PONE-D-24-02675Rethinking risk prediction: The role of albumin and other parameters in implant-associated complications after hip or knee arthroplastyPLOS ONE

Dear Dr. Maly,

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Academic Editor

PLOS ONE

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"Petr Domecky as a PhD student is supported by Charles University (Project SVV 260 665)."

  

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Additional Editor Comments:

Please find the comments of our reviewers attached below. We would be grateful if you could make the corrections suggested by the reviewers when revising your article.  Personally I find the article very interesting, and I believe that with some corrections it can be published.

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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: Yes

Reviewer #4: No

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

Reviewer #1: Yes

Reviewer #2: Yes

Reviewer #3: Yes

Reviewer #4: No

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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

Reviewer #4: Yes

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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

Reviewer #4: 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: the aims and objectives of the study is apt, the methodology including the design, data collection, the outcomes and statistical analysis is good.the ethical approval and consent were duly taken. the result was properly analysed

Reviewer #2: I have been given the opportunity to review your article aimed at predicting complications associated with total hip (THA) and knee (TKA) arthroplasty, highlighting the high risk of post-operative inflammatory reactions. The prospective observational study conducted on patients with primary knee or hip osteoarthritis undergoing THA or TKA was described with absolute clarity, identifying albumin, prealbumin, Intensive Care Infection Score (ICIS), Nutritional Risk Index, and white blood cell count as potential predictors. However, it should be noted that prosthetic infection may also result from the complex concomitant action of multiple factors: bacteria, prostheses, and host weakness. In this regard, I would kindly ask you to briefly elaborate on the possible role of host-related concomitant factors, as it is known that the immune response is able to limit infection. I would like to bring to your attention, solely for illustrative purposes, an interesting study (DOI: 10.1186/S10195-021-00607-6) that may be of specific interest to you and could potentially be considered in your references, if deemed useful. This study highlights that among the intraoperative reasons for the development of infectious complications after joint arthroplasty are a duration of surgery exceeding 180 minutes, significant blood loss (more than 800 ml), blood transfusion, excessive tissue trauma, the presence of nosocomial bacterial strains, and failure to adhere to aseptic and antiseptic rules.

Your study clearly demonstrates that parameters such as albumin, NRI, prealbumin, white blood cells, and ICIS can predict implant-related complications, emphasizing the importance of comprehensive inflammatory and nutritional assessments in managing and predicting complications, with significant implications for patient risk assessment. The text discusses the results of the study and refers to previous studies to provide context and comparisons. However, some points may require clarification. In this regard, it is necessary to clarify whether specific measures were taken to minimize the risk of confounding in data collection and statistical analysis. The text mentions some limitations of the study, such as the small sample size and the short follow-up of patients. However, it may be useful to further explore how these limitations may have influenced the results and conclusions of the study. It would be helpful to discuss more thoroughly the clinical implications of the study results and how they may affect daily clinical practice.

In conclusion, the analysis you have drawn provides a good overview of the study's objectives, methods, results, and conclusions, although some parts could be improved with additional clarification and insights, as mentioned above.

Reviewer #3: The manuscript is well-structured and the research question is clearly defined. However, there are some areas that require improvement or clarification.

Major comments:

The rationale for selecting the specific inflammatory and malnutrition parameters should be better justified in the background. While the authors mention that CRP is the most commonly used parameter, it is unclear why the other parameters were chosen.

The sample size calculation is not provided so if it's possible it's better include it.

The authors could provide more details on the surgical procedures and postoperative care in the methods if it possible. This information is important I think to understand potential confounding factors and assess the generalizability of the study findings.

The authors mention that 12 patients developed implant-associated complications. More details on the management, etiology, of complications and their severity could be provided.

While the study identified several potential predictors of IAC, it is unclear how these findings can be used in clinical practice to improve patient outcomes and how. The authors could discuss a little bit in depth the clinical significance of their findings.

The manuscript would benefit from a second round copyediting to improve the grammar, punctuation, and academic style, nut over all was written in very good English.

Minor comments:

The authors could provide more details on the patient population, including more like comorbidities, and medications if it's possible.

The authors could provide a little more details on the data collection and analysis methods, including how missing data were handled.

The authors could provide more details on the statistical analysis, there are any multiple linear regression analyses that you did analyzing the datas? If no, why you did not performed them?

You cited KL score referring to Kohn et all. in the (16.) i think it's better refer to the original classification Kellgren JH, Lawrence JS. The Epidemiology of Chronic Rheumatism. Atlas of Standard Radiographs. Vol 2. Oxford, UK: Blackwell Scientific; 1963.

why it's important for you the grade of arthrosis, did you consider it as factor for ICA in your analysis, or it was not influent?

Overall, the manuscript presents an interesting study with potential clinical implications. The manuscript would benefit from minor revisions to improve the clarity of the study findings.

Reviewer #4: Thank you for the invitation to review. This is a small prospective study of the predictive values of several biochemical markers in detecting post-operative infections in patients undergoing TKA/ THA. There are a few issues:

1) The hypothesis of the study was not stated and it is unclear how the authors had chosen the potential predictors. This creates confusion when interpreting the results. For example, we do not expect albumin or nutritional status to drastically fluctuate from one day before surgery to two days post surgery; are the authors using this predictor to inform the pre-operative risk of infection in patients? WCC, ICIS, NLR and CRP on the other hand are more commonly used as diagnostic aid post-operatively. Note that CRP also peaks on post-operative day 2-3, and while it is commonly used to mark a trend, it is not a good benchmark for comparison with potential predictors at this particular time point.

2) I do not agree with non-implant associated complications such as thromboembolism, urinary tract infection and peroneal nerve paralysis being categorised under implant-associated complications. They are poorly related to the chosen predictors and would invalidate the results of the study.

3) The authors stated there were twelve patients who developed implant-associated complications, including six SSIs, however this did not correspond to data presented in Table 1.

4) Interpretation of the data must be performed in the context of clearly stated hypothesis / aims. I am unable to provide specific comments without clarification of the study aims. Generally speaking, p-values alone are inadequate in terms of identifying significant results; the size of between-group difference and confidence intervals must also be taken into account. For example, the IAC negative group has a pre-operative albumin of 43.3 versus 39.6 in the IAC positive group with a p-value of 0.042. The size of the difference (less than 4 g/L) is small when compared with the SSI groups, where the values were 43.6 and 30.6 meaning a difference of 13 g/L between the SSI-positive and SSI-negative groups. The p-value was 0.076 which is above 0.05 due to the small sample size (n=6) in the SSI positive group.

5) Please update reference source on page 6 line 138

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Reviewer #1: Yes: Mustapha Alimi

Reviewer #2: Yes: Giuseppe Basile

Reviewer #3: No

Reviewer #4: No

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Rethinking risk prediction: The role of albumin and other parameters in implant-associated complications after hip or knee arthroplasty

PONE-D-24-02675R1

Dear Dr. Maly,

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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Kind regards,

Gennaro Pipino, Md

Academic Editor

PLOS ONE

Additional Editor Comments (optional):

All reviewers agree to accept the paper. Congratulations for the excellent work done.

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 #2: All comments have been addressed

Reviewer #3: All comments have been addressed

Reviewer #4: All comments have been addressed

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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 #2: Yes

Reviewer #3: Yes

Reviewer #4: Partly

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

Reviewer #2: Yes

Reviewer #3: Yes

Reviewer #4: 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 #2: Yes

Reviewer #3: Yes

Reviewer #4: No

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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 #2: Yes

Reviewer #3: Yes

Reviewer #4: 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 #2: Dear Authors, I have read your additions, finding them entirely consistent and in accordance with my expectations. I consider your work interesting. The purpose is clear and respected. I believe that the information provided is to be considered entirely sufficient and represents useful elements to encourage the development of new scientific work.

Reviewer #3: (No Response)

Reviewer #4: (No Response)

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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 #2: Yes: Giuseppe Basile

Reviewer #3: No

Reviewer #4: No

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