PONE-D-24-32799 Perception of Healthcare Administrators on the Impediments of Optimizing Adverse Events Following Immunization E-Reporting in Nigeria

Dear Dr. Isiaka,

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PLOS ONE

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Reviewers' comments:

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

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

Reviewer #1: Yes

Reviewer #2: Yes

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

The PLOS Data policy requires authors to make all data underlying the findings described in their manuscript fully available without restriction, with rare exception (please refer to the Data Availability Statement in the manuscript PDF file). The data should be provided as part of the manuscript or its supporting information, or deposited to a public repository. For example, in addition to summary statistics, the data points behind means, medians and variance measures should be available. If there are restrictions on publicly sharing data—e.g. participant privacy or use of data from a third party—those must be specified.

Reviewer #1: Yes

Reviewer #2: Yes

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

PLOS ONE does not copyedit accepted manuscripts, so the language in submitted articles must be clear, correct, and unambiguous. Any typographical or grammatical errors should be corrected at revision, so please note any specific errors here.

Reviewer #1: Yes

Reviewer #2: Yes

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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: Clarity and Structure:

The manuscript would benefit from clearer organization, particularly in the results section. Subheadings for each theme are helpful, but consider summarizing key findings at the beginning of each section to guide readers.

Thematic Analysis:

While the thematic categories are well-defined, the transitions between themes could be smoother. Consider providing a brief summary of how each theme relates to the overall findings, highlighting interconnections.

Literature Integration:

Integrate more references to existing literature on AEFI reporting challenges, within similar contexts. This would strengthen the manuscript by situating your findings within the broader research landscape.

Technical Details:

Provide more detail on the technological barriers mentioned. For example, discuss specific mobile technologies or platforms that could be improved or better utilized to enhance reporting.

Participant Diversity:

Consider discussing the diversity of respondents in more detail. Addressing the range of perspectives from different regions, roles, or levels of experience could enrich the analysis.

Cultural Context:

Incorporate a discussion of the cultural factors that may influence healthcare workers’ attitudes toward reporting AEFIs. Understanding local contexts can provide deeper insights into the identified barriers.

Training Programs:

Elaborate on existing training programs related to AEFI reporting. Discuss their effectiveness and any gaps that exist, which can inform recommendations for future training initiatives.

Government Role:

Provide a more nuanced discussion of the government's role in supporting AEFI reporting. Explore how policy changes or increased funding could facilitate improvements in reporting systems.

Follow-Up Mechanisms:

Address the need for follow-up mechanisms after reporting AEFIs. Discussing how feedback loops could enhance the reporting process might encourage more healthcare workers to engage in the system.

Technology Adoption:

Discuss barriers to technology adoption among healthcare workers in more depth. Exploring attitudes towards technology and previous experiences with reporting systems could provide a clearer picture of the challenges.

Visual Aids:

Consider including visual aids, such as charts or diagrams, to illustrate key themes and findings. Visual representation can enhance understanding and engagement with the material.

Stakeholder Engagement:

Highlight the importance of stakeholder engagement in the implementation of recommendations. Discuss how involving healthcare workers, policymakers, and community leaders can foster a more collaborative approach to addressing barriers.

Long-Term Strategies:

Propose long-term strategies for sustaining improvements in AEFI reporting. This could include establishing a continuous training framework or integrating reporting into regular health system assessments.

Case Studies:

If applicable, include brief case studies or examples of successful AEFI reporting systems from other regions or countries. This could provide a model for potential improvements in Nigeria.

Language and Terminology:

Ensure that technical terms and acronyms (like AEFI) are defined upon first use to make the manuscript accessible to a broader audience, including non-specialists.

Ethical Considerations:

Include a brief discussion of ethical considerations related to conducting interviews and reporting on sensitive issues in healthcare. This adds credibility to the research process.

Call to Action:

Conclude with a strong call to action that emphasizes the urgency of addressing the barriers identified. This can help mobilize stakeholders and create momentum for change.

Reviewer #2: The study appears to have technical soundness in several aspects but require to enhance methodological rigor and data presentation in order to alignment with publication standards. The choice of qualitative approach for exploring barriers to AEFI e-reporting allows for in depth insights for understanding nuances in reporting challenges. Information from stakeholders at both national and sub-national levels provides with a range of perspectives. The thematic analysis approach categories responses into well defined themes which is methodologically sound for qualitative studies. The sample size of 32 participants is reasonable for qualitative study. But, manuscript lack detailed descriptions of sampling method, interview protocols and specific data analysis processes. For instance, more information on participant recruitment criteria, sampling justification and interview guide content would improve the technical soundness of the study. The manuscript could also provide a clearer summary of data to support each theme, perhaps in a table. The discussion of how themes relate to existing literature is limited while incorporating a comparison with other studies strengthens the validity of findings. The conclusions align reasonably with findings, however, more direct references to participants' statements in relation to each conclusion would improve coherence and credibility. Ethical adherence is noted but explicitly discussing the informed consent process and any steps taken to reduced bias like training interviewers or using triangulations enhance transparency.

This manuscript is based on qualitative research and does not appear to involve quantitative data or statistical analysis. Instead, it employs thematic analysis, which is a standard approach for analyzing qualitative data. o While the manuscript mentions categorizing responses into themes, it would benefit from a more detailed description of the process, such as whether multiple coders were involved, how consistency in coding was ensured, or if any coding reliability measures were used. A clear explanation of coding process and any efforts to ensure consistency and examples of hoe the themes were derived from raw data improve rigor expected in qualitative analysis.

The manuscript is generally presented in an intelligible manner and uses standard English. It communicates the study's purpose, methodology, findings, and conclusions clearly. However, there are areas where the readability and clarity could be enhanced to meet publication standards fully. Adding clarifications for technical terms and more participant quotations would further enhance the intelligibility and engagement for readers. For Example, Some technical terms and concepts, such as “pharmacovigilance” and “thematic analysis,” could benefit from brief clarifications or definitions, particularly where these terms are first introduced.

While the data are technically available upon request, making de-identified data more accessible in a repository would strengthen the manuscript's adherence to open-access standards and facilitate reproducibility. If only summaries of the data (rather than full transcripts) can be shared, this should be specified along with instructions on how to request access. If ethical constraints prevent sharing full data, the authors should explain these limitations explicitly in the data availability statement and clarify that the data meet ethical standards regarding privacy and confidentiality.

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Reviewer #1: Yes: Sajjad Ahmed Khan

Reviewer #2: No

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PONE-D-24-32799R1 Perception of Healthcare Administrators on the Impediments of Optimizing Adverse Events Following Immunization E-Reporting in Nigeria

PLOS ONE

Dear Dr. Isiaka,

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 Aug 24 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,

Edison Arwanire Mworozi, M.D

Academic Editor

PLOS ONE

Additional Editor Comments :

Please address further comments as indicated by reviewers and resubmit on time for expedition. Thank you.

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

Reviewers' comments:

Reviewer's Responses to Questions

Comments to the Author

Reviewer #2: All comments have been addressed

Reviewer #3: (No Response)

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

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

Reviewer #2: Yes

Reviewer #3: Partly

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

Reviewer #2: Yes

Reviewer #3: N/A

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

The PLOS Data policy requires authors to make all data underlying the findings described in their manuscript fully available without restriction, with rare exception (please refer to the Data Availability Statement in the manuscript PDF file). The data should be provided as part of the manuscript or its supporting information, or deposited to a public repository. For example, in addition to summary statistics, the data points behind means, medians and variance measures should be available. If there are restrictions on publicly sharing data—e.g. participant privacy or use of data from a third party—those must be specified.

Reviewer #2: Yes

Reviewer #3: Yes

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

PLOS ONE does not copyedit accepted manuscripts, so the language in submitted articles must be clear, correct, and unambiguous. Any typographical or grammatical errors should be corrected at revision, so please note any specific errors here.

Reviewer #2: Yes

Reviewer #3: Yes

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6. Review Comments to the Author

Please use the space provided to explain your answers to the questions above. You may also include additional comments for the author, including concerns about dual publication, research ethics, or publication ethics. (Please upload your review as an attachment if it exceeds 20,000 characters)

Reviewer #2: (No Response)

Reviewer #3: This is an interesting qualitative study exploring barriers to AEFI reporting in Nigeria. The authors write that AEFIs are under-reported in Nigeria (though do not provide supporting evidence). To improve reporting, along with supporting vaccine safety surveillance and properly informing policy decisions, it is important to understand the reasons why AEFIs are not being reported, which may or may not be unique to this country. The authors identify four themes/potential challenges to AEFI reporting, though their only recommendation is health worker training. While overall, this manuscript is generally clearly written, there is some fine-tuning to do and details to iron out. For the Results section, the authors need to stick to the "facts" (strictly reporting) and in the Discussion, the authors might look at other systems that work emphasizing (what can be learned from other countries?), mention anything that is working well (has e-reporting improved AEFI reporting at all?), and really emphasize why this work is important.

Issues:

More important

• Check references: there are a number that need to be double checked for appropriateness/relevance. For example, references 2-4 (lines 40-45) do not appear to support the claims made in this paragraph. I was unable to see anything about preventing 2-3 million fatalities in reference 3. Reference 4 also does not seem very appropriate, and I am confident the authors can find a study that better supports the sentence. Additionally, references 1,3,14 are all the same – this needs to be corrected.

• Lines 65-72 include information on paper-based reporting. What is the process for e-reporting? Do the health workers report electronically through DHIS-2 and patients self-report through Med Safety? Or can health workers report through either app?

• In the Background section, you mention that AEFI reporting is low, below WHO reporting standards (for infants). It would be useful to provide statistics on this. How many AEFIs are reported annually in Nigeria? What is the reporting rate per population? Number or proportion of AEFIs reported electronically and number/proportion reported through the paper form would also be important to include here and gives readers a sense of the “problem”. Have rates increased/decreased/remained stable, including after implementing e-reporting? Additionally, are you interested in population-wide AEFIs, or only those associated with infant vaccines? If general population, the infant reporting standard is maybe less relevant.

• Lines 151-158: This paragraph gives some information on participants. It would be helpful to indicate which workers/positions are responsible for AEFI reporting and if possible, what they do. Is anyone directly involved in or responsible for reporting? I think it would be useful to briefly outline these participants’ roles in AEFI reporting.

• Lines 161-162: “Two states were chosen from each geo-political zone based on the highest reporting and lowest reporting indicators” – do highest and lowest reporting indicators refer to highest and lowest AEFI reporting? If not, what does this mean?

• Under “Data Collection”, can you include some examples of the questions asked or include a copy of the semi-structured interview questions in an appendix?

• Line 191: “…electronic pharmacovigilance systems defined by Agusoro et al (2018).” I think Agusoro may actually be Agoro et al [17]? Also, how was this paper/study used to make a codebook? Or what was used from the study? Was it the barriers these authors identified?

• Under “Results”, would it be feasible to number participants so the reader knows who is being quoted how many times? (The same person’s quotes could be used multiple times throughout the manuscript.)

• Under “Results”, are any of the participants responsible for reporting AEFIs? The quotes often use ‘they’, ‘those’ or ‘health workers’ instead of first person. It’s unclear if anyone interviewed has firsthand, direct experience and can speak to challenges directly. Otherwise, when I read the participant quotes, some of them sound as if they are passing on the blame to other people. It would be important to include the perspectives of those actually doing the reporting.

• Results for each of the four themes can be pared back a little bit – in some cases it seems like the reporting goes beyond the actual facts/information collected and may be expanding a little too much.

• The Discussion does not include a strengths and weaknesses section, which is an important omission.

• Lines 412-414: “Additionally, the study found that having the new platform report only AEFIs for COVID-19 was a form of deterrence to health workers , which was also considered a limitation of the reporting system.” This is confusing because it sounded like the reporting apps are not actually limited to just COVID and that this was a misconception related to lack of training/poor training. This should be clarified.

• Can you comment on the need to go from facility to facility for AEFI reporting? Would it be feasible to report AEFIs without having to visit each site? Is there anyway to streamline the process?

• One thing I would like to see in the Discussion is comparison of Nigeria’s AEFI reporting to other AEFI reporting systems. Are other countries doing the same thing? Who has a better system?

• Recommendation - I agree with this recommendation for continued/ongoing training. However, it sounds like the training hasn’t really improved reporting, or has it? Is this the only recommendation? Why not address the other 3 themes/barriers? Is there nothing else that can be improved or changed? If not, it would be good to mention that and why. What other steps or changes can help improve reporting? What parts of the system are working well?

More minor

• In the abstract, where it says “…but is probably not causally related to the vaccine” (line 15), I recommend changing this language. Instead of “probably not causally related” I would say something more along the lines of “may or may not be causally related” or even just “may not be causally…”

• In the abstract, under Objective (lines 19-20), I may include that you were identifying barriers to reporting, as that seems to be the focus of this manuscript. If changed, I would include this in the manuscript body as well.

