The effect of the CONSORT statement on the amount of “unclear” Risk of Bias reporting in Cochrane Systematic Reviews

Maaike M. Rademaker; Geerte G. J. Ramakers; Adriana L. Smit; Lotty Hooft; Inge Stegeman

doi:10.1371/journal.pone.0235535

Peer Review History

Original SubmissionNovember 12, 2019
9 Dec 2019 Decision Letter - Vance Berger, Editor PONE-D-19-31501 The effect of the CONSORT statement on the amount of “unclear” Risk of Bias reporting in Cochrane Systematic Reviews PLOS ONE Dear Drs Rademaker, 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. We would appreciate receiving your revised manuscript by Jan 23 2020 11:59PM. When you are 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. If you would like to make changes to your financial disclosure, please include your updated statement in your cover letter. To enhance the reproducibility of your results, we recommend that if applicable you deposit your laboratory protocols in protocols.io, where a protocol can be assigned its own identifier (DOI) such that it can be cited independently in the future. For instructions see: http://journals.plos.org/plosone/s/submission-guidelines#loc-laboratory-protocols 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). This letter should be uploaded as separate file and labeled 'Response to Reviewers'. A marked-up copy of your manuscript that highlights changes made to the original version. This file should be uploaded as separate file and labeled 'Revised Manuscript with Track Changes'. An unmarked version of your revised paper without tracked changes. This file should be uploaded as separate file and labeled 'Manuscript'. Please note while forming your response, if your article is accepted, you may have the opportunity to make the peer review history publicly available. The record will include editor decision letters (with reviews) and your responses to reviewer comments. If eligible, we will contact you to opt in or out. We look forward to receiving your revised manuscript. Kind regards, Vance W. Berger, PhD Academic Editor PLOS ONE Journal Requirements: 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. The PLOS ONE style templates can be found at http://www.plosone.org/attachments/PLOSOne_formatting_sample_main_body.pdf and http://www.plosone.org/attachments/PLOSOne_formatting_sample_title_authors_affiliations.pdf Please discuss why you have limited your search to systematic reviews published December, November and October 2016. We noticed you have some minor occurrence(s) of overlapping text with the following previous publication(s), which needs to be addressed: https://doi.org/10.1371/journal.pone.0173358 https://doi.org/10.1136/bmjopen-2018-023729 https://doi.org/10.1016/j.jclinane.2017.01.017 In your revision ensure you cite all your sources (including your own works), and quote or rephrase any duplicated text outside the Methods section. Further consideration is dependent on these concerns being addressed. 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/supportinxg-information. Additional Editor Comments (if provided): You seem to have missed the opportunity to challenge the very notion of "unclear risk of bias". What does that mean, really? "Risk", by its very definition, conveys a lack of certainty. If we lack certainty about risk, then by definition there is risk. Unclear risk means there is a risk of a risk, which is to say, there is a risk. We are far too tolerant of authors who do not provide sufficient information to allow a reader to assess risk. The onus, or burden of proof, is on the authors to rule out risk. If they fail to do so, then they do NOT get the benefit of the doubt. That is the essence of high risk of bias. See: Berger, VW (2006). ”Missing Data Should Be More Heartily Penalized”, Journal of Clinical Epidemiology 59, 7, 759-760. Berger, VW (2012). “Conservative Handling of Missing Data”, Contemporary Clinical Trials 33, 460. Berger, VW (2012). “Conservative Handling of Missing Information”, Journal of Clinical Epidemiology 65, 1237-1238. Berger, VW (2012). “Internal Validity and the Risk of Bias: A Case for a Comprehensive Review”, Journal of Anesthesia 26, 802-803. Berger, VW, Mickenautsch, S (2015). “On the Need for Objective Measures of Risk of Bias”, Contemporary Clinical Trials 41, 202-203. Also, since you mention CONSORT so prominently, it seems fair to question what it offers, in terms of value added, since 1) it is grossly incomplete; 2) in some cases it is demonstrably wrong; and 3) even where it is correct all it does is repackage sage advice that was already out there prior to 1996. Adherence to CONSORT is neither necessary nor sufficient for a good trial, and you have the opportunity to mention that, too. See: Palys, K, Berger, VW (2013). “On the Incompleteness of CONSORT”, JNCI 105, 3, 244. [Note: HTML markup is below. Please do not edit.] [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.] 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 us at figures@plos.org. Please note that Supporting Information files do not need this step. https://doi.org/10.1371/journal.pone.0235535.r001
Revision 1
23 Jan 2020 Author Response Dear dr. Berger, We would like to thank you for your review of our work. We have read your papers with joy and interest , and have added the mentioned discussion points to the paper. Please read our response to the points raised in the letter below. 1. Please ensure that your manuscript meets PLOS ONE's style requirements, including those for file naming a. We have revised the manuscript to adhere to the guidelines, we have substantially shortened the abstract 2. Please discuss why you have limited your search to systematic reviews published December, November and October 2016. a. In order to make our work feasible, we have limited our search to December, November and October 2016, we think this provides us with an extensive and representative sample of reviews. 3. We noticed you have some minor occurrence(s) of overlapping text with the following previous publication(s), which needs to be addressed: https://doi.org/10.1371/journal.pone.0173358 https://doi.org/10.1136/bmjopen-2018-023729 https://doi.org/10.1016/j.jclinane.2017.01.017 In your revision ensure you cite all your sources (including your own works), and quote or rephrase any duplicated text outside the Methods section. Further consideration is dependent on these concerns being addressed. a. We did not see the mentioned publications before, and after extensive reading, are unable to find the sentences in our paper. Could you give us an indication of the exact sentences?. 4. 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/supportinxg-information. a. We have included the captions for our supporting information file at the end of the manuscript. 5. You seem to have missed the opportunity to challenge the very notion of "unclear risk of bias". What does that mean, really? "Risk", by its very definition, conveys a lack of certainty. If we lack certainty about risk, then by definition there is risk. Unclear risk means there is a risk of a risk, which is to say, there is a risk. We are far too tolerant of authors who do not provide sufficient information to allow a reader to assess risk. The onus, or burden of proof, is on the authors to rule out risk. If they fail to do so, then they do NOT get the benefit of the doubt. That is the essence of high risk of bias. See: a. Thank you very much for your critical note. have now added this point in the discussion section of our paper. 6. Also, since you mention CONSORT so prominently, it seems fair to question what it offers, in terms of value added, since 1) it is grossly incomplete; 2) in some cases it is demonstrably wrong; and 3) even where it is correct all it does is repackage sage advice that was already out there prior to 1996. Adherence to CONSORT is neither necessary nor sufficient for a good trial, and you have the opportunity to mention that, too. See: a. We have revised the discussion in concern to this point. We would like to thank you again for your thorough work. We hope you consider the revisions suitable. We hope you consider our manuscript suitable for peer-review. Kind regards, On behalf of all co-authors, Maaike Rademaker Attachments Attachment Submitted filename: Response to Reviewers.docx https://doi.org/10.1371/journal.pone.0235535.r002
3 Mar 2020 Decision Letter - Vance Berger, Editor PONE-D-19-31501R1 The effect of the CONSORT statement on the amount of “unclear” Risk of Bias reporting in Cochrane Systematic Reviews PLOS ONE Dear Drs Rademaker, 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. We would appreciate receiving your revised manuscript by Apr 17 2020 11:59PM. When you are 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. If you would like to make changes to your financial disclosure, please include your updated statement in your cover letter. To enhance the reproducibility of your results, we recommend that if applicable you deposit your laboratory protocols in protocols.io, where a protocol can be assigned its own identifier (DOI) such that it can be cited independently in the future. For instructions see: http://journals.plos.org/plosone/s/submission-guidelines#loc-laboratory-protocols 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). This letter should be uploaded as separate file and labeled 'Response to Reviewers'. A marked-up copy of your manuscript that highlights changes made to the original version. This file should be uploaded as separate file and labeled 'Revised Manuscript with Track Changes'. An unmarked version of your revised paper without tracked changes. This file should be uploaded as separate file and labeled 'Manuscript'. Please note while forming your response, if your article is accepted, you may have the opportunity to make the peer review history publicly available. The record will include editor decision letters (with reviews) and your responses to reviewer comments. If eligible, we will contact you to opt in or out. We look forward to receiving your revised manuscript. Kind regards, Vance W. Berger, PhD Academic Editor PLOS ONE Additional Editor Comments (if provided): The revision looks much improved. Please address the reviewer comments, and also please note that the conclusions in the abstract are not, in fact, conclusions, since they are statements of what was directly observed. So this makes them results, and the question remains, what do you conclude from this study? [Note: HTML markup is below. Please do not edit.] 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: (No Response) ******** 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: Partly ****** 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 ****** 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 ****** 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: This is a relatively straightforward manuscript describing trends in time in the risk of bias in randomized clinical trials as determined by authors of Cochrane systematic reviews. The aim of the study was to evaluate the impact of the CONSORT reporting guidelines on the risk of bias as reported in these trials. The study was completed adequately, but there are a few questions about the methods that should be clarified in the manuscript. 1. Some justification needs to be included in the manuscript for why only the reviews published in December, November, and December 2016 were included. I see the authors responded to this question previously, but the reason needs to be included in the manuscript. 2. Were the 989 RCTs unique. Sometimes RCTs are used in more than one review. 3. Only one person extracted data. It would have been preferably for a second person to have extracted at least a sample. This is especially concerning in that the methods state that “Data on sub categories was not assessed.” Often the risk of bias for blinding/masking is assessed by outcome. If a systematic reviewer assessed risk of bias for more than one outcome, how was the data extracted? Were all these ignored or was there some kind of averaging done? ****** 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 [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.] 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 us at figures@plos.org. Please note that Supporting Information files do not need this step. https://doi.org/10.1371/journal.pone.0235535.r003
Revision 2
16 Apr 2020 Author Response Dear dr. Berger and reviewer, Thank you in advance for the effort of reviewing our manuscript. We have revised it carefully and adjusted some items. Please find our response to the commentary below. Additional Editor Comments (if provided): 1. The revision looks much improved. Please address the reviewer comments, and also please note that the conclusions in the abstract are not, in fact, conclusions, since they are statements of what was directly observed. So this makes them results, and the question remains, what do you conclude from this study? We have updated the abstract. Reviewer #1: This is a relatively straightforward manuscript describing trends in time in the risk of bias in randomized clinical trials as determined by authors of Cochrane systematic reviews. The aim of the study was to evaluate the impact of the CONSORT reporting guidelines on the risk of bias as reported in these trials. The study was completed adequately, but there are a few questions about the methods that should be clarified in the manuscript. 1. Some justification needs to be included in the manuscript for why only the reviews published in December, November, and December 2016 were included. I see the authors responded to this question previously, but the reason needs to be included in the manuscript. We have added this to the discussion. 2. Were the 989 RCTs unique. Sometimes RCTs are used in more than one review. Thank you for your point. We have checked this and adjusted in the review. There are 988 unique RCTS, one RCT was used for two reviews. Please see line 103. For the record both reviews judged the RoB for this RCT differently. 3. Only one person extracted data. It would have been preferably for a second person to have extracted at least a sample. Thank you for your comment, we have checked 10% of the RCTs randomly with research randomizer.com. This resulted in 145 RCTs and 1015 RoB assesments, of which 19 missings. We were able to discover 4 mistakes data extraction for one RCT (0.39%). We corrected the data file, reran our analyses and updated the result section of the paper. This is especially concerning in that the methods state that “Data on sub categories was not assessed.” Often the risk of bias for blinding/masking is assessed by outcome. If a systematic reviewer assessed risk of bias for more than one outcome, how was the data extracted? Were all these ignored or was there some kind of averaging done? In this paper we stuck to the seven RoB items as defined by the Cochrane Risk of Bias tool. If a review adjusted the tool; we ignored the adjustments and stuck to the ‘pure’ seven RoB items. There was no averaging done. This was also added to the discussion. We would like to thank you both again for your revisions. We hope you consider the revisions suitable. Kind regards, On behalf of all co-authors, Maaike Rademaker Attachments Attachment Submitted filename: Response to Reviewers.docx https://doi.org/10.1371/journal.pone.0235535.r004
18 Jun 2020 Decision Letter - Vance Berger, Editor The effect of the CONSORT statement on the amount of “unclear” Risk of Bias reporting in Cochrane Systematic Reviews PONE-D-19-31501R2 Dear Dr. Rademaker, 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, Vance Berger 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 ******** 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 ****** 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 ****** 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 ****** 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) ****** 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 https://doi.org/10.1371/journal.pone.0235535.r005
Formally Accepted
24 Jun 2020 Acceptance Letter - Vance Berger, Editor PONE-D-19-31501R2 The effect of the CONSORT statement on the amount of “unclear” Risk of Bias reporting in Cochrane Systematic Reviews Dear Dr. Rademaker: 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 Vance Berger Academic Editor PLOS ONE https://doi.org/10.1371/journal.pone.0235535.r006

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