PONE-D-22-15392Translation, Validation and Psychometric Evaluation of the Persian (Farsi) version of the QoLAF (Quality of Life in patients with Anal Fistula) questionnairePLOS 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 external reviewer and I have now evaluated the manuscript. There are major points to be addressed before taking a positive decision on it. You could find the comments below. Please submit your revised manuscript by Sep 24 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,

Zubing Mei, MD,Ph.D

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. Please include captions for your Supporting Information files at the end of your manuscript, and update any in-text citations to match accordingly. Please see our Supporting Information guidelines for more information: http://journals.plos.org/plosone/s/supporting-information.

[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: Partly

Reviewer #2: Yes

Reviewer #3: Yes

Reviewer #4: No

**********

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

Reviewer #1: Yes

Reviewer #2: Yes

Reviewer #3: Yes

Reviewer #4: No

**********

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

Reviewer #3: Yes

Reviewer #4: 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

Reviewer #2: Yes

Reviewer #3: Yes

Reviewer #4: 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: PLOS ONE – PONE-D-22-00013

Decision: Major revision

Thank you for the opportunity to review this manuscript. In my opinion, the manuscript has some major corrections to be made and my comments are done section by section:

Abstract

# The introduction is too long and abbreviation should be avoided as much as possible

# Number of distributed and retrieved questionnaire was not mentioned.

# How was the translation scientifically done

Introduction

# there is inconsistency of references in the text

# there is a missing gap of how this disease affects the men and women in your locality

# how do they react when they are infected

Materials and Methods

# ‘the study participants consisted of 60 patients over the age 18 who have recently been diagnosed with crytoglandular AF…..’ the age is not consistent with what is stated in the abstract. Please reconcile

# in convergent validity, is there no reference(s) to support your assertion?

# ‘a test-retest analysis was performed and participants were contacted after 7 to 21 days to fill out the questionnaire again’. Were the participants certified fit psychologically before filling the questionnaire and how was the certification done?

Results

# remove grid lines in all the tables

# incomplete sentence in the first paragraph of convergent validity, sensitivity and specificity

References

@ no 8 reference has no page number. Kindly check

Reviewer #2: Dear authors,

I had the chance to read your article entitled "Translation, Validation and Psychometric Evaluation of the Persian (Farsi) version of

the QoLAF (Quality of Life in patients with Anal Fistula) questionnaire." You have evaluated the reliability and validity of the Persian version of this questionnaire. The article is well-constructed, and the English used in the article seems appropriate in most parts. However, I have some concerns, which are listed below.

1. Page 4, line 60, 'have been seem to be' seems crowded. Please change the sentence accordingly.

2. Did you perform preliminary testing before constructing the final version of the questionnaire?

3. Please briefly clarify how the readers should interpret the values for Cronbach alpha, ICC, spearman's rho, etc.

4. How did you contact the patients after 7-21 days for a retest? By telephone, e-mail, or face-to-face?

5. I prefer seeing the means of retest scores in a separate table with the statistical results. I recommend you construct another table for this purpose.

6. In discussion, a paragraph containing the head-to-head comparison of reliability and validity scores of statistical analysis with the original questionnaire (e.g., Cronbach alpha scores, ICC scores) is necessary.

7. Doesn't your study have any limitations? Please add a limitations paragraph.

Reviewer #3: Dear Authors,

I want to appreciate you for drafting this manuscript. It was well written and needed for the population.

However, there is a need for adjustments to the manuscript's structure. Firstly, I will suggest the titled be changed to “Translation, Cross-cultural Adaptation, and Psychometric evaluation of the Persian (Farsi) version of the QoLAF (Quality of Life in patients with Anal Fistula) questionnaire. Secondly, the following should be noted in the abstract:

1. The study did not capture which specific translation process used. It should be mentioned if it was based on the WHO translation process or any other that was specifically followed. The assessment of the manuscript would be based on which specific guideline that was used.

2. The results section should briefly capture the translation, what was found during the cross-cultural adaptation (CCA) and major psychometrics like validity and reliability.

3. There are too many unnecessary results in the abstract.

Finally, the authors should be able to distinguish between the three parameters of cross-cultural adaptation of a tool and present their results separately; 1. Translation 2. Adaptation 3. Psychometric property testing.

A clear distinction should be made between translation, adaptation and cross-cultural

validation. The translation is the single process of producing a document from a source version

in the target language. Adaptation refers to the process of considering any differences

between the source and the target culture to maintain equivalence in meaning. This

adaptation is referred to CCA. The cross-cultural validation of a questionnaire is a different process from the CCA. Cross-cultural validation aims to ensure that the new questionnaire functions as intended, has the same properties as the original, and functions similarly.

Kindly note that no results of the adaptation were presented in the manuscript.

A clear distinction should be made between translation, adaptation and cross-cultural

validation. The translation is the single process of producing a document from a source version

in the target language. Adaptation refers to the process of considering any differences

between the source and the target culture to maintain equivalence in meaning. This

adaptation is referred to CCA. The cross-cultural validation of a questionnaire is different

process from the CCA. Cross-cultural validation aims to ensure that the new questionnaire

functions as intended and has the same properties as the original and functions in the same

way.

Reviewer #4: The authors conducted a cross-sectional study on translation, validation and psychometric evaluation of the Persian (Farsi) version of the QoLAF (Quality of Life in patients with Anal Fistula) questionnaire in a sample of patients with AF. The results showed that the Persian version of QoLAF is valid and reliable. However, there are some issues that the authors should be addressed before publication.

- Introduction:

o It would be nice if the authors more deeply refer to previous studies on outcomes of patients with AF.

o Are there available the other translated versions of the QoLAF?

- Methods

o The method section should be written in more details.

o Line 84: this is a validation study not the developmental one.

o Please describe that which international method was used for translation and validation process.

o In the method section, there is no information regarding the QoLAF. The authors should provide full description about the questionnaire including the number of items, number of domains (if any), and the scoring system.

o Please clarify that who the authors reached a sample size of 60 cases.

o The statistical analysis section should have sufficient information for reviewers and readers to be able to determine that the methodology is sound and valid for the planned analyses. This section also needs to provide information, such as a power analysis to support the accrual number request, which level of reliability and validity are clinically acceptable. The number of planned subjects to enroll should be adequate to provide sufficient data for validity and reliability results.

o Please provide the definition of content and convergent validities with supporting references. I strongly suggest the authors to read the following articles before revising the method section of this manuscript.

“Assessment of reliability and validity of the adapted Persian version

of the Spinal Appearance Questionnaire in adolescents with idiopathic

scoliosis. Spine Deform. 2022;10(2):317-26.”

“Guidelines for the process of cross-cultural adaptation of self-report measures.

Spine (Phila Pa 1976) 25(24):3186–3191”

“Quality criteria were proposed for measurement properties of health status questionnaires. J Clin Epidemiol 60(1):34–42”

o Line 125: what are the self-report scores?

o What was the sample size for test-retest reliability?

Results:

o Table 1: This table is not provided in a standard form.

o Line 155: Heading of “Consistency and reliability” should be written as “consistency and test-retest reliability”

- Discussion:

o In the last paragraph of the discussion section, please provide the study limitations.

**********

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: CHINEDU GODWIN UZOMBA

Reviewer #2: No

Reviewer #3: Yes: Prof Bashir Bello

Reviewer #4: 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.

Attachments

Attachment

Submitted filename: REVIEWER COMMENT ON CROSS-CULTURAL ADAPTATION.docx

Translation, Cross-cultural Adaptation, and Psychometric evaluation of the Persian (Farsi) version of the QoLAF (Quality of Life in patients with Anal Fistula) questionnaire

PONE-D-22-15392R1

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.

An invoice for payment will follow shortly after the formal acceptance. To ensure an efficient process, please log into Editorial Manager at http://www.editorialmanager.com/pone/, click the 'Update My Information' link at the top of the page, and double check that your user information is up-to-date. If you have any billing related questions, 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,

Zubing Mei, MD,Ph.D

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 #1: All comments have been addressed

Reviewer #2: All comments have been addressed

Reviewer #3: All comments have been addressed

Reviewer #4: 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 #1: (No Response)

Reviewer #2: Yes

Reviewer #3: Yes

Reviewer #4: Yes

**********

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

Reviewer #1: (No Response)

Reviewer #2: Yes

Reviewer #3: Yes

Reviewer #4: 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: (No Response)

Reviewer #2: Yes

Reviewer #3: Yes

Reviewer #4: 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: (No Response)

Reviewer #2: Yes

Reviewer #3: Yes

Reviewer #4: 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: MY SHORT COMMENT

I wish to express my happiness for the opportunity to review this manuscript the second time. I indeed went through it and was satisfied with the corrections from the authors. The outcome of the assessment is that the manuscript should be accepted for publication simply because it has met minimum standard for publishing in a reputable journal such as this.

Thank you

Reviewer #2: Dear Authors

Congratulations for your efforts. The manuscript is publishable in this form

Best Regards

Reviewer #3: The authors have satisfactorily addressed all my previous comments and the manuscript is now good to go.

Reviewer #4: The authors addressed all my previous comments and I have no comment on this revised version of the manuscript. Thank you.

**********

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: Yes: Chinedu Godwin Uzomba

Reviewer #2: Yes: Ozan Volkan Yurdakul

Reviewer #3: Yes: Prof Bashir Bello

Reviewer #4: No

**********

Attachments

Attachment

Submitted filename: PLOS ONE REVIEW.docx