PONE-D-24-41708Evaluation of antibiotic prescribing for the treatment of male community-acquired urinary tract infections using reimbursement dataPLOS ONE

Dear Dr. Biguenet,

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.

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PLOS ONE

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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

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2. Has the statistical analysis been performed appropriately and rigorously?

Reviewer #1: Yes

Reviewer #2: Yes

Reviewer #3: I Don't Know

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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

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4. Is the manuscript presented in an intelligible fashion and written in standard English?

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Reviewer #1: Yes

Reviewer #2: Yes

Reviewer #3: Yes

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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: I have carefully read the manuscript entitled “Evaluation of antibiotic prescribing for the treatment of male community-acquired urinary tract infections using reimbursement data”. Despite the constraints associated with access to information (e.g. precise indication, duration of treatment, etc.), I note the contribution of this study to current community practice.

You will find below some comments / suggestion.

INTRODUCTION

- Line 33: You mention a duration of antibiotic treatment ranging from 14 to 21 days for male UTIs. However, as indicated in reference 9, this kind of infection, also known as prostatitis, require a treatment period of just 14 days: “A 14-day treatment duration is recommended for infections treated with fluoroquinolones or co-trimoxazole (SMX-TMP), except for the uncommon cases of abscess that may require a prolonged treatment (IV-C)”.

MATERIALS AND METHODS

- Line 49: Can you specify the origin of the data (e.g. extraction from the SNDS, specific request to the CPAM, other)?

- Line 51: Can you be more precise about the dates? Also, there is a discrepancy between line 51 and line 130 (August or September?).

- Line 54: Did you use the date on which the medicines were dispensed, in addition to the prescription date? This data could have been relevant for assessing dispensing conditional on the result of the urinalysis (e.g. two dispensations from the same prescription).

- Line 88: Have you taken into account patients' medication histories? In particular, the use of a quinolone in the last 6 months?

- Line 94: Can you specify whether the number of boxes dispensed per pharmacy relates to one visit per patient? For example, does a patient who gets one box on Monday and two on Thursday appear on 2 lines?

RESULTS

- Line 135: In relation to the previous comment, it would be interesting to check compliance with the recommendations for patients undergoing 2 UTIs in the near future.

- Line 140: specify that the data in the database is restricted to a given area (and not the whole of France).

- Line 167: I wonder about the presence of cefotaxime. Unless I am mistaken, this is a hospital reserve antibiotic, which should not be included in the reimbursement data for outpatient treatment.

- Figure 2: I'm not sure that a figure is more readable than a table. We only have percentages, so please include at least the sample size in the legend.

- Line 198: same remark for cefotaxime (Figure 4).

- Line 209: Why not assess the duration of ceftriaxone treatment? This is the only unit-dose antibiotic for which we know the exact duration of prescription.

DISCUSSION

- Line 297: There is a contextual element that may be partly responsible for your analysis, and that is the availability of antibiotics. In the post-COVID period, there have been tensions over various quinolones.

- Limitations: on reading the data table, don't you think that the short duration of treatment can be explained by monitoring prescriptions rather than patients? For example, if the same patient obtains a box of ciprofloxacin on 1 January and 2 others on 4 January, how can this be assessed on the basis of the available data?

- Openness: what solutions could you suggest to improve compliance with the recommendations?

The work carried out using data from the city reflects daily medical practice. As the authors and other studies have pointed out, there is still a great deal of progress to be made in reducing the risk of antibiotic resistance. Access to knowledge of the indication appears to be a limitation of the study, but very probably for dispensing these therapies in pharmacies.

Reviewer #2: Thank you for the opportunity to review this manuscript aiming to evaluate the prescribing practices of general practitioners (GPs) for male urinary tract infections (UTIs) in France, with a focus on adherence to guidelines. It is a well-written article that addresses an important topic. However, for a less familiar and more international audience, it would be helpful to clarify certain aspects. Some of the definitions used are not entirely clear to me, making it difficult to fully assess whether all methodological choices are justified. Providing more context and explanations for these definitions would enhance the accessibility and transparency of the study.

Line 53-54:

Urine culture realization: It is unclear whether this refers to the moment the urine sample arrived at the microbiology laboratory or when the culture result became available. If it refers to the former, a two-day cutoff for empirical treatment seems quite short.

Line 71:

What does the diagnostic process for UTIs in France look like? Is it primarily based on culture results, or are point-of-care tests (POCTs) like dipsticks also used? Adding more information on the diagnostic workflow in your introduction could provide better insight into the setting. This would also help clarify whether the chosen cut-offs—such as excluding urine cultures when antibiotics were prescribed more than one day before or more than five days after culture realization—are logical.

Do you know what percentage of UTIs are diagnosed with a urine culture? In other words, could selecting only cases with a urine culture introduce bias?

Line 74:

"The date of the urine culture prescription should not differ by more than one day from the date of the urine culture." Does the latter refer to the day the sample arrives at the laboratory?

Line 81:

This criterion might introduce bias by excluding prescriptions where treatment failure occurs. Wouldn’t treatment failure be more common for certain bacterial uropathogens/AB than others? Could you elaborate on this? Additionally, is it possible to distinguish between a switch due to treatment failure versus a switch based on urine culture results?

Line 90:

"For documented antibiotics, prescriptions of FQ (CIP, LVX, or OFL), 3GC, or SXT were considered compliant, while other antibiotic treatments were considered non-compliant." Is this classification based on the French guidelines? I find it difficult to understand why alternatives such as amoxicillin/clavulanic acid are not considered valid options in case of documented susceptibility.

Line 149 and beyond:

Providing exact numbers here would be helpful.

Discussion:

The French guidelines take an aggressive approach to treating UTIs in men, recommending long-term treatment and broad-spectrum antibiotics. However, there is little discussion on why general practitioners (GPs) do not adhere to these guidelines. Is there any evidence suggesting that GPs find the French guidelines too strict? Are they aware of studies like the one by Drekonja and similar research, and do they adjust their practice accordingly? Additionally, it might be valuable to analyze adherence rates across different patient age groups.

Reviewer #3: Thank you for the opportunity to review this interesting article draft. Male UTIs remain an understudied topic, making this manuscript particularly valuable to the scientific community. However, the manuscript currently lacks critical methodological details, particularly in the methods section, which hinders the reader’s ability to fully understand the data analysis process and limits the reproducibility of findings. That being said, I am confident that these issues can be addressed with revisions. I encourage the authors to refine their manuscript and look forward to reading an improved version soon.

Introduction:

• “30-50% considered inappropriate”—This is a strong claim. Could you clarify the specific context (region, country, disease setting, etc.)?

• Lines 40-41: The mention of fictional data seems unnecessary, as many studies use routinely collected health claims data for this purpose (examples are provided below). You might consider limiting this sentence to France or clearly specifying the research gap your study addresses.

• Lines 43-45: The stated aims do not seem to fully align with the analyses presented in the manuscript. You may want to expand on the specific objectives at the end of the introduction to help guide the reader through your analyses.

• Line 44: The phrase “identify GPs who might benefit…” could be misleading, as it implies that individual GPs will be singled out. A more appropriate phrasing could be: “identify areas for improvement in prescribing practices.” Similarly, in Lines 244-245, consider rewording: “It therefore seems legitimate to try to identify GPs for whom information could improve their practice.”

Methods and Results:

• Data Sources & Dataset Description:

1) Can you elaborate on the data sources? Did you access multiple datasets? If so, was data linkage performed? Please clarify the process.

2) The unit of analysis is unclear—was it the GP, the prescription, or the UTI episode? Please specify.

3) Consider listing all ATC codes used in your analysis, ideally in a table, e.g. in the supplementary table, and indicate whether each was classified as appropriate or inappropriate.

4) How were urine cultures analyzed? Did multiple labs contribute data? If so, did they follow the same analytical standards and positivity cut-offs? Please specify and give details.

5) Figure 1 presents the flow of included cultures, participants, and treatments, but it does not fully address the data source or unit-of-analysis issues. Consider clarifying this in the methods section.

Figure 1: What is meant by a “probabilistic antibiotic”? Please define this term clearly.

