PONE-D-24-40961Diaper dermatitis and associated factors among 0-24 months children in low- and middle-income countries: A Systematic review protocolPLOS ONE

Dear Dr. Negera,

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.

Both reviewers are supportive but have some comments to address, particularly reviewer 2.   I hope they are useful in both correcting this paper and carrying out your full study.

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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: 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 #1: Yes

Reviewer #2: 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 #1: Yes

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: 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 #1: Yes

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: This is an intriguing and novel submission, addressing a gap in the literature. The outcomes of the meta-analysis will be valuable in contributing to ongoing efforts to reduce diaper dermatitis. However, I recommend reconsidering the paragraph on page 5, beginning with "Diaper dermatitis...," as it does not substantially enhance the background relevant to the study and could be omitted. Additionally, there is insufficient discussion regarding low- and middle-income countries within the introduction portion of the paper. It would be beneficial to expand on the significance of these populations and clarify whether comparisons will be made to developed countries. Finally, the overarching aim of the review appears somewhat simplistic, and further clarification on how the results will guide future research in diaper dermatitis would strengthen the manuscript.

Reviewer #2: Reviewer comments:

Overall:

It was not clear to me how “low- and middle-income countries (LMIC) will be defined. What criterion will be used?

The title of the protocol states that it will be looking at Diaper Dermatitis “and associated factors”, and the protocol states a key question as “2) What are the factors associated with diaper dermatitis among children aged 0-24 months in low- and middle-income countries?” It is not clear if this includes “causes” of diaper dermatitis, sequelae of diaper dermatitis (for example, ill temperament of the child, poor sleep, pain/crying) or other factors.

There is a statement in the “Introduction” related to the prevalence of diaper dermatitis. “Although the prevalence of DD varies from country to country, it is estimated that about 50% to 65% of infants and young children will suffer from diaper dermatitis at some time and up to 25% of children seek healthcare due to this problem (6, 7, 8).” The literature is quite scattered about the percentage of babies who experience diaper dermatitis. However, data from Visscher et al (Pediatric Dermatology Vol 17, No. 52-57, 2000) , indicates that diaper dermatitis rates are ~ 70% in the first week of life which is higher than the 50-65% reported in the publication. Further, Gustin et al (Pediatric Dermatology 2021. Jul;38(4):768-774) indicated that diaper dermatitis was found in 65-83% of newborns. Carr et al. (Pediatric Dermatology 2020 Jan;37(1):130-136) also found high rates of diaper dermatitis in Germany across 4 common sites within the diaper. Given these data, it should be noted that in reality, ‘every baby will experience diaper dermatitis as some point during their diaper wearing years’.

The Introduction also states “Its typical sign is a red, itchy, and sometimes ulcerated rash in the diaper area (perineum, peri-genital area, perianal area, and the upper thigh) occurring most often as a reaction to increased moisture due to prolonged contact with urine, feces, or retained soap or detergent (14).” I would change this to read: “It’s typical sign is a red, itchy, and sometimes ulcerated rash in the diaper area and may include the presence of papules and pustules (Buckley et al, Pediatric Dermatology Vol 33 No 6 632-639, 2016; Odio MR et al Dermatology 2000; 200:238-243). The primary diaper sites include the perineum, peri-genital area, perianal area, genital region, buttocks and groin and occur most often as a reaction to increased moisture (skin overhydration) due to prolonged contact with urine, feces, or retained soap or detergent (14).”

Introduction: “Major causes that impair the integrity of the skin are irritants in urine and feces, overhydration of the epidermal stratum and corneum, excessive skin pH, and friction against the skin (14-16).” I would reword this to say “…elevated skin pH…”

Introduction: “Disposable diapers contain absorbent chemicals that are able to absorb liquids, and have to be disposed of after usage.”. I would rephrase to state “Disposable diapers contain absorbent gel materials (AGM) that are able to absorb liquid and runny feces and are single-use.”

The Search Strategy is listed as: “The search strategy included a combination of subject terms and free text terms combined with Boolean operators (‘OR’, and ‘AND’). The Medical Subject Headings (MeSH) terms included “diaper”, OR “napkin”, OR “nappy” AND “dermatitis”, OR “rash”, OR “irritation”, AND “neonate”, OR “infant”, OR “toddler”, OR “children”, OR “pediatrics”, OR “kids”, OR “babies”, AND “developing countries”, OR “resource-limit” OR “resource-poor”, OR “low-income”, OR

“lower-middle-income”, OR “middle-upper income countries”.” I would also include “papule”, “pustule”, . I believe search terms for “income” can be included but I strongly suggest the investigators define the criterion for LMIC and then include only those publications where the study was conducted in a LMIC, as a publication may not identify its sources as LMIC.

The inclusion criteria includes data collected at the “under-five clinic”, however, given the episodic, unpredictable and short-term nature of diaper dermatitis (typically 3-10 days) the incidence of diaper dermatitis that is observed at a clinic visit may not reflect the actual rate of diaper dermatitis in the population.

The “Search date” is listed as “All research articles accessed from 20 September 2024 to 10 October 2024 without time limits will be included.”. This date is in the past.

In the exclusion criteria it states, “Studies that did not assess the magnitude of diaper dermatitis/rashes (studies that evaluate treatments for children with DD, knowledge of DD, the quality of life of children with DD, etc.) will be excluded.”. If parental habits and practices are able to be obtained, this will be critical to understand the potential causes of the diaper dermatitis, as are skin products being used, bathing frequency, diet information and family history of skin disorders, including atopic dermatitis and the like.

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Reviewer #1: No

Reviewer #2: No

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Attachments

Attachment

Submitted filename: PONE-D-24-40961 Diaper Dermatitis 0-24 month LMIC .docx

Diaper dermatitis and associated factors among children aged 0-24 months in low- and middle-income countries: A systematic review protocol

PONE-D-24-40961R1

Dear Dr. Negera,

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,

Alison Parker

Academic Editor

PLOS ONE

Additional Editor Comments (optional):

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 #2: Yes

**********

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 #2: Yes

**********

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 #2: Yes

**********

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 #2: Yes

**********

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

**********

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 #2: I thank the authors for the numerous clarifications to the protocol. Best wishes for successful findings.

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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

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