PONE-D-24-06857Enhancing Men's Awareness of Testicular Diseases (E-MAT) Using Virtual Reality: A Two-Arm Parallel-Group Randomised Pilot Feasibility Study and Embedded Mixed Method Process EvaluationPLOS ONE

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Reviewers' comments:

Reviewer's Responses to Questions

Comments to the Author

1. Is the manuscript technically sound, and do the data support the conclusions?

The manuscript must describe a technically sound piece of scientific research with data that supports the conclusions. Experiments must have been conducted rigorously, with appropriate controls, replication, and sample sizes. The conclusions must be drawn appropriately based on the data presented.

Reviewer #1: Partly

Reviewer #2: Yes

Reviewer #3: Yes

Reviewer #4: Yes

Reviewer #5: Yes

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

Reviewer #1: No

Reviewer #2: Yes

Reviewer #3: Yes

Reviewer #4: Yes

Reviewer #5: Yes

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3. Have the authors made all data underlying the findings in their manuscript fully available?

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Reviewer #1: Yes

Reviewer #2: Yes

Reviewer #3: Yes

Reviewer #4: Yes

Reviewer #5: Yes

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

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Reviewer #1: Yes

Reviewer #2: Yes

Reviewer #3: Yes

Reviewer #4: Yes

Reviewer #5: 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 manuscript is quite well presented but could be further improved.

The title could be improved. For the exclusion criteria, other criteria are to be stated.

The following requires further information.

i) Page 10, the person who collected the info 'T0 and T1 data were collected in person in participants’ respective GAA clubs' is to be stated.

ii) Page 10, the person who performs the randomization.

iii) Blinding information whether just involving the participants and data analyst.

Information on the pilot testing of the researcher-designed instruments prior to their usage is to be described.

The information for the sample size is unclear. More elaboration for the statement ‘detect failures in study processes that occur just 5% of the time’ is to be provided. The primary outcome, effect size, power, significance level, expected proportion of participants experiencing the outcome, sample size prior the consideration of attrition rates is to be stated

For the statement ‘’Qualitative data analysis was conducted by one researcher and checked for accuracy by two researchers to minimise errors and improve data credibility and confirmability’ is the researcher(s)referring to the authors of this study?

Page 19, the analysis of whether intent to treat or per protocol is to be stated.

Information on handling missing (if any) is to be stated.

Table 2, the decimal point for percentage figure is to be standardized e.g. 1 decimal point. Likewise in the text and the supplementary tables.

Page 20, the number of participants who participated in the interview/Focus Group with the researchers for the qualitative study is to be stated.

Page 23, the statement Thirty-six (97%) participants in both E-MATVR and E-MATE either agreed or strongly agreed that the intervention' does not reflect figure(s) in Supplementary Table S2.

For the supplementary tables, ensure the decimal points are standardized and to double-check the p values.

Supplementary Table S2, S4, symbol > for p value to be avoided. Actual p value is to be presented.

Supplementary Table S8, the decimal point for internal consistency is to be reduced.

Table 5, Supplementary Table S9, S12, the discrepancy n=66 and n=74 at T2 is to be denoted in the table footnote.

Ensure all the statistical tests used in the results section are mentioned in the statistical methods in page 19.

For Fisher’s exact test, 1 or 2-tailed test is to be stated.

The accepted level of statistical significance (and 1 or 2-tailed test) is to be stated.

Ensure all information that were reported in the CONSORT checklist are presented/clearly presented in the manuscript.

The numbering for each subtopic/subtitle is to be omitted.

Reviewer #2: 1-I recommend to revise the keywords ; as the "sport" isn't appropriate keyword.

2-The golden time of 6 hours for testicular torsion is not the rule , and this phrase is a little misleading , it depends on degree of torsion , I think it should be replaced with most recent literature

3-I suggest to include all meaningful data in Abstract.

4-I recommend to summarize or merge findings to better presentation of work , it seems the findings reported several times in text.

