Peer Review History

Original SubmissionJune 20, 2019
Decision Letter - Wisit Cheungpasitporn, Editor

PONE-D-19-17507

Are trials of psychological and psychosocial interventions for schizophrenia and psychosis included in the NICE guidelines pragmatic?

PLOS ONE

Dear Dr. CHIARA GASTALDON,

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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ACADEMIC EDITOR: Although it is of interest, the reviewers have raised a number of points which we believe major modifications are necessary to improve the manuscript, taking into account the reviewers' remarks.  

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We look forward to receiving your revised manuscript.

Kind regards,

Wisit Cheungpasitporn, MD, FACP

University of Mississippi Medical Center

Twitter: @wisit661 Email: wcheungpasitporn@gmail.com 

Academic Editor

PLOS ONE

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[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: Partly

Reviewer #3: Partly

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

Reviewer #1: Yes

Reviewer #2: Yes

Reviewer #3: I Don't Know

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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: Yes

Reviewer #2: Yes

Reviewer #3: 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: No

Reviewer #3: 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: General aspects

It is a review paper in which he seeks arguments for a treatment guide for schizophrenia and other psychoses. There was a careful inclusion criterion of statistical studies and care, although of basic statistics, the results have discussed aspects that gives support to the conclusion.

Here there are some questions:

1)      The study presents the results of scientific research. Despite being a systematic review study, the presentation of the results is adequate, being a study of the evaluation of NICE pragmatism from previously published works. This point is important for using the guide.

2. Results reported have not been published elsewhere. Although being a review article, the results were organized in an appropriate way to think about the validity or not of the NICE.

3. A basic statistic was used, but the way the authors clustered the data was adequate.

4. Conclusions are presented in an appropriate fashion and are supported by the data.

5. Regarding the references of the 143 studies, will these studies be in supplemental material?

6. There are two initials that don’t have meanings.

7. It was observed that the author does not explain the meaning of two initials – see pg 7.

Reviewer #2: Some revision of the English language is needed. There are some parts of the paper where it is quite difficult to make sense of some sentences. English edit will help to improve the quality of the manuscript. To mention as several as below:

“These cut-offs where selected to distinguish” ???where

“more pragmatic then others” ???then

“other diagnosis” is not correct in grammar

“the risk of bias dimensions were dichotomized” is not correct in grammar.

“both pragmatism” is not correct in grammar

“evidences” is not correct. It is uncountable noun.

“may be interpret” is not correct in grammar.

“involved to stimulate” is not correct in grammar.

Reviewer #3: Definition of pragmatism is unclear. Authors assumed that most people are well versed in the definition and topic of pragmatism in psychiatry. It will be easier for people to understand the message of this paper if definitions of important keywords such as pragmatism and explanatory are well defined.

Authors mentioned that cut off point for studies included was 2009 and NICE was published in 2014, therefore more studies should have been included. However, to honor the protocol of the NICE guidelines, only studies up to 2009 were taken. Therefore it is not a good suggestion to highlight NICE should take more recent studies, as that would violate their protocol. Furthermore, it takes time from the studies taken within the cut off period to the production of a guideline. Furthermore, the authors did say that no statistical significance found between years of publication with pragmatism (page 14 of manuscript).

In page 6 of the manuscript, authors mentioned PRECIS-2 was developed in 2015. NICE guideline was published in 2014, therefore it is not possible to use PRECIS-2 as a measure of pragmatism in including relevant studies for this guidelines, prior to its publication. However it is a good idea to use these criteria retrospectively to examine the level of pragmatism.

Their strength and limitations were addressed.

As for conclusion, in my opinion it is acceptable to say “2/3 of studies used to produce NICE recommendations on psychosocial interventions for the treatment of schizophrenia and psychosis in adults are based on studies that did not employ a pragmatic design”. But to say “This poses serious concerns to the applicability of NICE recommendations” is a rather strong statement as we are aware that studies involving psychosocial treatments are already very scarce in the current picture. Even if these studies were not as pragmatic as indicated by the PRECIS-2, they are still important and relevant in production of the NICE 2014 guideline, which uses an evident-based medicine approach. Perhaps suggestion to use PRECIS-2 as a measure of pragmatism for future studies before including them in future guidelines suggestion is sufficient, without needing to point out the threat that it poses with regards to NICE’s applicability.

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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.

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Reviewer #1: Yes: Anuska Irene de Alencar

Reviewer #2: No

Reviewer #3: 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 to be viewed.]

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Attachments
Attachment
Submitted filename: Pone D 19 17507 review.pdf
Revision 1

JOURNAL REQUIREMENTS:

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

Please ensure that your manuscript meets PLOS ONE's style requirements, including those for file naming.

Author: thank you, we changed the file according to the requirements

2. Please include captions for your Supporting Information files at the end of your manuscript, and update any in-text citations to match accordingly. Please see our Supporting Information guidelines for more information: http://journals.plos.org/plosone/s/supporting-information.

Author: thank you, we included what you asked

3. At this time we request that you update the title of this manuscript to identify it as a systematic review, as indicated in the PRISMA checklist.

Author: thank you, we changed the title as required by the PRISMA STATEMENT

RESPONSE TO REVIEWERS

Reviewer #1: General aspects

It is a review paper in which he seeks arguments for a treatment guide for schizophrenia and other psychoses. There was a careful inclusion criterion of statistical studies and care, although of basic statistics, the results have discussed aspects that gives support to the conclusion.

Author: thank you, no revision needed

Here there are some questions:

1) The study presents the results of scientific research. Despite being a systematic review study, the presentation of the results is adequate, being a study of the evaluation of NICE pragmatism from previously published works. This point is important for using the guide.

