PONE-D-21-30384International Consultation on Incontinence Questionnaire – Urinary Incontinence Short Form ICIQ-UI SF: Validation of its use in a Danish speaking population of municipal employeesPLOS ONE

Dear Dr. Grøn Jensen,

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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ACADEMIC EDITOR: Apart from the reviewers comments I ask you to consider that the readers may want to know how your analysis of the questionnaire relates to the original, eg are floor and ceiling effects, consistency and or test retest variation (very) different from the original, or not?

Please submit your revised manuscript by Jan 10 2022 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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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.

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We look forward to receiving your revised manuscript.

Kind regards,

Peter F.W.M. Rosier, M.D. PhD

Academic Editor

PLOS ONE

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Please review your reference list to ensure that it is complete and correct. If you have cited papers that have been retracted, please include the rationale for doing so in the manuscript text, or remove these references and replace them with relevant current references. Any changes to the reference list should be mentioned in the rebuttal letter that accompanies your revised manuscript. If you need to cite a retracted article, indicate the article’s retracted status in the References list and also include a citation and full reference for the retraction notice.

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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: Yes

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: Yes

Reviewer #2: Yes

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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

Reviewer #2: No

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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 the opportunity to peer review your manuscript

In this study you have performed a validation of a Danish version of the International Consultation on Incontinence Questionnaire-urinary incontinence-short form (ICIQ-UI-SF) named VersionDUGS using Classical Test Theory (TCC).

In a pilot test with 14 public workers and six health care professionals you have performed thorough qualitative analyses of both face and content validity and construct validity has been evaluated through three hypotheses (known-group validity) (sex, age, BMI). Furthermore, you have examined internal consistency of the three items that can be scored with the Cronbach’s alfa.

Pretesting (field test) of the questionnaire has been performed in male and female municipal workers who have been invited through email to complete an online version of the questionnaire

Test-retest reliability has been examined by calculating an Intraclass correlation coefficient (ICC)

You find good face and content validity and two of your three hypotheses are confirmed (Sex and BMI).

1814 municipal workers (1402 female), have completed the questionnaire and 215 (50.5%) of 426 invited complete it twice

You find low internal consistency of the three items (0.48) while floor and ceiling effect is low. Distribution of scores is adequate.

Test-retest reliability based on the ICC is moderate (0.73)

You conclude that the Danish VersionDUGS has acceptable validity and reliability

Major comment

This is a well performed study with an adequate sample size. You have followed the COSMIN checklist and fulfill the criteria for a high-quality study. Your methods are well described including your qualitive method which is very well explained.

You describe that there are two versions of the ICIQ-UI SF in Danish, and that the VersionDUGS is widely used in a Danish database but not approved by the ICIQ (Bristol Institute). Could it be a problem to have two versions of the ICIQ-UI SF in Danish? Did you consider comparing the two versions in a study? Would it be possible to merge the two versions?

You determine relative reliability using ICC and your ICC is only moderate. It would be of interest to the reader know the absolute reliability: I.e. standard error of measurement (SEM 95%), Smallest real difference (SRD) or minimal detectable change (MDC). Alternatively, you could present limits of agreement (Bland and Altman method)

Minor comments

Gaussian is an old term, for the reader the term “normal distribution” would be preferred

P. 10, l. 187: The ICC model: 2.3 agreement, where does the “3” come from?

How were the participants for the pilot test recruited?

How did you recruit respondents for the retest? Randomly?

You find a low Cronbach´s alfa but do not describe the value of each item? Probably, the low alfa is not a problem since number of items has an influence on this. Even though inter-item correlation may be higher if you add more items as you suggest in your discussion this may not improve content validity.

Reviewer #2: I congratulate the authors for composing a work towards the use of a valid version

of the ICIQ in Denmark. I'm certain this will expand their possibilities to study the

outcomes of their patients in a more reliable way. Authors often state that a quality of life scale is

''valid''. However, these instruments should not be viewed as valid or not valid since validity and

reliability are based on evidence accumulated over time, not one-time, dichotomous concepts.

Validation studies attempt to measure the extent to which evidence supports that the instruments

are measuring what they are supposed to measure and quantitate the error in doing so. Based on

this, the study is useful since it demonstrated that the instruments performed as designed in a

different population with a different language.

I suggest improving discussion with some of the validation studies which have demonstrated higher Cronbach-alpha value - such as: Mikuš M, Ćorić M, Matak L, Škegro B, Vujić G, Banović V. Validation of the UDI-6 and the ICIQ-UI SF - Croatian version. Int Urogynecol J. 2020 Dec;31(12):2625-2630. doi: 10.1007/s00192-020-04500-4. Epub 2020 Aug 21. PMID: 32821964. AND Rotar M, Tršinar B, Kisner K, et al. Correlations between the ICIQ- UI short form and urodynamic diagnosis. Neurourol Urodyn. 2009;28(6):501–5.

Also, there is need for improvement in English style and overall language.

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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.]

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PONE-D-21-30384R1International Consultation on Incontinence Questionnaire – Urinary Incontinence Short Form ICIQ-UI SF: Validation of its use in a Danish speaking population of municipal employeesPLOS ONE

Dear Dr. Grøn Jensen,

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: A small challenge remains, can you add the information to the manuscript?==============================

Please submit your revised manuscript by Mar 27 2022 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,

Peter F.W.M. Rosier, M.D. PhD

Academic Editor

PLOS ONE

Journal Requirements:

Please review your reference list to ensure that it is complete and correct. If you have cited papers that have been retracted, please include the rationale for doing so in the manuscript text, or remove these references and replace them with relevant current references. Any changes to the reference list should be mentioned in the rebuttal letter that accompanies your revised manuscript. If you need to cite a retracted article, indicate the article’s retracted status in the References list and also include a citation and full reference for the retraction notice.

Additional Editor Comments (if provided):

None

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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: (No Response)

Reviewer #2: All comments have been addressed

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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: Partly

Reviewer #2: Yes

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

Reviewer #1: No

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: 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 #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: Thank you for your revised manuscript

As requested, you have provided the equation for the calculation of absolute reliability (Standard Error of Measurement (SEM)) and you also very shortly report the result from your calculation, but you have not explained what it means in relation to the reliability of the ICIQ-VersionDUGS.

It seems that you have calculated a SEM (68% at group level), but you do not tell what 1.57 means to the test-retest reliability of the ICIQ-VersionDUGS. Furthermore, this figure would be 3.1, if you had calculated SEM (95% at group level), which is relevant for research settings (SEM x1.96), and 4.3 at an individual level. The latter representing the smallest real difference (SRD) (SEM x 1.96 x √2).

The implications of the results above should be described and discussed since it is important knowledge for both researchers and clinicians.

In your discussion page 12, line 234 you write:” The intraclass correlation coefficient of 0.73 is moderate, which is confirmed in the calculated standard error of measurement”. Why does the ICC affect SEM and could you have calculated the SEM based on another analysis (ANOVA)?

Line 235: should be a zero.

Reviewer #2: Thank you for the opportunity to re-revise this manuscript. The revised version is fully acceptable for publication in PLOS ONE.

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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.

International Consultation on Incontinence Questionnaire – Urinary Incontinence Short Form ICIQ-UI SF: Validation of its use in a Danish speaking population of municipal employees

PONE-D-21-30384R2

Dear Dr. Grøn Jensen,

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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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,

Peter F.W.M. Rosier, M.D. PhD

Academic Editor

PLOS ONE

Additional Editor Comments (optional):

Reviewers' comments: