PONE-D-24-20769Effect of online module on nursing students’ knowledge acquisition about leadership: A randomized clinical trial protocolPLOS ONE

Dear Dr. Dantas,

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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- The results of this randomized clinical trial will have a positive impact on the participants’ knowledge acquisition, as well as enabling actions/interventions to be developed which promote more effective learning about Leadership in the training context, in turn providing students with greater knowledge and increased confidence in the subject, training nurses capable of promoting an efficient and collaborative work environment, optimizing the results achieved in patient care and contributing to the success of the healthcare institution.

Article accepted with few small corrections mentioned as below-

1. Author writes the rebuttal against reviewers comments point wise to justify the significance and relevance of study.
2. The method, experimental, statistical and discussion part improved with justified references to understand the study more better way.
3. The significance and future prospect of the study should be emphasize more on clinical benefit.

Acceptance- Yes

Decision- Major revision

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Please submit your revised manuscript by Oct 05 2024 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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We look forward to receiving your revised manuscript.

Kind regards,

Anshuman Mishra, PhD

Academic Editor

PLOS ONE

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Additional Editor Comments:

Title-Effect of online module on nursing students’ knowledge acquisition about leadership: A randomized clinical trial protocol

Summary of Article- Study by Jucielly Ferreira da Fonseca, et al, proposes to evaluate the impact of an online educational module focused on leadership for Nursing students, recognizing the importance of training future professionals from the beginning of their careers. 

Comments- The results of this randomized clinical trial will have a positive impact on the participants’ knowledge acquisition, as well as enabling actions/interventions to be developed which promote more effective learning about Leadership in the training context, in turn providing students with greater knowledge and increased confidence in the subject, training nurses capable of promoting an efficient and collaborative work environment, optimizing the results achieved in patient care and contributing to the success of the healthcare institution.

Article accepted with few small corrections mentioned as below-

1. Author writes the rebuttal against reviewers comments point wise to justify the significance and relevance of study.

2. The method, experimental, statistical and discussion part improved with justified references to understand the study more better way.

3. The significance and future prospect of the study should be emphasize more on clinical benefit.

Reviewers' comments:

Reviewer's Responses to Questions

Comments to the Author

1. Does the manuscript provide a valid rationale for the proposed study, with clearly identified and justified research questions?

The research question outlined is expected to address a valid academic problem or topic and contribute to the base of knowledge in the field.

Reviewer #1: Yes

Reviewer #2: Yes

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2. Is the protocol technically sound and planned in a manner that will lead to a meaningful outcome and allow testing the stated hypotheses?

The manuscript should describe the methods in sufficient detail to prevent undisclosed flexibility in the experimental procedure or analysis pipeline, including sufficient outcome-neutral conditions (e.g. necessary controls, absence of floor or ceiling effects) to test the proposed hypotheses and a statistical power analysis where applicable. As there may be aspects of the methodology and analysis which can only be refined once the work is undertaken, authors should outline potential assumptions and explicitly describe what aspects of the proposed analyses, if any, are exploratory.

Reviewer #1: No

Reviewer #2: Yes

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3. Is the methodology feasible and described in sufficient detail to allow the work to be replicable?

Descriptions of methods and materials in the protocol should be reported in sufficient detail for another researcher to reproduce all experiments and analyses. The protocol should describe the appropriate controls, sample size calculations, and replication needed to ensure that the data are robust and reproducible.

Reviewer #1: No

Reviewer #2: Yes

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4. Have the authors described where all data underlying the findings will be made available when the study is complete?

The PLOS Data policy requires authors to make all data underlying the findings described in their manuscript fully available without restriction, with rare exception, at the time of publication. 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: 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 #1: No

Reviewer #2: Yes

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6. Review Comments to the Author

Please use the space provided to explain your answers to the questions above and, if applicable, provide comments about issues authors must address before this protocol can be accepted for publication. You may also include additional comments for the author, including concerns about research or publication ethics.

You may also provide optional suggestions and comments to authors that they might find helpful in planning their study.

(Please upload your review as an attachment if it exceeds 20,000 characters)

Reviewer #1: Comment from the review of Effect of online module on nursing students’ knowledge acquisition about leadership: A randomized clinical trial protocol- PONE-D-24-20769

This study is a protocol for a 2-arm RCT that seek to evaluate the effectiveness of an online Nursing leadership module on the knowledge on leadership of participants who are nursing student in the sixth semester. The study proposed to use two treatment groups: a control group assigned to traditional teaching of nursing leadership and an experiential group assigned to an online nursing leadership module.

The concept is to equip participant with needed leadership skills to help them make good choices in patient care. However, the authors did not report hypotheses to define the concept as well as a clear methodology. This undermines the whole proposal.

The study is timely in the era where the Nursing profession is highly visible with some nurses holding higher offices in various universities and even in the political front across the globe.

However, few concerns were noted during the review, I believe when addressed it will better shape the manuscript.

• The title clinical trial is not appropriate, the setting of the trial is at school and not a clinical site or not involving patients or client- Unless there is some information I couldn’t access in the manuscript.

• Sample size

The sample size is not clear (140,141). Kindly restate it clearly

• Recruitment / Sampling strategy

the name of the randomised technique should be indicated ie. simple, systematic….? (122)

The recruitment and allocation is not so clear and it inconsistent under each section it appeared (153-157&172 to 175). Restructure and ensure it flows for easy comprehension.

with regards to the statement “interested students must register using a form Google forms” (153). what are the students registering for? course, to participate in the study? The students should also register the course in the SIGAA before recruitment into the study (150, 175 &187). clarification of these registrations is important.

The point at which participants are to be recruited and when they will sign the consent form is inconsistent across subsections (170 and 181) . Also how will the authors divide the two study groups? what strategy will they adopt (156)

• Duration of intervention

The duration for the intervention is not clearly stated, if the 4 hours is the duration for the intervention as indication in line 200 and 206.Will the intervention take place for only four hours or will it be four hours per week?, or will the it cover for the whole semester ? . what about the workload of 30 hour assigned to the course (150), Authors should reconcile this for clarity?

• Intervention

You need to indicate how you will deal with confounding factors.

The allocation of the intervention to the two treatment groups should be well defined from the beginning of the methodology, so that readers can know what exactly you are comparing.

The proposal should show the differences between the group. ie CG=face to face instruction with traditional time of 4 hours…..? whiles EG= online teaching with flexibility of 5days with added component to the subject matter or teaching methodology such as clinical cases?.

it is also not clear the mode of teaching researchers will employ for the online class, will it be real-time or recorded lecture? (206 - 208). Please indicate.

• Outcome measurement

How often will the authors measure the outcome parameters? is it after each lesson? This is not clear in the manuscript (267,272),

What is to be measured for primary outcome is not clear as well as the tool they will use to measure it? (268-270).

General Comments

1. Authors should clearly state the commonality and differences in the intervention given to in the study groups. ie. clinical case should be clearly defined

2. Randomising technique should be stated and process well defined

3. data collection tool under 219–will be google forms for all, while face to face group will be evaluated post intervention using printed questionnaire (201)

4. Sub heading are saying different things and mostly with additional information that are not relevant preventing the flow of ideas

5. I suggest the definition of terms should be included in the manuscript

6. psychometric properties of the assessment tools should be included in the manuscript to indicate the credibility of the tools.

7. Authors should add more information to the ethical consideration.

8. This study is a randomised control trial, hence the methodology should be more robust and RCT standards be strictly adhered to. Otherwise the authenticity of results will be undermined.

9. no research questions or hypothesis

Reviewer #2: Thank you for the opportunity to review this manuscript. While I find it promising I felt there were a few areas that could be more developed.

Abstract

1. Should include a brief mention of the intended or expected sample size or demographic information to provide context on the study's scope.

Materials and Methods

1. The description of the data collection instruments and the pre- and post-tests could be more detailed, particularly regarding the content of the clinical case and the questionnaire used.

2. It should be more clear how the outcomes are defined, measured, and treated and how the questionnaire and clinical case specifically measure team engagement, organizational culture, conflict management and feedback.

3. The explanation of the experimental intervention (online module) and control intervention (traditional lecture) could benefit from additional details about the specific content and structure.

Blinding

1. The section on data collection could provide more information on how data integrity will be maintained, particularly regarding the handling of digital data from Google Forms and Classroom.

2. While the blinding procedures are detailed, there could be a clearer explanation of how this will be maintained throughout the study, especially concerning post-test administration.

Data Analysis

1. This section could benefit from more specific information about the statistical tests that will be used to compare outcomes between the control and experimental groups.

2. It should specify how missing data will be handled, as this is a common issue in clinical trials.

Discussion

1. While the discussion is generally well-rounded, it could delve deeper into potential challenges or limitations of the study, such as varying levels of student engagement with the online module or differences in baseline knowledge levels

Overall

1. There is a minor inconsistency regarding the semester of students involved (sixth vs. seventh semester), which should be clarified. The abstract reads seventh whereas the methods section reads sixth.

