PONE-D-21-35572Patients and healthcare professionals perspectives on creating a chronic pain support line in Portugal: a qualitative study protocolPLOS ONE

Dear Dr. Cruz,

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 reviewers have highlighted important aspects to improve this study protocol. Specifically, although there cannot be results (being it a protocol), all methodological aspects needs to be clarified so that this paper can inspire close replication and close/similar research in the field. 

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PLOS ONE

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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: Partly

Reviewer #3: 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 #2: No

Reviewer #3: Partly

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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: No

Reviewer #3: No

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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 #2: No

Reviewer #3: 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

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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: Thanks for the Authors for the valuable protocol that looks in an issue which require a good care. looking forwards to see the study manuscript and its results.

Reviewer #2: The manuscript written by Cruz et al describes the procedure implemented by the researchers in order to gather patients’ and healthcare’s professional standpoints about the Implementation of a support line for chronic pain patients in Portugal.

I have some concerns about the information provided by the authors that merit further consideration:

In my opinion, the main problem of this manuscript that there are major gaps in the information provided in terms of the preparation of the scientific protocol and the presentation of the results. The latter are reduced to few paragraphs in the discussion without sharing the real numbers obtained from the study which makes impossible to elaborate an exhaustive review of the present manuscript.

Even though authors make clear the need for such support line and the potential benefit for the Portuguese population suffering of chronic pain, there are some gaps in the elaboration of the context:

- In line 58, the authors cited “recent studies” that revealed the prevalence of chronic pain in Europe and the US. However, those references dated from 2016 and 2013, which makes me wonder if there are not more recent studies that could be more accurate with the present situation, moreover, taking into consideration the advances in pain management that have occurred in the last year.

- In line 64, the authors mentioned that access to care is “somehow restricted” but it is not specified why or where. Are they talking in general in the developed countries? Only in Portugal? Why access to care is restricted and for whom? As this is one of the central pillars to justify the need of implementing the support line, it should be much more elaborated and rationalized.

- In line 76, it is mentioned that there are currently similar systems already implemented in different countries. Please add here references or links to those systems to help both the reviewers and the readers to get an idea. Moreover, authors explain how those lines previously referred, are having a positive impact on user’s lines. However, the reference alludes to a study performed in the US (not even mentioned among the countries listed before).

- Taking into consideration the very well know differences between the healthcare systems across countries and how different the access to basic or specialized care could be depending on having public, private or semiprivate health infrastructures, I would appreciate that this issue would have been considering when presenting the effect of a support line. Indeed, the explanation for the expected benefit of such implementation in Portugal should have been based on the results obtained in countries with similar systems.

Concerning the Study design, I would appreciate to see a clearer and more detailed timeline of the implementation of the study, including a more exhaustive description of the study groups (number of groups, number of people participating, distribution of participants according to their profiles, gender, age). How were participants distributed in the groups? Has any participant been rejected?

Even if Tables 1 and 2 collect the Major and Specific discussion items, it remains not clear how those aspects were addressed during the meetings.

Nowadays, data privacy is one of the major topics when refers to research involving human beings, even if only healthy subjects are recruited. In that direction, authors have not provided any information concerning where the videos from the groups were stored, how they were protected from being accessed by non-authorized staff, how privacy has been secured…

However, as previously mentioned, the main problem of this manuscript is that the authors do not present any results that can be reviewed or contrasted. They mentioned in line 232 a potential limitation due to an over-representation of groups that the reviewers cannot judge because there is no data provided to support any discussion or conclusion.

Reviewer #3: The authors have presented a nice paper about the protocol adopted to evaluate and validate the possibility to set up "a chronic pain support line" in Portugal.

The topic is important to be discussed and the unmet need of this approach is well described by the authors.

Unfortunately there are some major concerns that should be addressed before considering it for possibile publication

The major concern is a methodological issue that should be better clarified. It is not clear how you have defined the criteria to "balance" chronic non oncological and oncological patients and healthcare providers. This is really important as the two different populations of patients and also of caregiver providers could have different needs.

Another concern is always related to the selection of your population who will evaluate the "support line". In the text it is not described if the authors have taken in consideration how to avoid bias related to select people only from countryside/city, type of pain, etc etc. Please describe better which are all the parameters that you consider in the evolution of patients and healthcare providers selected. If you have not planned it please describe it better in limitations of the protocol

The authors should describe better the protocol in order to permit the possibility to replicate in another country if possible.

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Reviewer #1: Yes: Hossam ELDien A. ELShamaa

Reviewer #2: No

Reviewer #3: Yes: Massimo Allegri

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Patients and healthcare professionals perspectives on creating a chronic pain support line in Portugal: a qualitative study protocol.

PONE-D-21-35572R1

Dear Dr. Cruz,

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,

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 #3: 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 #3: Yes

**********

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 #3: 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 #3: No

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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 #3: 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 #3: The authors have satisfactory replied to all concerns previously raised. The text is now clearer and more readable

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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 #3: No

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