Transfer Alert

This paper was transferred from another journal. As a result, its full editorial history (including decision letters, peer reviews and author responses) may not be present.

PONE-D-22-15436Advance Care Planning to Promote Cancer Patients’ Receipt of Value-Concordant CarePLOS ONE

Dear Professor Prigerson,

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.

The manuscript has been evaluated by two reviewers, and their comments are available below. I, as Academic Editor, acted as one of the reviewers as this topic lies within my area of research and expertise. 

The reviewers have raised a number of concerns that need attention largely around interpretations of this study's findings and communicating its limitations. 

Could you please revise the manuscript to carefully address the concerns raised?

Please submit your revised manuscript by Nov 04 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.

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,

Cari Malcolm

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. In ethics statement in the manuscript and in the online submission form, please provide additional information about the patient records/samples used in your retrospective study. Specifically, please ensure that you have discussed whether all data/samples were fully anonymized before you accessed them and/or whether the IRB or ethics committee waived the requirement for informed consent. If patients provided informed written consent to have data/samples from their medical records used in research, please include this information.

3. We note that the grant information you provided in the ‘Funding Information’ and ‘Financial Disclosure’ sections do not match. 

When you resubmit, please ensure that you provide the correct grant numbers for the awards you received for your study in the ‘Funding Information’ section.

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

This research was supported, in part, by the following grants from the National Institute of Health: R01 MH63892 (HGP) from the National Institute of Mental Health, R01 CA106370 (HGP) from the National Cancer Institute; R01 MD007652 (PKM, HGP) from the National Institute on Minority Health and Health Disparities; R35 CA197730 (HGP) from the National Cancer Institute; and UL1 TR002384 (Weill Cornell Medicine CTSC) from the National Center for Advancing Translational Sciences, from the National Institute on Aging-funded K99 grant (K99 AG073509).

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: 

NO The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.

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

5. 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.

6. 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. 

7. Please include your tables as part of your main manuscript and remove the individual files. Please note that supplementary tables (should remain/ be uploaded) as separate "supporting information" files

8. 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.

[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

**********

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

Reviewer #1: I Don't Know

Reviewer #2: Yes

**********

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

**********

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

**********

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 is an important analysis of that includes consideration of patient preferences and assesses goal concordance with outcomes, offering a more granular look at the influence of ACP and its included elements.

The manuscript is well-written and also speaks to the current controversy over the value and utility of ACP. There are some areas of clarity for consideration included below. Further, while the statistical methods appear appropriate, it would be best for a statistician to review the specific analyses described.

The authors include 3 components of ACP – EoL discussions with a physician, completion of a DNR, and identification of a proxy. There are some potential limitations with this structure that should be addressed. First, if this only includes EoL discussions with a physician, there may be important EoL discussions with other qualified clinical care providers that are missed (for example, advanced practice practitioners can also bill for ACP). But more importantly, are the three categories truly separate and without overlap- for example, is completing a DNR truly distinct from EoL discussion? It seems reasonable that some of these discussions might include a review of DNR status and decision-making, as well as who a patient might select as a proxy.

From the original study protocol- why exclude patients with terminal cancer if receiving palliative care? Wouldn’t this be clinically appropriate for many of these patients?

This paper does briefly note an important limitation in the discussion – the analysis assumes patient preferences remain stable from baseline measure to outcomes to assess goal concordance – and these preferences could change after the median 111 days.

It appears, although is not completely clear, that all ACP measures are exclusively collected at the baseline interview. Could a participant have engaged in or changed any of the elements noted at baseline prior to death that are not captured in the data (or indicated ‘no DNR’ at baseline but later had one? Is it possible to check for, for ex., updated DNR status along with the outcome data?) Reviews of EoL preference stability shows a range of variability across studies, although generally are more stable for seriously ill patients.

It would be helpful to include more discussion of implications for patients prioritizing life extending care. What are recommendations for this group?

Reviewer #2: This is a very well written paper communicating novel research around the complex issue of promoting value-concordant care in people with cancer through the use of advance care planning (ACP).

The introduction/background section is excellent and, importantly, highlights recent controversies and debate around the utility of and challenges around ACP. Key and recent evidence is integrated throughout this section, leading to the authors’ hypotheses.

The methods are detailed and clearly communicated.

Given that data/participants from two studies (CWC1 and CWC3) and therefore time periods (CWC1 2002-2008 and CWC2 2015-2019) were used in this retrospective analysis and cognisant of the fact that the landscape of ACP and value-concordant care has changed and evolved considerably over the nearly 20 years since 2002, this needs to be acknowledged by the authors and explicitly discussed in the limitations section. I would also like to see greater transparency around how comparable data from CWC1 and CWC2 participants were in terms of, particularly, treatment preferences. The 278 participants are communicated as a whole sample in table 1 so it isn’t clear.

An additional limitation which needs to be addressed is around the inclusion of solely end of life care discussions with a physician. It is more than often the case that there is overlap and ongoing supportive discussions from a range of professionals, the family/significant others and the patient that lead to the patient’s decision around treatment preferences. There is also a growing body of evidence that having trusting and empathic relationships with a professional/s is a key motivator for engaging individuals and families in ACP discussions. The current study isn’t able to tease that out and therefore needs to acknowledge that. It may be worth referring to the following recent article in the discussion:

Rosa WE, Izumi S, Sullivan D, Lakin J, Rosenberg AR, Creutzfeldt CJ, Lafond D et al. Advance Care Planning in Serious Illness: A Narrative Review. Journal of Pain and Symptom Management. 2022 Aug 24 https://doi.org/10.1016/j.jpainsymman.2022.08.012

Finally, the fact that retrospective analysis is based around the patient’s preferences for end of life care to stay the same in the last weeks and months of life is a considerable limitation of this research and the findings and conclusions need to be interpreted with some caution. There needs to be greater transparency around this and it needs to be explicitly stated.

**********

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

**********

[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.

Advance Care Planning (ACP) to promote receipt of value-concordant care: Results vary according to patient priorities

PONE-D-22-15436R1

Dear Dr. Prigerson,

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,

Cari Malcolm

Academic Editor

PLOS ONE

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

**********

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

**********

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

Reviewer #1: I Don't Know

Reviewer #2: Yes

**********

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: a very minor final revision prior to publication - the revised section of the final paragraph in the discussion "not with other member of the care team" should state "not with other members of the care team"

Reviewer #2: Thank you for submitting your revised manuscript. I am satisfied that all recommendations have been considered and the current version is suitable for publication.

**********

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: Amanda Jane Reich

Reviewer #2: No

**********