Peer Review History

Original SubmissionJuly 3, 2019
Decision Letter - Federico Bilotta, Editor

PONE-D-19-18628

Effects and cost-effectiveness of postoperative oral analgesics for additional postoperative pain relief in children and adolescents undergoing dental treatment: Health technology assessment including a systematic review

PLOS ONE

Dear Dr Berlin,

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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We look forward to receiving your revised manuscript.

Kind regards,

Federico Bilotta

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

http://www.journals.plos.org/plosone/s/file?id=wjVg/PLOSOne_formatting_sample_main_body.pdf and http://www.journals.plos.org/plosone/s/file?id=ba62/PLOSOne_formatting_sample_title_authors_affiliations.pdf

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

"This study was supported by research funds from Oral Health Related Research by Region Skåne (Odontologisk Forskning i Region Skåne, OFRS 569491), Sweden".

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 funders had no role in study design, data collection and analysis, decision to

publish, or preparation of the manuscript".

3. Please include a copy of Table 1 which you refer to in your text on page 6.

[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: No

Reviewer #2: Yes

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

Reviewer #1: No

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: No

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: No

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: The preparation of Systematic review was erroneous.

Several lacunae were noted and authors should discuss with someone who has prepared SRs before, especially those who have worked with the Cochrane Collaboration.

Outcomes are not well defined and the PICO statement is incorrectly prepared.

Professional help should have been taken for preparation of Search Strategies.

Reviewer #2: Manuscript Number: PONE-D-19-18628

Title: Effects and cost-effectiveness of postoperative oral analgesics for additional postoperative pain relief in children and adolescents undergoing dental treatment: Health technology assessment including a systematic review

Submitted to:

PLOS ONE

1. ABSTRACT.

- Abstract appropriately summarize the manuscript.

- There aren´t discrepancies between the Abstract and the remainder of the manuscript.

- The Abstract can be understood without reading the manuscript.

2. BACKGROUND/AIM

- The Introduction is concise.

- The purpose of the study is well defined.

- The authors provide a rationale for performing the study based on a review of the medical literature with an appropriate length.

- This manuscript is Original Research, with a well-defined hypothesis.

3. MATERIALS AND METHODS

- Please, add a PRISMA statement checklist.

- Please, add an AMSTAR checklist.

4. RESULTS

- The results are clearly explained.

- The results are reasonable and expected.

- There aren´t results introduced that are not preceded by an appropriate discussion in the Methods section.

5. DISCUSSION

- The discussion is concise.

- Their research question was answered.

- Please, define Limitations of the study.

- Authors’ conclusions are justified by the results found in the study.

6. FIGURES

- Figure is appropriate and it is appropriately labeled.

- Adequately show the important results.

7. TABLES (Supl)

- Appropriately describe the results.

8. REFERENCES

- The reference list follows the format for the journal.

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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: Yes: Rafael Badenes

[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 to be viewed.]

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Attachments
Attachment
Submitted filename: Badenes Review PLOS ONE 3.docx
Revision 1

Reviewers' and editor's comments has been responded to in the document "Response to Reviewers", that has been attached to present re-submission.

We have considered the Journal Requirements and comments and critique from the reviewers. We have made changes accordingly, but also have following comments:

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 http://www.journals.plos.org/plosone/s/file?id=wjVg/PLOSOne_formatting_sample_main_body.pdf and http://www.journals.plos.org/plosone/s/file?id=ba62/PLOSOne_formatting_sample_title_authors_affiliations.pdf

[Authors’ comments]: We have updated the file names according to the links above, and adjusted the manuscript to meet PLOS ONE’s style requirements.

2. Thank you for stating the following in the Acknowledgments Section of your manuscript: "This study was supported by research funds from Oral Health Related Research by Region Skåne (Odontologisk Forskning i Region Skåne, OFRS 569491), Sweden". 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 funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript".

[Authors’ comments]: The funding information is removed from the manuscript. For the Funding section, we would like to update the text with the following:

“This study was supported by research funds from Oral Health Related Research by Region Skåne (Odontologisk Forskning i Region Skåne, OFRS 569491), Sweden.

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

3. Please include a copy of Table 1 which you refer to in your text on page 6.

[Authors’ comments]: Table 1 is now included in present re-submission.

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: No

[Authors’ comments]: The manuscript has been prepared according to common principles for systematic reviews (SR) and health technology assessments (HTA). We have followed the guidelines for SRs, from SBU (Swedish Agency for Health Technology Assessment and Assessment of Social Services) (Line 393-397, page 16). SBU is in the same network as Cochrane Sweden, which is a part of the Cochrane global community. This SR also follows the PRISMA-statement (Line 158-159, page 6)

Reviewer #2: Yes

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

Reviewer #1: No

[Authors’ comments]: Since this SR came out empty, no statistical analysis could be performed. This question is to our understanding therefore not applicable.

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: No

[Authors’ comments]: Reviewer #1 has not given any thorough review on what is missing. We therefore find it difficult to revise the manuscript, without this detailed information.

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: No

[Authors’ comments]: Language editing was undertaken before submitting the manuscript. This was done by an English speaking professional English Language Consultant with long experience in scientific language.

Reviewer #2: Yes

5. Review Comments to the Author

Reviewer #1:

• The preparation of Systematic Review was erroneous. Several lacunae were noted and authors should discuss with someone who has prepared SRs before, especially those who have worked with the Cochrane Collaboration.

