The Effects of the Clinical Simulation of Transfusion Reactions on Nursing Students’ Knowledge Gain: A Pragmatic Clinical Trial

Round 1

Reviewer 1 Report

Comments and Suggestions for Authors

The manuscript explores the effectiveness of clinical simulation as a pedagogical strategy for increasing nursing students’ knowledge regarding transfusion reactions. The study design involves an intervention group exposed to simulation-based training and a control group adhering to more traditional instructional methods, with learning assessed through pre-tests and post-tests. Overall, this is a timely topic, given the growing emphasis on simulation in nursing education, patient safety concerns related to transfusion practices, and the need for stronger empirical evidence in this domain.

Methodological Observations and Suggestions

1. Randomization and Sample Characteristics

   • Randomization: The manuscript refers to an “intervention” and “control” group, yet it is not entirely clear how participants were allocated. If randomization was used, specify the randomization process (e.g., simple randomization, block randomization, etc.). If non-random methods were employed, clarify that this was a convenience or quasi-experimental approach.
   • Sample Size and Power: While 60 participants were ultimately analyzed, the manuscript could strengthen its methodological rigor by mentioning whether a sample-size calculation or power analysis was conducted before recruitment. This can help justify that 60 participants were sufficient to detect meaningful differences.

2. Blinding or Minimizing Bias

   • It is understandable that blinding participants to an educational intervention is typically not feasible. However, consider whether the individuals assessing post-test outcomes were blinded to group assignment. If not, explicitly acknowledge any potential for detection bias in the limitations.

3. Timing of Outcome Assessments

   • The manuscript indicates that pre- and post-tests were administered, but the interval between the intervention and the post-test measurement could be more clearly specified. Was the post-test immediately after the simulation, or was there a follow-up period (e.g., one week or longer)? If any longer-term retention testing was done, that would significantly strengthen the conclusions.

4. Procedural Details of the Simulation

   • The text provides a general description of the simulation scenario (e.g., “stage simulation with actors”) but could benefit from a more structured explanation. For instance, the use of validated checklists (e.g., the Healthcare Simulation Standards of Best Practice™) or whether the scenario was pilot-tested for realism, might give readers more insight into the fidelity and reproducibility of the simulation approach.

5. Instrument Validity and Reliability

   • The paper references a questionnaire measuring knowledge of transfusion reactions but offers limited detail about its validation. Was the questionnaire newly developed, or adapted from an existing validated instrument? Provide reliability statistics (e.g., Cronbach’s alpha) if available, along with references or rationale for item selection.

Presentation and Data Reporting

1. Tables and Figures

   • Table 2 and Figure 3: The data are clearly labeled, but ensuring consistency in how results are labeled in the text, tables, and figures will further improve readability (e.g., consistently referring to “pre-test score” vs. “total correct answers in pre-test”).
   • Table 3: The itemized breakdown of errors and correct answers is highly informative. Including an overall “% change” column could further highlight the extent of improvement or decline.

2. Statistical Significance vs. Practical Significance

   • The manuscript reports p-values and Cohen’s d. It might help to interpret these effect sizes directly in the text, explaining whether the effect was small, medium, or large (e.g., “d = 1.14 indicates a large effect size according to standard benchmarks [29]”).

3. Consistency in Reporting

   • Double-check references to p-values: Table 2 cites p=0.053 twice, once for the difference in total correct answers in the pre-test and once for the difference in the pre-test scores themselves. Make sure the readers can distinguish between these metrics and that the results are not duplicated inadvertently.

Discussion and Contextualization

1. Integrating with Current Literature

   • The authors effectively cite numerous recent studies on transfusion errors and simulation in nursing education. Strengthening the discussion by contrasting the present findings with those studies (e.g., how do your effect sizes compare with them, or do you see consistent improvements in certain skills?) will deepen the scholarly conversation.

2. Limitations and Future Directions

   • While the manuscript mentions limitations (infrastructure, time constraints, student reluctance, and teacher training), elaborating on how future studies could address these challenges—such as adopting a longer retention period, multiple simulation sessions, or multi-center trials—would give readers a clearer roadmap for subsequent research.

3. Implications Beyond Knowledge Gain

   • The results primarily focus on theoretical knowledge improvements. If available, consider mentioning whether the simulation also influenced student confidence or clinical skill performance (e.g., measured by an objective structured clinical exam). If not measured here, suggest it as a future direction.

Conclusion

1. Summary of Key Outcomes

   • The conclusion clearly states that simulation led to greater gains in knowledge relative to traditional methods. This is a solid and important finding, especially given ongoing efforts to improve patient safety in transfusion practices.

