Peer Review History
Original SubmissionMarch 17, 2020 |
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PONE-D-20-07703 Potentially inappropriate prescribing in older adults with advanced CKD PLOS ONE Dear Dr Molnar, 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. Thank you for the submission of this manuscript and I apologise for the delay in the review process. I have recommended minor corrections in accordance with the reviewers. Both reviewer 1 and 3 requested clarification regarding the statistical analyses and on review, the time-series analysis should be paid some attention. There are several approaches to interrupted time-series analysis so please explain the rationale for the approach taken any limitations to the approach. Due to the complexity of the analysis, revisions may require statistical review. We would appreciate receiving your revised manuscript by Jun 18 2020 11:59PM. 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. To enhance the reproducibility of your results, we recommend that if applicable you deposit your laboratory protocols in protocols.io, where a protocol can be assigned its own identifier (DOI) such that it can be cited independently in the future. For instructions see: http://journals.plos.org/plosone/s/submission-guidelines#loc-laboratory-protocols Please include the following items when submitting your revised manuscript:
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, Carl Richard Schneider, BN, BPharm (Hon), PhD 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 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. We suggest you thoroughly copyedit your manuscript for language usage, spelling, and grammar. If you do not know anyone who can help you do this, you may wish to consider employing a professional scientific editing service. Whilst you may use any professional scientific editing service of your choice, PLOS has partnered with both American Journal Experts (AJE) and Editage to provide discounted services to PLOS authors. Both organizations have experience helping authors meet PLOS guidelines and can provide language editing, translation, manuscript formatting, and figure formatting to ensure your manuscript meets our submission guidelines. To take advantage of our partnership with AJE, visit the AJE website (http://learn.aje.com/plos/) for a 15% discount off AJE services. To take advantage of our partnership with Editage, visit the Editage website (www.editage.com) and enter referral code PLOSEDIT for a 15% discount off Editage services. If the PLOS editorial team finds any language issues in text that either AJE or Editage has edited, the service provider will re-edit the text for free. Upon resubmission, please provide the following:
3. We noticed you have some minor occurrence of overlapping text with the following previous publication(s), which needs to be addressed: https://doi.org/10.1093/ndt/gfz167 In your revision ensure you cite all your sources (including your own works), and quote or rephrase any duplicated text outside the Methods section. Further consideration is dependent on these concerns being addressed. 4. We note that you have indicated that data from this study are available upon request. PLOS only allows data to be available upon request if there are legal or ethical restrictions on sharing data publicly. For information on unacceptable data access restrictions, please see http://journals.plos.org/plosone/s/data-availability#loc-unacceptable-data-access-restrictions. In your revised cover letter, please address the following prompts: a) If there are ethical or legal restrictions on sharing a de-identified data set, please explain them in detail (e.g., data contain potentially identifying or sensitive patient information) and who has imposed them (e.g., an ethics committee). Please also provide contact information for a data access committee, ethics committee, or other institutional body to which data requests may be sent. b) If there are no restrictions, please upload the minimal anonymized data set necessary to replicate your study findings as either Supporting Information files or to a stable, public repository and provide us with the relevant URLs, DOIs, or accession numbers. Please see http://www.bmj.com/content/340/bmj.c181.long for guidelines on how to de-identify and prepare clinical data for publication. For a list of acceptable repositories, please see http://journals.plos.org/plosone/s/data-availability#loc-recommended-repositories. We will update your Data Availability statement on your behalf to reflect the information you provide. 5. Thank you for stating the following in the Acknowledgments Section of your manuscript: 'This study was supported by the ICES Western and Ottawa sites. ICES is funded by an annual grant from the Ontario Ministry of Health and Long-Term Care (MOHLTC). Core funding for ICES Western is provided by the Academic Medical Organization of Southwestern Onta 342 rio (AMOSO), the Schulich School of Medicine and Dentistry (SSMD), Western University, and the Lawson Health Research Institute (LHRI). The research was conducted by members of the ICES Kidney, Dialysis and Transplantation team, at the ICES Ottawa and Western facilities, who are supported by a grant from the Canadian Institutes of Health Research (CIHR). The opinions, results and conclusions are those of the authors and are independent from the funding sources. No endorsement by ICES, AMOSO, SSMD, LHRI, CIHR, or the MOHLTC is intended or should be inferred. Parts of this material are based on data and/or information compiled and provided by CIHI. However, the analyses, conclusions, opinions and statements expressed in the material are those of the authors, and not necessarily those of CIHI. Amber O Molnar receives salary support from the KRESCENT Foundation and the McMaster Department of Medicine. Manish M Sood is supported by the Jindal Research Chair for the Prevention of Kidney Disease.' We note that you have provided funding information that is not currently declared in your Funding Statement. However, funding information should not appear in the Acknowledgments section or other areas of your manuscript. We will only publish funding information present in the Funding Statement section of the online submission form. Please remove any funding-related text from the manuscript and let us know how you would like to update your Funding Statement. Currently, your Funding Statement reads as follows: 'Yes. This study was conducted with the support of Cancer Care Ontario through funding provided by the Government of Ontario (awarded to AOM; https://www.cancercareontario.ca/en). The sponsor had no role in the study design, conduct, data analysis or manuscript preparation.' 6. Thank you for stating the following in your Competing Interests section: 'I have read the journal's policy and the authors of this manuscript have the following competing interests: Manish M. Sood has received grant funding from Otsuka and speaker fees from Astrazeneca unrelated to this study. All other authors have no conflicts to declare.' Please complete your Competing Interests on the online submission form to state any Competing Interests. If you have no competing interests, please state "The authors have declared that no competing interests exist.", as detailed online in our guide for authors at http://journals.plos.org/plosone/s/submit-now This information should be included 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: Yes Reviewer #2: Yes Reviewer #3: Partly ********** 2. Has the statistical analysis been performed appropriately and rigorously? Reviewer #1: Yes Reviewer #2: Yes 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: Yes 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: Yes 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: Comments to authors: This study is a retrospective analysis of linked administrative databases from Canada examining the incidence of inappropriate prescribing in older adults with advanced CKD and evaluating the impact of including pharmacists as part of the multidisciplinary team in the ambulatory kidney care model on inappropriate prescribing. The study is relevant, was conducted by a highly qualified team, and the manuscript reads well. I applaud the authors for following the Reporting of Studies Conducted Using Observational Routinely Collected Health Data (RECORD) guidelines for observational studies. I have a few suggestions to improve the manuscript, which I hope the authors find helpful. Thank you for the opportunity to review this paper. Introduction Line 60: there is a more recent systematic review pertaining to the role of pharmacists in CKD that you may want to cite. PMID: 30963447 Methods Lines 80-95: it seems that the information about the clinics would make more sense to be included under “Setting” Line 92: is there information regarding pharmacist recommendations and acceptance rate by physicians? Line 66: what was the rationale for picking equal or greater than 66 years-old instead of equal or greater than 65 years-old to define older adults? Line 121: the authors refer to measures of “healthcare utilization”. What measures do the authors mean and what were they used for? Line 126-148: I suggest rearranging this section in the following manner: 1) lines 127-129; 2) lines 139-143; 3) lines 132-136; 4) lines 143-148; 5) end of line 136 through 138: 6) lines 130-131. Line 132: the authors used the 2015 version of the Beers criteria. Would you anticipate any changes to the results had you used the 2019 version of the Beers criteria (PMID: 30693946)? Lines 151-158: Cumulative incidence calculation – can the authors provide more information about the numerator and denominator used to calculate cumulative incidence to help guide the reader? What were considered ‘new cases’ and what was the ‘number of individuals free of disease at the beginning of time period’ per the definition of cumulative incidence? Along the same lines, the authors state that “The number of days each patient had potentially inappropriate prescribing […] and the total follow-up days for each patient were used to determine the potentially inappropriate prescribing rate per 100 person-years.” How does the ‘number of days’ give a rate in ‘person-years’. On Table 2, it seems that the rate of potentially inappropriate prescribing was calculated by dividing ‘total person years of potentially inappropriate prescribing’ by ‘total person years of follow-up’, which I can understand. I think it will help the reader if you clarify what the numerator and denominator are for every calculation performed. Line 196: please state the statistical level used in the analysis. Results Line 193: please state clearly what the calculated cumulative incidence is as well as numerator and denominator. Line 196: The overall rate of potentially inappropriate prescribing was 125.6 per 100 person-years, calculated by dividing 72,453 total person years of potentially inappropriate prescribing by 57,707 total person years of follow-up. Please clarify the n and the follow-up period (is it 2011-2017?) used to calculate the latter rates. Line 224: “No immediate change at pharmacist introduction was detected” – it looks like it became significant after pharmacist introduction (p<0.001) and the difference between slopes was also significant (p<0.001) per information on Supplementary Table S2. Can that be considered more than just a trend? The authors summarize the findings stating that there was a "significant reduction in potentially inappropriate prescribing" (Lines 246-247). References Reference #48: there seems to be an issue with the author name. Tables and Figures Table 1: Suggest including what variables are presented as mean (SD) and what variables are presented as n(%) on the table and not as a footnote. It is confusing as it stands. Table 3: in the fourth column, I suggest clarifying that this means statins prescribed Figure 1: this figure is hard to read and the color coding is not apparent because the figure is in black and white Reviewer #2: I would like to commend the authors for their work. It is well written and argued paper, which I am happy to accept in its current form. I was just curious if there is a reason why females had more rates of potentially inappropriate medication. Does it have anything to do with the higher probability of some drugs which are inappropriate in females? Otherwise, I am happy to accept this work as is. Reviewer #3: Thank you for the opportunity to review the manuscript. The manuscript is well written and adds to the literature for support to include pharmacists as part of the MD team in CKD. However, few points below for clarification • Suggest adding the definition for older adults in the introduction • What was the rationale for involving only <30ml patients? • Why was the only use of statin examined? There are other potential therapies that may be under used. • What about the use of ESAs? ESA can be inappropriate especially with regards to the Hb rise? • How many patients were conservatively managed? Or under renal supportive care team given that a significant proportion is very old • Suggest adding further details on the 24% who were not prescribed statins. How many of them had coexisting CVD • Suggest adding some details on the use of certain meds. For example, prazosin can be a very useful agent to reduce BP in patients with CKD and is used frequently in Australia. Furthermore, this population is older. Although less preferred it could be used for BPH. Gabapentin and pregabalin are also used with appropriate dose management • Suggest adding a supplementary table with all meds prescribed inappropriately with dosage considerations • Suggest a stat review. I am not clear on how the pharmacists involvement conclusion has been performed. ********** 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: Teresa M Salgado 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. 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Revision 1 |
Potentially inappropriate prescribing in older adults with advanced chronic kidney disease PONE-D-20-07703R1 Dear Dr. Molnar, 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, Carl Richard Schneider, BN, BPharm (Hon), PhD Academic Editor PLOS ONE Additional Editor Comments (optional): Thank you for the careful revision. There are a couple of additional minor comments by Reviewer 1 that you may wish to consider for the final manuscript. 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: Thank you for addressing all my comments. I think you did a really nice job with the manuscript, congratulations! A couple minor comments: Page 5, line 74 - please spell out ICES Page 19, lines 328-334 - suggest presenting some data here to support the claim that the slopes differed before and after pharmacists introduction in the clinics. ********** 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: Teresa M Salgado |
Formally Accepted |
PONE-D-20-07703R1 Potentially inappropriate prescribing in older adults with advanced chronic kidney disease Dear Dr. Molnar: 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. Carl Richard Schneider Academic Editor PLOS ONE |
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