Peer Review History
| Original SubmissionMay 22, 2024 |
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PONE-D-24-20434Discrepancies between pre-specified and reported primary outcomes: a cross-sectional analysis of randomized controlled trials in gastroenterology and hepatology journalsPLOS ONE Dear Dr. Zhang, 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 submit your revised manuscript by Sep 29 2024 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:
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. We look forward to receiving your revised manuscript. Kind regards, Sascha Köpke Academic Editor PLOS ONE 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. 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 2. Thank you for stating the following in the Competing Interests section: "I have read the journal's policy and the authors of this manuscript have the following competing interests: Adriano R. Tonelli plays as an advisory board for Janssen and Merck and received grant from Janssen; Szymon Bialka is the secretary of the Silesian Branch of the Polish Society of Anesthesiology and Intensive Care from 2021 till now, the president of the Section of Regional Anesthesia and Pain Therapy and Polish Society of Anesthesiology and Intensive Care from 2021 til now, continued Treasurer of the Polish Society of Regional Anesthesia and Pain Therapy from 2023 till now, a co-creator patent device for isolating a patient with suspected infectious disease (exclusive right number: Pat.243051)." Please confirm that this does not alter your adherence to all PLOS ONE policies on sharing data and materials, by including the following statement: ""This does not alter our adherence to PLOS ONE policies on sharing data and materials.” (as detailed online in our guide for authors http://journals.plos.org/plosone/s/competing-interests). If there are restrictions on sharing of data and/or materials, please state these. Please note that we cannot proceed with consideration of your article until this information has been declared. Please include your updated Competing Interests statement in your cover letter; we will change the online submission form on your behalf. [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: Yes ********** 2. Has the statistical analysis been performed appropriately and rigorously? Reviewer #1: I Don't Know Reviewer #2: Yes ********** 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 ********** 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 ********** 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: Dear editor, dear authors, thank you for giving me the opportunity to review the paper entitled „Discrepancies between pre-specified and reported primary outcomes: a cross-sectional analysis of randomized controlled trials in gastroenterology and hepatology journals“. The paper describes registration rates, discrepancies between pre-specified and reported primary outcomes, as well as publication and reporting bias in RCTs focusing on journals in gastroenterology and hepatology. While registration rates are found to be relatively high and stable over time, about one quarter of assessed trials contain discrepancies in their registered and reported primary outcomes, in particular differences in assessment timing. The manuscript also reports many statistical tests aimed at finding associations of these practices with trial or journal characteristics. I would like to congratulate the authors to their well-conducted work that adds important knowledge on registration rates and outcome switching in a specific field. ***** During review, I fould a few major points that I would suggest the authors address: First, I would like to suggest that you have a native English speaker read through the document. I am not a native speaker myself, but I got the impression that there are a few sections that could use a bit of language polishing. Second, could you provide - if available - any link of reference to where your study was preregistered? ll. 28-29: I think the statement „However, whether similar discrepancies exist in RCTs focusing on gastrointestinal and liver diseases remains unclear.“ is not warranted. You yourself state that another study has already been conducted in the field. Please tone down that statement. ll. 45.46 (and similar text passages throughout the manuscript): I consider sentences like "There was a lower risk of primary outcome discrepancies associated with more recent publication years (OR=0.267, 46 95% CI: 0.101, 0.706, p=0.008)" in the Abstract's conclusions a bit overstretching. You report a large number of univariate analyses (I counted approximately 50). Under the circumstances, this could as well be a chance finding and should not be featured so prominently. ll. 114-118: I would like to better understand the reasoning how the journals were chosen. Why did you choose the "top" journals in each quartile, as oppopsed to, for example, a random sample from each quartile or a random sample overall? I am sure you have very good reasons for your choice, but more detail would help readers understand this better. l. 166: Sentence „or if a nonsignificant primary outcome was omitted“. I am still struggling to understand how you can assess this. If the outcome was omitted, there is no way of telling whether it was significant or non-significant, right? Please explain this in a bit more detail. Table 3: I don’t think this Table works as it is. Although it is very concise (which was probably your intention), I think it will be rather confusing to readers because the numbers do not add up. My suggestion is that you make three different tables, with: Table 3a - Column 1: Registered trials, Column 2: Unregistered trials, Column 3: Total of all trials. Table 3b - Column 1: Trials with prospective registration, Column 2: Trials with retrospective registration, Column 3: Total of all registered trials. Table 3c - Column 1: Trials with primary outcome agreement, Column 2: Trials with primary outcome disagreement, Column 3: Total of all eligible trials (i.e., all trials for which primary outcome discrepancies were assessed). Then you can present the P-Values at the right side (similar to Table 4), so it becomes clear which groups were compared. I know this leads to more and larger tables, but I think they will be much more understandable. Of course, feel free to choose a different presentation if you have a better idea. Figure 1: The