Author: no revision needed

2. Results reported have not been published elsewhere. Although being a review article, the results were organized in an appropriate way to think about the validity or not of the NICE.

Author: no revision needed

3. A basic statistic was used, but the way the authors clustered the data was adequate.

Author: no revision needed

4. Conclusions are presented in an appropriate fashion and are supported by the data.

Author: no revision needed

5. Regarding the references of the 143 studies, will these studies be in supplemental material?

Author: yes studies are already available in supplementary material

6. There are two initials that don’t have meanings.

Author: Corrected

7. It was observed that the author does not explain the meaning of two initials – see pg 7.

Author: Corrected

Reviewer #2: Some revision of the English language is needed. There are some parts of the paper where it is quite difficult to make sense of some sentences. English edit will help to improve the quality of the manuscript. To mention as several as below:

“These cut-offs where selected to distinguish” ???where

“more pragmatic then others” ???then

“other diagnosis” is not correct in grammar

“the risk of bias dimensions were dichotomized” is not correct in grammar.

“both pragmatism” is not correct in grammar

“evidences” is not correct. It is uncountable noun.

“may be interpret” is not correct in grammar.

“involved to stimulate” is not correct in grammar.

Author: revision of the English language was done, thank you.

Reviewer #3: Definition of pragmatism is unclear. Authors assumed that most people are well versed in the definition and topic of pragmatism in psychiatry. It will be easier for people to understand the message of this paper if definitions of important keywords such as pragmatism and explanatory are well defined.

author: ok, thank you. A definition of pragmatism was added. The new text reads as follows: “Pragmatic randomised trials are usually undertaken to help support a decision on whether an intervention should be delivered in a real-world setting. Explanatory randomised trials, by contrast, are undertaken to test whether an intervention is effective under ideal circumstances. There is no simple threshold to determine whether a trial is explanatory or pragmatic, and there are few purely explanatory or pragmatic trials. In most cases, trials include both explanatory and pragmatic characteristics, suggesting a continuum, rather than a dichotomy, between these two polarities (3).”

Authors mentioned that cut off point for studies included was 2009 and NICE was published in 2014, therefore more studies should have been included. However, to honor the protocol of the NICE guidelines, only studies up to 2009 were taken. Therefore it is not a good suggestion to highlight NICE should take more recent studies, as that would violate their protocol. Furthermore, it takes time from the studies taken within the cut off period to the production of a guideline. Furthermore, the authors did say that no statistical significance found between years of publication with pragmatism (page 14 of manuscript).

Author: Actually we are not suggesting that NICE should have taken more recent studies in that guideline, but that NICE should update the guideline itself. The guideline is based on evidence published up to 2009. We think that it would be important to update the guideline including newer studies, considering that this field is rapidly evolving.

In page 6 of the manuscript, authors mentioned PRECIS-2 was developed in 2015. NICE guideline was published in 2014, therefore it is not possible to use PRECIS-2 as a measure of pragmatism in including relevant studies for this guidelines, prior to its publication. However it is a good idea to use these criteria retrospectively to examine the level of pragmatism.

Author: As reported by the referee, and as mentioned in the paper, we retrospectively examined the level of pragmatism of those trials using PRECIS-2.

Their strength and limitations were addressed.

Author: thank you, no revision needed

As for conclusion, in my opinion it is acceptable to say “2/3 of studies used to produce NICE recommendations on psychosocial interventions for the treatment of schizophrenia and psychosis in adults are based on studies that did not employ a pragmatic design”. But to say “This poses serious concerns to the applicability of NICE recommendations” is a rather strong statement as we are aware that studies involving psychosocial treatments are already very scarce in the current picture. Even if these studies were not as pragmatic as indicated by the PRECIS-2, they are still important and relevant in production of the NICE 2014 guideline, which uses an evident-based medicine approach. Perhaps suggestion to use PRECIS-2 as a measure of pragmatism for future studies before including them in future guidelines suggestion is sufficient, without needing to point out the threat that it poses with regards to NICE’s applicability.

Author: We believe the referee is right. The sentence “This poses serious concerns to the applicability of NICE recommendations” was deleted from the conclusions of the abstract and main text.

Attachments
Attachment
Submitted filename: Response to Reviewers.docx
Decision Letter - Wisit Cheungpasitporn, Editor

[EXSCINDED]

Are trials of psychological and psychosocial interventions for schizophrenia and psychosis included in the NICE guidelines pragmatic? A systematic review

PONE-D-19-17507R1

Dear Dr. CHIARA GASTALDON,

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.

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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,

Wisit Cheungpasitporn, MD, FACP

University of Mississippi Medical Center

Twitter: @wisit661 Email: wcheungpasitporn@gmail.com 

Academic Editor

PLOS ONE

Additional Editor Comments:

I want to commend the authors on their superb efforts to revise the manuscript according to all reviewers’ suggestions. The quality of the manuscript has improved substantially.

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: Yes

**********

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

Reviewer #1: Yes

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: It is a review paper in which he seeks arguments for a treatment guide for schizophrenia and other psychoses. There was a careful inclusion criterion of statistical studies and care, although of basic statistics, the results have discussed aspects that gives support to the conclusion.

Reviewer #2: the authors have addressed the raised issues, no further comment. all comments were appropriate and welcome accept as is

**********

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: Anuska Irene de Alencar

Reviewer #2: No

Formally Accepted
Acceptance Letter - Wisit Cheungpasitporn, Editor

PONE-D-19-17507R1

Are trials of psychological and psychosocial interventions for schizophrenia and psychosis included in the NICE guidelines pragmatic? A systematic review

Dear Dr. Gastaldon:

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. Wisit Cheungpasitporn

Academic Editor

PLOS ONE

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