• Also in the abstract, under Conclusion (lines 31-34), I would work on strengthening the conclusion because it currently reads somewhat vague.

• Line 62: spell out District Health Information Software 2 the first time and make sure Med Safety App has the proper spacing and capitalization

• Study Settings – While this information is interesting, it may not be necessary especially since none of it is used later in the manuscript - I could see it being included if there was discussion about how these factors or differences impact reporting rates or reporting culture or something along those lines/if later sections build off this information. This section could be shortened considerably.

• Line 99: Would be helpful to name the 12 states here in the text.

• Under Data Analysis, “The recorded files were equally transcribed verbatim in English language” (lines 185-186), what does “equally” mean here? Additionally, how were the interviews transcribed? Using AI software, a human, etc?

• Line 203: “…approval number NHREC/01/01/2007-19/08/2022” – is this study part of another study? When I tried to look up the NHREC approval number to find out more information, the only thing I can find is that “Patient-reported outcomes of adverse events after COVID-19 vaccination in Nigeria: A mixed methods study” published in 2024 has the same approval number.

• Line 216: Table 3 – this table does not seem to add much to the manuscript or reader understanding so I suggest either reporting these numbers in the text or trying to combine with Table 2.

• Health workers vs healthcare workers – I would choose one term and try to stick with it consistently throughout the manuscript. Also encourage you to pay attention to capitalization throughout.

• Line 261: what exactly is meant by “sensitization program”?

• Lines 294-296: “…healthcare workers are willing to report and share the AEFI event that has been presented to them in their respective facilities but are usually confronted with the challenge of lacking data to synchronize and send out the reported data.” Here, I would remove the bit about workers being willing to report if only they had data plans provided to them. Unless participants actually stated this, we don’t know whether they would be reporting if they had a mobile phone/data, especially given the other barriers to reporting, so this is along the lines of speculation.

• Lines 296-300: “In other words, the provision of mobile network data to healthcare workers for reporting AEFI electronically will not only serve as a tool for executing their responsibilities, but also as an agent of extrinsic motivation to the healthcare workers, as such mobile data could help them reach out to their co-workers, especially the DSNOs, via social media pages such as WhatsApp.:” I imagine the government/ministry does not want workers to use their work phones or work mobile plans to go on social media. If this would help them reach out to coworkers using a messenger app (such as WhatsApp) for work purposes, I think that would be a different story.

• Lines 363-364: “Participants enumerated that the general lack of knowledge of reporting AEFIs in health facilities was driven by negligence on the part of the healthcare workers…” My recommendation here would be tone down this language from ‘negligence’ to something else. This word sounds a little harsh and as though you are placing the blame on the workers when there are other factors at play as well.

• Lines 367-369: “This corroborates the work of Omoleke et al [19] who found the existence of varied and suboptimal knowledge levels of healthcare providers on AEFI definitions and classifications.” The previous sentence talks about japa and it’s unclear how this sentence relates to japa. You need to connect these two ideas better.

• Lines 430-431: “…and tend to over-rely on the government , with the notion that the government through the appropriate health authority is expected help them address their needs.” It strikes me as odd to say – who should they be looking to?

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7. PLOS authors have the option to publish the peer review history of their article (what does this mean?). If published, this will include your full peer review and any attached files.

If you choose “no”, your identity will remain anonymous but your review may still be made public.

Do you want your identity to be public for this peer review? For information about this choice, including consent withdrawal, please see our Privacy Policy.

Reviewer #2: No

Reviewer #3: No

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[NOTE: If reviewer comments were submitted as an attachment file, they will be attached to this email and accessible via the submission site. Please log into your account, locate the manuscript record, and check for the action link "View Attachments". If this link does not appear, there are no attachment files.]

While revising your submission, please upload your figure files to the Preflight Analysis and Conversion Engine (PACE) digital diagnostic tool, https://pacev2.apexcovantage.com/. PACE helps ensure that figures meet PLOS requirements. To use PACE, you must first register as a user. Registration is free. Then, login and navigate to the UPLOAD tab, where you will find detailed instructions on how to use the tool. If you encounter any issues or have any questions when using PACE, please email PLOS at figures@plos.org. Please note that Supporting Information files do not need this step.

Perception of Healthcare Administrators on the Impediments of Optimizing Adverse Events Following Immunization E-Reporting in Nigeria

PONE-D-24-32799R2

Dear authors,

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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Academic Editor

PLOS ONE