PONE-D-20-28626

Translation, Validation and Psychometric Evaluation of Farsi version of the Low Anterior Resection Syndrome Score

PLOS ONE

Dear Dr. Keramati,

Thank you for submitting your manuscript to PLOS ONE. After careful consideration, we feel that it has merit but does not fully meet PLOS ONE’s publication criteria as it currently stands. Therefore, we invite you to submit a revised version of the manuscript that addresses the points raised during the review process.

The manuscript and the reviewers’ comments were carefully evaluated. The manuscript was appreciated by the Reviewers. Nevertheless, as suggested, the manuscript requires improvements before to be considered for publication. Further suggested revisions are in detail reported in the Reviewers’ comments.

Please submit your revised manuscript by Jan 10 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.

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We look forward to receiving your revised manuscript.

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Simone Garzon

Academic Editor

PLOS ONE

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2. Thank you for stating in the text of your manuscript that you acquired permission from the original authors to translate the LARS score into Farsi. Please also add this information to your ethics statement in the online submission form.

3. In your Methods section, please provide additional information about the participant recruitment Please ensure you have provided sufficient details to replicate the analyses such as:

a) the recruitment date range (month and year),

b) a statement as to whether your sample can be considered representative of a larger population, and

c) a description of how participants were recruited.

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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: Partly

Reviewer #2: Partly

Reviewer #3: Yes

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

Reviewer #1: No

Reviewer #2: No

Reviewer #3: 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: Yes

Reviewer #3: 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: Yes

Reviewer #3: 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: PONE-D-20-28626

Translation, Validation and Psychometric Evaluation of Farsi version of the Low Anterior Resection Syndrome Score

Thank you for the opportunity to review the manuscript. I reviewed this manuscript carefully with a great interest. I respectfully provided my comments below

1: It is recommended to change the title of the manuscript

Psychometric characteristics of the Persian version of the Low Anterior Resection Syndrome Score (LARS-P)

2: The abstract needs major editing.

3: In validity, explain face and content validity

4: In methods convergent and discriminative validity of the LARS score explain in two separate sections.

5: The standard time interval for the test re test is at least two weeks. Based on what reference did you consider this time period to be one week?

6: For test–retest reliability you must use Bland–Altman plot of the differences between LARS scores on the first and second tests.

Reviewer #2: The authors present the translation and psychometric validation of the e Low Anterior Resection Syndrome (LARS) score in Farsi. The sample size of 101 patients is sufficient for psychometric analyses.

Abstract

The abstract is punctual and well written.

Introduction

- Please provide reference for the second sentence in lines 57 and 58.

- Pleas change the last sentence of the introduction 'Herein, we would like to translate and validate the LARS score Farsi questionnaire and to measure its psychometric properties.' to clearly present an aim for the study in a separate paragraph. 'The aim of the present study was to translate the LARS score into Farsi and to test its psychometric properties.

Otherwise the introduction is well orchestrated.

Methods

Please provide reference for guidelines to which the translation process adhered. The most widely used guidelines are those of Beaton et al. and Wild et al. (ISPOR).

The authors should calculate reproducibility (test-retest reliability) values using the intraclass correlation coefficient (ICC), standard error of measurement (SEM) and if possible coefficient of repeatability (CR). This is the first time I have come across using the alpha for assessing test-retest reliability. If the authors prefer and insist in using the Cronbach's alpha coefficient (internal consistency) in test-retest reliability assessment, further clarification of analysis process and due references for the method should be provided. I could not find any suitable reference with a quick search for this method. Cronbach alpha provides an estimate of the internal consistency of the PROM and, to the best of my knowledge, does not indicate the stability or consistency of the test over time, which would be better estimated using the test-retest reliability strategy such as ICC, SEM and/or CR analyses. The authors can check this approach also from the COSMIN checklist (https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2852520/)

Results

- Please provide a flow chart for patient selection.

- Please check the alpha in last row 208 according to my comment for the Methods section.

Discussion

- Please provide the main findings of the present study in the first paragraph of the Discussion section.

- Please provide a paragraph for strengths and weaknesses of the study

- The discussion is otherwise very good and provides sufficient comparison with previous studies.

Coclusion

This is fine.

Congratulations for this good paper. I will recommend minor to major revision before publication.

Reviewer #3: Review of Translation, Validation and Psychometric Evaluation of Farsi version of the Low Anterior Resection Syndrome Score

Thanks for giving me the opportunity to review this very relevant and well-written paper. The LARS score has proved to be a useful tool for measuring bowel dysfunction after sphincter preserving surgery for rectal cancer, and although it is relatively new, it has already been used in a high number of research projects, as well as in clinical practice, around the world. With the publication of this paper, it will be possible to conduct more research within this area in a population of Farsian speaking patients as well, which is very important. I hope the tool will be used to gain a deeper insight in the prevalence of bowel dysfunction and the impact on QoL after rectal cancer in Iran and other Farsian-speaking countries.

However, I have a few comments/questions/suggestions, which I hope the authors are willing to address:

Introduction:

(l 56) “…and the principal cause of cancer death in males and females, respectively”. I think that’s incorrect. Please check the results of the referenced paper.

Materials and methods:

(l 82-83) I believe it would be more correct to say that “The score-values were based on the item's impact on the qol of the patients.”

(l 129-30) “To evaluate the discriminative validity of the questionnaire, we tested the ability of the translated version of the LARS score to make a distinction between various groups of patients…” I would suggest adding “…who were expected to differ with regards to LARS” (and add some references which support this assumption)

(l 138) I don’t believe Cronbach’s alpha is appropriate for this tool measuring a SYNDROME consisting of five different symptoms, which are NOT necessarily strongly associated (but surely they sometimes are). If you are measuring a concept, such as anxiety (just an example) by means of summarizing several items, you would definitely require all of them to be closely related, and hence Cronbach´s alpha would be a relevant measure. If you still consider internal consistency relevant, please explain why and how we should interpret the result in detail.

Results:

In general, non-normally data should be presented as Median(IQR). Please check the distribution of your continuous variables, and make sure that you are using non-parametric tests whenever appropriate.

How many days between the two tests of the test-retest?

Table 1: “Stage of tumor" – is that UICC?

I think Table 2 is a bit confusing, since it is related to section 3.3. - Discriminative validity. The second part of the table (QoL) is not really relevant for any analyses of this validation paper, is it? You could consider dropping the QoL part, and move the table to section 3.3. (or drop Table 2 completely)

If “age” and/or “Distance of tumour from anal verge” are non-normally distributed, I think you should consider using the medians as cut off for the groups of in section 3.3. – Discriminative validity.

Discussion:

Please thoroughly discuss how these issues may impact the results/risk of bias:

Low response rate.

Short time after stoma reversal (33 days) (Bowel function might not be stable this early, and this might a problem in the test-retest – which requires a stable function).

Number of included patients.

Thanks.

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Reviewer #1: Yes: Razieh Bandari

Reviewer #2: No

Reviewer #3: No

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Attachments

Attachment

Submitted filename: PONE29.10.docx

PONE-D-20-28626R1

Translation, Validation and Psychometric Evaluation of the Persian (Farsi) version of the Low Anterior Resection Syndrome Score (LARS-P)

PLOS ONE

Dear Dr. Keramati,

Thank you for submitting your manuscript to PLOS ONE. After careful consideration, we feel that it has merit but does not fully meet PLOS ONE’s publication criteria as it currently stands. Therefore, we invite you to submit a revised version of the manuscript that addresses the points raised during the review process.

The manuscript and the reviewers’ comments were carefully evaluated. The manuscript was appreciated by the Reviewers. However, minor revisions are required before final acceptance.

Please submit your revised manuscript by Mar 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,

Simone Garzon

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: All comments have been addressed

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: Yes

Reviewer #3: Yes

**********

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

Reviewer #1: Yes

Reviewer #2: Yes

Reviewer #3: 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

Reviewer #3: 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

Reviewer #3: 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: (No Response)

Reviewer #2: I recommended publication as all issues raised by the Reviewers are accounted for. I have no further comments or requirements.

Reviewer #3: line 295 (Discussion):" Cronbach’s alpha displayed good internal consistency and reliability in our study". I believe you took this analysis out of the manuscript, hence it should not be mentioned in the discussion.

I recommend to show not just the minimum days between the two tests in the test-retest, but also the maximum number of days.

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If you choose “no”, your identity will remain anonymous but your review may still be made public.

Do you want your identity to be public for this peer review? For information about this choice, including consent withdrawal, please see our Privacy Policy.

Reviewer #1: No

Reviewer #2: No

Reviewer #3: 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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Translation, Validation and Psychometric Evaluation of the Persian (Farsi) version of the Low Anterior Resection Syndrome Score (LARS-P)

PONE-D-20-28626R2

Dear Dr. Keramati,

We’re pleased to inform you that your manuscript has been judged scientifically suitable for publication and will be formally accepted for publication once it meets all outstanding technical requirements.

Within one week, you’ll receive an e-mail detailing the required amendments. When these have been addressed, you’ll receive a formal acceptance letter and your manuscript will be scheduled for publication.

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Kind regards,

Simone Garzon

Academic Editor

PLOS ONE

Additional Editor Comments (optional):

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 #3: All comments have been addressed

**********

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 #3: Yes

**********

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

Reviewer #3: 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 #3: Yes

**********

5. Is the manuscript presented in an intelligible fashion and written in standard English?

PLOS ONE does not copyedit accepted manuscripts, so the language in submitted articles must be clear, correct, and unambiguous. Any typographical or grammatical errors should be corrected at revision, so please note any specific errors here.

Reviewer #3: Yes

**********

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 #3: (No Response)

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7. PLOS authors have the option to publish the peer review history of their article (what does this mean?). If published, this will include your full peer review and any attached files.

If you choose “no”, your identity will remain anonymous but your review may still be made public.

Do you want your identity to be public for this peer review? For information about this choice, including consent withdrawal, please see our Privacy Policy.

Reviewer #3: No