Reviewer #3: 1. The study design, including the randomized controlled trial (RCT) format, is well-conceived and appropriate for evaluating the feasibility and potential effectiveness of the E-MATVR intervention.

2. The inclusion of a control group (E-MATE) allows for a direct comparison of the two interventions, which is crucial for determining the relative benefits of the virtual reality (VR) approach.

3. The choice of outcome measures, including knowledge scores, self-examination behaviors, and qualitative feedback, is relevant and comprehensive for assessing the feasibility and potential impact of the intervention.

4. The inclusion of both immediate post-test (T1) and 3-month follow-up (T2) assessments provides valuable insights into the sustainability of the intervention's effects.

5. The recruitment strategy, utilizing various digital platforms and physical posters, appears to be effective, as evidenced by the enrollment of 74 participants.

6. The high retention rate of 66 participants (89%) is commendable and suggests that the study procedures and interventions were well-accepted by the target population.

7. The high levels of delivery quality and participant satisfaction reported for both the E-MATVR and E-MATE interventions are encouraging, indicating that the interventions were well-received and feasible to implement.

The feedback on the strengths and challenges of the VR intervention, such as its interactive and engaging nature as well as the potential issues with nausea and technical challenges, provides valuable insights for refining the intervention in the future.

8. The observed improvements in knowledge scores and self-examination behaviors across both intervention groups are promising, suggesting that both approaches may have a positive impact on men's awareness and engagement with testicular health.

9. The maintenance of these improvements at the 3-month follow-up further supports the potential long-term benefits of the interventions.

Overall, the pilot feasibility study and process evaluation provide a solid foundation for the proposed future RCT. The findings are promising and support the continued development and evaluation of the E-MATVR intervention, while also considering the lessons learned from this study to optimize the intervention and study design.

To improve the quality of the article, 1. Explore strategies to further enhance the accessibility and user experience of the VR intervention, addressing the challenges identified in this pilot study.

2. Consider incorporating more interactive elements and gamification features to engage participants and potentially improve the effectiveness of the interventions.

3. Carefully examine the survey length and content to ensure optimal participant engagement and data collection.

4. Expand the study population to include a more diverse sample of men, potentially beyond the current focus on Gaelic game athletes.

I believe this pilot study has successfully demonstrated the feasibility of conducting a future definitive RCT to evaluate the E-MATVR intervention. With the lessons learned and the promising initial results, the proposed RCT is well-justified and has the potential to contribute valuable insights to the field of testicular cancer awareness and prevention.

Reviewer #4: Authors have put together a very nice feasibility study on the use of virtual reality as an educational tool in men's testicular health.

The study is very sound and well written. I have no issues with the premises, nor with the content. There is good recruitment and followup, and I like the addition of a couple of paragraphs at the start of the discussion regarding successful recruitment.

My only comment would be that there does not seem to be any real difference in efficacy between the two arms, suggesting that the use of VR is not necessarily an improvement over more conventional interventions. It would be nice to see this commented on in more detail in the discussion. In particular, the assertion that VR may 'ensure access to hard to reach people and places' and is an 'alternative opportunity in delivering health promoting information to hard to reach populations' would seem counterintuitive, given the additional technology burden and distribution issues with VR. I think these statements would benefit from more consideration and explanation.

Otherwise I have no real issues or corrections. Well done to all authors.

Reviewer #5: Dear esteemed authors,

I would like to express my appreciation for your diligent efforts in producing the article titled "Enhancing Men's Awareness of Testicular Diseases (E-MAT) Using Virtual Reality: A Two-Arm Parallel-Group Randomized Pilot Feasibility Study and Embedded Mixed Method Process Evaluation."The article is well-structured and effectively communicates its findings. Materials and methods are well crafted and meticulously designed. There are no deviations from the registered protocol. The points are articulated and a reasonable flow exists throughout the manuscript. I want to thank you for making your data and code open source, which is a great practice leading to improved reproducibility of the science. However, I have to propose some comments that conceivably improve the quality of your study. Therefore, I believe that a minor revision can benefit the manuscript.

1- Please add line numbering to your manuscript to enhance communications.

2- The sentence "challenges related to getting used to VR, nausea, and technical issues." is a fragment of a sentence and should be edited.

3- A structured abstract would be a better fit for your study. I recommend sectioning your abstract in a way that helps the reader to grasp the essence of your report.

4- The abstract's conclusion is too brief and does not fully communicate the limitations, interpretations, etc. Please trim it and make room for more necessary information.

5- A good proportion of your introduction is devoted to the clinical and epidemiological aspects of the diseases. I think focusing more on details directly related to your topic will greatly enhance the readability and relevance of your study. I suggest to discuss the rationale for the future RCT, the reasons to justify why the pilot trial is needed, and areas of uncertainty that need to be addressed before the future RCT can take place, in depth at the end of your introduction.

6- The ending statement of the introduction's second paragraph:

Your statement comes from a late reference (2014), while currently, there are evidence suggesting watchful observation (aka active surveillance) for testicular cancer. Please update your citation.

7- The study has limited the exclusion criteria to ones with seizure and/or motion sickness. However, in my opinion, a very important characteristic that can affect and potentially, confound the results is having prior encounters with testicular diseases in the person being studied or his close relatives and acquaintances. Such individuals are reasonably and naturally more familiar with clinical manifestations, burdens, treatments and overall experience of a patient with testicular diseases. Furthermore,most of the participants enrolled in the study are players and coaches in the GAA clubs that are more susceptible to testicular injuries and consequent diseases and might be more aware of testicular diseases. The mentioned points might affect not only the main outcomes but also the dose exposure, reach, and internal validity. It may be beneficial to provide justification for not considering such information at recruitment or mention it as a limitation to your study.

8- The study compares an interactive (VR) VS a non-interactive (PDF document) method of education. I assume the first question that comes to the mind of readers (providers and policymakers) is whether VR, which is an expensive technology, can outperform other interactive methods and whether it is cost-effective for them to adopt in in their system. Nonetheless, it is well-known that using interactive models is usually more effective than non-interactive ones. It would be helpful if the authors provide explanations for this point or include it as a limitation of the study.

9- I see the authors provide a lot of supporting information. While this abundance is a good and encouraged practice, I recommend gathering them into a single file with an informative table of contents to facilitate the readers experience. Downloading that many files could be tedious.

10- Table 2 contains redundant information regarding the gender combination of the participants.

11- On page 24, part 3.2.5, the information mentioned in the sentence, "Elements of the VR game that participants did not favor ..." is not the same as those in the supplementary table S5.

12- The discussion could benefit from explaining the limitations in detail and arguing whether and how they could be overcome in the future RCT.

In summary, your article makes a valuable contribution to the field, and I believe the aforementioned suggestions will further enhance it.

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Reviewer #1: No

Reviewer #2: No

Reviewer #3: Yes: Alireza Jafari

Reviewer #4: No

Reviewer #5: No

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Enhancing Men's Awareness of Testicular Diseases (E-MAT) Using Virtual Reality: A Randomised Pilot Feasibility Study and Mixed Method Process Evaluation

PONE-D-24-06857R1

Dear Dr. Saab,

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.

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Kind regards,

Alireza Sadeghi, M.D., M.P.H.

Academic Editor

PLOS ONE

Additional Editor Comments (optional):

Dear Respected Authors,

I have meticulously examined your revisions and responses. It brings me great pleasure to inform you that, in my opinion, your article is now suitable for publication. I anticipate that the novel concept presented can make a positive impact on our existing knowledge.

I am satisfied that you have addressed all the comments from the reviewers accurately. However, I noticed that the role of the funder has only been mentioned in the cover letter. I kindly request you to incorporate this information into the main body of the manuscript as it could potentially affect the interpretation of your findings.

Best Wishes,

Reviewers' comments: