Peer Review History

Original SubmissionJune 16, 2022
Decision Letter - Giuseppe Limongelli, Editor

PONE-D-22-13809Digital technology and patient and public involvement (PPI) in routine care and clinical research - a pilot study

PLOS ONE

Dear Dr. Chen,

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 Oct 26 2022 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.

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  • 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'.
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We look forward to receiving your revised manuscript.

Kind regards,

Giuseppe Limongelli

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. Please amend your current ethics statement to address the following concerns:

a) Did participants provide their written or verbal informed consent to participate in this study?

b) If consent was verbal, please explain i) why written consent was not obtained, ii) how you documented participant consent, and iii) whether the ethics committees/IRB approved this consent procedure."

3. Please include your full ethics statement in the ‘Methods’ section of your manuscript file. In your statement, please include the full name of the IRB or ethics committee who approved or waived your study, as well as whether or not you obtained informed written or verbal consent. If consent was waived for your study, please include this information in your statement as well. 

4. Thank you for stating the following in the Acknowledgments Section of your manuscript: 

"ADS is supported by a postdoctoral fellowship from THIS Institute, grants from NIHR and the UCL British Heart Foundation Research Accelerator. FWA and YC are supported by UCL Hospitals NIHR Biomedical Research Centre. AH is supported by a Health Education Eng-land Topol Digital Fellowship. The PPI event was kindly supported by funds from the NIHR UCLH BRC PPI bursary fund. The British Heart Foundation Heart Voices network were in-strumental in helping to recruit patients and we are grateful for the assistance of Chloe Gold-man in this regard. We are additionally grateful to Tom Lumbers for help with reviewing slides for the PPI day and contributing to the content and themes for the research element of the day. Lastly, we are grateful to all patients who expressed interest in the day and who kindly volunteered their time and views in helping to support this study and to inform the design of the two projects that have been discussed during this paper."

We note that you have provided funding information that is not currently declared in your Funding Statement. However, funding information should not appear in the Acknowledgments section or other areas of your manuscript. We will only publish funding information present in the Funding Statement section of the online submission form. 

Please remove any funding-related text from the manuscript and let us know how you would like to update your Funding Statement. Currently, your Funding Statement reads as follows: 

"The author(s) received no specific funding for this work"

Please include your amended statements within your cover letter; we will change the online submission form on your behalf

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

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

**********

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 study contributes to the literature about hybrid PPI events to understand patients' points of view. However, it would make a more substantial contribution if a more comprehensive analysis of the qualitative findings were presented, not just presenting informants' quotations without further explanation of what they imply.

Reviewer #2: The manuscript by Yang Chen and Colleagues is a well written and sound exploratory report, and may offer some relevant messages for assessing PPI. Patient and public involvement and engagement is gradually becoming part of standard cardiovascular and cancer research and an increasing number of statements are being released regularly to support it.

However, methods description and results presentation still have room for improvement and may be addressed. Please find my suggestions below.

- Little information is currently present regarding the steps that led to the final study cohort selection. It would be useful to know how the final study cohort was selected and derived (especially in light of the pre-event survey that Researchers conducted before the pilot study).

-Do Authors have more information regarding social variables of participants or do they have access to healthcare data?

-From a practical point of view, it would be useful to have more information regarding study timeline, staff training, and study and interview duration.

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6. 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: No

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Revision 1

Reviewer #1: This study contributes to the literature about hybrid PPI events to understand patients' points of view. However, it would make a more substantial contribution if a more comprehensive analysis of the qualitative findings were presented, not just presenting informants' quotations without further explanation of what they imply.

Thank you. We have added the following pieces of analysis:

“These quotes were indicative of the enthusiasm for remote monitoring that the group had and their inquisitiveness about how such their BP data would be shared with their usual care team. However, there was an emphasis additionally placed on safeguarding required to mitigate against over-measurement and the possible anxiety that elevated readings could create, though this was balanced with points made about elevated readings being positively viewed, in terms of being a motivating factor to engage in lifestyle behaviours such as exercise to reduce BP.”

“This quote summarised the consensus view of the group in terms of how to balance the feasibility and safety of doing research studies of electronic alerts aimed at clinicians which seek to change their behaviour and downstream management strategies that can affect patients, In this regard, the group understood that thresholds for tolerating waived consent may vary case by case. There was a majority consensus for waived consent in the context of comparing existing non-pharmaceutical interventions such as fluid restriction versus no restriction, given the patient is the final arbiter of oral fluid intake.”

Reviewer #2: The manuscript by Yang Chen and Colleagues is a well written and sound exploratory report, and may offer some relevant messages for assessing PPI. Patient and public involvement and engagement is gradually becoming part of standard cardiovascular and cancer research and an increasing number of statements are being released regularly to support it.

Thank you.

However, methods description and results presentation still have room for improvement and may be addressed. Please find my suggestions below.

- Little information is currently present regarding the steps that led to the final study cohort selection. It would be useful to know how the final study cohort was selected and derived (especially in light of the pre-event survey that Researchers conducted before the pilot study).

We have added the following:

“A shortlist of 10 participants was purposively selected to generate a balanced group. This was based on protected characteristics such as age and gender, as well as pre-event confidence in using digital tools.”

-Do Authors have more information regarding social variables of participants or do they have access to healthcare data?

We have added the following:

“Other background information including social determinants of health were not collected in order to prioritise accessibility and ease of completion.”

-From a practical point of view, it would be useful to have more information regarding study timeline, staff training, and study and interview duration.

We have added these relevant details to the supplementary material.

Response to editorial comments

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. Please amend your current ethics statement to address the following concerns:

a) Did participants provide their written or verbal informed consent to participate in this study?

b) If consent was verbal, please explain i) why written consent was not obtained, ii) how you documented participant consent, and iii) whether the ethics committees/IRB approved this consent procedure."

3. Please include your full ethics statement in the ‘Methods’ section of your manuscript file. In your statement, please include the full name of the IRB or ethics committee who approved or waived your study, as well as whether or not you obtained informed written or verbal consent. If consent was waived for your study, please include this information in your statement as well.

We have added the following:

“The pre-attendance short survey allowed prospective participants to provide written consent before the event, and verbal consent was taken on the day for use of non-attributable quotations that arose from discussions.”

“In accordance with the UK Health Research Authority decision tool on ethical requirements for research [11] and specific guidance from the National Institute for Health and Care Research on the ethics of PPI events, no approval from an ethics committee was sought.[12]”

4. Thank you for stating the following in the Acknowledgments Section of your manuscript:

"ADS is supported by a postdoctoral fellowship from THIS Institute, grants from NIHR and the UCL British Heart Foundation Research Accelerator. FWA and YC are supported by UCL Hospitals NIHR Biomedical Research Centre. AH is supported by a Health Education Eng-land Topol Digital Fellowship. The PPI event was kindly supported by funds from the NIHR UCLH BRC PPI bursary fund. The British Heart Foundation Heart Voices network were in-strumental in helping to recruit patients and we are grateful for the assistance of Chloe Gold-man in this regard. We are additionally grateful to Tom Lumbers for help with reviewing slides for the PPI day and contributing to the content and themes for the research element of the day. Lastly, we are grateful to all patients who expressed interest in the day and who kindly volunteered their time and views in helping to support this study and to inform the design of the two projects that have been discussed during this paper."

We note that you have provided funding information that is not currently declared in your Funding Statement. However, funding information should not appear in the Acknowledgments section or other areas of your manuscript. We will only publish funding information present in the Funding Statement section of the online submission form.

Please remove any funding-related text from the manuscript and let us know how you would like to update your Funding Statement. Currently, your Funding Statement reads as follows:

"The author(s) received no specific funding for this work"

We have removed the relevant sentences related to funding in the acknowledgements section.

In the funding statement, we have updated this to:

This work was directly supported by a BRC PPI Bursary Award - BRC849/PPI/AH/104990

Attachments
Attachment
Submitted filename: Response to reviewers.docx
Decision Letter - Giuseppe Limongelli, Editor

Digital technology and patient and public involvement (PPI) in routine care and clinical research - a pilot study

PONE-D-22-13809R1

Dear Dr. Chen,

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,

Giuseppe Limongelli

Academic 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 #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: Partly

Reviewer #2: Yes

**********

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

Reviewer #1: N/A

Reviewer #2: N/A

**********

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

**********

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. 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 well-addressed the reviewers' responses. However, the additional explanation to the quotation would also need to be further mentioned and analyzed in the discussion section. The discussion is still bland. For instance, the statement: "However, there was an emphasis additionally placed on safeguarding required to mitigate against over-measurement and the possible anxiety that elevated readings could create, though this was balanced with points made about elevated readings being positively viewed in terms of being a motivating factor to engage in lifestyle behaviours such as exercise to reduce BP.". How does the sentence support the authors' arguments in the discussion: "When compared to the distribution of current PPI events, [14] it is unclear if participation levels are representative of patients affected by each condition or treatment studied, or if the distribution of known and published PPI events match up to patient priorities more generally. The former in the results indicates a positive tone of the PPI initiative. However, the latter shows otherwise unless the authors provide thorough information to support their argument about the gap.

Reviewer #2: The report has some intrinsic limitations but the Authors have, nonetheless, acknowledged most of them at the end of the manuscript and have re-structured the paper according to recommendations raised during the Reviewing process.

I have no further comments.

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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: No

**********

Formally Accepted
Acceptance Letter - Giuseppe Limongelli, Editor

PONE-D-22-13809R1

Digital technology and patient and public involvement (PPI) in routine care and clinical research - a pilot study

Dear Dr. Chen:

I'm pleased to inform you that your manuscript has been deemed suitable for publication in PLOS ONE. Congratulations! Your manuscript is now with our production department.

If your institution or institutions have a press office, please let them know about your upcoming paper now to help maximize its impact. If they'll be preparing press materials, please inform our press team within the next 48 hours. 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.

If we can help with anything else, please email us at plosone@plos.org.

Thank you for submitting your work to PLOS ONE and supporting open access.

Kind regards,

PLOS ONE Editorial Office Staff

on behalf of

Dr. Giuseppe Limongelli

Academic Editor

PLOS ONE

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