Drug induced pancreatitis: A systematic review of case reports to determine potential drug associations

Dianna Wolfe; Salmaan Kanji; Fatemeh Yazdi; Pauline Barbeau; Danielle Rice; Andrew Beck; Claire Butler; Leila Esmaeilisaraji; Becky Skidmore; David Moher; Brian Hutton

doi:10.1371/journal.pone.0231883

Peer Review History

Original SubmissionJanuary 29, 2020
4 Mar 2020 Decision Letter - Francisco X. Real, Editor PONE-D-20-02739 Drug Induced Pancreatitis: a systematic review of case reports to determine potential drug associations PLOS ONE Dear Dr. Hutton, 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 within 3 months. 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. 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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, Francisco X. Real Academic Editor PLOS ONE 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 http://www.plosone.org/attachments/PLOSOne_formatting_sample_main_body.pdf and http://www.plosone.org/attachments/PLOSOne_formatting_sample_title_authors_affiliations.pdf [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: Yes 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: Yes ****** 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: This is a very interesting review dealing with the topic of drug-induced AP. The authors carefuly defined criteria to revise the available literature and conclude that evidence is typically very low in most instances for the reported assoications. The authors should be congratulated for the big effort and for the clarity of the presentation. I do have minor comments: 1. While I agree that including only studies that accomplish Atlanta criteria is ok, I would ask to make a further sensitivity analsysis on studies that had positive CT scan or MRI. The other two crietria (pain and elevated levels of pancreatic enzymes) can occurr in digestive disorders (typically i nIBD) without having an AP. Please try and do that and comment. 2. Among the drugs, especially in class I and II there are a lot of statins. A recent systematic review and meta-analysis (PMID: 30288283 )on C-C and cohort studies concluded that there is no evidence for such drugs causing AP. this should be commented and discussed. Reviewer #2: The manuscript by Hutton is a tour de force on the topic of case reports on drug associated acute pancreatitis. The authors are to be commended on going back to the primary sources. The manuscript is primarily descriptive, with extracted data being organized and classified into tables. This largely verifies what is known - i.e. the source material in clinical reports is poor. The manuscript would be strengthened with some attempts to classify the drugs by mechanistic classes. For example, are they channel blockers, anticholinergic agents, specific types of antibiotics, etc. (They did address hyperglycemic agents in the discussion as a class). Otherwise, it is a lot of data that is hard to synthesize and use. ****** 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: No Reviewer #2: Yes: David C. Whitcomb MD PhD [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.0231883.r001
Revision 1
14 Mar 2020 Author Response March 14, 2020 Dear Editor: On behalf of my co-authors, I would like to re-submit our revised manuscript “Drug Induced Pancreatitis: a systematic review of case reports to determine potential drug associations”. We thank you for the opportunity to revise and resubmit this manuscript. We appreciate the favorable review of our manuscript and we thank the reviewers for the helpful comments provided. We have responded to each reviewer comment and have revised the manuscript to reflect these responses. Point-by-point responses to all comments are noted below, as are notations of the places in the text where changes have been made to address the reviewers’ suggestions. We have submitted a “Track Changes” and “Clean – No Track Changes” version of the manuscript. Please note that in error, one co-author was accidentally omitted from the initial submission (Danielle Rice); she has been appropriately added for the re-submission. We hope that you agree that the revised manuscript has addressed the concerns raised by the reviewers and is now ready for publication in PLOS One. Sincerely, Brian Hutton, MSc, PhD Director and Senior Scientist \| Knowledge Synthesis Group \| Clinical Epidemiology Program Assistant Professor, Ottawa University School of Epidemiology and Public Health Adjunct Scientist, Royal Ottawa Institute of Mental Health Research Ottawa Hospital Research Institute Center for Practice Changing Research Building The Ottawa Hospital - General Campus 501 Smyth Road \| PO Box 201B \| Ottawa \| Ontario \| Canada \| K1H 8L6 email: bhutton@ohri.ca Phone: 613-737-8899 (ext. 73842) \| Fax: 613 - 739 - 6938 Reviewer Comments Reviewer #1: This is a very interesting review dealing with the topic of drug-induced AP. The authors carefully defined criteria to revise the available literature and conclude that evidence is typically very low in most instances for the reported associations. The authors should be congratulated for the big effort and for the clarity of the presentation. I do have minor comments: 1. While I agree that including only studies that accomplish Atlanta criteria is ok, I would ask to make a further sensitivity analsysis on studies that had positive CT scan or MRI. The other two criteria (pain and elevated levels of pancreatic enzymes) can occur in digestive disorders (typically in IBD) without having an AP. Please try and do that and comment. 2. Among the drugs, especially in class I and II there are a lot of statins. A recent systematic review and meta-analysis (PMID: 30288283) on C-C and cohort studies concluded that there is no evidence for such drugs causing AP. This should be commented and discussed. Response: We thank Reviewer 1 for this high praise, it was indeed a considerable amount of work. To augment the submitted findings, we have conducted a brief sensitivity analysis, as proposed by the reviewer, and revised the manuscript accordingly. An additional appendix has been added to the supplement, with more detailed findings from the sensitivity analysis (see the updated Appendix S6 Text); we invite the reviewer to inspect the tracked changes version of the re-submitted manuscript to see all of the text additions made to allude to findings from the sensitivity analysis. We have also added a line regarding the suggested systematic review in the Discussion section which reads as follows: “Similarly, meta-analyses of cohort and case-control study data have been recently published, refuting an association between statins and AP, of which several were implicated in cases included in our review.” Reviewer #2: The manuscript by Hutton is a tour de force on the topic of case reports on drug associated acute pancreatitis. The authors are to be commended on going back to the primary sources. The manuscript is primarily descriptive, with extracted data being organized and classified into tables. This largely verifies what is known - i.e. the source material in clinical reports is poor. The manuscript would be strengthened with some attempts to classify the drugs by mechanistic classes. For example, are they channel blockers, anticholinergic agents, specific types of antibiotics, etc. (They did address hyperglycemic agents in the discussion as a class). Otherwise, it is a lot of data that is hard to synthesize and use. Response: We thank Reviewer 2 for the glowing comments. We considered categorizing the implicated drugs by the AHFS system; however, subsequently we recognized that the level of evidence that we were synthesizing was low, and we then consciously elected not to promote inferences about drug categories based upon what many would likely consider to be very weak evidence. We have added a comment in the Discussion section regarding this consideration, which reads as follows: “Given recent efforts to evaluate associations between individual drug categories and AP, we considered categorizing the drugs implicated in our review by the AHFS system. However, ultimately, we consciously elected not to categorize and risk potentially promoting inferences about specific drug categories that were based upon low-quality evidence. Instead, we encourage the reader to explore the raw data set as well as the supplement available online.” We have provided the original file of raw data online, and would encourage readers to develop their own inferences, keeping in mind the low level of evidence. https://doi.org/10.1371/journal.pone.0231883.r002
3 Apr 2020 Decision Letter - Francisco X. Real, Editor Drug Induced Pancreatitis: a systematic review of case reports to determine potential drug associations PONE-D-20-02739R1 Dear Dr. Hutton, 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, Francisco X. Real 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: The present version of the manuscript is acceptable for publication after the requested changes have been made. I do not have additional comments. ****** 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.0231883.r003
Formally Accepted
6 Apr 2020 Acceptance Letter - Francisco X. Real, Editor PONE-D-20-02739R1 Drug Induced Pancreatitis: a systematic review of case reports to determine potential drug associations Dear Dr. Hutton: 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. Francisco X. Real Academic Editor PLOS ONE https://doi.org/10.1371/journal.pone.0231883.r004

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