PONE-D-20-21414

Mistreatment among newborns after childbirth in health facilities in Nepal: results from a prospective cohort observational study

PLOS ONE

Dear Dr. KC,

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.

On of the reviewers raised question about ethics.

Please first of all  provide the accordance and the protocol of the ethics commission to clarify  this crucial point.

Please submit your revised manuscript by Nov 15 2020 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.

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We look forward to receiving your revised manuscript.

Kind regards,

David Desseauve, MD, MPH, PhD

Academic Editor

PLOS ONE

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2. Please amend your current ethics statement to address the following concerns:  

a) Did participants provide their written or verbal informed consent to participate in this study?

b) If consent was verbal, please explain i) why written consent was not obtained, ii) how you documented participant consent, and iii) whether the ethics committees/IRB approved this consent procedure.

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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

Reviewer #2: Yes

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

Reviewer #1: I Don't Know

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: No

Reviewer #2: No

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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: No

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: Thank you for allowing me to review the manuscript entitled “Mistreatment among newborns after childbirth in health facilities in Nepal: results from a prospective cohort observational study”.

In this paper, Ashish et al. report a large, prospective, multicentric cohort conducted in 4 public hospitals in Nepal and including 31’804 newborns. This observational study nested in a larger study on neonatal resuscitation aimed to assess frequency and risk factors of mistreatments at childbirth among vaginally-born spontaneous breathing newborns. Results show a high rate of inadequate care, notably, that nearly two thirds of newborns received medical interventions without parental consent, 25% were handled roughly, and 21% were suctioned without need. Main risk factors associated to mistreatment were ethnicity, young maternal age, and newborn female sex. Authors also propose a set of indicators based on the WHO standards to assess neonatal mistreatment.

This study is one of the first investigating the question of “mistreatment” of newborns at birth. It is indeed an interesting and relevant topic, and it deserves not only to be published, but also to be reproduced in other care settings, including high income countries.

I have the following questions and comments to address to the authors:

1. General: the article is well and logically written, but it is too long and will gain in being more concise and straight, in particular: abstract (2 pages), author summary, introduction, discussion (4 pages)

2. Abstract: information on cord clamping, breast-feeding during the first hour and skin to skin contact would be important to report.

3. Methods: more information about the four hospitals would be interesting (number of yearly deliveries, rates of C-section, number of midwifes, nurses and physicians)

4. Statistics: complex and not easy to follow for a non-statistician. Anyway, it seems it could be interesting to add a composite dichotomic variable of “any” or “no” mistreatment to know which proportion of babies are concerned, even (or especially!) if very high.

5. Discussion, page 20, lines 20-21: “Newborns who were spontaneously breathing also received unnecessary and vigorous stimulation, which is not evidence-based”. In the methods, it is set that non spontaneously breathing was a criteria exclusion.

Minor:

6. Abstract, page 3, line2: “women age 35 or more were more likely to be mistreated” � “Infants born to women (?!)were more likely to be mistreated”

7. Abstract, results, pages 2-3 and author summary, pages 5-6: presentations of factors should be in the same way, either increasing or decreasing the risk of mistreatment, but mixing the two is somewhat confusing for the reader.

8. Method, page 14, lines 1-2: “The single index similar to a single factor analysis setting”: missing verb?

9. Method, page 15, line 15-19: “In the third model, there were three different levels (birth, observer and hospital), so the model became complicatenand we were unable to get the convergence and The outcome from the first and second 18 model is presented in table 3 and the outcome of the first model has been reported in the 19 main text: missing punctuation?

Reviewer #2: Reviewer N° 4

Manuscript entitled “Mistreatment among newborns after childbirth in health facilities in Nepal: results from a prospective cohort observational study” is a well written interesting manuscript focusing on mistreatment of mothers and newborn infants just after birth.

The results of this study are a side product of a prospective cohort observational study of around 80’000 deliveries conducted over a period of 18 months in 12 hospitals in Nepal.

The relationship of the here presented data to the initial study is not quite clear and leads to some major questions:

1. Consent: It is not quite clear what was included in the consent obtained by the mothers. Some fundamental questions might arise and should be cleared before publishing this paper:

a) One of the major results is the lack of consent for treatment issues in spontaneously breathing infants. It seems difficult to understand that mothers who consented for this study should be asked for additional consent for each treatment approach.

b) Was stated in the consent form that the well-trained study nurse would not intervene in the treatment of the newborn infant, although this treatment might be misconducted and not performed according to the international standards?

2. Hospital selection? The data presented in the abstract demonstrate that the influence of hospitals might have an important impact on the results, as adjustment for hospital heterogeneity inverse the results from more to less mistreatment in women over 35 years.

Abstract:

Methods and Findings:

In the second paragraph is stated: In multi-variate regression analysis, women age 35 years or more were more likely to be mistreated (β, 0.466; p value, 0.000) in reference to 18 years or less.

In the next paragraph is stated: After adjusting for hospital heterogeneity, women aged 30-34 years (β, -0.041; p value, 0.01) and aged 35 years or more (β, -0.064; p value, 0.029) were less mistreated in reference to women aged 18 years or less.

I could not find any explanation, why this study was performed only in four out of the twelve hospitals and how they have been selected.

3. Cesarean section: In Figure 1 the flow chart is given for the 39’652 women admitted to one of the four hospitals, leading to the 31’804 deliveries, which were observed. The abstract indicates as one major limitations that newborns delivered by caesarean section have not been included. The number of children born by CS should be given and substracted from the 31’804 deliveries in order to get the final denominator.

4. Evolution over time: The goal of the original study was to measure the impact of training regarding quality improvement in mother and newborn care. No information in the here presented study is given regarding the timely evolution over the 18 months study period. There is a potential study bias, which should unveiled.

Minor points:

Methods:

Design: April 2017 – October 2018 = 19 months (exact data of study period should be stated).

Final remark:

I do not comment on the questions and remarks of the other reviewers, which I fully agree with.

I would conclude that the study unveils important lack of newborn care in four Nepalese Hospitals which might point to similar problems in many other maternity wards worldwide.

There are systematic problems which should be taught differently:

o late cord clamping and breast feeding within the first hour seems not to be part of the teaching standards as it was not performed in > 73% of situations.

o Even more the fact that the well-being newborn is separated from the mother in > 95% of all vaginal deliveries.

o The question of informed consent needs to be approached differently.

o Temperature control in the delivery room is in 50% of the hospitals not given.

o Preparedness and hygiene is important to increase

Therefore, the information of this study is important. However, the abovementioned major questions should be answered before publication.

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Reviewer #1: No

Reviewer #2: No

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PONE-D-20-21414R1

Mistreatment of newborns after childbirth in health facilities in Nepal: results from a prospective cohort observational study

PLOS ONE

Dear Dr. KC,

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.

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

ACADEMIC EDITOR:

Thank you for this revised version of the manuscript which improve the quality and the message of thsi manuscript. Nevertheless, some majors reviewers comments have to be answered clearly. 

In this form and without clear explanations about ethical consideartion and methodology this article couldn't be accepted. We invite you to provide us a newe version of this manuscript answering clearly each point arised by the reports reviewers  below.

Please ensure that your decision is justified on PLOS ONE’s publication criteria and not, for example, on novelty or perceived impact.

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

Please submit your revised manuscript by Jan 15 2021 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: http://journals.plos.org/plosone/s/submission-guidelines#loc-laboratory-protocols

We look forward to receiving your revised manuscript.

Kind regards,

David Desseauve, MD, MPH, PhD

Academic Editor

PLOS ONE

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Reviewers' comments:

Reviewer's Responses to Questions

Comments to the Author

1. If the authors have adequately addressed your comments raised in a previous round of review and you feel that this manuscript is now acceptable for publication, you may indicate that here to bypass the “Comments to the Author” section, enter your conflict of interest statement in the “Confidential to Editor” section, and submit your "Accept" recommendation.

Reviewer #1: All comments have been addressed

Reviewer #2: (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 #1: Yes

Reviewer #2: Partly

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

Reviewer #1: I Don't Know

Reviewer #2: Yes

**********

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 #1: Yes

Reviewer #2: No

**********

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

**********

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 #1: In this revised version, authors adressed most of the comments of the reviewer. The current manuscript deserves to be published, regarding notably the new and important insights of the study on neonatal mistreatment at birth.

I have only 2 additional comments :

1- more emphasis could be brought on the mots frequent mistreatment , id est lack of skin to skin contact immediatly after birth that concerns almost all of the infants and could be easy to improve; what was the reason/barrier for this delay?

2- a possible impact of observation on care givers behaviour could be mentioned as a study limitation and possible bias

Reviewer #2: Thanks for giving me the opportunity to review the revised manuscript.

A general problem remains: This study seems more to describe a health care system in which evidence based neonatal basic care is almost absent, than a voluntarily applied mistreatment of newborn infants. The title might be reconsidered.

This study is important as it shows an absence of knowledge regarding neonatal care and an important need for improvement. However, to declare it as mistreatment as suggested in the second paragraph of the Background chapter, might be questionable. The main information of this study is comprised in Table 1 and the description in the first paragraph of the discussion (page 18, line 3 - 9).

However, although highly advanced statistical methods have been applied, the interpretation of the results are not always clear or are laking. Therefore several questions remain:

1. Sex of infants : In lines 5ff of page 17 is stated : « There was no association between mistreatment with woman’s literacy, parity, and newborn sex ». In line 13 is stated: « Female newborns were more likely to be mistreated than male newborns. » What is now true?

2. After adjustment, there is a change of the risk being mistreated for infants of mothers > 35 years, initially higher, after adjustment lower risk. Explanation is still missing for this risk change.

3. Page 15 lines 14/15 : Statement about mistreatment of women, however, the study is about their newborns. This should be clarified.

4. There is a statement that newborns of mothers of less advantaged ethnic groups are at higher risk for mistreatment. However, there is no explanation why newborns of mothers of the ‘janjati’ ethnic group, although less advantaged are at lower risk for mistreatment. Hypothèses?

Furthermore, there remain some more questions which were not clearly answered.

1. What exactly is the content of the parental information? This is important, as one of the major finding of this study is the non-consented treatment of the newborn infants. Although it is stated in the revised manuscript that consent was given to observation and not for treatment, this difference might be difficult to be understood by mothers and also by health care workers.

One conclusion of this point is to be made: information of mothers about neonatal care should be improved, but for this being possible, health care workers should be formed about basic skills and trained in their application.

2. Caesarean section and clear definition of the denominator: it is still not clearly written that there are only newborns after vaginal birth included.

Page 14 line 9ff :

It is stated: “Of the total 39,652 women admitted for delivery in the hospitals during the study period, 34,125 of them consented and were enrolled in the study. Among their newborns, 31,804 breathed spontaneously at birth and were eligible for inclusion in the study (figure 1).”

However: there was a caesarean section rate of 18 – 27%. Numbers have to be explained.

3. The statement on page 19, lines 13ff has to be changed : « The use of unnecessary interventions such as suctioning to a spontaneously breathing newborns has been observed in previous study on neonatal resuscitation[26]. Reducing this intervention would also allow delayed cord clamping, early initiation of breast-feeding, and immediate skin to skin contact. » The suctioning is not responsible for dealyed breat-feeding and immediate skin to skin contact.

Taken together :

The results of the highly performed statistics are not sufficiently explained. The important findings of this study are the fact that basic neonatal care is mainly absent in the four major maternity wards of Nepal and that there is a tremendous need for training of neonatal care algorithms and skills.

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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 #1: No

Reviewer #2: No

[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.

Mistreatment of newborns after childbirth in health facilities in Nepal: results from a prospective cohort observational study

PONE-D-20-21414R2

Dear Dr. KC,

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,

David Desseauve, MD, MPH, PhD

Academic Editor

PLOS ONE