PONE-D-24-10925Development and validation of the GebStart-tool for advising primiparous women in early labourPLOS ONE

Dear Dr. Grylka-Baeschlin,

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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The reviewer's comments are available below. They have requested a few clarifications about the Methods, including the sample size calculation. They have also asked that you provide further details about the utility of the model. Demonstrating the utility tool of a new method or tool is an essential criterion for publication in PLOS ONE, as is availability (https://journals.plos.org/plosone/s/submission-guidelines#loc-methods-software-databases-and-tools), so please ensure that you address this carefully as part of your revision, and also ensure you have shared a copy of the tool.

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Staff Editor

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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

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

Reviewer #1: 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

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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: 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: This is an interesting article, and I appreciate you working to fulfill an unmet need for advising patients in early labor.

Introduction: I'm a little challenged by the overall premise of the model. You report that patients should remain at home as long as possible to avoid unnecessary labor interventions, but for many patients laboring at home without sufficient support is unsatisfying. This is presented as a dichotomy, but could we improve the process of labor care such that we can support people in early labor without a decision tool?

Methods - can you please clarify planned sample size? For example you write that the target sample size was 550 participants assuming 20% dropout rate but that would target an analytic goal of 440 patients and I don't see in the paragraph where that number is explained.

I recognize the desire to maximize sample size, but given your tool is designed to determine which patients should present to the hospital inclusion of the patients who are in active labor is problematic with the adjustment in time to 0.001 hours. At very least, I think you need a sensitivity analysis re: stability of your results to this assumption.

Results - can you clarify what is meant by "median workload"? Is this equivalent to saying someone is a full time employee rather than someone who works a part time position?

I am not certain we can identify the correct threshold for hospital admission based on figure 3, since the percentage of patients recommended to 'keep in contact' is still higher.

Discussion: As a practicing clinician, I was left wondering about the role of this tool. The tool seems to perform pretty modestly at predicting admission / etc, and requires significant effort to complete as you note. I can imagine if I were to tell a patient that they should remain at home or come to the hospital because that's what most pregnant people chose to do under similar circumstances people responding that this is a case in which direct elicitation of individual preferences and shared decisionmaking would likely be faster and more fruitful.

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Reviewer #1: No

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PONE-D-24-10925R1Development and validation of the GebStart-tool for advising primiparous women in early labourPLOS ONE

Dear Dr. Grylka-Baeschlin,

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.

Please submit your revised manuscript by Jan 09 2025 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,

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)

Reviewer #3: (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

Reviewer #3: Yes

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

Reviewer #1: Yes

Reviewer #2: Yes

Reviewer #3: Yes

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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: Yes

Reviewer #3: No

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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: No

Reviewer #3: Yes

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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: I appreciate the detailed response to my prior comments and have no further comments at this time.

Reviewer #2: TITLE

These are not primiparous women – see below

Same for the abstract

In the abstract conclusion I think that the term ‘evidence-based’ is somewhat confusing and disingenuous. The development methodology may be so, but using this term indicates that the tool itself has been the subject of a prospective interventional study or part of a systematic review, and this is clearly not case. Either change the phrase to be more precise or remove it entirely.

INTRODUCTION

I agree with the rational for an objective early labour assessment tool and the issues related to early or late presentation at the hospital.

This section is well written and creates a cogent and coherent argument for the study.

MATERIALS AND METHODS

• Typo : line 95 hospitals (plural)

• Terminology issues

Primiparous = someone who has given birth to one child

Primigravida = someone who is pregnant for the first time

Nulliparous = someone who has never had a live birth (not someone who has never been pregnant e.g. abortion, miscarriage)

You cannot use primiparous and primigravid interchangeably, as they are NOT the same.

• Understanding the methodology – very difficult due to the complexity of the steps required to arrive at the definitive 19 item tool

• Very difficult to understand what the plan was and how it was executed.