• Exclusion Criteria:

Exclusion criterion 4 (Lines 81-84) appears to contradict definitions provided in Lines 62-63. Could

you clarify this potential inconsistency?

• Unit of Analysis:

I don´t understand which was the unit of analysis. Some studies use UTI episodes as the unit of analysis—could this apply to your dataset?

• Antibiotic Reassessment:

1) Line 58: “An antibiotic treatment was considered reassessed if an empirical treatment and a documented treatment were prescribed for the same urine culture, regardless of whether the antibiotic was the same or not.”

2) Please specify the timeframe—how many days after the culture did you assume the antibiotic was prescribed in response to that culture result?

3) Line 88: Readers outside France may find these recommendations surprising. Consider expanding the introduction to provide a broader context on treatment guidelines in Europe and the US before focusing on France.

Relevant guidelines/recommendations:

Europe: EAU, German guidelines for uncomplicated UTI, NICE/SIGN

US: IDSA (though outdated), Kurotschka, P. K.; Gágyor, I.; Ebell, M. H. Acute Uncomplicated UTIs in Adults: Rapid Evidence Review. Am Fam Physician 2024, 109 (2), 167–174

• Assessment of Treatment Duration:

1) Line 98-99: “In the case of abscess or uncontrolled underlying urological disorder” - Is “absence” meant? What qualifies as “uncontrolled”? How was this information obtained, given that your dataset does not contain antibiotic indications? Did it contain comorbidities?

2) Line 99: “It is not possible to calculate the actual effective treatment duration.” Could you clarify why this is the case? If this is a limitation of your dataset, please explain; if it is a general issue, references would be helpful.

3) Lines 103-109: The explanation of treatment duration standardization is unclear. What method of standardization did you use (direct, indirect, other)? Please specify.

4) If one CIP package covers 6 days, how do two packages cover 7-10 days, if 2×6 = 12?

5) In the results, treatment duration is categorized as 1-5 days and 11-15 days—this categorization should be mentioned in the methods with justification.

• Clustering of GPs:

1) The selection criteria for GPs (≥10 or ≥7 prescriptions) need further justification and context.

2) The hierarchical agglomeration clustering method (Ward’s method) and the elbow/silhouette methodsrequire additional explanation regarding their purpose in this study.

• Statistical Analysis:

1) Mean and median of what variables and distribution? Also, usually SD and IQR or ranges are reported near to point estimates and need to be mentioned here. Please clarify.

2) Why was bootstrapping used instead of more standard methods (e.g., Wald CIs)?

3) Chi-squared test—what variables were tested for independence? Please provide a general explanation (e.g., antibiotic appropriateness y/n vs. X y/n?).

4) More details on clustering methods and relevant methodological references should be included in this section.

5) Specify the software version used for the analysis.

For reference, please review the level of methodological detail in the following studies:

https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0312620

https://pubmed.ncbi.nlm.nih.gov/37487642/

https://pubmed.ncbi.nlm.nih.gov/35740228/

https://pubmed.ncbi.nlm.nih.gov/37974396/

https://pubmed.ncbi.nlm.nih.gov/33923682/

https://pubmed.ncbi.nlm.nih.gov/36823068/

https://pubmed.ncbi.nlm.nih.gov/32956399/

https://pubmed.ncbi.nlm.nih.gov/37528415/

These references may also be useful for strengthening your introduction and discussion.

Additional Points:

1) Line 35: Trimethoprim/sulfamethoxazole is commonly abbreviated as TMP/SMX—consider using this standard notation.

2) The terms “documented antibiotics” and “reassessed antibiotics” were difficult to follow; consider rewording or defining them more clearly.

3) Line 88: Avoid excessive use of non-standard abbreviations—this makes the text harder to follow. Consider using full drug names in each major section (introduction, methods, results, discussion).

4) Line 287: “…although there is only one context for male UTI in France.”—This sentence is unclear. Please clarify.

5) Line 289: Justify why the data filter used was appropriate, here you state opnly that you believe it was. You will need to convince the reader.

6) Line 290: You mention “dispensing data” - was this from a different database? Please specify the source (see comments above).

