PONE-D-23-40070Effect of community-based health education led by women's groups on mothers' knowledge of obstetric danger signs and birth preparedness and complication readiness practices in southern Ethiopia: A cluster randomized controlled trial.

PLOS ONE

Dear Dr. Yoseph Samago,

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.

 I currently have four reviews for your paper PONE-D-23-40070. The reviewers, who have important expertise in areas your paper covers, including health interventions and methodology, overall found the manuscript of potential interest and useful findings, however they raised important topics that need be addressed by author in the resubmission..

Taking into account the reviewers' comments will improve the manuscript for acceptance. The changes should be observed mainly in terms of synthesizing the introduction, strengthening the methodology and strengthening the discussion and conclusions.

My suggestions: follow the criteria for publications in PLOS ONE, reduce the number of keywords, and check consistency between all sections of the manuscript.

Please submit your revised manuscript by Sep 14 2024 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,

Doris Verónica Ortega-Altamirano, PhD

Academic Editor

PLOS ONE

Journal requirements:

When submitting your revision, we need you to address these additional requirements.

1. 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. Note from Emily Chenette, Editor in Chief of PLOS ONE, and Iain Hrynaszkiewicz, Director of Open Research Solutions at PLOS: Did you know that depositing data in a repository is associated with up to a 25% citation advantage (https://doi.org/10.1371/journal.pone.0230416)? If you’ve not already done so, consider depositing your raw data in a repository to ensure your work is read, appreciated and cited by the largest possible audience. You’ll also earn an Accessible Data icon on your published paper if you deposit your data in any participating repository (https://plos.org/open-science/open-data/#accessible-data).

3. Thank you for stating the following financial disclosure: 

 [Hawassa University and Sidama region president office].  

Please state what role the funders took in the study.  If the funders had no role, please state: "The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript." 

If this statement is not correct you must amend it as needed. 

Please respond by return e-mail so that we can amend your financial disclosure and competing interests on your behalf.

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

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: Yes

**********

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

Reviewer #1: Yes

**********

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

**********

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

**********

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: 1. There are a lot Keywords, usually require about 3-8 keywords but 9 are a lot.

2. The title is so long too. I suggest: "community health education on mothers' knowledge

with obstetric risk signs, birth preparedness and complication readiness practices in

southern Ethiopia: A cluster randomized controlled trial"

3. Focus on the variables identified in the title so as not to make the writing so extensive.

**********

6. 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 #1: Yes: Claudia MACIAS-CARRILLO

**********

[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.

PONE-D-23-40070R1Effect of community health education on mothers' knowledge of obstetric danger signs and birth preparedness and complication readiness practices in southern Ethiopia: A cluster randomized controlled trialPLOS ONE

Dear Dr. Yoseph ,

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 comments and suggestions of 2-4 reviewers were not answered in their previous submission. I realized that it was a mistake and did not arrive properly. I apologize for the inconvenience. The decision on the Major Revision is still valid and may be answered by the authors in the following submission.

==============================

Please submit your revised manuscript by Sep 29 2024 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,

Doris Verónica Ortega-Altamirano, PhD

Academic Editor

PLOS ONE

Additional Editor Comments:

The comments and suggestions of 2-4 reviewers were not answered in their previous submission (R1). I realized that it was a mistake and did not arrive properly. I apologize for the inconvenience.

Reviewer 1

1. There are a lot Keywords, usually require about 3-8 keywords but 9 are a lot.

2. The title is so long too. I suggest: "community health education on mothers' knowledge

with obstetric risk signs, birth preparedness and complication readiness practices in

southern Ethiopia: A cluster randomized controlled trial"

3. Focus on the variables identified in the title so as not to make the writing so extensive.

Reviewer 2

Comments to authors:

Thank you for the opportunity to review this manuscript. Their results highlight the effectiveness of community-based interventions to increase women’s knowledge about pregnancy complications and best practices which is necessary to reduce maternal and infant mortality rates worldwide. The manuscript would benefit from some editing and summarizing some sections as it is very long and hard to follow at times. Please see comments below.

Introduction

1. The introduction could be significantly shortened, and some of the information used more in the discussion section. I would suggest the following structure;

a. Paragraph describing ODS including some prevalence data

b. Paragraph addressing the women’s knowledge gap of ODS

c. Paragraph describing interventions and government efforts

d. Paragraph describing the lack of research and objectives of this manuscript

2. It would be good for the authors to add some data on prevalence of ODS and maternal mortality particularly in Ethiopia.

Methods

3. Adding a flow chart or diagram depicting the participant’s selection and randomization process would be helpful to follow the study design, population and randomization paragraphs a little better.

4. Study variables: I suggest the authors only focus on variables that are relevant for this manuscript.

5. I suggest moving the description of the intervention to supplementary material and including only a brief summary of it in the manuscript. I also think it should be placed before talking about the outcomes.

6. Page 14 paragraph 2 talks about data collection and then goes back to randomization, this is a little confusing. I would suggest authors to mention everything that has to do with randomization in the appropriate paragraph and not coming both.

7. While the authors offer very detailed information and justifications for their model selection, I’m a little confused if their multilevel models were linear or Poisson models. It is not the standard to estimate ICC from a Poisson model and usually variance portioning is used. If fitting a logistic model then MOR is what is usually estimated as opposed to ICC If authors estimated ICC from non-linear models I would suggest that they add the formula of how they did it to the manuscript.

8. Why did authors decide the cutoff of p < 0.25 to be included in multivariate models

9. What was the reasoning behind the effect modification tests? Which variables were tested? I would suggest authors to elaborate more on this.

10. In general, authors provide many statistical terms and details to the methods section that makes it hard to follow. I would suggest authors simplify it and add only the important information readers would need in order to replicate this analysis. The section is very hard to follow and all the justification and details can be distracting.

Results

11. On the description of table 1, it would be important to highlight the differences between groups, given that this is an RCT and Table 1 should be used to assess balance between groups. The statistically significant differences for Mass Media access and wealth index are important and could be associated with the outcome as well so should be highlighted.

12. Similar to previous comment, it is important to highlight significant differences between groups, previous history of neonatal death and ODS during last pregnancy could be associated with the outcomes as well and should be highlighted as potential confounders.

13. I find tables 3 and 4 a little confusing. I would separate the N(%) of good and poor knowledge into a separate table and just leave the model results. Also, it is not very clear which models the authors are showing. In the methods they refer to a sequence of four models and they only show results for 2, clarifying that would be very helpful.

Discussion

14. While the information provided is good and authors do a good job of comparing their findings to other literature, the limitations section is very long and disorganized. I would strongly advise to summarize better the limitations with regards to clustered RCTs and then they can talk about limitations of analysis or other types instead of going back an forth which makes it hard to follow.

Reviewer 3

Amanuel Yoseph and co-authors evaluated the effect of community-based health education intervention facilitated by women's groups (women's development team) on mothers' knowledge of SDG and BPCR practice in Sidama region in the southern Ethiopia.

I would like to thank the authors for this excellent manuscript. A problem that affects a high proportion of women in underdeveloped countries is outlined: high maternal morbidity and mortality. But, even more importantly, the authors present evidence on effective strategies to mitigate this important public health problem. Adding to the relevance of the topic is the correct design, the careful handling of ethical aspects, a robust analysis and the writing of the manuscript.

My only suggestion is to review the title, its length seems a bit excessive to me. Additionally, I consider the comment "while another paper is focused on three skilled [...], in the "Study variables" section, unnecessary.

Congratulations, I really enjoyed reading the manuscript

Reviewer 4

The topic is relevant because of the social impact and inequalities that occur in developing countries. It is essential to recognize indicators of potential risks during childbirth in order to make informed decisions and prevent complications that could lead to the death of both mother and baby. However, we have some observations.

Overall, the current version of the article is quite dense and difficult to understand because of long and ambiguous sections. To ensure clarity for the reader, it is essential to reorganize the structure of the paper. In addition, it is substantial in the paper, to balance the section statistical analysis with importance of the impact of the intervention, will allowing the validity of the study to be measured.

The specific comments below recommend reducing the text in certain sections:

Introduction Section: From our perspective, the ideas in this section are long and repetitive. We recommend condensing sentences 2, 3, and 8. Sentence 6 could be rewritten or omitted.

In order to develop an educational intervention that addresses complications and reduces maternal and infant mortality rate, it is crucial to have a solid theoretical and causal framework. The causal framework is a diagram that considers the factors associated with social knowledge and establishes clear theoretical relationships between these factors. By incorporating a causal framework, the intervention can show its function and impact, highlighting the desired variable of change and the desired health outcomes. In addition, the baseline measure allows identifying should identify the variables that should be included in the analysis conceptual and ensure factor similarity between the intervention and non-intervention groups. It also allows for including relevant variables in the statistical analysis. The causal framework will justify the importance and scope of the intervention. For further help, see the following references:

• Rossi, P. H., Lipsey, M. W., & Freeman, H. E. (2004). Evaluation: A Systematic Approach (7th ed.). Thousand Oaks, CA: SAGE Publications. This classic program evaluation text underscores the importance of understanding and documenting causal relationships in intervention programs.

Centers for Disease Control and Prevention (CDC). (2011). Developing an Effective Evaluation Plan. Atlanta, GA: CDC, National Center for Chronic Disease Prevention and Health Promotion. This paper details the importance of causal and logic frameworks in health program evaluation.

• Funnell, S. C., & Rogers, P. J. (2011). Purposeful Program Theory: Effective Use of Theories of Change and Logic Models. San Francisco, CA: Jossey-Bass. This book provides comprehensive guidance on how to develop and use theories of change and logic models in program evaluation.

• Weiss, C. H. (1997). Theory-Based Evaluation: Past, Present, and Future. New Directions for Evaluation, 1997(76), 41-55. This article reviews the history and utility of theory-based evaluations, including the importance of causal frameworks.

• Bamberger, M., Rugh, J., & Mabry, L. (2012). RealWorld Evaluation: Working Under Budget, Time, Data, and Political Constraints (2nd ed.). Thousand Oaks, CA: SAGE Publications. This book addresses the challenges and strategies for evaluation in real-world settings, including justifying interventions through causal frameworks.

Method Section:

As a general comment, this section should be revised and summarized.

It is recommended that the participant recruitment process be described in more detail both in the text and in Figure 1.

I am confused by the way participant recruitment is described. If pregnant women were selected by visiting all households, if so, how was the response rate assessed if some households had a pregnant woman who did not want to be interviewed, or was not home because she had been hospitalized for complications of pregnancy? Other questions: How many households were visited in total? What is the rate of refusal or nonparticipation? During what stage of the recruitment process must women provide consent to take part? What was the community consent process? Given that the intervention was part of a major project, at what point in the study process were the groups randomized?

How do you measure the equivalence of the two groups in personal, social, and health service variables that theoretically take part in knowledge?

In the sample size calculation section, if a household census was conducted and pregnant women were identified, the most appropriate thing to do is to identify the statistical power or precision got when identifying knowledge in the total number of women who took part in the study.

On the other hand, what were the criteria for generating the clusters?

It would be appropriate to summarize this section as well.

After randomization: Are the factors that determine knowledge the same in both groups (intervened and non-intervened)? How do you check if randomization worked in creating kebeles?

In the variables section of the study, when it is noted that “The respondents in the study spontaneously mentioned three questions… spontaneous knowledge was defined… they could spontaneously name two or more…” Question: During the validation of the questionnaire and in particular of the knowledge questions, was the potential information bias that could influence the results quantified?, and in this context, did they measure its potential impact on the misclassification of knowledge in the statistical analysis?

Regarding the measurement of conceptual constructs such as “knowledge” during the analysis of the information, does the questions have the same value to measure the dimensions of the Knowledge construct?

In the last sentence of the same section, they show that this study is part of another larger project with another aim. It is not clear if it affected the creation of representativeness of women in the community or the recruitment and randomization process. Can you clarify?

IES process section. How did the topics offered to improve knowledge used in the intervention emerge? What competencies should participants have at the end of the educational training? Were assessments conducted before the intervention? What were the assessment results at the beginning and during the training process? If so, is there a parameter at the beginning of the intervention to measure the difference in knowledge between the intervention and non-intervention groups? If so, were these controlled for in the statistical analysis? Please comment.

Regarding the sections on data collection procedures, data techniques, and ethical statements, please reduce the length of these sections and rewrite them.

Results section. The statistical analysis should begin by evaluating the difference in the knowledge indicators that allow the initial counterfactual to be evaluated and induce the final counterfactual. It is important, measure the change before and after the intervention in both groups. A knowledge index be developed to meet the stated aim.

The tables are extensive. Please include the results of the important variables.

Explain the statistical differences that allow the identification of variables used in the adjusted statistical model.

Tables 3 and 4, please include at the bottom of the table the variables used to adjust the final model, and show the most essential findings that allow the subsequent discussion of the results.

Create a bar graph showing the percentage of increase in knowledge caused by the intervention that is the objective of the study.

In the Discussion section, it is recommended that the authors include the percentage of change in knowledge about the SDG and BPCR practices got at the end of the intervention.

An important aspect of the discussion of the study findings is the statistical analysis, which includes both intention to treat and final analysis.

The authors refer to an increased likelihood of women performing BPCR after the intervention, but do not specify which specific outcomes they are referring to.

The discussion mentions potential cost and material savings, but it is unclear whether this was one of the study’s goals.

In conclusion, the paper cannot be published as it is, observations and comments are necessary.

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

[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.

Attachments

Attachment

Submitted filename: Reviewers Dr. Amanuel Yoseph.pdf

Effect of community health education on mothers' knowledge of obstetric danger signs and birth preparedness and complication readiness practices in southern Ethiopia: A cluster-randomized controlled trial

PONE-D-23-40070R2

Dear Dr. Amanuel,

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.

An invoice will be generated when your article is formally accepted. Please note, if your institution has a publishing partnership with PLOS and your article meets the relevant criteria, all or part of your publication costs will be covered. Please make sure your user information is up-to-date by logging into Editorial Manager at Editorial Manager® and clicking the ‘Update My Information' link at the top of the page. If you have any questions relating to publication charges, please contact our Author Billing department directly at authorbilling@plos.org.

If your institution or institutions have a press office, please notify them about your upcoming paper to help maximize its impact. If they’ll be preparing press materials, please inform our press team as soon as possible -- no later than 48 hours after receiving the formal acceptance. Your manuscript will remain under strict press embargo until 2 pm Eastern Time on the date of publication. For more information, please contact onepress@plos.org.

Kind regards,

Doris Verónica Ortega-Altamirano, PhD

Academic Editor

PLOS ONE

Additional Editor Comments (optional):

The manuscript is ready for publication

Reviewers' comments: