The rates and measurement of adherence to acamprosate in randomised controlled clinical trials: A systematic review

Kim Donoghue; Laura Hermann; Eileen Brobbin; Colin Drummond

doi:10.1371/journal.pone.0263350

Peer Review History

Original SubmissionOctober 6, 2021
14 Nov 2021 Decision Letter - Tariq Jamal Siddiqi, Editor PONE-D-21-32169The rates and measurement of adherence to acamprosate in randomised controlled clinical trials: A systematic reviewPLOS ONE Dear Dr. Donoghue, 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 Dec 29 2021 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. 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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 https://journals.plos.org/plosone/s/file?id=ba62/PLOSOne_formatting_sample_title_authors_affiliations.pdf 2. Thank you for submitting the above manuscript to PLOS ONE. During our internal evaluation of the manuscript, we found significant text overlap between your submission and the following previously published works, some of which you are an author. - http://docplayer.net/13017100-Protocol-number-page-1-of-30.html The text that needs to be addressed involves the final paragraph of the Discussion. We would like to make you aware that copying extracts from previous publications, especially outside the methods section, word-for-word is unacceptable. In addition, the reproduction of text from published reports has implications for the copyright that may apply to the publications. Please revise the manuscript to rephrase the duplicated text. Please note that further consideration is dependent on the submission of a manuscript that addresses these concerns about the overlap in text with published work. Additional Editor Comments: Donoghue et al. has performed a systematic review on, “The rates and measurement of adherence to acamprosate in randomised controlled clinical trials” in which they show that adherence to acamprosate is poor. In my opinion, this study can be improved by incorporating the following points: 1. The exclusion criteria needs to be clearly mentioned in the methods section of the study. 2. Mentioning which particular factors were assessed in the risk of bias of RCTs can improve the quality of methods. 3. The company for the software used in data analysis is not mentioned. 4. Any sensitivity analysis that was performed is not clearly mentioned in the study. 5. The results can be improved by including the mentioning the results of trial quality assessment as well. 6. There is no evidence for how the heterogeneity of the results was improved. 7. It is not stated whether any tests for assessing the publication bias were used or not. 8. Future implications regarding the trials required or the gap in literature which can be covered is not clearly mentioned. 9. Subgroups analysis was not performed on the results which would have improved the quality of results further. 10. The discussion can be improved by discussing more about the gaps in the literature and how this study has identified new aspects in this field which can be significant in improving the medical literature. [Note: HTML markup is below. Please do not edit.] Reviewers' comments: [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. https://doi.org/10.1371/journal.pone.0263350.r001
Revision 1
15 Dec 2021 Author Response Journal requirements 1. Please ensure that your manuscript meets PLOS ONE's style requirements, including those for file naming Thank you for raising this, we have consulted PLOS ONE’s style requirements and amended as applicable. 2. Thank you for submitting the above manuscript to PLOS ONE. During our internal evaluation of the manuscript, we found significant text overlap between your submission and the following previously published works, some of which you are an author. Apologies for this oversight. The work in question is our unpublished trial protocol that is freely available through the funder’s website. The text has been amended as below; Original text Swift et al. [15] suggest a hierarchy from low to high confidence in the method of adherence monitoring for naltrexone based on a patient’s ability to evade measurement of adherence. Patient self-report, counting of returned medication or inspection of blister packs were assigned “low” confidence, electronic monitoring of pill bottle opening (Medication Events Monitoring System (MEMS) caps) or biomarkers such as the addition of riboflavin were assigned a “medium” confidence. “High” confidence was assigned to supervised dosing, long-acting injectable preparations, or monitoring of blood levels of the prescribed medication. Updated text A hierarchy from low to high confidence in the method used to monitor adherence to naltrexone has been proposed by Swift et al. [15]. The hierarchy, based on a patient’s ability to evade measurement of adherence, considered patient self-report and counting returned pills to have a “low” confidence. A “medium” confidence was assigned to Medication Events Monitoring System (MEMS) caps to electronically monitor pill bottle opening, or biomarkers such as the addition of riboflavin. Methods considered to have a “High” confidence included supervision of dosing, long-acting injectable preparations, or monitoring of the level of prescribed medication in the blood. Additional Editor Comments 1. The exclusion criteria needs to be clearly mentioned in the methods section of the study. The exclusion criteria have been stated more clearly in the methods as follows (line 100-101); Studies were excluded if they used a cross-over or open label design or included pregnant women. 2. Mentioning which particular factors were assessed in the risk of bias of RCTs can improve the quality of methods. The following text has been added (line 155-157); Eligible studies were assessed for risk of bias using the Cochrane Risk of Bias Tool [16], which included risk of bias arising from the randomisation process, deviations from the intended interventions, missing outcome data, measurement of the outcome and selection of the reported results. 3. The company for the software used in data analysis is not mentioned. The following has been added (line 133); If separate percentages are reported for different sub-groups, for example type of psychological therapy received, all were included in the adherence rate calculations that were completed in Microsoft Excel. And also (line 138-139) The method described by Swift et al. [15] was used to calculate an adherence-assurance score for the trials included in this review. All data was entered into Microsoft Word and calculated manually. 4. Any sensitivity analysis that was performed is not clearly mentioned in the study. We explored the relationship between study length and adherence and found no relationship (line 169 to 171); Pearson’s correlation found no statistically significant correlation between the length of treatment with acamprosate and the percentage of prescribed medication taken (r=-0.308, p=0.357). 5. The results can be improved by including the mentioning the results of trial quality assessment as well. Risk of bias is already mentioned on (line 183-184); All eligible studies were judged to have a high risk of bias, which was largely due to risk of bias arising from missing data (S2 table). 6. There is no evidence for how the heterogeneity of the results was improved. This paper sought to determine the rates of adherence to acamprosate and the reliability of the adherence monitoring and measurement methods. Identifying heterogeneity was therefore part of the aims of the paper. We therefore do not think it is appropriate to look at improving heterogeneity for this paper. 7. It is not stated whether any tests for assessing the publication bias were used or not. Thank you for highlighting this, we have added the following to the limitations (line 242-246); We were unable to assess publication bias in this systematic review. It is possible that publication bias could have led to an overestimation of the rates of adherence to acamprosate in clinical trials. There is an association between adherence to acamprosate and its efficacy and therefore unpublished trials with negative results may have had greater rates of non-adherence to acamprosate. 8. Future implications regarding the trials required or the gap in literature which can be covered is not clearly mentioned. Thank you for this suggestion we have added the following text (line 215-216); Despite the successful inclusion of psychosocial interventions to enhance adherence in clinical trials, there has been little research into its application in a more typical clinical setting. Psychosocial interventions supporting adherence to medications for alcohol relapse prevention may not be directly transferable to clinical practice due to the burden on staff and costs of delivery [17, 37]. Further research into how we can best support people completing treatment for alcohol dependence to take acamprosate as prescribed is needed. 9. Subgroups analysis was not performed on the results which would have improved the quality of results further. Thank you for this suggestion. There was a wide variation in the reporting of adherence with some studies using percentage of participants who took 80% of medication prescribed and others reporting the mean percentage of medication taken. Consequently, there was limited data to perform further subgroup analysis. The following has been added to the limitations section (line 239-240); Studies were heterogeneous in their method, measurement and reporting of adherence to acamprosate making comparison between studies difficult and further subgroup analysis not possible. 10. The discussion can be improved by discussing more about the gaps in the literature and how this study has identified new aspects in this field which can be significant in improving the medical literature. Please see number 8 above and we have also amended the following to be clearer in our discussion about the gaps in current research (line 233-234); The implementation of standardised reporting of adherence rates and accurate, high confidence adherence measurement methods in clinical trials would assist with comparison of efficacy results across trials. Attachments Attachment Submitted filename: Response to reviewers.docx https://doi.org/10.1371/journal.pone.0263350.r002
18 Jan 2022 Decision Letter - Tariq Jamal Siddiqi, Editor The rates and measurement of adherence to acamprosate in randomised controlled clinical trials: A systematic review PONE-D-21-32169R1 Dear Dr. Donoghue, We’re pleased to inform you that your manuscript has been judged scientifically suitable for publication and will be formally accepted for publication once it meets all outstanding technical requirements. Within one week, you’ll receive an e-mail detailing the required amendments. When these have been addressed, you’ll receive a formal acceptance letter and your manuscript will be scheduled for publication. An invoice for payment will follow shortly after the formal acceptance. To ensure an efficient process, please log into Editorial Manager at http://www.editorialmanager.com/pone/, click the 'Update My Information' link at the top of the page, and double check that your user information is up-to-date. If you have any billing related questions, please contact our Author Billing department directly at authorbilling@plos.org. If your institution or institutions have a press office, please notify them about your upcoming paper to help maximize its impact. If they’ll be preparing press materials, please inform our press team as soon as possible -- no later than 48 hours after receiving the formal acceptance. Your manuscript will remain under strict press embargo until 2 pm Eastern Time on the date of publication. For more information, please contact onepress@plos.org. Kind regards, Tariq Jamal Siddiqi 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 #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: Yes ****** 3. Has the statistical analysis been performed appropriately and rigorously? Reviewer #1: Yes Reviewer #2: 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 #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: (No Response) Reviewer #2: (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 #2: No https://doi.org/10.1371/journal.pone.0263350.r003
Formally Accepted
24 Jan 2022 Acceptance Letter - Tariq Jamal Siddiqi, Editor PONE-D-21-32169R1 The rates and measurement of adherence to acamprosate in randomised controlled clinical trials: A systematic review Dear Dr. Donoghue: I'm pleased to inform you that your manuscript has been deemed suitable for publication in PLOS ONE. Congratulations! Your manuscript is now with our production department. If your institution or institutions have a press office, please let them know about your upcoming paper now to help maximize its impact. If they'll be preparing press materials, please inform our press team within the next 48 hours. Your manuscript will remain under strict press embargo until 2 pm Eastern Time on the date of publication. For more information please contact onepress@plos.org. If we can help with anything else, please email us at plosone@plos.org. Thank you for submitting your work to PLOS ONE and supporting open access. Kind regards, PLOS ONE Editorial Office Staff on behalf of Dr. Tariq Jamal Siddiqi Academic Editor PLOS ONE https://doi.org/10.1371/journal.pone.0263350.r004

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