Dear Dr. Mwale,

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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We look forward to receiving your revised manuscript.

Kind regards,

Nik Hisamuddin Nik Ab. Rahman

Academic Editor

PLOS ONE

Journal Requirements:

1. When submitting your revision, we need you to address these additional requirements.-->--> -->-->Please ensure that your manuscript meets PLOS ONE's style requirements, including those for file naming. The PLOS ONE style templates can be found at -->-->https://journals.plos.org/plosone/s/file?id=wjVg/PLOSOne_formatting_sample_main_body.pdf and -->-->https://journals.plos.org/plosone/s/file?id=ba62/PLOSOne_formatting_sample_title_authors_affiliations.pdf-->--> -->-->2. Thank you for stating in your Funding Statement: -->-->This project is part of the European and Developing Countries Clinical Trials Partnership 2 programme supported by the European Union (Grant number RIA20201-3294 – IMPALA). The grant was awarded to JC. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript. edctp.org -->--> -->-->Please provide an amended statement that declares *all* the funding or sources of support (whether external or internal to your organization) received during this study, as detailed online in our guide for authors at http://journals.plos.org/plosone/s/submit-now.  Please also include the statement “There was no additional external funding received for this study.” in your updated Funding Statement. -->-->Please include your amended Funding Statement within your cover letter. We will change the online submission form on your behalf.-->--> -->-->3. Please know it is PLOS ONE policy for corresponding authors to declare, on behalf of all authors, all potential competing interests for the purposes of transparency. PLOS defines a competing interest as anything that interferes with, or could reasonably be perceived as interfering with, the full and objective presentation, peer review, editorial decision-making, or publication of research or non-research articles submitted to one of the journals. Competing interests can be financial or non-financial, professional, or personal. Competing interests can arise in relationship to an organization or another person. Please follow this link to our website for more details on competing interests: http://journals.plos.org/plosone/s/competing-interests-->--> -->-->4. We note that you have indicated that there are restrictions to data sharing for this study. For studies involving human research participant data or other sensitive data, we encourage authors to share de-identified or anonymized data. However, when data cannot be publicly shared for ethical reasons, we allow authors to make their data sets available upon request. For information on unacceptable data access restrictions, please see http://journals.plos.org/plosone/s/data-availability#loc-unacceptable-data-access-restrictions. -->--> -->-->Before we proceed with your manuscript, please address the following prompts:-->--> -->-->a) If there are ethical or legal restrictions on sharing a de-identified data set, please explain them in detail (e.g., data contain potentially identifying or sensitive patient information, data are owned by a third-party organization, etc.) and who has imposed them (e.g., a Research Ethics Committee or Institutional Review Board, etc.). Please also provide contact information for a data access committee, ethics committee, or other institutional body to which data requests may be sent.-->--> -->-->b) If there are no restrictions, please upload the minimal anonymized data set necessary to replicate your study findings to a stable, public repository and provide us with the relevant URLs, DOIs, or accession numbers. Please see http://www.bmj.com/content/340/bmj.c181.long for guidelines on how to de-identify and prepare clinical data for publication. For a list of recommended repositories, please see https://journals.plos.org/plosone/s/recommended-repositories. You also have the option of uploading the data as Supporting Information files, but we would recommend depositing data directly to a data repository if possible.-->--> -->-->Please update your Data Availability statement in the submission form accordingly.-->--> -->-->5. One of the noted authors is a group or consortium “IMPALA consortium”. In addition to naming the author group, please list the individual authors and affiliations within this group in the acknowledgments section of your manuscript. Please also indicate clearly a lead author for this group along with a contact email address.-->--> -->-->6. Please include captions for your Supporting Information files at the end of your manuscript, and update any in-text citations to match accordingly. Please see our Supporting Information guidelines for more information: http://journals.plos.org/plosone/s/supporting-information.-->--> -->-->7. Please review your reference list to ensure that it is complete and correct. If you have cited papers that have been retracted, please include the rationale for doing so in the manuscript text, or remove these references and replace them with relevant current references. Any changes to the reference list should be mentioned in the rebuttal letter that accompanies your revised manuscript. If you need to cite a retracted article, indicate the article’s retracted status in the References list and also include a citation and full reference for the retraction notice.?>

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Reviewers' comments:

Comments to the Author

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

Reviewer #1: Yes

Reviewer #2: Yes

Reviewer #3: Yes

Reviewer #4: Yes

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

Reviewer #1: Yes

Reviewer #2: Yes

Reviewer #3: Yes

Reviewer #4: Yes

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

The PLOS Data policy

Reviewer #1: Yes

Reviewer #2: Yes

Reviewer #3: Yes

Reviewer #4: Yes

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

Reviewer #1: No

Reviewer #2: Yes

Reviewer #3: Yes

Reviewer #4: No

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Reviewer #1:  Sampling and Potential Bias:

Please clarify the sampling strategy for caregivers and healthcare providers to ensure transparency and highlight the representativeness of the study population.

Consider discussing potential selection and courtesy bias in caregiver responses, especially since interviews were conducted post-discharge.

Clarity and Language:

A thorough language review is recommended to correct grammatical inconsistencies, repetitive phrasing, and tense shifts.

Please revise long or redundant sentences, particularly in the Discussion section, to improve readability.

Ethical Procedures:

Kindly specify who conducted the informed consent process and how it was administered, especially for illiterate participants.

Data Availability Statement:

The current statement indicates that data are available upon request due to confidentiality. In line with PLOS ONE's open data policy, I recommend that the authors de-identify and publicly share applicable quantitative datasets or provide a clear justification for the restriction.

Statistical Analysis:

Where appropriate, please consider including confidence intervals or p-values to give more context to the descriptive statistics.

Clarify whether any comparative analyses were performed (e.g., before vs. after implementation, or between trained vs. untrained staff), even if exploratory.

Policy Implications and Scalability:

Consider expanding the conclusion to highlight how these findings can inform broader implementation or scale-up in other low-resource settings.

Monitor Design and Alarm Features:

Given the recurring issue of false alarms and alarm fatigue, please elaborate on whether alarm thresholds or settings were adjustable and how this will be addressed in future iterations of the IMPALA monitor.

Visual Aids and Figures:

Please ensure that all figures (e.g., floor plan, monitor diagram) are of publication quality, with clear labeling and resolution.

Non-response in Survey Data:

In Table 1, nearly half of the caregivers did not respond to some items related to alarm response. Please address this non-response and discuss its potential implications for interpretation of the data.

Reviewer #2:  This is an important and well-structured study that addresses a significant gap in pediatric critical care in low-resource settings. The mixed-methods approach is appropriate and strengthens the depth and credibility of the findings. The study clearly outlines both barriers and facilitators to implementing the IMPALA monitoring system in a real-world hospital environment in Malawi.

The qualitative component is well-executed, with thoughtful use of the CFIR framework and rich insights from both caregivers and healthcare providers. The quantitative data are clearly presented and appropriately analyzed. Together, the findings support the authors’ conclusions about the potential benefits of the IMPALA system, especially in improving clinical decision-making, reducing staff workload, and involving caregivers more effectively in monitoring.

There are just a few minor language and typographical errors that can be addressed at the copyediting stage (e.g., a few spelling inconsistencies like “verson” instead of “version”). Otherwise, the manuscript is written in clear and standard English.

Overall, this is a well-conducted implementation study with important implications for pediatric care in similar low-resource settings, and I support its publication.

Reviewer #3:  Dear Author,

Thank you for your submission.

The authors assessed the implementation barriers and facilitators of a locally adapted,

robust, low-cost continuous monitoring system (IMPALA) in Malawi. The study used a mixed-methods design. Including healthcare provider and caregiver perspectives enriches the contextual understanding of implementation barriers and facilitators. Nevertheless, there are some aspects that can be improved for the readability of the paper. Some typo errors should be corrected.

Additional comments:

1- Introduction:

• The researchers are encouraged to add some statistics from the literature regarding morbidity/ mortality of children in critical care units in Malway or other relevant healthcare contexts. This could further clarify the research problem

2- Method and setting

Design:

• The researchers are recommended to report the reason for selecting the mixed method design and explain how it was useful in investigating the research problem.

Data collection:

• The researchers are encouraged to attach the two structured observation guides

The questionnaire:

- The researchers are recommended to report information about the validity and reliability of the self-administered EMPATHIC-65 questionnaire.

Intervention:

• The researchers should add more information to support the novelty of the IMPALA Continuous Monitoring System.

Quantitative Data:

• The researchers did not use inferential statistics. Such statistical tests could help to explain the credibility of the intervention.

Sample size:

• The sample size is recommended to be calculated for the statistical test used to ensure the power, ES, and alpha level of significance are appropriate for the reported sample size.

4. Results:

• The quality of the figures should be improved regarding clarity and resolution.

Sincerely,

Reviewer #4:  The manuscript presents an important and timely study evaluating the implementation of the IMPALA monitoring system for paediatric critical care in a low-resource setting. The use of a mixed-methods design, guided by the CFIR framework, is appropriate and methodologically sound. The authors have made an impressive effort in collecting and analysing a large amount of qualitative and quantitative data. The integration of multiple perspectives, including caregivers and frontline healthcare providers, is a strength of the study.

However, several revisions are recommended to enhance the clarity, conciseness, and overall impact of the manuscript:

Abstract:

The abstract is overloaded with numeric details (e.g., 300+ hours of observation, n=14, n=72) which detract from the clarity of the findings. The text would benefit from a more concise presentation using compact summaries, such as:

“Using over 300 hours of observations, interviews with 14 providers and 9 caregivers, and surveys from 24 providers and 72 caregivers…”

Introduction:

The introduction could benefit from a more technically specific description of the IMPALA system. For example, outlining the technical advantages, usability features, or target age group would help better position the device within the paediatric care landscape.

Methods:

The methods section is comprehensive and demonstrates strong methodological planning. The use of multiple data sources and triangulation is a clear strength.

However, the section is too lengthy and contains some redundancies. For example, the detailed training procedures on IMPALA use could be summarized and partially moved to the Results or Supplementary Materials.

References to figures (especially Figure 2) are underdeveloped. More context should be provided on how the physical setup of the HDU (e.g., multiple children sharing beds, limited equipment) influenced monitoring practices.

While the software used for analysis is clearly stated (NVivo, STATA), the manuscript should briefly describe how potential biases in qualitative interpretation (e.g., lack of blinding, interpreter bias) were mitigated.

Results:

The results section is informative but overly long and repetitive. Several points (e.g., alarm features, technical issues) are discussed multiple times. The use of clear subheadings based on the CFIR domains is commendable but should be streamlined for brevity.

A significant theme—caregiver mistrust and superstition (e.g., “IMPALA kills children”)—is only superficially covered. Its prevalence, distribution by caregiver demographics, and potential impact on implementation should be further explored or quantified.

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Reviewer #1: No

Reviewer #2: Yes:  Abdullah Abdullah Abbas Al-Murad

Reviewer #3: Yes:  Saleh Al Omar

Reviewer #4: No

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Implementing the IMPALA Continuous Monitoring System for Paediatric Critical Care in Malawi: A mixed methods study of barriers and facilitators

PONE-D-25-13594R1

Dear Dr. Mwale,

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.

Within one week, you’ll receive an e-mail detailing the required amendments. When these have been addressed, you’ll receive a formal acceptance letter and your manuscript will be scheduled for publication.

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Kind regards,

Nik Hisamuddin Nik Ab. Rahman

Academic Editor

PLOS ONE

Additional Editor Comments (optional):

Reviewers' comments: