Peer Review History

Original SubmissionDecember 3, 2019
Decision Letter - Andrew Soundy, Editor

PONE-D-19-33366

Patient preferences when searching for clinical trials and adherence of study records to ClinicalTrials.gov guidance in key registry data fields

PLOS ONE

Dear Prof Schindler,

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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Kind regards,

Andrew Soundy

Academic Editor

PLOS ONE

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"No. All authors and contributors were members of the TransCelerate Clinical Research Access and Information Exchange Initiative. The authors and contributors received support from TransCelerate in regard to project management. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript."

   

We note that one or more of the authors are employed by commercial companies: 'Boehringer Ingelheim Pharma', 'UCB BioSciences GmbH', 'Merck Sharp & Dohme Corp', 'Astellas Pharma', 'AbbVie Inc.', 'F. Hoffmann-La Roche Ltd' and 'GSK'.

a)    Please provide an amended Funding Statement declaring this commercial affiliation, as well as a statement regarding the Role of Funders in your study. If the funding organization did not play a role in the study design, data collection and analysis, decision to publish, or preparation of the manuscript and only provided financial support in the form of authors' salaries and/or research materials, please review your statements relating to the author contributions, and ensure you have specifically and accurately indicated the role(s) that these authors had in your study. You can update author roles in the Author Contributions section of the online submission form.

Please also include the following statement within your amended Funding Statement.

“The funder provided support in the form of salaries for authors [insert relevant initials], but did not have any additional role in the study design, data collection and analysis, decision to publish, or preparation of the manuscript. The specific roles of these authors are articulated in the ‘author contributions’ section.”

If your commercial affiliation did play a role in your study, please state and explain this role within your updated Funding Statement.

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Additional Editor Comments (if provided):

Please consider the comments made by the reviewer. Where possible use a framework to support choices e.g., https://www.equator-network.org.

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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: Partly

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

Reviewer #1: Yes

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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

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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

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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: As the authors point out, the information contained in glinicaltrials.gov should be adapted to the needs of the patients. There are no previous studies that have evaluated this aspect, so the work is relevant, very current and may have implications for improving the information in the database.

The project, divided into several phases, has generated some interesting results. However, in my opinion, neither the structure of the work nor its contents follow the basic rules of an original article. The work has more the structure of a "report" than of a scientific article. Although it is structured in the classic sections of “introduction, material and methods”, “discussion” and “conclusions”, each of these sections mixes aspects of the rest.

Objectives: the main objectives of the study must be clearly specified at the end of the introduction, avoiding the inclusion of aspects of the methodology (first paragraph on page 5).

Methods: At the beginning of this section, the authors should give a general perspective on the methodology used, indicating the primary, secondary objectives, as well as all the analyzes that will be carried out, the rating scales included, the criteria used etc. The Validation Assessment section includes “results” that should go to the corresponding section.

Results: the reading of this section is extremely complex, excessively fragmented and it is not obvious which are the most relevant findings. In addition, each of the sections begins with a methodological description that was not previously specified in the "Methods" section. For example, the last paragraph on page 13, the last paragraph on page 14, the first paragraph on page 16, or the last paragraphs on pages 17 and 18 describe for the first time the methods used, the scales applied, etc.

Tables 4 and 5 are not easy to interpret and their contents do not seem to be aligned with the results of the text. In my opinion, the work should include fewer tables and figures, selecting the most relevant findings of the work. Although they include different analyses, some of the results in Tables 2-4 seem contradictory. For example, “location” appears as one of the most important items in table 2 and occupies a lower place in table 3. This type of inconsistencies should be explained in the Discussion.

The reason for the diversity in the rating scales and the criteria used should be explained: some range from 1 to 7, others from 1 to 8, figures 1 and 2 do not use the same credentials (one of the three most helfulp vs the item is helpful). The reasons for these variations should be explained.

Discussion: The discussion must interpret the results, however, the authors repeat again the objectives (last paragraph of page 23, second paragraph of page 24) and the methods (first paragraph of the discussion, third paragraph of page 24, second paragraph on page 25 etc.). The most important results should be discussed and interpreted, emphasizing what the study provides, the most relevant results, the most surprising, the limitations, etc.

The main results (first paragraph on page 25) should be commented at the beginning of the discussion and not on the third page. The first 3-4 paragraphs of the discussion are repetitive and do not constitute a discussion on the subject.

It seems that one of the conclusions of the study is that a short title should include information on: the condition, health measures (??), the age of the participants, the name of the drug, and the form of the drug. Is this really the relevant information for patients? Do authors think that information on the health measures used contributes more to patients engagement in research than information on start and end dates of the study? These are somewhat surprising results that the authors should comment on the discusion.

Conclusion: It is not clear which are the 2-3 main conclusions of the study.

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Reviewer #1: No

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Revision 1

In response to an email from Michelle Ellis (received 15 April 2020) we updated the funding statement and updated competing interest statements and included the revised versions in the cover letter as instructed.

Attachments
Attachment
Submitted filename: Response to reviewers.docx
Decision Letter - Andrew Soundy, Editor

Patient preferences when searching for clinical trials and adherence of study records to ClinicalTrials.gov guidance in key registry data fields

PONE-D-19-33366R1

Dear Dr. Schindler,

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,

Andrew Soundy

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

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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

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

Reviewer #1: 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

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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

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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 addressed satisfactorily to most of this reviewer's comments. The structure of the work is more in line with what is expected from an original article. The introduction section has been remarkably improved, although the last sentence “The insights gained were then to be used in the development of a tool that helps sponsors to assess the quality of their clinical trial submissions to ClinicalTrials.gov.” should be removed as it refers to the method. The results are correct, although in my opinion the number of tables is excessive. The discussion has improved very much, and it is easier to read.

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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

Formally Accepted
Acceptance Letter - Andrew Soundy, Editor

PONE-D-19-33366R1

Patient preferences when searching for clinical trials and adherence of study records to ClinicalTrials.gov guidance in key registry data fields

Dear Dr. Schindler:

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. Andrew Soundy

Academic Editor

PLOS ONE

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