Unlike as it written in the BMJ Open protocol, it is unclear at which point and how the tool was implemented; and by whom. I suggest that this information is added as written in the published protocol (see below)

Data collection section of BMJ Open article:

‘The preliminary newly developed tool for the structured assessment is applied at the first contact with the parturient during early labour, which can either be by telephone or face to face. Midwives complete the questionnaire by asking the questions orally’

This is, in contrast, very clear

• I understand why the CBSEI and the CWS were used to validate the new tool, but it seems that neither has an exceptionally high sensitivity for objectively assessing confidence to cope with labour and nor accurately evaluating concerns about labour. Were there no other options? Also, it states that German language versions were used but were these translated versions also correctly validated prior to inclusion in the study? Each newly translated questionnaire requires validation prior to clinical use.

• These questions are very important as these methods were fundamental to the validation of the GebStart tool.

• Line 127: typo – mandatory (missing y)

• Line 129: ‘accidentally’ only the first subscale – this means what exactly? Full explanation in the text please.

• Line 164: can you do this and keep the data relevant? The Cox Regression excludes negative time intervals for good reason.

• Line 177: I find the term ‘outcome effective management unclear. Could this be changed or phrased better?

Do the authors know, on average, how long it took for the study midwives/clinicians to complete the 32-item questionnaire?

Someone who is anxious, and in discomfort is probably not going to want to spend too much time completing a questionnaire about their current condition. They want a fairly rapid response to their question: stay at home or come to hospital.

Presumably a 15-item questionnaire would take about half as long to get through.

RESULTS

Line 216 The term dropouts (37%) suggest a voluntary withdrawal from the study, however the context in which this is used is more of an exclusion. For example, a woman who was induced or underwent caesarean before the onset of labour. These were recruited women who were EXCLUDED but they were not ‘dropouts’ in the classic sense

For 15% of the 37% of dropouts (92 of 233) it is stated that the tool was not completed: reasons = forgotten, too much work or admission was urgent. BUT in the protocol, the tool was to be applied at the onset of labour, so for planned inductions and caesareans before the onset of labour, these patients did not satisfy the inclusion criteria to complete the GebStart Tool. Correct? So how could it have been forgotten when the patients were never suitable?

Characteristics of the population

The population is highly selective and would not be representative of populations in other similar European countries in terms of marital status, educational attainment, full-time employment, financial status, medical insurance and antenatal preparation. This is not a typical large (university) hospital population, so the results are unlikely to be externally valid.

These characteristics are also likely to suggest better physical and psychological preparation and coping strategies for labour, which may produce results considered as outliers when compared to more standard maternity populations.

Line 231 cannot be correct. If all participants were primiparous (one previous liveborn) how could 82% be in their first pregnancy? (primigravid) The terminology is incorrect throughout and must be amended. You cannot be both primiparous AND primigravid. This means that the terminology must be consistent throughout the article.

Primigravid or nulliparous but not primiparous. Please amend to provide consistency in the article.

Participants have been defined as ‘women expecting their first child’.

So nulliparous OR primigravid please but not primiparous.

Item reduction

This section is quite clear and well written despite being a rather complex process.

Validation

Should not the validation of the FINAL tool come after the section on cut-off points and designing the final versions?

This is a bit confusing made more so by the terminology and use of final Gebstart-tool for two different time points.

Is the final GebStart-tool mentioned in the validation section Line 310-311, the same final Gebstart-tool mentioned in Lines 351-360? I believe that this cannot be true.

Validation was a mathematical/comparative validation (using amongst other the CBSEI + CWS scores) rather than a prospective clinical validation of the final tool. I assume that there is a plan to prospectively evaluate the FINAL tool in clinically diverse populations, to confirm or refute the findings.

Could you also explain the difference between full CBSEI scale and a partial scale? Is a partial scale as valid as a full one? Please clarify in the text as this was an error it seems. And does this not weaken the assessment of the validation?

Cut-off points for the final instrument

The cut-off points are explained and the lack of intersect for the second-one, justified by the Bersabé and Riva reference. However, I think that given this anomaly, and the importance of the cut-off to the clinical use of the tool, the authors need to give more detail as to why they feel that this calculation (statistical fudge) is valid in these circumstances. Just citing reference is insufficient for me.

This is discussed in the strengths and limitations, but its significance is not explained.

Designing the final version

Just to be sure, it was not this final version with15 items and described modifications that was prospectively trialed clinically, rather the full 32 item list that was then reduced. This was more of a mathematical validation based on the patient responses to the 15 items selected from the original 32, aided by the CWS and partial CBSEI scoring systems to provide some alternative indirect clinical validity.

It seems that if the items were re-phrased based on the feedback of study centers, then the true final version of GenStart-tool is yet to be trialled/studied?

This is not very clear and needs to be clarified

DISCUSSION

Line 364 – primigravid NOT primiparous.

I would rephrase this whole paragraph as the it is the most important at summarising the findings of the study. In this form, the findings are not very clear.

‘Effective management decision’ – this term is a quite ambiguous in isolation. Why effective and not just management decision? Stay at home, stay in contact or go to hospital?

The output of the study was indeed a short GebStart tool but to state at this stage, without real world evaluations in diverse populations, that it is practical, remains to be confirmed.

Line 417-418: The results OF not TO the GebStart-tool should demonstrate this? Does this mean demonstrated in future clinical studies?

Strengths and weaknesses

I am not sure that the readers will correctly interpret ‘evidence-based’ as described. I assume that the authors refer to an ‘evidence-based methodology’ and nothing else.

They need to be very careful referring to ‘evidence-based’ as many will assume that this relates to the clinical use of the tool rather than its development. It would be quite a stretch to consider the GebStart tool ‘evidence-based at such an early stage of development.

Also, the study population is certainly not like that of any hospital where I have ever worked, and I have been lucky enough to have worked in several countries on 3 different continents. This makes external validity of the tool in other regions/countries essential if you are to prove its effectiveness. Currently it seems that it is designed for wealthy, well-educated, well insured and well supported married women. This type of population in most other countries is only found in the private sector.

These women are more likely to be better prepared for birth, physically and mentally stronger than most women that are seen in other larger European units.

As the tool attempts to evaluate coping and confidence in early labour, I would argue that the results of this study are only valid for this specific and unique group of women.

The discussion is too long and as with other sections, is not easy to follow.

I would suggest a complete re-write and then ask for feedback from some native English speakers, to confirm that it is relatively easy to understand.

CONCLUSION

I agree with the authors that more work is needed. At this stage the tool has been implemented in very small numbers in a very specific population of pregnant women, who are not at all representative of most women attending larger, university maternities in other European countries.

Reviewer #3: The aim of the study is interesting. The scientific answer is rather well constructed, with a coherent statistical basis. But I wonder about the selection bias, which I think reduces the external validity of this study. Indeed, patients who agree to be included are less worried about staying at home, which is not necessarily the case for a large part of the population. This type of patient will not come to hospital if the midwife is reassured that she is not in labour.

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Reviewer #1: No

Reviewer #2: No

Reviewer #3: No

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PONE-D-24-10925R2Development and preliminary validation of the GebStart-tool for advising nulliparous women in early labourPLOS ONE

Dear Dr. Grylka-Baeschlin,

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 study is well-conducted and relevant. However, I suggest the following improvements:

1. Expand the discussion on the tool's clinical utility.
2. Emphasize the preliminary nature of the findings due to sample size limitations.

With these revisions, the manuscript will be ready for publication.

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

Please submit your revised manuscript by Mar 13 2025 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'.
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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,

David Desseauve, MD, MPH, PhD

Academic Editor

PLOS ONE

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Development and preliminary validation of the GebStart-tool for advising nulliparous women in early labour

PONE-D-24-10925R3

Dear Dr. Grylka-Baeschlin,

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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PLOS ONE

Reviewers' comments: