Peer Review History

Original SubmissionJuly 9, 2020
Decision Letter - Alan D Hutson, Editor

PONE-D-20-21077

Is Reporting Quality in Medical Publications Associated with Biostatisticians as Co-Authors? A Registered Report Protocol.

PLOS ONE

Dear Dr. Held,

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.

Please attend to the minor comments.  All of the reviewers thoroughly found this work important.

Please submit your revised manuscript by Oct 29 2020 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: http://journals.plos.org/plosone/s/submission-guidelines#loc-laboratory-protocols

We look forward to receiving your revised manuscript.

Kind regards,

Alan D Hutson

Academic Editor

PLOS ONE

Additional Editor Comments:

Please attend to the minor comments. All of the reviewers thoroughly found this work important.

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. 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.

[Note: HTML markup is below. Please do not edit.]

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 #3: Yes

Reviewer #4: Yes

**********

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 #3: Yes

Reviewer #4: Yes

**********

3. Is the methodology feasible and described in sufficient detail to allow the work to be replicable?

Reviewer #1: Yes

Reviewer #3: Yes

Reviewer #4: 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 #1: Yes

Reviewer #3: Yes

Reviewer #4: 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 #3: Yes

Reviewer #4: 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 #1: I have only minor comments.

1) Your use of 'case' and 'control' is non-standard and may confuse some readers. This is the distinction that is used in observational studies where sampling is by outcome. Sometimes these are called retrospective studies but more commonly the preferable term 'case-control' study is used. For example, you might sample cases of lung-cancer and controls who do not have lung cancer. Other types of study classify groups by exposure, not by outcome. For example, you might classify subjects as exposed 'smoker' or not-exposed 'non-smoker'. Such studies are referred to as cohort studies. It is a standard epidemiological teaching that case control studies are good at studying multiple putative causal factors and cohort studies are good at studying multiple possible effects. Here you have the analogue of a cohort study, albeit with papers rather than subjects as the unit of study. I think it would be more usual to refer to the two groups as either exposed or non-exposed (as in an observational study) or 'treated' or possibly 'experimental' versus 'control' as for an interventional study. I agree that this terminology is not ideal here but I worry about what you have chosen. Perhaps all you need to note at the beginning is that 'case' and 'control' are not being used as in many observational studies.

2) I have checked your sample size calculation and find it to be correct provided that you intend to use a two-sample t-test with equal variances to perform a conventional significance test. Is this what you intend? You don't actually say what the intended analysis corresponding to your sample size calculation is.

3) Later you refer to t-tests and Wilcoxon test and say they will be used 'as appropriate' but you don't actually say how you will decide what is appropriate. (Note I am definitely not encouraging you to use a test of Normality to decide between them. Nevertheless this sort of 'as appropriate' statement is something that would not generally be accepted as adequate for a statistical analysis plan in drug development.)

4) Various typos and minor issues

a) L40 'Doug' not 'Dough'

b)L41 This quotation does not sound quite right. Please check it and provide a reference.

c)L50. Suggest 'most frequently used' rather than 'most frequent'

d) L120. 'TRIPOD' not 'TROPID'

e) L158 0.41 is a rather unusual choice of effect size. Is it the case that this is the value that guarantees 80% power for the sample size you intend to use?

f) L179. How will the confidence intervals be calculated? T-test. Hodges-Lehmann Wilcoxon

Reviewer #3: This is a novel and important research idea that is much needed. As statistical techniques increase in sophistication, somewhat due to increased computing power, we can’t expect physicians and practitioners to always know every statistical nuance that could be applied to their research. Reliance on statisticians to guide methodological decision-making should be normalized to advance science in the best, most sophisticated way.

The authors nicely lay out the purpose of this work, especially in the introductory discussion to include biostatisticians on interdisciplinary research teams despite following STROBE check-lists.

My suggestions to improve this report protocol are as follows:

1. Consider re-labeling the “control” publications group as a “comparison” publications group. Since biostatisticians were not randomly assigned to author teams / projects, it is not a true control, but rather a comparison.

2. In the introductory paragraph that describes the comparison / control group, please be explicitly clear that this group is of papers who do not have a statistician listed as an author. This is implied in the introduction, but it could be clearer in this paragraph. (Lines 84-90, page 5).

3. One item to discuss or acknowledge is whether the research center from which you pull these papers has an authorship policy of some sort that would impact whether a biostatistician is added to the authorship list. For example, is there a standard policy of deciding authorship on papers? If yes or no, please describe. Also, is there an informal or collegial policy that this research center follows with reagrds to authorship? For example, if you know that statisticians are always included as authors when they help with methodologies in this research center, that would be good to state in this report protocol as a certainty that the study cases will be correctly classified.

4. Another thought, that may or may not be relevant, but you may wish to address – are statisticians sometimes acknowledged or thanked in papers but not added as authors? If they are thanked and were a part of the research, but not an author on the manuscript which is then classified in the control group, this may represent a mis-classification of that paper.

Otherwise, the proposed methodology that is laid out in this submission is very well-thought and rigorous. I look forward to reading about the results of this important and interesting work.

Reviewer #4: This is a very interesting study. I especially like the use of R and Shiny. Here are some suggested edits.

Intro section, first sentence - if possible, please say a few words on what you mean by quality.

Second sentence - should be "In times when the mere..." Add the word 'the'?

You quote Doug Altman - but it is misspelled. Please add reference if there is one.

'Some medical journals' are mentioned. can you give examples: (e.g., Lancet, ...)

You mention reliability, perceived value, and reporting quality. Please define these briefly here.

The EQUATOR network is mentioned. Please give a reference or website link.

Methods section:

The frequency matching approach is mentioned. Please give a definition and/or reference.

In the fifth paragraph, initials are used. I realized later these are for the authors. Please mention that here.

I liked how you identified the quality measures.

**********

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: Stephen Senn

Reviewer #3: No

Reviewer #4: 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.

Revision 1

Dear Dr. Hutson

Thank you for informing me and my co-authors about the minor revision of the registered report protocol.

We are resubmitting a revised version of the protocol, that was improved by the reviewer suggestions.

All reviewer comments were addressed in our response letter.

Kind regards

Ulrike Held

Attachments
Attachment
Submitted filename: response.pdf
Decision Letter - Alan D Hutson, Editor

Is Reporting Quality in Medical Publications Associated with Biostatisticians as Co-Authors? A Registered Report Protocol.

PONE-D-20-21077R1

Dear Dr. Held,

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,

Alan D Hutson

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

Reviewer #4: Yes

**********

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

Reviewer #4: Yes

**********

3. Is the methodology feasible and described in sufficient detail to allow the work to be replicable?

Reviewer #3: Yes

Reviewer #4: 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: Yes

Reviewer #4: 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 #3: Yes

Reviewer #4: 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 nicely addressed all of the reviewers' comments. I recommend the article for publication.

Reviewer #4: The paper is much improved. All of my comments were addressed adequately, and I have no further edits or issues to address. Thank you.

**********

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: Yes: Melissa Kovacs

Reviewer #4: No

Formally Accepted
Acceptance Letter - Alan D Hutson, Editor

PONE-D-20-21077R1

Is reporting quality in medical publications associated with biostatisticians as co-authors? A registered report protocol

Dear Dr. Held:

I'm 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 let them know about your upcoming paper now to help maximize its impact. If they'll be preparing press materials, 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.

If we can help with anything else, please email us at plosone@plos.org.

Thank you for submitting your work to PLOS ONE and supporting open access.

Kind regards,

PLOS ONE Editorial Office Staff

on behalf of

Dr. Alan D Hutson

Academic Editor

PLOS ONE

Open letter on the publication of peer review reports

PLOS recognizes the benefits of transparency in the peer review process. Therefore, we enable the publication of all of the content of peer review and author responses alongside final, published articles. Reviewers remain anonymous, unless they choose to reveal their names.

We encourage other journals to join us in this initiative. We hope that our action inspires the community, including researchers, research funders, and research institutions, to recognize the benefits of published peer review reports for all parts of the research system.

Learn more at ASAPbio .