PONE-D-24-38448Pelvic floor disorders and associated factors among women in sub-Saharan Africa: A Systematic Review and Meta-analysis Protocol

PLOS 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.

The manuscript has been evaluated by four reviewers, and their comments are available below.

The reviewers have raised a number of concerns that need attention. They request additional information on methodological aspects of the study, and reconsideration of the inclusion criteria.

Could you please revise the manuscript to carefully address the concerns raised?

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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: No

Reviewer #2: Yes

Reviewer #3: Yes

Reviewer #4: Yes

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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: Yes

Reviewer #3: Partly

Reviewer #4: Yes

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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

Reviewer #3: Yes

Reviewer #4: 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

Reviewer #3: Yes

Reviewer #4: 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

Reviewer #3: Yes

Reviewer #4: 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: The authors present a protocol for a systematic review of pelvic floor disorders and associated factors among women in sub-Saharan Africa. While this is an important topic for understanding the burden and determinants of pelvic floor disorders in this population, the rationale for publishing the protocol, as opposed to the actual study, is not clearly articulated. The protocol outlines a comprehensive approach to data collection and interpretation; however, the authors do not explain why the protocol itself warrants publication. Additionally, the aim and scope of this research might be better addressed through collaboration with the Global Burden of Disease study. Even if the authors wish to pursue this review by analyzing the literature, this approach does not necessarily justify the protocol's publication, as it neither significantly advances the literature nor provides a clear trajectory for future research. Moreover, the authors fail to present a comprehensive search strategy across relevant databases, which is crucial for conducting a systematic review. Given the stated goal of performing a thorough systematic search, it is imperative that the complete strategy be provided.

Reviewer #2: The review question is clear

The protocol is adequately developed based on international Rw guidelines

Tools such as Covidence helps for an efficient screening of the included studies

The methodological approach using PRISMA-P is adequate and clear as the review protocol.

How the research team will implement each step and who will be involved at each stage is well detailed

Joanna Bridge Institute's (JBI) appraisal should read as Joanna Briggs Institute

Reviewer #3: December 23rd, 2024

Dear Editor,

Dear Authors,

Thank you for affording me the valuable opportunity to review this manuscript.

This methodological study offers significant insights into the prevalence and risk factors of pelvic floor disorders (PFDs) in sub-Saharan Africa, an area where existing evidence remains limited. The findings are poised to make a substantial contribution to the field.

However, the inclusion criteria need to be reassessed.

Pelvic floor disorders (PFDs) can be evaluated through clinical examination or self-administered questionnaires. For instance, the Pelvic Floor Disability Index (PFDI-20) is a self-reported questionnaire that does not determine prevalence but quantifies symptom burden.

In such cases, the findings primarily elucidate symptomatic presentation rather than true prevalence, as exemplified in the reference study (Suemitsu T, Mikuni K, Matsui H, Suzuki M, Takahashi T. Prevalence and Risk Factors of Pelvic Floor Disorders After Delivery in Japanese Women Using the Pelvic Floor Distress Inventory: A Retrospective Cohort Study. Cureus. 2023;15(6):e40152. Published 2023 Jun 8. doi:10.7759/cureus.40152).

The inclusion criteria will inevitably vary depending on whether the study aims to determine prevalence or symptom burden. Conducting a preliminary evaluation of previous studies to clarify their assessment methods, the volume of relevant literature, and the reliability of these sources would be prudent.

Additionally, I suggest considering treatment and intervention strategies, including rehabilitation, as secondary evaluation outcomes. Identifying risk factors does not always equate to their mitigation. For example, the increased incidence of PFDs associated with instrumental delivery, obstetric anal sphincter injuries (OASIS), and epidural analgesia is a well-documented phenomenon worldwide, not exclusive to sub-Saharan Africa.

A review of this nature may yield findings similar to previous studies. Nevertheless, presenting potential solutions would substantially enhance the review's significance. Therefore, I recommend incorporating this aspect into the evaluation criteria.

I appreciate your consideration, and I look forward to your response.

Sincerely,

T.SUEMITSU

Reviewer #4: I would like to thank you for the opportunity to review the study protocol entitled "Pelvic Floor Disorders and Associated Factors Among Women in Sub-Saharan Africa: A Systematic Review and Meta-Analysis Protocol". This protocol raises considerations regarding the inclusion of studies for analysis, and I would like to make a few suggestions.

First, it is important to determine whether the studies selected for review have adequately addressed the prevalence of pelvic floor disorders. It is recommended that the included studies use validated assessment tools that are appropriate for the target population. The lack of validity may be a source of bias in the results. Some examples of validated instruments are the Epidemiology of Prolapse and Incontinence Questionnaire (EPIQ), the Pelvic Floor Distress Inventory Short Form (PFDI-20), and the International Consultation on Incontinence Questionnaire (ICIQ), etc.

In addition, it is important to clarify whether the approach will rely solely on clinical history to identify pelvic floor dysfunction, or whether both methods will be used. It is important to include validated methods in the data extraction, as this would provide a more robust basis for the results obtained. Therefore, it would be beneficial to include a specific field in the Excel file for data extraction to indicate how prevalence was measured in each study.

Finally, it is important to consider whether pelvic pain should be included or excluded from the analysis alongside pelvic floor dysfunction for a global analysis of pelvic floor dysfunction.

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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 #1: Yes:  alireza hadizadeh

Reviewer #2: Yes:  Prof. Lilly Varghese

Reviewer #3: Yes:  Tokumasa Suemitsu M.D.

Reviewer #4: No

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Pelvic floor disorders and associated factors among women in sub-Saharan Africa: A Systematic Review and Meta-Analysis Protocol

PONE-D-24-38448R1

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.

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,

Richard Kao Lee, M.D.

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 #3: Yes

Reviewer #4: 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 #3: Yes

Reviewer #4: 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 #3: Yes

Reviewer #4: 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 #3: Yes

Reviewer #4: 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 #3: Yes

Reviewer #4: 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 #3: Dear Authors,

I appreciate receiving your manuscript again.

I confirm you addressed the manuscript now and adequately improved the clarity and readability.

Now, I am sure that this manuscript will be accepted.

Reviewer #4: Thank you for addressing the pending comments - I feel that the manuscript has gained a lot of clarity and wish you success with your further studies.

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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 #3: Yes:  Tokumasa Suemitsu

Reviewer #4: No

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