Peer Review History
| Original SubmissionMarch 20, 2024 |
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PONE-D-24-06895Reduced injection risk behavior with co-located Hepatitis C treatment at a syringe service program: Findings from the Accessible Care Randomized TrialPLOS ONE Dear Dr. Eckhardt, 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 Jun 15 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:
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Please see our Supporting Information guidelines for more information: http://journals.plos.org/plosone/s/supporting-information. Additional Editor Comments: This is a randomized control trial of HCV syringe services conducted in New York. The purpose of this study is quite interesting. However, the methods are a bit confusing and the results are not very surprising or compelling. The terms “accessible” care versus “usual” care are not described in the abstract and require additional explanation for the casual reader. Similarly, the explanation in the methods requires additional details as given in Supplementary Figure 1. The authors should explain lines 145-146 in more detail: The on-site treatment team facilitated a non-stigmatizing atmosphere during their interactions with the AC arm participants. Lines 149-151: is this information standardized in written / oral / virtual form? The HCV care coordinator provided on-site education on HCV and prevention of re-infection, and support regarding treatment navigation, insurance, and adherence. It is unclear what drugs were injected and if that had any impact on injection behaviors, SVR, and/or study visits. The data presented in Supplementary Figure 1 should be explained in more detail in the first paragraph of the Results. More context about the cohort is needed. [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: No Reviewer #3: Partly ********** 2. Has the statistical analysis been performed appropriately and rigorously? Reviewer #1: No Reviewer #2: No Reviewer #3: No ********** 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: No Reviewer #2: Yes Reviewer #3: No ********** 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: No 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: Here is a list of specific comments. Note: line and page numbering in reviews and comments is based on ruler applied in Editorial Manager-generated PDF. 1. Page 3, lines 48–51: I suggest considering reporting coefficients of interactions in a clinical term. In addition, I suggest reporting 95% confidence intervals. 2. Page 9, lines 190–191: I suggest adding ‘mean with standard deviation’ per tables. 3. Page 9, lines 191–192: These tests were not reported. I suggest excluding this sentence. 4. Page 9, lines 194–195: I suggest clarifying the calling out of Table 2. The title of Table 2 indicated “baseline.” However, the sentence described the ordinal category at all study points. 5. Page 9, lines 197–198: I recommend providing additional information about the generalized estimating equations (GEE) such as the distribution, the link function, and model specification. Also, please confirm the use of t-test in GEE. The most popular test in GEE is the Wald test with naive or robust standard errors. 6. Page 9, lines 198–200: I recommend assessing the balance in the numbers of days and events of injection drug use at baseline between arms and determining the need for adjustment based on this balance, rather than solely on statistical significance. 7. Page 10, Table 1: Were there any concerns regarding imbalance in the parent study? 8. Page 11, lines 220–221: Would it be possible to declare the balance without referring the statistical significance? 9. Page 12, lines 226–228: Can you please elaborate the average number of participants in non-attendance? It was not clear how to interpret the numbers of 53.5 and 59. 10. Page 12, lines 228–229: I suggest considering removing this sentence. 11. Page 12, line 231: Did the intervention-by-time effect analysis refer to the GEE with interaction terms between intervention and time? If so, I suggest providing the specifications in the Statistical Analysis section. See Comment #5 above. 12. Page 12, lines 233–239: Would you mind providing the SPSS outputs from GEE as a supplementary material or an attachment to the response? It was not easy to envision the models. 13. Page 13, Table 3: The coefficient of the interaction would only be directly interpretable if the outcome was continuous; i.e., the distribution of GEE was Gaussian and the link function was identity. Modeling the percentage as a continuous outcome might not be ideal but it was acceptable given GEE. Reviewer #2: This paper describes a secondary analysis of a previously published paper and rehashes those findings at length rather than referring the reader to the publication and summarizing the results here in brief. Moreover, in the Discussion, the authors describe the key outcome differences in the parent study due to "...rates of advancement along the care cascade" (p. 18/lines 275-78), which is not mentioned in the previous description of the primary study. There is no mention of possible recall bias or acceptability bias despite the fact that participants were asked to enumerate the frequency of specific drug use behaviors over a 30-day period. In addition, there are a number of awkward phrasings (e.g. "within PWID" rather than "among PWID") that could benefit from a less stilted style. The tables are long (esp Table 3) and I wonder if there is a more visual way to display this information. Reviewer #3: This paper reports on the outcomes of a randomized clinical trial of an accessible care approach to providing Hepatitis C treatment relative to treatment as usual condition on the primary outcomes of frequency of injection drug use and engagement in high-risk injection drug use engagement. Results indicate that those randomized to the accessible care condition had lower frequency of injection drug use and high-risk injection practices relative to the treatment as usual condition. The following are suggestions to improve the manuscript. -In the introduction (pg. 5): It would be helpful to clarify what patient navigation in the control arm entailed. -The authors note in the introduction that past, previously reported results of this trial indicated the accessible care approach was associated with higher sustained virologic response relative to the usual care arm. The authors should make more explicit in the abstract that the primary outcome of the trial was not the primary outcome(s) being reported in this paper (i.e., injection drug use frequency, frequency of high-risk injection practices). -In the methods, I would recommend describing the extent to which content focused on altering injection practices was included in either the accessible care or usual care conditions. I would assume this counseling is part of all the SSP services provided, but wasn’t clear whether there was additional emphasis provided on reducing frequency of injection drug use in either condition. -On page 9, the authors also indicate that uptake of MOUD is an outcome, but this hasn’t been addressed as an outcome in the manuscript to this point. There is a need for incorporating MOUD into the abstract and introduction. -Additional description of the measurement of the manuscript’s primary outcomes is needed. Further, how were categories of number of days injecting determined? What was a continuous measure not employed? The rationale for separating 29 days from 30 days is unclear, for example. -Additional information regarding the retention and attrition by condition is needed along with how missing data was handled in the analysis. Further description of modeling over all assessment points relative to examination at the 12-month follow-up is needed. -Table 2: Not clear what first 2 rows represent. This should be revised. -The presentation of results in Table 3 should be revised. -Figures 3 and 4 should indicate what the bars represent. Reviewing the figures it would appear while there may be a statistically significant difference, there may not be clinically meaningful differences between the two conditions. Further, these figures are somewhat misleading if the analysis utilized the ordinal categories rather than the continuous measures. -The authors list outliers as a limitation of this study. The rationale for ordinal categories is not well supported and it is unclear why the authors did not consider alternative analytic approaches. -There were a few instances where tracked changes remained in the document that should be addressed. Figure 1 did not appear correctly in the final submitted document. ********** 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: 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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Reduced injection risk behavior with co-located Hepatitis C treatment at a syringe service program: The Accessible Care model PONE-D-24-06895R1 Dear Dr. Eckhardt, 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, Jason T. Blackard, PhD Academic Editor PLOS ONE Additional Editor Comments (optional): None 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: No Reviewer #3: (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 #3: No ********** 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) 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: No ********** |
| Formally Accepted |
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PONE-D-24-06895R1 PLOS ONE Dear Dr. Eckhardt, 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 Dr. Jason T. Blackard Academic Editor PLOS ONE |
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