replacement of journals is not included in the flowchart. If one took it literally, one would expect that only trials from 10 journals were included. Figure 2A: For the Table on the right, the year should rather be the top row, not the bottom row. ***** Please also note the following minor points: Short title: The short title reads „Discrepancies between registered and reported primary outcome“ - it probably should be „primary outcomes“? l. 38: I suggest you do not list all the statistical tests and models used, but instead, only the tests that are reported in the Abstract’s results section (which I understand is only the logistic regression model). l. 45 (and other parts in the text): Please rather write „lower chance“ instead of „lower risk“. I think "risk" has too much of an accusing tone in this context. ll. 47-48: Regarding the non-significant influences, please also consistently report ORs and CIs. ll. 77-79: Please provide the original citation for this finding, not another paper that cited the original source. If possible, I’d also suggest you report a median instead of a mean, with no decimal places. ll.129-130: I don’t understand why you did not include crossover trials? Are they not a type of randomized-controlled trial? (This could be a misunderstanding from my side, of course.) ll. 130-131: Can you provide more detail on how exactly you searched for the full text? l. 137: Rather „resolved through discussion“ instead of „resolved through consensus“? ll. 147-148: „If the registry number was uncovered in this way, the trial was deemed unregistered.“ Can you provide a reasoning why? ll. 169-170: How are „initially registered“ primary outcomes defined? As the first registry entry at all? Or the first registry entry after study start? Did all of the included registries actually allow for an assessment of historical versions? Please provide more detail on these questions. ll. 193-196: Minor suggestion: Since the journal names are already in the table, I’d leave them out of the text. Table 5: Please write „univariate analyses“ (plural, not singular). l. 292 („28% to 88.4%“): Please be consistent in how many digits after the comma you report. ll. 388-389: „Notably, factors such as high journal quartile, developed regions, industry funding, multiple centers, prospectively registered trials, adherence to CONSORT guidelines, and mandatory registration did not show a significant association with discrepancies in primary outcome reporting. This suggests that discrepancies in primary outcome reporting may be a prevalent issue within the gastroenterology and hepatology research community.“ I dont understand how the second sentence follows the first logically. Again, thank you for letting me review this paper, and good luck with the publication process! Reviewer #2: First of all, the authors have to be congratulated for this interesting and extensive study. However, there are some points that need to revised, especially regarding the presentation of methods and of the results in the tables. 1. Abstract: Please include in the methods from where the information on prespecified primary endpoints was taken. 2. Please specify the “more recent publication” year in the results section. 3. Introduction: Generally, the introduction is well written, but on line 97 there seem to be break when introducing the field of gastroenterology. Why should there be a study in this field, when we already have data across other fields? Why should findings differ in gastroenterology? 4. Materials & methods: Please delete the statement regarding PRISMA (line 118) as PRISMA is, firstly, a reporting guideline and, secondly, only suitable for systematic reviews. 5. The screening process seems a bit unclear. Did 3 investigators independently screen each title/ abstract as well as full-text? Why did you choose 3 instead of 2? 6. I was wondering whether discrepancies regarding endpoint assessment were not an own category, for instance, when instead of 2 independent investigators to assess an endpoint data from patients’ records were drawn or quality of life was measured using another instrument than prespecified in the protocol. 7. Results: You write that figure 2 shows the trends (line 228), but there are no trends over the years. The figure just shows the distribution over years. 8. I have some difficulties in understanding table 3. For instance, you write that there are differences in study location between registered and unregistered trials. However, study locations of unregistered trials are not shown in table 3. This is not only confusing for the reader (and unclear to which comparisons these p-values belong to) but also omits important results. The same is true for all other columns, as one wants to compare studies with vs. those without prospective registration, but data are not shown. 9. You further have to think whether these proportions presented in table 3 are really necessary or whether the important information is which proportion of trials (e.g. from 2017, 2018 … 2021 or by study location) are registered, prospective registered and showed agreement between registry and publication. In my opinion, these are the very informative results here that are important to know for the reader. This is also true for totals, the important information is not that the crude denominator with agreements is 209 but that the proportion is 209/285=73.3%. Maybe you can also show both proportions (and maybe it would also be more appropriate not to show proportions with (dis)agreement here in table 3 but in table 5, see my comment below). 10. Table 5 is also a difficult one. You show that in 2021 a statistically significant lower proportion of disagreements was found. But, again, the proportion of (dis)agreements by years (or any other covariates) is never shown. What you are showing here is not the information the reader needs. Overall, tables 3 and 5 need to be rearranged and more stratified proportions should also be described in the text. 11. Furthermore, in the header of table 5, odds ratios from the logistic regression should also be named as such (as you also showed kappa coefficients, which would otherwise be confusing for the reader). 12. Discussion: A (although weak) reason for not registering a trial maybe that a study protocol was published beforehand. Did you assess this? 13. Furthermore, to get it right, what about studies that did not report registration (or a registration number) but were indeed registered. Have you checked that possibility and how often was that the case? Maybe this also needs to be more elaborated in methods sections as it is not clear how you assessed whether a study was registered or not. Along with that, you write that you found invalid registration numbers (line 299). How did you deal with that (was this a non-registered study)? 14. One important piece of information would also be which endpoints were most often changed (e.g. mortality or quality of life) and in which studies (e.g. on drugs effectiveness or screening). Was this assessed or is there some kind of data from the literature on that? 15. On line 310-313, you discuss that your findings of higher proportions of disagreements than in earlier studies might imply that a divergence has concurrently risen. However, this is a bad argument not supported by your data, where in 2021 this proportions was even lower. Are there any other methodological explanations? 16. Furthermore, there might be (more or less plausible) reasons to change endpoints, that, of course, need to be transparently discussed in a study publication. Have you assessed how often this was the case (as you write in line 320 that in many cases this was not explained)? When you have assessed this systematically, these data need to be presented. Otherwise, you need to be somewhat more cautious in your own discussion. 17. I do not understand what you mean with the inabilities in the registry (lines 357-359). 18. Other limitations include the restrictions of your work to one field and a small period of time. 19. In my opinion, implications and actions needed (lines 361-382) are some kind of superficial but at the same time also too enthusiastic. Is there really a need for a cultural shift (this is a very strong statement)? Is there evidence that more and more journals recognize non-significant results (and since when is this the case)? 20. Is there really a need for training of reviewers (lines 369-372)? Is it the task of a reviewer to check whether endpoints were changed? In the following paragraph you write, that this should be done by the journal. 21. What about authors? They need to report such changes transparently. This should be trained in courses on good clinical practice and biometricians or clinical study centers need also be aware of this (as they often supervising many RCTs). ********** 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: Yes: Martin Holst Reviewer #2: 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 |
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PONE-D-24-20434R1Discrepancies between pre-specified and reported primary outcomes: a cross-sectional analysis of randomized controlled trials in gastroenterology and hepatology journalsPLOS ONE Dear Dr. Zhang, 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. The reviewers have provided some further comments that should be considered for a possible revision. In addition, I would ask you to reconsider your answer to comment (13) by reviewer 1 and include ORs and CIs also for non-significant results (or provide a more convincing explanation for not doing so). Please submit your revised manuscript by Dec 01 2024 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:
We look forward to receiving your revised manuscript. Kind regards, Sascha Köpke Academic Editor PLOS ONE Journal Requirements: Please review your reference list to ensure that it is complete and correct. If you have cited papers that have been retracted, please include the rationale for doing so in the manuscript text, or remove these references and replace them with relevant current references. Any changes to the reference list should be mentioned in the rebuttal letter that accompanies your revised manuscript. If you need to cite a retracted article, indicate the article’s retracted status in the References list and also include a citation and full reference for the retraction notice. [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: All comments have been addressed Reviewer #2: 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 Reviewer #2: Partly ********** 3. Has the statistical analysis been performed appropriately and rigorously? Reviewer #1: Yes Reviewer #2: No ********** 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: Dear authors, dear editor, thank you for the opportunity to again review the manuscript entitled „Discrepancies between pre-specified and reported primary outcomes: a cross-sectional analysis of randomized controlled trials in gastroenterology and hepatology journals.“ I would like to thank the authors for their extensive effors to implement the changes requested by the reviewers, including reworking all the tables (whic I find much more readable now!). I believe the maunscript has greatly improved and can be accepted for publication. There are, however, three minor points I would like to address: (1) My Comment 6 You provided a detailed answer to my question, thank you! However, you made no changes to the text. I would appreciate if you could explain this to readers, too. (2) My Comment 16 You added that there was only one paper for which you could not obtain the full text. Could you also add this information to the manuscript? (3) My Comment 18 Thank you for providing a detailed explanation! I think this was a misunderstanding, however. I had just been wondering - should the sentence not read: „If NO registry number was uncovered in this way, the trial was deemed unregistered.“ If this is a misunderstanding from my side, please feel free to ignore the comment. Reviewer #2: Thank you for your valuable response and for revising the manuscript. Most of my points are addressed, but there are still some things that should be improved. 1. Introduction: On line 101, it still remains unclear why a study from the field of gastroenterology is needed and why results should differ from other fields. 2. On lines 105 and 107, there is now a redundancy on studies that did not assess discrepancies on journal quartiles and high vs. low impact journals. 3. Regarding my earlier comment 13, you still did not make clear how you proceed regarding whether a study was registered or not. This is important because different scenarios are possible (e.g. no registration number is in the publication and you a) did not find or b) did find a registration or c) the registration number is wrong). Please describe your approach in the methods section in more detail. 