7) I would recommend copyediting/careful revision as I spotted some spelling/punctuation errors.

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Reviewer #1: Yes:  Arthur PIRAUX

Reviewer #2: Yes:  Tamara N. Platteel, MD PhD

Reviewer #3: No

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PONE-D-24-41708R1Evaluation of antibiotic prescribing for the treatment of male community-acquired urinary tract infections using reimbursement dataPLOS ONE

Dear Dr. Biguenet,

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 especially by Reviewer 3.

Please submit your revised manuscript by May 30 2025 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:

• A rebuttal letter that responds to each point raised by the academic editor and reviewer(s). You should upload this letter as a separate file labeled 'Response to Reviewers'.
• A marked-up copy of your manuscript that highlights changes made to the original version. You should upload this as a separate file labeled 'Revised Manuscript with Track Changes'.
• An unmarked version of your revised paper without tracked changes. You should upload this as a separate file labeled 'Manuscript'.

If you would like to make changes to your financial disclosure, please include your updated statement in your cover letter. Guidelines for resubmitting your figure files are available below the reviewer comments at the end of this letter.

If applicable, we recommend that you deposit your laboratory protocols in protocols.io to enhance the reproducibility of your results. Protocols.io assigns your protocol its own identifier (DOI) so that it can be cited independently in the future. For instructions see: https://journals.plos.org/plosone/s/submission-guidelines#loc-laboratory-protocols . Additionally, PLOS ONE offers an option for publishing peer-reviewed Lab Protocol articles, which describe protocols hosted on protocols.io. Read more information on sharing protocols at https://plos.org/protocols?utm_medium=editorial-email&utm_source=authorletters&utm_campaign=protocols .

We look forward to receiving your revised manuscript.

Kind regards,

Muhammad Qasim, Ph.D

Academic Editor

PLOS ONE

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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: (No Response)

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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: Partly

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3. Has the statistical analysis been performed appropriately and rigorously?

Reviewer #1: Yes

Reviewer #3: Yes

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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

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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

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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: I sincerely thank the authors for taking into account all the comments made by the various reviewers. The manuscript is improved, and the results more robust.

I would like to emphasize once again the contribution of these results in relation to male urinary tract infections, which are much less studied than female urinary tract infections.

Reviewer #3: The manuscript improved with revisions, however I still find some points questionable.

At the editor´s discretion, some more changes might be useful. I think that although the French databases allow, in theory, to go back to the prescriber, researchers are usually not allowed to do that. Even if they are (e.g. because who is doing the study is the same group of people that decides on further training of individual physicians), a research study normally does not aim to go back to individual prescribers (or groups of them) for retraining. This aim is more consistent with a clinical audit. Therefore, again, I would suggest you to rephrase referring to an aim that is consistent with the results of your analyses, i.e. I would refer to the identification of areas of improvement or similar, which are, as pointed out in your summary of findings, antibiotic type and duration.

The authors pushed back some of my suggestions. This is fine to me, however, after reading the revised manuscript again, I still think that a more international contextualisation of male UTI treatment would be important, given the many observational studies on the topic published internationally. I agree that comparing guidelines was not an objective of the study. However, the discussion of a manuscript normally broadens the perspective comparing what was found to what is already known. As the explicit focus was on guideline adherence, a more international perspective on what in other contexts might be considered appropriate and why in other context GPs adhere or do not adhere to guideline recommendations would be useful and would make the manuscript more interesting for an international readership.

Lastly, I realised that the results of the urine culture were not available. What I understand here is that you were not provided with data on urine culture positivity (as S1 table suggests). What I don´t understand is how the authors assessed if the "documented" antibiotic was appropriate or not. This would need, in my opinion, further explanation in the methods section.

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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:  Arthur PIRAUX

Reviewer #3: No

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[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.

Evaluation of antibiotic prescribing for the treatment of male community-acquired urinary tract infections using reimbursement data

PONE-D-24-41708R2

Dear Dr. Biguenet,

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.

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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,

Muhammad Qasim, Ph.D

Academic Editor

PLOS ONE

Additional Editor Comments (optional):

Reviewers' comments: