Choosing important health outcomes for comparative effectiveness research: 5th annual update to a systematic review of core outcome sets for research

Elizabeth Gargon; Sarah L. Gorst; Paula R. Williamson

doi:10.1371/journal.pone.0225980

Peer Review History

Original SubmissionAugust 7, 2019
18 Oct 2019 Decision Letter - Florian Naudet, Editor PONE-D-19-22167 The use of automated article ranking in the fifth annual update to a systematic review of core outcome sets for research PLOS ONE Dear Dr Gargon, 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. Reviewer 2 thought that the title could be misleading and I must say that I agree. Please make sure that the title is more focused on the content of the paper. For this specific reason he said that he was not willing review the manuscript that was outside his area of expertise. The two other reviewers were however positive and provided some (major and minor) issues that must be addressed before any final decision concerning your manuscript. 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Please include your updated Competing Interests statement in your cover letter; we will change the online submission form on your behalf. Please know it is PLOS ONE policy for corresponding authors to declare, on behalf of all authors, all potential competing interests for the purposes of transparency. PLOS defines a competing interest as anything that interferes with, or could reasonably be perceived as interfering with, the full and objective presentation, peer review, editorial decision-making, or publication of research or non-research articles submitted to one of the journals. Competing interests can be financial or non-financial, professional, or personal. Competing interests can arise in relationship to an organization or another person. Please follow this link to our website for more details on competing interests: http://journals.plos.org/plosone/s/competing-interests Additional Editor Comments (if provided): [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: Partly Reviewer #2: Partly Reviewer #3: Yes ******** 2. Has the statistical analysis been performed appropriately and rigorously? Reviewer #1: Yes Reviewer #2: N/A Reviewer #3: 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: No Reviewer #3: 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 Reviewer #3: 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: Introduction : (minor comments) Line 62 : the first sentence sounds like if « saving money » was the final goal of COS research. Is it ? Don’t you think that choosing meaningful outcomes could also improve patient’s condition ? Line 73 : is this « awareness » only a COS developer awareness or also an awareness of COS users (trialists ? ) Line 75 : could you please cite any recent « guidance and standards » such as the COMET guidelines or more recently the revised OMERACT handbook. Do you think that these guidelines are the only method for COS development or is there any room for other methods ? Line 86 : are you aware of any initiative to implement MeSH with headings for COS ? It would be very helpful Line 98 : using an automated screenning approach is not an aim but a method. You already proved it worked in a previous paper cited ref 11. Line 99 : using the COS-STAD is not an aim but a method also. The aim is to check if the included COS were developed with reasonable methods (as formulated by Kirkham 2017) METHODS : (major comment) Line 145 : Two comments to express that I doubt that only one researcher without medical background can assess the development of COSs for a large diversity of disease. The quality of assessment may be discussable. Only one researcher assessed the included COS against COS Stad criteria. A double assessment of two researchers, one with an expertise in the given disease would be more transparent and relevant. Moreover, the table 2 of the reference 8 has been made for cancer while supplementary data 3 show that cancer COSs were a minority. Did you adapt the criteria for each disease, for instance criteria 3 ? I doubt that it could be done without the advice of an expert of the disease. DISCUSSION (minor comments) Line 369 : It could be useful to have an online access to the assessment of each published tools on the COMET website for instance ie a table with the disease, the COS, and the COS-STAD assessment. Reviewer #2: The title of the paper is misleading. No information about the algorithm is given in the paper. I am sorry, but without this information it does not make sense for me to review this paper. I strongly recommend to change the title of the paper. Reviewer #3: The following manuscript reports an important and updated systematic review of COS published in 2018. This review is an update of a yearly published systematic review, methods are well know and described. Results are clear and comprehensive. I only have a couple of comments on a single point: - the authors aimed at assessing the use of an automated screening approach prospectively. Could the authors elaborate on this in the methods section? - in the discussion, p21, lignes 364 and 366 : is there two different automated processes? from my understanding of the methods reported in the manuscript the authors used an automated screening method to rank the citations also reported as an automated ranking process. ****** 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: No Reviewer #3: Yes: Youri Yordanov [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.0225980.r001
Revision 1
29 Oct 2019 Author Response Reviewer #1: Introduction : (minor comments) Line 62 : the first sentence sounds like if « saving money » was the final goal of COS research. Is it ? Don’t you think that choosing meaningful outcomes could also improve patient’s condition ? Response: We agree that the inclusion of patient-important outcomes is one of the main benefits/features of COS, and have added an opening sentence into the introduction about the importance of outcomes being relevant to patients. Line 73 : is this « awareness » only a COS developer awareness or also an awareness of COS users (trialists ? ) Response: There is an increased awareness in both of these groups. We have added in a sentence, and a reference to a survey of COMET database users, that highlights this. Line 75 : could you please cite any recent « guidance and standards » such as the COMET guidelines or more recently the revised OMERACT handbook. Do you think that these guidelines are the only method for COS development or is there any room for other methods ? Response: References to the COMET Handbook and standards have been added in, as well as a sentence to say that “As methodological research in this area is still in its infancy, COMET guidance and standards will be updated in the future to reflect new evidence as it becomes available.” Line 86 : are you aware of any initiative to implement MeSH with headings for COS ? It would be very helpful Response: Thanks for this comment. This is an ongoing discussion within the COMET Management Group. The introduction of a COS MeSH term in MEDLINE and other bibliographic databases for identifying COS papers would most definitely be very helpful. However, the inclusion of a new MeSH term in itself might be a challenge. MeSH is the National Library of Medicine’s controlled vocabulary thesaurus, who state that before a new descriptor is introduced, consideration must be given to how much is published about that topic; if little is published the Library see little purpose or advantage in creating a new descriptor in a vocabulary which has to encompass the subject content of the entire published literature. Although COS development is a growing area of research, it is relatively niche when compared to the broad nature of most medical subject headings. It is therefore probable that the proposal of a COS heading is unrealistic at this time. In the absence of a COS MeSH term, standards for reporting and development, as highlighted in the introduction to this paper, help with the searching and identification of COS studies. The use of standardised terms, for example ‘core outcome set’ in the title and abstract make it much easier to identify appropriate COS development papers. Line 98 : using an automated screening approach is not an aim but a method. You already proved it worked in a previous paper cited ref 11. Response: We have edited this to ‘test’ instead of use. Line 99 : using the COS-STAD is not an aim but a method also. The aim is to check if the included COS were developed with reasonable methods (as formulated by Kirkham 2017) Response: Edit made. METHODS : (major comment) Line 145 : Two comments to express that I doubt that only one researcher without medical background can assess the development of COSs for a large diversity of disease. The quality of assessment may be discussable. Only one researcher assessed the included COS against COS Stad criteria. A double assessment of two researchers, one with an expertise in the given disease would be more transparent and relevant. Response: Thank you for this comment. Our assessment was made on whether there was evidence in the paper(s) that the specific COS-STAD criteria were considered. This assessment does not require clinical expertise. However an assessment of the applicability or usefulness of a COS in a particular scenario would need to be evaluated by the user for the intended purpose of use. In this instance, it is likely that relevant clinical knowledge and understanding would be vital. We have added a comment about this into the discussion (see 2nd paragraph lines 401-404 in revised manuscript). Moreover, the table 2 of the reference 8 has been made for cancer while supplementary data 3 show that cancer COSs were a minority. Did you adapt the criteria for each disease, for instance criteria 3 ? I doubt that it could be done without the advice of an expert of the disease. Response: Table 2 of the previous assessment of COS against COS-STAD was developed using cancer COS as an example, but not specifically for cancer COS. It was intended to facilitate users being able to compare a published COS to the standards. The paper states that consideration should be given to the specific disease area being considered (criteria 3), and that users need to use their own judgement regarding the scope for the purpose of use they require. Table 2 of the previous paper was only used to provide some guidance on how to compare the COS to the standards when needed, but the standards themselves were used for the assessment and the standards (COS-STAD) were developed to be applicable across diseases. We have edited this sentence to ‘remove the word ‘cancer’ to avoid any confusion. DISCUSSION (minor comments) Line 369 : It could be useful to have an online access to the assessment of each published tools on the COMET website for instance ie a table with the disease, the COS, and the COS-STAD assessment. Response: Thanks for this comment. We are currently considering this. While we recognise the potential merit of this, there is a need for individual consideration by the user of a COS for the specific intended purpose, therefore we have concerns that by including our assessment it could detract from people making their own critical assessment. However, we recognise this could be useful to some users, and are therefore considering it for our upcoming update to the COMET website and database, coming in 2020. Reviewer #2: The title of the paper is misleading. No information about the algorithm is given in the paper. I am sorry, but without this information it does not make sense for me to review this paper. I strongly recommend to change the title of the paper. Response: We have updated the title to be more in keeping with the previous updates to this systematic review: Choosing important health outcomes for comparative effectiveness research: 5th annual update to a systematic review of core outcome sets for research Reviewer #3: The following manuscript reports an important and updated systematic review of COS published in 2018. This review is an update of a yearly published systematic review, methods are well know and described. Results are clear and comprehensive. Response: Thank you for these comments. I only have a couple of comments on a single point: - the authors aimed at assessing the use of an automated screening approach prospectively. Could the authors elaborate on this in the methods section? Response: Thank you for this comment. We have added in to the methods section and the results section the estimated time saved by using this method. - in the discussion, p21, lignes 364 and 366 : is there two different automated processes? from my understanding of the methods reported in the manuscript the authors used an automated screening method to rank the citations also reported as an automated ranking process. Response: Your understanding is correct. We have edited this sentence to make this clearer. Attachments Attachment Submitted filename: Response to reviewer comments_Final.docx https://doi.org/10.1371/journal.pone.0225980.r002
18 Nov 2019 Decision Letter - Florian Naudet, Editor Choosing important health outcomes for comparative effectiveness research: 5th annual update to a systematic review of core outcome sets for research PONE-D-19-22167R1 Dear Dr. Gargon, 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. I would like to thank you for the changes you made to the initial draft and the 2 reviewers for the insightful comments they made on the first draft. 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, Florian Naudet, M.D., M.P.H., Ph.D. 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 Reviewer #3: 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 #3: Yes ****** 3. Has the statistical analysis been performed appropriately and rigorously? Reviewer #1: Yes Reviewer #3: 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 Reviewer #3: 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 ****** 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: We thank the authors for having responded to all the comments. this paper will e useful for all researchers working on COS. Reviewer #3: (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 Reviewer #3: Yes: Youri Yordanov https://doi.org/10.1371/journal.pone.0225980.r003
Formally Accepted
26 Nov 2019 Acceptance Letter - Florian Naudet, Editor PONE-D-19-22167R1 Choosing important health outcomes for comparative effectiveness research: 5th annual update to a systematic review of core outcome sets for research Dear Dr. Gargon: 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. Florian Naudet Academic Editor PLOS ONE https://doi.org/10.1371/journal.pone.0225980.r004

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