4. On line 197, it does not make sense that a binary regression included all significant variables in the univariate analysis, as both approaches assess the same and all variables were included. 5. Table 3c is the same as table 5, which is confusing. Please delete table 3c. 6. What is the outcome for the odds ratios in table 5, agreement or disagreement? 7. Regarding the year in table 5 and in the text you write that 2021 was significant different (OR=0.267). However, the proportions with disagreements between 2017 and 2021 are the same (33.9% and 34.0%). Something is wrong here. Maybe this result is for 2020. Furthermore, the odds ratios for 2018 and 2019 also do not fit together. 8. The same seem to hold true for other analyses in table 5, e.g. the proportion from Europe and Asia are quite the same (29.2% and 30.6%) but the odds ratio is given to be 0.523. Please check all analyses carefully. 9. Regarding my comment 19, it would be nice when the arguments and references given could be discussed in the manuscript. ********** 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: Martin Holst Reviewer #2: 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 2 |
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PONE-D-24-20434R2Discrepancies between pre-specified and reported primary outcomes: a cross-sectional analysis of randomized controlled trials in gastroenterology and hepatology journalsPLOS ONE Dear Dr. Zhang, 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. The reviewer has highlighted further inconsistencies! So, apart from correcting the mentioned aspects, please be sure to check the complete manuscript for inconsistencies and errors. Please submit your revised manuscript by Dec 21 2024 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:
We look forward to receiving your revised manuscript. Kind regards, Sascha Köpke Academic Editor PLOS ONE Journal Requirements: Please review your reference list to ensure that it is complete and correct. If you have cited papers that have been retracted, please include the rationale for doing so in the manuscript text, or remove these references and replace them with relevant current references. Any changes to the reference list should be mentioned in the rebuttal letter that accompanies your revised manuscript. If you need to cite a retracted article, indicate the article’s retracted status in the References list and also include a citation and full reference for the retraction notice. [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: All comments have been addressed Reviewer #2: (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: Yes Reviewer #2: (No Response) ********** 3. Has the statistical analysis been performed appropriately and rigorously? Reviewer #1: N/A Reviewer #2: (No Response) ********** 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: (No Response) ********** 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: (No Response) ********** 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: Dear Dr Zhang, dear authors, thank you for another opportunity to review your work and for addressing my comments. I believe they have now been completely addressed and the manuscript is acceptable for publication from my side. Good luck and best regards, Martin Holst Reviewer #2: Thank you for clarifying and improving the manuscript. There are few points regarding the differences for 2020 and 2021. 1. In the abstract, in 48 please describe that the OR for the publication year 2020 is in comparison to 2021. 2. In the discussion, please correct (line 298) “A more recent publication year (year 2021) was associated with a lower chance of primary outcome discrepancy.” This result now refers to 2020 and might not be explained by some kind of trend but rather by chance. 3. This also needs to be corrected in line 345 “Moreover, most baseline characteristics showed no significant influence on changes in primary outcomes, except for the year of publication, where more recent studies were associated with fewer outcome discrepancies.” ********** 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: Martin Holst Reviewer #2: 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 3 |
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Discrepancies between pre-specified and reported primary outcomes: a cross-sectional analysis of randomized controlled trials in gastroenterology and hepatology journals PONE-D-24-20434R3 Dear Dr. Zhang, 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 will be generated when your article is formally accepted. Please note, if your institution has a publishing partnership with PLOS and your article meets the relevant criteria, all or part of your publication costs will be covered. Please make sure your user information is up-to-date by logging into Editorial Manager at Editorial Manager® and clicking the ‘Update My Information' link at the top of the page. If you have any questions relating to publication charges, 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, Sascha Köpke Academic Editor PLOS ONE |
| Formally Accepted |
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PONE-D-24-20434R3 PLOS ONE Dear Dr. Zhang, I'm pleased to inform you that your manuscript has been deemed suitable for publication in PLOS ONE. Congratulations! Your manuscript is now being handed over to our production team. At this stage, our production department will prepare your paper for publication. This includes ensuring the following: * All references, tables, and figures are properly cited * All relevant supporting information is included in the manuscript submission, * There are no issues that prevent the paper from being properly typeset If revisions are needed, the production department will contact you directly to resolve them. If no revisions are needed, you will receive an email when the publication date has been set. At this time, we do not offer pre-publication proofs to authors during production of the accepted work. Please keep in mind that we are working through a large volume of accepted articles, so please give us a few weeks to review your paper and let you know the next and final steps. Lastly, 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 customercare@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 Professor Sascha Köpke Academic Editor PLOS ONE |
Open letter on the publication of peer review reports
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