[Authors’ comments]: This systematic review has been performed according to the guidelines from the Swedish Agency for Health Technology Assessment and Assessment of Social Services (SBU), which is a Swedish governmental agency focusing on assessing and evaluating methods in use in healthcare and social services. It is one of the world’s oldest HTA agencies, collaborating with Cochrane Sweden. We have referred to this in the manuscript (Line 175-178, side 7-8; ref #16 (Swedish Agency for Health Technology Assessment and Assessment of Social Services (SBU). Assessment of methods in health care—A handbook. Stockholm. 2018. Available: https://www.sbu.se/contentassets/76adf07e270c48efaf67e3b560b7c59c/eng_metodboken.pdf)). The PRISMA-statement has been followed as well (Line 159, side 6; ref #14 (Moher D, Liberati A, Tetzlaff J, Altman DG, The PG. Preferred reporting items for systematic reviews and meta-analyses: the PRISMA statement. PLoS Med. 2009;6(7):e1000097. doi: 10.1371/journal.pmed.1000097. PMID: 19621072)).

• Outcomes are not well defined and the PICO statement is incorrectly prepared.

[Authors’ comments]: We believe that the PICO is formulated correctly. We have defined the Population (Line 104, page 4), Interventions (Line 108, page 4 and Line 109-114, page 5), Control (line 116-124, page 5), and Outcome Measures (line 126-130, page 5). The SR has also been registered on PROSPERO (https://www.crd.york.ac.uk/PROSPERO/).

• Professional help should have been taken for preparation of Search Strategies.

[Authors’ comments]: This has been made (line 155-156, page 6). Two librarians specialized in informatics performed the search in all five databases, used in this SR.

Reviewer #2 (only the bullet points requiring revision):

• Please, add a PRISMA statement checklist.

[Authors’ comments]: PRISMA checklist was added in the first submission. We have however added it again with the current re-submission.

• Please, add an AMSTAR checklist.

[Authors’ comments]: This is added with the current re-submission.

• Please, define Limitations of the study.

[Authors’ comments]: Limitations of our study are mentioned, see Line 268-286, page 11-12. However we have inserted a phrase in the beginning of Line 268, page 11, and at the end of the first sentence on line 275, page 11, to make it clearer that limitations are discussed. “Possible limitations of this SR could be that the outcome measure (pain after dental treatment assessed by the child patient) was too narrow.”, and “The definition of the population could also be discussed, as a limitation of this SR.”

Attachments
Attachment
Submitted filename: Response to Reviewers.docx
Decision Letter - Federico Bilotta, Editor

Effects and cost-effectiveness of postoperative oral analgesics for additional postoperative pain relief in children and adolescents undergoing dental treatment: Health technology assessment including a systematic review

PONE-D-19-18628R1

Dear Dr. Berlin,

We are pleased to inform you that your manuscript has been judged scientifically suitable for publication and will be formally accepted for publication once it complies with all outstanding technical requirements.

Within one week, you will receive an e-mail containing information on the amendments required prior to publication. When all required modifications have been addressed, you will receive a formal acceptance letter and your manuscript will proceed to our production department and be scheduled for publication.

Shortly after the formal acceptance letter is sent, an invoice for payment will follow. To ensure an efficient production and billing process, please log into Editorial Manager at https://www.editorialmanager.com/pone/, click the "Update My Information" link at the top of the page, and update your user information. 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 enable them to help maximize its impact. If they will be preparing press materials for this manuscript, you must inform our press team as soon as possible and 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.

With kind regards,

Federico Bilotta

Academic Editor

PLOS ONE

Additional Editor Comments (optional):

PONE-D-19-18628R1

In this SR, the Authors conducted a systematic review (SR) and health technology assessment (HTA) of oral analgesics administered after dental treatment to prevent postoperative pain in children and adolescents aged 3-19 years.

A PICO-protocol was constructed and registered in PROSPERO (CRD42017075589). Searches were conducted in PubMed, Cochrane, Scopus, Cinahl, and EMBASE, November 2018. The researchers (reading in pairs) assessed identified studies independently, according to the defined inclusion and exclusion criteria, following the PRISMA-statement.

A total of 3,963 scientific papers were identified, whereof 216 read in full text. None met the inclusion criteria, leading to an empty SR. Ethical issues were identified related to the recognized knowledge gap in terms of challenges to conduct studies that are well-designed from methodological as well as ethical perspectives.

The Authors concluded that, there is no scientific support for the use or rejection of oral analgesics administered after dental treatment in order to prevent or reduce postoperative pain. Thus, no guidelines can be formulated on this issue based solely on scientific evidence. Well-designed studies on how to prevent pain from developing after dental treatment in children and adolescents is urgently needed.

The study is interesting and well conducted. The manuscript is well written and informative

Comments

Reviewer 1: No competing interests. Accept

Reviewer 2: The authors have satisfactorily responded to all my questions and made the necessary changes to the manuscript. Accept

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: Yes

Reviewer #2: Partly

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

Reviewer #1: I Don't Know

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

**********

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: (No Response)

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: Rafael Badenes

Formally Accepted
Acceptance Letter - Federico Bilotta, Editor

PONE-D-19-18628R1

Effects and cost-effectiveness of postoperative oral analgesics for additional postoperative pain relief in children and adolescents undergoing dental treatment: Health technology assessment including a systematic review

Dear Dr. Berlin:

I am 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 notify them about your upcoming paper at this point, to enable them to help maximize its impact. If they will be preparing press materials for this manuscript, 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.

For any other questions or concerns, please email plosone@plos.org.

Thank you for submitting your work to PLOS ONE.

With kind regards,

PLOS ONE Editorial Office Staff

on behalf of

Dr. Federico Bilotta

Academic Editor

PLOS ONE

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