Nurse-Driven Interventions Reduce Central Line-Associated Bloodstream Infection Close to Zero in One Pediatric Oncologic Facility: A Single-Center Retrospective Observational Study

Round 1

Reviewer 1 Report

Comments and Suggestions for Authors Authors presented a study that assesses the impact of nurse-originated changes in central venous catheter management on the incidence of central line-associated and catheter-related bloodstream infections, a single-center retrospective cohort study conducted at an urban, tertiary referral, and academic center serving pediatric patients. They found out that their institution's CVC-related infection rates are significantly lower than other, comparable italian pediatric institutions and that their data confirm the effectiveness of local CVC management guidelines in preventing CVC-related infectious complications. The study has some merit and is interesting from a clinical point of view but there are some concerns that must be addressed. 1. The topic is relevant to the field but it lacks novelty because many similar articles describing this topic have been published. However, this study is the first report in the literature of a personal CVC logbook filled out at each notable catheter handling, as described in the article, and could represent a specific gap in the field that has been addressed. Authors should, therefore, add an example of such personal CVC logbook, either as a figure or a supplementery file, as suggested in a comment inside the article. Otherwise, it does not add much to the subject area compared with other published material. 2. There are some specific improvements that should be considered by the authors regarding the methodology as well as Results and their presentation. 3. In addition, there is no "Conclusions" section but, instead, just one sentence at the end of "Discussion". This should be rewritten and be more concise and in line with results of the study. There are some other comments and concerns that I inserted in the manuscript file as "notes", which I attached during revision process. However, I am attaching it again hereby, in case it was missed previously. With kind regards,

Comments for author File: Comments.pdf

Comments on the Quality of English Language

Minor editing of English language required.

Author Response

We thank the reviewer for taking the time to review our manuscript. Please find the detailed responses below and the revisions/corrections highlighted/in track changes in the re-submitted files.

Authors presented a study that assesses the impact of nurse-originated changes in central venous catheter management on the incidence of central line-associated and catheter-related bloodstream infections, a single-center retrospective cohort study conducted at an urban, tertiary referral, and academic center serving pediatric patients. They found out that their institution's CVC-related infection rates are significantly lower than other, comparable italian pediatric institutions and that their data confirm the effectiveness of local CVC management guidelines in preventing CVC-related infectious complications. The study has some merit and is interesting from a clinical point of view but there are some concerns that must be addressed.

1. The topic is relevant to the field but it lacks novelty because many similar articles describing this topic have been published. However, this study is the first report in the literature of a personal CVC logbook filled out at each notable catheter handling, as described in the article, and could represent a specific gap in the field that has been addressed. Authors should, therefore, add an example of such personal CVC logbook, either as a figure or a supplementery file, as suggested in a comment inside the article. Otherwise, it does not add much to the subject area compared with other published material.
   Thank you for your valuable suggestion. We have included an example of the CVC logbook in the article as Figure 1. Given our department's meager infection rate, this study provides important insights. It highlights the effectiveness of our nurse-driven protocol, demonstrating how meticulous attention and introducing new tools, such as a personal CVC logbook, contribute to positive patient outcomes. We hope this example will provide readers with a practical tool for implementing similar protocols in their own settings.
2. There are some specific improvements that should be considered by the authors regarding the methodology as well as Results and their presentation.
   We improved the Methods and Results sections based on the suggestions received. We hope that the article now looks more precise and direct.
3. In addition, there is no "Conclusions" section but, instead, just one sentence at the end of "Discussion". This should be rewritten and be more concise and in line with results of the study.
   Thanks for your helpful suggestion. We included a Conclusion section that sums up what was previously discussed:
   “In conclusion, given our department's meager infection rate, this study provides important insights: It highlights the effectiveness of our nurse-driven protocol and demonstrates how meticulous attention and the introduction of new tools, such as a personal CVC logbook, contribute to positive patient outcomes. Targeted interventions with protocols produced by highly trained professionals, their sharing, and intensive training of satellite hospital staff led to a significant drop in infectious complications among pediatric hematological oncology patients with CVC. This example will provide readers with a practical tool for implementing similar protocols in their settings. “
4. There are some other comments and concerns that I inserted in the manuscript file as "notes", which I attached during revision process. However, I am attaching it again hereby, in case it was missed previously. With kind regards,

• Title is too long

Thanks for the suggestion. We choose a shorter title to make it more direct.

 

• I suggest to use the term "modifiable factors" instead of "adjustable factors". This is a more usual term in the literature and in concordance with further text

We revised the term as suggested.

 

• How come that signed informed consent was obtained at the first visit if this was a Retrospective study? Do all the patients give such a consent in advance?

Our hospital is a Scientific Research Institute (I.R.C.C.S. Buro Garofalo). According to our Institute regulations, parents or guardians had to give written informed consent on the first visit to use any clinical data in research. We modified the sentence in the Material section.

 

• This company derives from England, according to the first statement in this paragraph.Authors should check this so there will be no doubts.

Indeed, it looks like the company is English, and there was an error in its country of origin. We amended the geographical origin.

 

• Correct abbreviation is: CRBSI, according to previous explanation.

Thanks for noticing. This was a spelling mistake, and we promptly corrected it.

 

• if 100 cases of solid tumors among 236 patients - this is 42% and not 31%.
• if 145 cases of ac. lymphoblast leucemia among 236 patients - this is 61% and not 45%.
• In total, 236 patients were selected. How is it possible then that 245 patients received TPP? Authors should check and correct this.

Percentages were calculated based on the number of CVCs managed during the study period rather than the number of patients. Some patients had multiple CVC placements, often at different times, with potential variations in patient characteristics or the CVC itself. For this reason, each CVC placement was treated as a separate entry. We have added a sentence to clarify this point in the Results section.

 

• Table 1 presents some data that are already presented in text. This is doubling of data presentation and should be avoided. Data should be presented either in text or in tables but not in both of them.

Thank you for the suggestion. To make the article more direct, we simplified the tables and the text. Table 3 was displaced in the Supplementary numbered Table S1.

 

 

• All abbreviations must be explained at the table legend.
  Thank you for pointing this out. We added the explanation for missing abbreviations.

 

• Tables are generally too large and should present less data, which are most relevant. Therefore, some data should be deleted or combined.

We have simplified and aligned the tables to enhance readability.

• This figure has low quality, mainly due to dark grey background. It should be corrected.

We modified Figure 1. The revised version of the manuscript is numbered as Figure 2.

• This figure is difficult to understand and is non-transparent. It should be redesigned in order to be more logical and easier to understand.

We have reconsidered Figure 2 and decided to replace it with a table, which we believe will enhance readability. Table 3 provides incidence estimates for different patient groups, categorized by the frequency of CVC dressing changes.

• It would be useful and more convincing to add an example of such personal CVC logbook to the article, either as a figure or a supplementaey file, without patient's personal information, of course.

Thank you for your valuable suggestion. We have included an example of the CVC logbook in the article as Figure 1.

• References should be cited in an uniform way.

Thanks for pointing this out. We modified the References section, uniforming the format of reference.

 

 

Reviewer 2 Report

Comments and Suggestions for Authors

Comments:

1. The authors have not described the rationale for conducting the study in detail. It is recommended to describe what is the need for the study and also introduce why the nurses have been chosen for interventions. 

2. The acronyms (CVC) should be written in full at first use in the manuscript except the abstract. 

3. The aim in the abstract, introduction, and materials & methods do not match each other. 

4. The inclusion and exclusion criteria were not defined priorly. Also, the control cohort population is not clear. How they were identified and selected.

5. The authors mentioned the study as a retrospective cohort study. Also, the authors stated that they have taken the informed consent from the patient. Hence, the exact study design is not clear. It is recommended that the study's retrospective and prospective parts be clearly distinguished by using figures (if applicable).

6. The results presented are of a retrospective observational study rather than a retrospective cohort study. Kindly clarify the study design, analyze the data, and present the results accordingly.

7. All the tables should be left aligned for clarity.  

8. Figure 1 appears to be darker; hence, it is not clear. 

Author Response

We thank the reviewer for taking the time to review our manuscript. Please find the detailed responses below and the revisions/corrections highlighted/in track changes in the re-submitted files.

Comments:

1. The authors have not described the rationale for conducting the study in detail. It is recommended to describe what is the need for the study and also introduce why the nurses have been chosen for interventions. 
   We modified the introduction section as follows to improve clarity:
   “In our Institute, CVC management is the responsibility of dedicated nursing staff, per standard practice. The decision to conduct this study was dictated by the need to verify whether we can reduce CVC-related infectious complications thanks to the rigorous and collaborative application of local CVC management guidelines.

After introducing the CVC management protocol, designed by highly qualified oncology nurse staff, and its application in all satellite hospitals, we aimed to estimate the incidence of CVC-related infections, placing this question as the study's primary aim.”    

 

2. The acronyms (CVC) should be written in full at first use in the manuscript except the abstract. 
   Indeed, the full-length term for CVC was missing at the first use. Thanks to your suggestion, we included it in the first section.
3. The aim in the abstract, introduction, and materials & methods do not match each other. 
   Thanks for pointing this out. We revised the aforementioned sections to clarify that the first aim was to assess the validity of the nurse-designed CVC management protocol by estimating the incidence of infections.
4. The inclusion and exclusion criteria were not defined priorly. Also, the control cohort population is not clear. How they were identified and selected.
   We added the inclusion and exclusion criteria in the Material and Method section: “Inclusion criteria were: CVC inserted in our hospital between January 2012 and July 2022, hematological or oncological diagnosis, age less than 18 at the time of CVC insertion, and informed consent for using clinical data signed by parents at admission. Exclusion criteria were CVC removal within the first 24 hours of insertion and personal CVC logbook unavailability.”
5. The authors mentioned the study as a retrospective cohort study. Also, the authors stated that they have taken the informed consent from the patient. Hence, the exact study design is not clear. It is recommended that the study's retrospective and prospective parts be clearly distinguished by using figures (if applicable).
   Thanks for pointing this out. We improved the materials and method section, defining the study design as a retrospective observational study, with the descriptive primary aim of estimating the incidence of CVC-related infections in our department. As a secondary aim, we investigated the risk factors for these infections. Nevertheless, as a standard protocol in our Scientific Institute, parents and custodians signed informed consent at the first visit, agreeing that clinical data may be used for clinical research purposes, epidemiology, the study of pathologies, and training to improve knowledge, care, and prevention.
6. The results presented are of a retrospective observational study rather than a retrospective cohort study. Kindly clarify the study design, analyze the data, and present the results accordingly.
   Indeed, the definition of retrospective observational study seems more appropriate, given that the primary aim was to describe the incidence of infections based on historical information. When mentioned, we changed the study design accordingly.
7. All the tables should be left aligned for clarity.  
   We have simplified and aligned the tables to enhance readability. Table 3 was displaced in the Supplementary numbered Table S1.
8. Figure 1 appears to be darker; hence, it is not clear. 
   We modified Figure 1. The revised version of the manuscript is numbered as Figure 2.

 

Round 2

Reviewer 2 Report

Comments and Suggestions for Authors

The authors have addressed the comments I raised. Additionally, I have one suggestion: consider including the study design in the title.

Author Response

We want to thank the reviewer for reviewing our manuscript. We have changed the title as suggested.