2. Practical Relevance

   • The manuscript highlights that clinical simulation can and should be integrated more fully into nursing curricula. Providing a concise statement on how educators can incorporate these findings into immediate course improvements (e.g., adopting scenario-based training for hemotherapy, standardizing simulation protocols) can emphasize its real-world utility.

3. Call for Further Study

   • Given the identified limitations, consider encouraging replication in broader, more diverse settings (different universities, larger cohorts) and measuring longer-term retention or clinical competencies that go beyond knowledge. Doing so would strengthen the overall body of evidence for simulation-based instruction in transfusion safety.

Author Response

Section    Reviewer 1 comments    Authors' response
Methodological Observations and Suggestions
    
1.    Randomization and Sample Characteristics
•    Randomization: The manuscript refers to an “intervention” and “control” group, yet it is not entirely clear how participants were allocated. If randomization was used, specify the randomization process (e.g., simple randomization, block randomization, etc.). If non-random methods were employed, clarify that this was a convenience or quasi-experimental approach.
•    Sample Size and Power: While 60 participants were ultimately analyzed, the manuscript could strengthen its methodological rigor by mentioning whether a sample-size calculation or power analysis was conducted before recruitment. This can help justify that 60 participants were sufficient to detect meaningful differences.
2.    Blinding or Minimizing Bias
•    It is understandable that blinding participants to an educational intervention is typically not feasible. However, consider whether the individuals assessing post-test outcomes were blinded to group assignment. If not, explicitly acknowledge any potential for detection bias in the limitations.
3.    Timing of Outcome Assessments
•    The manuscript indicates that pre- and post-tests were administered, but the interval between the intervention and the post-test measurement could be more clearly specified. Was the post-test immediately after the simulation, or was there a follow-up period (e.g., one week or longer)? If any longer-term retention testing was done, that would significantly strengthen the conclusions.
4.    Procedural Details of the Simulation
•    The text provides a general description of the simulation scenario (e.g., “stage simulation with actors”) but could benefit from a more structured explanation. For instance, the use of validated checklists (e.g., the Healthcare Simulation Standards of Best Practice™) or whether the scenario was pilot-tested for realism, might give readers more insight into the fidelity and reproducibility of the simulation approach.
5.    Instrument Validity and Reliability
•    The paper references a questionnaire measuring knowledge of transfusion reactions but offers limited detail about its validation. Was the questionnaire newly developed, or adapted from an existing validated instrument? Provide reliability statistics (e.g., Cronbach’s alpha) if available, along with references or rationale for item selection.
    

All the requested items have been included, and these changes are indicated in the text by the yellow color marking. 

Presentation and Data Reporting
    1.    Tables and Figures
•    Table 2 and Figure 3: The data are clearly labeled, but ensuring consistency in how results are labeled in the text, tables, and figures will further improve readability (e.g., consistently referring to “pre-test score” vs. “total correct answers in pre-test”).
•    Table 3: The itemized breakdown of errors and correct answers is highly informative. Including an overall “% change” column could further highlight the extent of improvement or decline.
2.    Statistical Significance vs. Practical Significance
•    The manuscript reports p-values and Cohen’s d. It might help to interpret these effect sizes directly in the text, explaining whether the effect was small, medium, or large (e.g., “d = 1.14 indicates a large effect size according to standard benchmarks [29]”).
3.    Consistency in Reporting
•    Double-check references to p-values: Table 2 cites p=0.053 twice, once for the difference in total correct answers in the pre-test and once for the difference in the pre-test scores themselves. Make sure the readers can distinguish between these metrics and that the results are not duplicated inadvertently.    All the requested items have been included, and these changes are indicated in the text by the yellow color marking. 

Discussion and Contextualization
    1.    Integrating with Current Literature
•    The authors effectively cite numerous recent studies on transfusion errors and simulation in nursing education. Strengthening the discussion by contrasting the present findings with those studies (e.g., how do your effect sizes compare with them, or do you see consistent improvements in certain skills?) will deepen the scholarly conversation.
2.    Limitations and Future Directions
•    While the manuscript mentions limitations (infrastructure, time constraints, student reluctance, and teacher training), elaborating on how future studies could address these challenges—such as adopting a longer retention period, multiple simulation sessions, or multi-center trials—would give readers a clearer roadmap for subsequent research.
3.    Implications Beyond Knowledge Gain
•    The results primarily focus on theoretical knowledge improvements. If available, consider mentioning whether the simulation also influenced student confidence or clinical skill performance (e.g., measured by an objective structured clinical exam). If not measured here, suggest it as a future direction.    All the requested items have been included, and these changes are indicated in the text by the yellow color marking. 

Conclusion
    1.    Summary of Key Outcomes
•    The conclusion clearly states that simulation led to greater gains in knowledge relative to traditional methods. This is a solid and important finding, especially given ongoing efforts to improve patient safety in transfusion practices.
2.    Practical Relevance
•    The manuscript highlights that clinical simulation can and should be integrated more fully into nursing curricula. Providing a concise statement on how educators can incorporate these findings into immediate course improvements (e.g., adopting scenario-based training for hemotherapy, standardizing simulation protocols) can emphasize its real-world utility.
3.    Call for Further Study
•    Given the identified limitations, consider encouraging replication in broader, more diverse settings (different universities, larger cohorts) and measuring longer-term retention or clinical competencies that go beyond knowledge. Doing so would strengthen the overall body of evidence for simulation-based instruction in transfusion safety.    All the requested items have been included, and these changes are indicated in the text by the yellow color marking. 

 

Author Response File: Author Response.pdf

Reviewer 2 Report

Comments and Suggestions for Authors

The manuscript Effects of Clinical Simulation about Transfusion Reaction on Nursing Students' Knowledge Gain: A Pragmatic Clinical Trial

Addresses a timely and relevant topic, highlighting the importance of an innovative approach to acquiring knowledge and competencies among nursing students about the risky aspects of blood transfusion. Although the concept is promising, the manuscript has limitations regarding scientific rigour and expert information. Therefore, several recommendations are provided for its improvement.

Abstract:
Although the abstract is structured, significant revisions are needed:

• The Objective is inconsistent with the statement in lines 58-59.
• In the methods section, specify the instrument used in the study
• There is no reporting of statistical and numerical data. The authors have elected to summarize the findings in text form. I recommend the addition of descriptive and statistical results in this section so the reader can understand the size and strength of the reported effect.

Keywords:

• incomplete in relation to the title and content of the manuscript.

Introduction:
Inadequate Literature Review: The introduction does not sufficiently engage with the existing literature. Revisions are necessary for the following:

- To expand the facts about transfusion reactions, the importance of their prevention and monitoring for the patient and the health system; to specify the data on recommendations on their prevention, monitoring and treatment, frequency globally and in the region/country where the study was conducted

- Support statements (in lines 37-42) with appropriate references.

- Data in lines 43-46 should be supplemented with concrete data on types of simulation and procedures where it is applied in nursing education.

- State whether the data, how much simulation is represented in the teaching, and whether there are legal regulations in the country/region where the study was conducted.

- State the level of education of nurses in the country/region where the study was conducted and to what extent the topic covered by the manuscript is studied.

Methodology:
The methodology is insufficiently detailed, hindering study replication. Clarifications needed include:

• clarify the data in lines 78-80 whether students who did not meet the inclusion criteria attend the course
• Support statements in lines 103-104 with appropriate references.
• Define who were the facilitators for the procedure mentioned in lines 124-128
• There is a lack of data on whether and by whom the validity of the simulation content was considered. Also, whether a pilot study has been done.
• For a better understanding of the study, more information is needed about the simulation scenario, which procedures and transfusion reactions are included, whether each student participated independently or were divided into groups (size and criteria for the number of students in the group, who was the "patient" in the simulation.
• There is a lack of data on the instruments used for each aspect listed in the study's objectives (cognitive knowledge, satisfaction and self-confidence). If previously validated instruments were used, state the authors/references and validation data. If the instruments were created for the study, state the criteria, references, and validation data. Specify the specific number and questions for each aspect of the study stated in the objectives, the method of scoring the obtained results, and whether there were cut-off values.
• Provide precise information about the distribution of instruments.
• Report on the reliability measures of the instruments used.

Results:
- The results are partially aligned with the objectives.

- Most of the results from Table 1 are presented textually in lines 172-175, so there is no need for a tabular presentation.

- In Table 2, provide data on Mann-Whitney test values.

- -Include an explanation of the Cohen’s test data in Figure 3.

- Improve table/figure titles and ensure the legend is in English.

Discussion:
The discussion is extensive, but like other parts of the manuscript, it only partially aligns with the study objectives. So, after correcting other sections of the manuscript, it is necessary to revise this section.

The statement in lines 279-280 does not align with the study objectives and results.

Implications and limitations:

The data in lines 285-286 is inconsistent with the lines 65-68 statements.

Conclusions:

Generalization and interpretation issues: The conclusion does not adequately discuss the results obtained, the limitations of the study design, or the generalizability of the findings. In addition, specific recommendations for future research are lacking.

Quality and Recency of References:

• While the references are generally appropriate.

 

The manuscript may confuse readers rather than contribute new scientific insights in its current form. A thorough revision is recommended to enhance the clarity, scientific rigour, and overall presentation of this valuable study.

I hope you find my comments helpful.

Author Response

Section    Reviewer 2 comments    Authors' response
Abstract    Although the abstract is structured, significant revisions are needed:
•    The Objective is inconsistent with the statement in lines 58-59.
•    In the methods section, specify the instrument used in the study
•    There is no reporting of statistical and numerical data. The authors have elected to summarize the findings in text form. I recommend the addition of descriptive and statistical results in this section so the reader can understand the size and strength of the reported effect.
Keywords:
•    incomplete in relation to the title and content of the manuscript.
    

All the requested items have been included, and these changes are indicated in the text by the yellow color marking. 

Introduction    1.    Inadequate Literature Review: The introduction does not sufficiently engage with the existing literature. Revisions are necessary for the following:
2.    - To expand the facts about transfusion reactions, the importance of their prevention and monitoring for the patient and the health system; to specify the data on recommendations on their prevention, monitoring and treatment, frequency globally and in the region/country where the study was conducted
3.    - Support statements (in lines 37-42) with appropriate references.
4.    - Data in lines 43-46 should be supplemented with concrete data on types of simulation and procedures where it is applied in nursing education.
5.    - State whether the data, how much simulation is represented in the teaching, and whether there are legal regulations in the country/region where the study was conducted.
6.    - State the level of education of nurses in the country/region where the study was conducted and to what extent the topic covered by the manuscript is studied.    All the requested items have been included, and these changes are indicated in the text by the yellow color marking. 

Methodology:    The methodology is insufficiently detailed, hindering study replication. Clarifications needed include:
1.    clarify the data in lines 78-80 whether students who did not meet the inclusion criteria attend the course
2.    Support statements in lines 103-104 with appropriate references.
3.    Define who were the facilitators for the procedure mentioned in lines 124-128
4.    There is a lack of data on whether and by whom the validity of the simulation content was considered. Also, whether a pilot study has been done.
5.    For a better understanding of the study, more information is needed about the simulation scenario, which procedures and transfusion reactions are included, whether each student participated independently or were divided into groups (size and criteria for the number of students in the group, who was the "patient" in the simulation.
6.    There is a lack of data on the instruments used for each aspect listed in the study's objectives (cognitive knowledge, satisfaction and self-confidence). If previously validated instruments were used, state the authors/references and validation data. If the instruments were created for the study, state the criteria, references, and validation data. Specify the specific number and questions for each aspect of the study stated in the objectives, the method of scoring the obtained results, and whether there were cut-off values.
7.    Provide precise information about the distribution of instruments.
8.    Report on the reliability measures of the instruments used.    All the requested items have been included, and these changes are indicated in the text by the yellow color marking. 

Results    1.    - The results are partially aligned with the objectives.
2.    - Most of the results from Table 1 are presented textually in lines 172-175, so there is no need for a tabular presentation.
3.    - In Table 2, provide data on Mann-Whitney test values.
4.    - -Include an explanation of the Cohen’s test data in Figure 3.
5.    - Improve table/figure titles and ensure the legend is in English.    All the requested items have been included, and these changes are indicated in the text by the yellow color marking. 

Discussion:    The discussion is extensive, but like other parts of the manuscript, it only partially aligns with the study objectives. So, after correcting other sections of the manuscript, it is necessary to revise this section.
The statement in lines 279-280 does not align with the study objectives and results.
Implications and limitations:
The data in lines 285-286 is inconsistent with the lines 65-68 statements.    All the requested items have been included, and these changes are indicated in the text by the yellow color marking. 
Conclusions:
    Generalization and interpretation issues: The conclusion does not adequately discuss the results obtained, the limitations of the study design, or the generalizability of the findings. In addition, specific recommendations for future research are lacking.

    All the requested items have been included, and these changes are indicated in the text by the yellow color marking. 
        

Author Response File: Author Response.pdf

Round 2

Reviewer 2 Report

Comments and Suggestions for Authors

The manuscript Effects of Clinical Simulation about Transfusion Reaction on Nursing Students' Knowledge Gain: A Pragmatic Clinical Trial

Addresses a timely and relevant topic, highlighting the importance of an innovative approach to acquiring knowledge and competencies among nursing students about the risky aspects of blood transfusion.

The manuscript has been sufficiently improved to warrant publication in the journal Education Sciences.