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Reviewer #1: No

Reviewer #2: No

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PONE-D-24-20769R1Effect of the Online Module on Leadership in Knowledge Acquisition among Nursing Students: A Randomized Controlled Study ProtocolPLOS ONE

Dear Dr. Dantas,

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 Jan 27 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,

Anshuman Mishra, PhD

Academic Editor

PLOS ONE

Additional Editor Comments:

Dear Authors,

Study- Effect of online modules on nursing students’ knowledge acquisition about leadership: A randomized clinical trial protocol is one of important study for public health, patient care and clinical research perspectives. This study evaluates the effectiveness of Nursing module, healthcare management, treatment groups, etc. However, study lacks several key points and lacks basic information for the standard article (introduction, methodology, discussion, figures, latest references, results, etc.). This undermines the whole review article structure; therefore, I would suggest addressing the reviewers comment point-wise with a clear highlighted version along with a clean version (to understand changes in a better way).

Reveiwers comments are appended below for better understanding.

[Note: HTML markup is below. Please do not edit.]

Reviewers' comments:

Reviewer's Responses to Questions

Comments to the Author

1. Does the manuscript provide a valid rationale for the proposed study, with clearly identified and justified research questions?

The research question outlined is expected to address a valid academic problem or topic and contribute to the base of knowledge in the field.

Reviewer #3: Yes

Reviewer #4: Yes

Reviewer #5: Yes

Reviewer #6: No

Reviewer #7: Yes

Reviewer #8: No

Reviewer #9: No

Reviewer #10: Yes

Reviewer #11: Partly

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2. Is the protocol technically sound and planned in a manner that will lead to a meaningful outcome and allow testing the stated hypotheses?

The manuscript should describe the methods in sufficient detail to prevent undisclosed flexibility in the experimental procedure or analysis pipeline, including sufficient outcome-neutral conditions (e.g. necessary controls, absence of floor or ceiling effects) to test the proposed hypotheses and a statistical power analysis where applicable. As there may be aspects of the methodology and analysis which can only be refined once the work is undertaken, authors should outline potential assumptions and explicitly describe what aspects of the proposed analyses, if any, are exploratory.

Reviewer #3: Yes

Reviewer #4: Yes

Reviewer #5: Yes

Reviewer #6: No

Reviewer #7: Partly

Reviewer #8: No

Reviewer #9: No

Reviewer #10: Partly

Reviewer #11: Partly

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3. Is the methodology feasible and described in sufficient detail to allow the work to be replicable?

Descriptions of methods and materials in the protocol should be reported in sufficient detail for another researcher to reproduce all experiments and analyses. The protocol should describe the appropriate controls, sample size calculations, and replication needed to ensure that the data are robust and reproducible.

Reviewer #3: No

Reviewer #4: Yes

Reviewer #5: Yes

Reviewer #6: Yes

Reviewer #7: Yes

Reviewer #8: No

Reviewer #9: Yes

Reviewer #10: No

Reviewer #11: No

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4. Have the authors described where all data underlying the findings will be made available when the study is complete?

The PLOS Data policy requires authors to make all data underlying the findings described in their manuscript fully available without restriction, with rare exception, at the time of publication. 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 #3: Yes

Reviewer #4: Yes

Reviewer #5: Yes

Reviewer #6: No

Reviewer #7: No

Reviewer #8: No

Reviewer #9: Yes

Reviewer #10: No

Reviewer #11: 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 #3: Yes

Reviewer #4: Yes

Reviewer #5: Yes

Reviewer #6: Yes

Reviewer #7: Yes

Reviewer #8: Yes

Reviewer #9: No

Reviewer #10: Yes

Reviewer #11: Yes

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6. Review Comments to the Author

Please use the space provided to explain your answers to the questions above and, if applicable, provide comments about issues authors must address before this protocol can be accepted for publication. You may also include additional comments for the author, including concerns about research or publication ethics.

You may also provide optional suggestions and comments to authors that they might find helpful in planning their study.

(Please upload your review as an attachment if it exceeds 20,000 characters)

Reviewer #3: The authors have described the methodology in the future tense, making it unclear whether they have performed the study or they are still in the process of performing the study. If they have already conducted the study then the methodology should be described in past tense rather than future tense.

Reviewer #4: 1. Online Module on Leadership in Knowledge Acquisition among Nursing Students is an important research area for the scientific community. Good leadership is important in every profession including nursing as it influences teamwork, decision-making, and the quality of service delivery and patient care. Yes, the manuscript provides a valid rationale for the proposed study, with clearly identified and justified research questions. The research question outlined is expected to address a valid academic problem and contribute to the base of knowledge in the field.

2. Despite the importance of leadership, nursing curricula often prioritize clinical skills over soft skills like leadership and communication. This Protocol is technically sound and planned in a manner that will lead to a meaningful outcome and allow testing of the stated hypotheses. Data analysis will be conducted rigorously, using a randomized controlled trial, a rigorous methodology that will strengthen the reliability of its findings. This method is appropriate and adequate for a study of this nature.

3. Yes, the methodology is feasible and described in sufficient detail to allow the work to be replicable.

4. Yes, the author has described where all data underlying the findings will be made available when the study is complete.

5. Yes, the manuscript is presented in an intelligible fashion and written in standard English.

Additional Comments:

a. Research efforts from past studies in this area should be reviewed.

b. Findings from past research efforts should be integrated to bolster the findings of the current study.

c. Practical implications/applications of the current study's findings should be the focus of the research outcomes. This will serve as the author's contributions to the literature when the study's outcomes are applied to real life issues.

d. Appropriate medical/nursing authorities/regulators should be mentioned in the body and recommendations of the study.

Reviewer #5: The authors have successfully addressed the reviewer's comments. However, the comment posed by the previous reviewer about the outcome measurement that how often will the authors measure the outcome parameters still seems to be unaddressed.

I have also included a few additional minor suggestions for further improvement below.

Title Geographical location: The title of the manuscript effectively conveys the focus of the research, however, to enhance clarity and specificity, it would be beneficial to include the geographical area where the research is going to be conducted. For example, " Effect of the Online Module on Leadership in Knowledge Acquisition among Nursing in Students in Nepal: A Randomized Controlled Study Protocol" would provide readers with a clearer understanding of the study's context (1,2)

Data Analysis: The plan mentions using the Content Validity Index (CVI) and the Kappa test to assess the normality of data distribution. However, these tests are not designed for normality assessment. The CVI is used to measure the validity of items, often in survey research, and the Kappa test measures inter-rater reliability. Instead, normality should be evaluated using tests like the Shapiro-Wilk or Kolmogorov-Smirnov test. This limitation may lead to an inaccurate assumption about data distribution, affecting the choice of statistical tests. (275)

While the authors designate this study as a randomized controlled trial (RCT), there is frequent reference to it as a clinical trial in the abstract. (27,36) To avoid potential confusion, it may be helpful to consistently use the term “randomized controlled trial” to highlight the study’s design rigor and emphasize the randomization process, which is a critical feature in distinguishing it from other types of clinical trials.

Reviewer #6: Thank you for submitting your manuscript, titled "Effect of the Online Module on Leadership in Knowledge Acquisition among Nursing Students: A Randomized Controlled Study Protocol". I appreciate the time and effort you have invested in preparing this work. After careful evaluation, I regret to inform you that your manuscript does not meet the specific standards or requirements of my view. I hope this feedback will help you in further developing your research for publication.

Reviewer #7: I appreciate the authors' efforts to address the suggestions made in the previous review. The revised manuscript shows improvement in clarity and detail. However, some key areas still require further clarification before the manuscript can be considered for publication.

Specific Revisions Requested:

Sample Size: While the authors clarify that the sample will be one class of approximately 40 participants, it would be helpful to justify why a convenience sample is chosen and discuss potential limitations of this approach.

Recruitment and Sampling Strategy: The revised response provides a more detailed description of the recruitment process. However, there are still some inconsistencies that need to be addressed: Clearly state if registration for the Google Forms and SIGAA course are for the same purpose or separate steps.

Ensure consistency in the timing of obtaining informed consent across different sections.

Intervention: The response clarifies the duration and format of the online module. However, it would be beneficial to address potential confounding factors:

Explain how the researchers will minimize interaction between the control and experimental groups to avoid contamination of knowledge.

Further detail the teaching methods employed in the online module (e.g., solely recorded lectures, opportunities for interaction).

Additional Comments: Outcome Measurement: The revised response clarifies the data collection tool and its components. However, consider specifying how often the pre-test and post-test will be administered (e.g., before and after the intervention only).

Overall: I encourage the authors to address the points mentioned above. A more detailed and consistent description of the methodology will strengthen the manuscript and enhance its clarity for readers. Once these revisions are made, I would be happy to re-evaluate the manuscript for publication.

Reviewer #8: The paper lacks depth and does not clearly articulate its contribution to the body of knowledge, aside from a few speculative remarks about the expected outcomes. The scientific methodology employed is questionable. If the outcomes are already presumed before the experiment is conducted, it raises the question: what is the purpose of the experiment?

Firstly, the authors describe the study as a "clinical trial"; however, the content of the paper bears no resemblance to a clinical trial. By definition, a clinical trial is a research study conducted to evaluate the safety, effectiveness, and potential side effects of a medical intervention, such as a new drug, medical device, or treatment method. Clinical trials are critical for advancing medical science and ensuring that new treatments are both effective and safe for patients.

Secondly, the abstract contains duplication; while both versions present the same content, they fail to clearly define the purpose of the research or its actual outcomes. Furthermore, there are ambiguous statements regarding the duration of the experiment—is it 4 hours or 30 hours? There is also ambiguity about the study resources provided to the control group and the experimental group. For instance, will the control group have access to quizzes like the experimental group? How did the authors ensure that neither group was disadvantaged?

Lastly, there is no clear analysis of the results. It is unclear whether the experiment has been conducted or if the study is still in the design phase, as no results are included in the paper. Additionally, there is no conclusion, nor are there any suggestions for future experiments or implications for extending the results—results which, again, have not been described—to a broader cohort.

Suggestions for Improvement:

1. Abstract: Ensure the abstract is concise, not duplicated, and clearly states the purpose, methodology, and expected outcomes of the research.

2. Methodology: Clearly outline the experimental design, including the duration, resources provided to each group, and steps taken to ensure fairness between the control and experimental groups.

3. Result Analysis: Provide a detailed analysis of the experimental results. If the study is in the design phase, clarify this and outline plans for future analysis.

4. Conclusion: Include a conclusion that summarises the findings, suggests directions for future research, and discusses implications for extending the results to a wider cohort.

Reviewer #9: Dear Authors,

Sorry to say that but after reading this paper I can not make a sense who is your participants, Like in various lines you mentioned different cohort:

paze 1 line 27, All seventh period students? what is 7th period ( a course or 7th semester)

paze 2 line 60, All sixth period students? if its 7th or 6th.

page 5 line 137, those enrolled in the sixth period of the course? What is this 6th period or 7th period course.

page 6 line 149, sixth semester of the UFRN Nursing. I am confused if its 1st semester students in 6th period or 7th period or 6th or 7th semester students, so confusing.

Second part when already an reviewer commented that its not a clinical trial but still you mention it at:

paze 1 line 27, clinical trial? it's not a clinical trial.

page 2 line 36 and page 3 line 68, randomized clinical trial

Third thing, the study sample is very low to get any fruitful outcome from this study.

Reviewer #10: this manuscript describes plans for a study to compare learning about and understanding of leadership by nursing students. Although the authors have mostly addressed questions raised by a previous reviewer, I have the following questions, suggestions, and concerns.

One point that should be addressed is that there appear to be numerous differences between the conditions other than modality (in-person vs. online), so what exactly might be concluded from this study other than that this online course differs from this in-person course should be explained

In addition, as noted below in #14, it seems that far more detail should be provided about what data will be coilected and how it will be coded and mapped into whatever response variables will be studied. The data appear to not be just numbers that can be subjected to the ordinary tools of descriptive and inferential statistics. What actually are the variables that will be studied and compared? The absence of this information is why I answered "No" to the question about whether the methodology was described sufficiently to permit the work to be replicable. It seems that a study protocol should be sufficiently detailed so that another researcher could pick it up and implement the study.

1. Although the authors seem to agree with the reviewer of the previous version of this manuscript that "clinical trial" is not an appropriate descriptor for this study, there are still two references to "clinical trial" in the abstract.

2. Within the manuscript, the abstract is duplicated (lines 17-41 and 49-73).

3. Delete the “therefore”s on lines 84 and 86.

4. If it is journal policy, titles of cited articles listed in the reference list should be translated to English.

5. Although the information provided in the cover pages says “N/A” for ethics statement, there is one on lines 116-119.

6. The sentence on lines 124-126 seems to contribute nothing and can probably be deleted. The statement about measurements before and after the intervention might be moved to the end of that paragraph.

7. For the context of this study, it doesn’t really make sense to have separate “Study population” and “Sample size” sections. It’s not really clear what the population is (all nursing students?, all nursing students in Brazil?, all nursing students at this university?), and that probably doesn’t matter. What does matter is that this is a convenience sample that is being divided at random between two groups subject to the constraint that the groups be equal in size. That that constraint is planned should be stated at the same time random assignment is mentioned. However, the constraint is not mentioned in the statement about “allocation” on lines 169-170. If the constraint of equal-sized groups is planned, that has to be stated at around line 170.

8. Will the consent form explain the in-person vs. online difference between the groups? Knowing that the groups differ in modality could influence either rate of agreement or attrition. (This is actually answered on lines 190-192, but should probably also be included where consenting is first mentioned on lines 161-162.

9. It’s not clear what the 30 hours are for the intervention condition. Will participants in that condition be expected to engage with the course for 30 hours (in comparison to the control condition’s four)? Or will the materials be available for 30 hours during the five-day window? Or will they be available for all 120 hours of the five days?

10. The statement on lines 184-186 is somewhat mysterious and should either be deleted or clarified. It’s not clear what single-blinding means in this context. The participants will know in which condition they are participating (but, depending on the answer to comment 8, above, may not know of the existence of the other condition, although it’s hard to imagine how the existence of the two conditions would be revealed by communication between students). If one of the researchers is teaching the lecture course for the control condition, the researcher will know in which condition participants are participating.

The section about Blinding that comes later (lines 248-253) really doesn’t make sense,. It says that participants will be unaware of the condition to which they are allocated, but of course they will be aware of the condition to which they were allocated, especially if, as stated on lines 190-192, they are told about the two conditions as part of the consent process. The only blinding that I can imagine taking place in this study is that coders of any responses that require some sort of coding could be blind to condition.

11. On lines 198-199, what does “both online and remotely” mean? Should this be “both online and in person”?

12. Why, on lines 210-211, does it say “Participants will not be informed of their group

assignment at any point.” when the previous sentence has just said that participants will be informed of their group assignments?

13. Somewhere, probably at around line 230, there should be an explicit statement of how much time will elapse between the online gathering of all participants for the pretest and the in-person gathering of all participants for the posttest.

14. For all the detail that is provided about recruitment and allocation, shockingly little is provided about what will be measured and how. The questionnaire that I understand to provide the “secondary outcomes” data is included (although parts of it are confusing, maybe due to some error in translation—e.g., what does frequency from never to always have to do with understanding statements), the “problem” and questions that provide the information for primary outcomes is not included. As I understand things, each of these includes some open-ended answers, what the questions are and how answers will be coded and mapped into response variables seems to be crucial information for a study protocol.

15, The authors say that data will be made available when a final manuscript is published, but do not say where.

Reviewer #11: 1. First of all, it is randomized control trial and not randomized trial control. please correct it.

2. It is not at all clear to me what methodology will be used by the authors to evaluate the effect of the intervention. is it regression or a simple ttest?

3. Since, the authors are receiving the applications from the students and then they are randomizing. There could be a self selection. Even if you are do randomization after the application are received, how would you generalize your results because your sample is not random anymore. The kind of students who have agreed to be participants have self-selected themselves. Something to think about.

4. Sample size is very small, how would you generalize your results?

5. You have mention about balance test and common support.

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Reviewer #3: No

Reviewer #4: No

Reviewer #5: Yes:  Rima Mishra

Reviewer #6: Yes:  Rajeev Kumar Mishra

Reviewer #7: Yes:  Rahul Kumar Mishra

Reviewer #8: Yes:  Obinna Johnphill

Reviewer #9: Yes:  Manish Mishra

Reviewer #10: Yes:  Albert F. Smith

Reviewer #11: No

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Effect of the Online Module on Leadership in Knowledge Acquisition among Nursing Students: A Randomized Controlled Study Protocol

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Dear Dr. Dantas,

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Additional Editor Comments (optional):

Study-Effect of the Online Module on Leadership in Knowledge Acquisition among Nursing Student, by Daniele Vieira Dantas et al., suggest, optimize patient care outcomes and contribute to the overall success of the healthcare institution. The findings from this randomized clinical trial will significantly enhance participants’ knowledge acquisition and help develop strategies or interventions that foster more effective learning about leadership within the training context. This, in turn, will equip students with a deeper understanding of the subject, boosting their confidence and preparing nurses who can cultivate an efficient and collaborative work environment.

Reviewers' comments: