in form of consent and from the students in form of assent.

Consent for the students to participate in the pilot will be given by the headteachers and teachers and students and their parents will have the same right to refuse participation in piloting the resources as they do for any other learning resources used in schools. Although this will be limited, teachers, students and policymakers, whenever required to attend meetings off-site of their professional premises (schools, ministry offices etc) will be compensated for their transport expenses.".

a. Please amend your current ethics statement to include the full name of the ethics committee/institutional review board(s) that approved your specific study.

b. Once you have amended this/these statement(s) in the Methods section of the manuscript, please add the same text to the “Ethics Statement” field of the submission form (via “Edit Submission”).

For additional information about PLOS ONE ethical requirements for human subjects research, please refer to http://journals.plos.org/plosone/s/submission-guidelines#loc-human-subjects-research.

3. We note that you have stated that you will provide repository information for your data at acceptance. Should your manuscript be accepted for publication, we will hold it until you provide the relevant accession numbers or DOIs necessary to access your data. If you wish to make changes to your Data Availability statement, please describe these changes in your cover letter and we will update your Data Availability statement to reflect the information you provide.

4. PLOS requires an ORCID iD for the corresponding author in Editorial Manager on papers submitted after December 6th, 2016. Please ensure that you have an ORCID iD and that it is validated in Editorial Manager. To do this, go to ‘Update my Information’ (in the upper left-hand corner of the main menu), and click on the Fetch/Validate link next to the ORCID field. This will take you to the ORCID site and allow you to create a new iD or authenticate a pre-existing iD in Editorial Manager. Please see the following video for instructions on linking an ORCID iD to your Editorial Manager account: https://www.youtube.com/watch?v=_xcclfuvtxQ

5. Please ensure that you refer to Figure 1 and 2 in your text as, if accepted, production will need this reference to link the reader to each figure.

6. We note that Figure 1 includes an image of participants in the study.

As per the PLOS ONE policy (http://journals.plos.org/plosone/s/submission-guidelines#loc-human-subjects-research) on papers that include identifying, or potentially identifying, information, the individual(s) or parent(s)/guardian(s) must be informed of the terms of the PLOS open-access (CC-BY) license and provide specific permission for publication of these details under the terms of this license.

Please download the Consent Form for Publication in a PLOS Journal (http://journals.plos.org/plosone/s/file?id=8ce6/plos-consent-form-english.pdf). The signed consent form should not be submitted with the manuscript, but should be securely filed in the individual's case notes.

Please amend the methods section and ethics statement of the manuscript to explicitly state that the patient/participant has provided consent for publication: “The individual in this manuscript has given written informed consent (as outlined in PLOS consent form) to publish these case details”.

If you are unable to obtain consent from the subject of the photograph, you will need to remove the figure and any other textual identifying information or case descriptions for this individual.

[Note: HTML markup is below. Please do not edit.]

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: Partly

Reviewer #2: Yes

**********

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: Partly

**********

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

Reviewer #1: No

Reviewer #2: Yes

**********

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

**********

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

**********

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 paper addresses a very interesting and timely topic, and this is not just for the project aims but also for the overall context in which it develops. However, the manuscript is often too generic when presenting future actions, which is a bit odd for a protocol paper. I do not think the manuscript in its present form it is suitable for publication. Below my main concerns.

• In the Background section the authors point to differences in the concepts of public involvement and engagement, both in terms of definitions and approaches and provide their working definition. They also report on models and framework of engagement, but the aim of the paper is not explicit. I believe this digression, even though interesting, could be definitely condensed, as this is not a perspective or position paper but a protocol.

• The overview of the project is also very detailed and appreciated, however it should be integrated in the methods to my mind. Again, it seems odd to me to read the description of the objectives at the end of page 5.

• Methods section is the most problematic part of the paper. The authors state their objective clearly, the multi-stage stratified sampling method is clearly exemplified. However, I feel that the objectives of each phase, the exact process of involvement, and the methods used for collecting and analyzing data should be more precisely presented. This section is at present too discursive.

• Going back to the objectives of the study: they seem to be in contradiction. On the one hand the aim is to ensure that stakeholders are appropriately engaged, and on the other is to evaluate the extent to which they were successfully engaged. It may be that the first objective follows a top-down reasoning on engagement and design the process (and here the focus would be on how this has been informed and which are the motivations behind), and the second one is more of a bottom-up (understanding if it actually worked). However, I believe that the two may be difficult to be represented in the same study, and it is actually maybe the reason behind what now seem to me mix of input from the literature and good ideas for a project planning (but not yet a protocol).

Reviewer #2: Unfortunately, the title is too long. Please consider reducing it’s length considerably.

This manuscript is a registers report protocol. The authors of this manuscript should know that while this reviewer is an experienced reviewer, this represents the first time that I’ve reviewed this type of manuscript.

Health claims and choices, it’s not quite clear what that means.

Page 2, Abstract. It’s not clear how long this project is projected to take. This seems like an important piece of information to include in the Abstract.

Page 3, Background. The reader doesn’t know what the Informed Health Choices Project is. You are talking about thinking critically about health claims and choices, but you do not give us any information as to what exactly that is that was done in these meetings and what it is that you discovered.

Page 8, Figure 2. This is the core of the stakeholder engagement process. As indicated above, it is important to understand the timescale of these phases.

Page 8. It would seem that a snowball sampling technique might be useful to occupy enough spaces in each strata, but it’s just not clear how the researchers will know when their sample is representative.

Page 12. Success Criteria. It’s not clear how you are going to measure any of these criteria.

Page 12, Analysis. Yes, this is an interpretative description approach, but it’s unclear how that qualitative data will be analyzed. Researchers should have some idea of what analysis techniques you are planned to use for this excellent research approach for applied approach for understand human health. It’s inductive, but that doesn’t mean it’s absent from a statistical analytic method of analysis, if that’s what you are planning on doing.

The research claims it will use a multi-stage stratified sampling method, This method is best when subpopulations are expected to yield response differences that are significant. What is the motivation for this expected differences? Another related question is what analytic method are you going to use to analyze the data? How are you going to account for the validity (precision) and reliability (consistency) of the responses that you do get? Furthermore, it’s not clear what your sample size is going to be and how you are going to determine what the proper sample size is for your research?

**********

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: John Lawrence Dennis

[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.

Protocol for assessing stakeholder engagement in the development and evaluation of the Informed Health Choices resources teaching secondary school students to think critically about health claims and choices

PONE-D-20-04939R1

Dear Dr. Oxman,

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.

An invoice for payment will follow shortly after the formal acceptance. To ensure an efficient process, please log into Editorial Manager at http://www.editorialmanager.com/pone/, click the 'Update My Information' link at the top of the page, and double check that your user information is up-to-date. If you have any billing related questions, please contact our Author Billing department directly at authorbilling@plos.org.

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,

Sara Rubinelli

Academic Editor

PLOS ONE

Additional Editor Comments (optional):

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

**********

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 #2: Yes

**********

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

Reviewer #1: Yes

Reviewer #2: Yes

**********

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

**********

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

**********

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: The authors have reviewed their manuscript by taking into account and addressing appropriately almost all reviewers' comments. I also find acceptable the response to my fourth comment.

Reviewer #2: Thank you for following all of the recommendations that have been provided. This reviewer is grateful for the authors efforts.

**********

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: John Lawrence Dennis